Download JANUARY 1, 2015 TREATMENT AUTHORIZATION (TAR) CRITERIA

EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
ACTOS/INVOKANA
Drugs included in
TAR Group
• Pioglitazone
(ACTOS)
• Canaglifozin
(INVOKANA)
ADHD• dextroAMPHETAMINE TABS amphetamine IR
(DEXEDRINE,
ZENZEDI)
• dextroamphetamineamphetamine IR
(amphetamine salts
combination,
ADDERALL)
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Covered Use
For the treatment of type 2
diabetes mellitus in adults
(who have failed first line
alternatives).
Exclusion Criteria
For the treatment of
attention-deficit
hyperactivity disorder
(ADHD).
Pre-existing cardiac condition
including: Advanced
arteriosclerosis, symptomatic
CVD, moderate to severe
HTN. Other
contraindications:
hyperthyroidism, history of
drug abuse.
Required Medical
Age Restriction
Information
Lab reports which include
Adults only.
HgA1C drawn within the last
90 days.
Clinic notes documenting
Adderall: 3 and
previous use (doses,
older
duration, and clinical
Dexedrine: 3-16
evaluation) of both formulary
short-acting methylphenidate
and long-acting stimulants
(Adderall XR, Dexedrine SR,
Concerta, Metadate CD,
Ritalin LA--all of which
require a TAR for adults over
17). Psychiatric
consult/recommendation
may be required in cases of
high dose, high utilization (fill
frequency is greater than
indicated by SIG),
polypharmacy with other CNS
active medications.
Additional information may
be requested if prescription
profile indicates potential
contraindications.
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
Criteria waived if
TBD
prescribed by boardcertified
endocrinologist (state
credentials on TAR), or
if TAR accompanied by
consult/recommendati
on of Certified
Diabetic Educator.
Other Criteria
Limited to: (1) Prescribed by an endocrinologist,
or on recommendation of a Certified Diabetic
Educator, or (2) Trial and failure or
contraindication to metformin, insulin and a DPP4 inhibitor with a HgA1C 7.0- 9.0 in the last 90
days.
HK: Not FDA approved for use in ages under 18
(submit safety/efficacy pediatric studies for caseby-case review).
Ped: 1 year. Adult: 6 Pediatric use (3-16): Trial and failure of
mo
formulary methylphenidates (including longacting forms).Adults, ages 17 and older: Note
that studies are lacking in this age group.
Continuation of existing treatment prior to 17th
birthday is allowed, however transition to an
extended-release product will be recommended
if member is not already on such.
New starts age 17 and older: (1) Trial and failure
of formulary short-acting methylphenidate, (2)
Trial and failure of 2 long-acting stimulants, one
of which must be an amphetamine, (3)
attestation by prescriber that member is not at
risk for abuse or diversion.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
Drugs included in
TAR Group Name
TAR Group
ADHD-CENTRAL
• clonidine hcl ER tab
ACTING ADRENERGIC 12 hr (KAPVAY)
• guanfacine ER tab
24hr (INTUNIV)
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Covered Use
Exclusion Criteria
For the treatment of
attention-deficit
hyperactivity disorder
(ADHD) as monotherapy or as
adjunctive therapy to a
psychostimulant.
Required Medical
Age Restriction
Prescriber Restriction Coverage Duration
Information
Documentation (eg,
Ages 6-17yo. (FDA
TBD
prescriber notes, pharmacy approved ages).
profile) showing: An
adequate trial (minimum 14
days) of both immediate
release guanfacine and
immediate release clonidine,
AND an acceptable reason for
failure.
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Other Criteria
New start approval is limited to those requests
which include documentation (eg, prescriber
notes, pharmacy profile) showing: (1)An
adequate trial (minimum 14 days) of both
immediate release guanfacine and immediate
release clonidine, AND (2)An acceptable reason
for failure. An acceptable reason for failure
would be: (1)The medication works, but effect is
not long enough, AND either (A)significant
compliance issues exist after at least a 14 day
trial with using immediate release OR (B)the
member has a documented contraindication to
use of formulary CNS stimulants (eg, tics, sleep
problems, hx abuse, aggression). NOTES: (A)Lack
of effectiveness or side effect with one IR agent
should result in switching to a trial of the other
IR agent. (B)Sedation and somnolence are
expected side effects of both immediate and
extended-release guanfacine, and
sedation/somnolence alone is not justification
for bypassing the above approval criteria.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
ADHD-DAYTRANA
Drugs included in
TAR Group
• methylpheni- date
trans- dermal patch
(DAYTRANA)
ADHD-DEXEDRINE SR • dextroamphetCAPS
amine ER/SR caps
(DEXEDRINE
SPANSULE)
Covered Use
For the treatment of
attention-deficit
hyperactivity disorder
(ADHD) in children.
Dextroamphetamine
Extended release Capsules:
For the treatment of
attention-deficit
hyperactivity disorder
(ADHD)
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
Required Medical
Age Restriction
Information
Prescriber notes and/or
Member must be
pharmacy records
age 6-16
documenting previous
adequate trial with formulary
methylphenidate products
(minimum 14 days).
Prescriber notes and/or
pharmacy records
documenting previous
adequate trial with formulary
methylphenidate products
(minimum 14 days).
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
12 months
TBD
Other Criteria
Requests must document that member has had:
Adequate trial with unsatisfactory result with
both formulary methylphenidate IR and
formulary methylphenidate ER/Methylin
ER/Metadate ER (generic forms of Ritalin SR
tablets), such as being effective, but effect does
not last through the treatment period (wears off
too soon) and multiple daily doses cannot be
given, AND adequate trial and failure with
formulary long-acting methylphenidate products:
generic Ritalin LA, Concerta or Metadate CD.
NOTE: In the case of swallowing difficulties, trial
of sprinkling capsule contents on applesauce is
also required. Generic Ritalin LA and Metadate
CD can be sprinkled.
For Pediatric use, ages 4-17: Adequate trial of
formulary generic methylphenidate immediate
release, with Rx being effective but effect does
not last through the needed treatment period
(ie, wears off too soon). In addition, trial and
failure of formulary long-acting methylphenidate
agents (generic Ritalin LA, Concerta or Metadate
CD) and amphetamine, generic Adderall XR will
also be required. Adults, age 18 and older:
Documented evaluation of unacceptable side
effects, contraindication to or partial effect or no
effect after trial and failure to formulary
methylphenidate agents.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
ADHD-FOCALIN
Drugs included in
TAR Group
• dexmethylphenidate IR
(FOCALIN)
Covered Use
For the treatment of
attention-deficit
hyperactivity disorder
(ADHD) in children.
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
Pre-existing cardiac condition
including: Advanced
arteriosclerosis, symptomatic
CVD, moderate to severe
HTN. Other
contraindications:
hyperthyroidism, history of
drug abuse.
Required Medical
Age Restriction
Information
Clinic notes documenting
Member must be
previous use (doses,
age 6-16
duration, and clinical
evaluation) of both formulary
short-acting methylphenidate
and long-acting stimulants
(Adderall XR, Dexedrine SR,
Concerta, Metadate CD,
Ritalin LA). Additional
information may be
requested if other
prescription profile indicates
potential contraindications.
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
1 year with adequate
documentation
meeting criteria for
use
Other Criteria
Member must be age 6-16. Trial and failure with
formulary short-acting methylphenidate product
(generic Ritalin, Ritalin SR) AND a formulary longacting product (generic Ritalin LA, Concerta or
Metadate CD).
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
ADHD-FOCALIN XR
Drugs included in
TAR Group
• dexmethylphenidate ER
(FOCALIN XR)
Covered Use
For the treatment of
attention-deficit
hyperactivity disorder
(ADHD)
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
Required Medical
Age Restriction
Information
Prescriber notes and/or
pharmacy records
documenting previous
adequate trial with formulary
methylphenidate products
(minimum 14 days).
Prescriber Restriction Coverage Duration
TBD
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Other Criteria
Pediatric (Ages 4-17): Adequate trial with
unsatisfactory result with both formulary
methylphenidate IR and formulary
methylphenidate ER/Methylin ER/Metadate ER
(generic forms of Ritalin SR tablets), such as
being effective, but effect does not last through
the treatment period (wears off too soon) and
multiple daily doses cannot be given, AND
adequate trial and failure with formulary longacting methylphenidate products: generic Ritalin
LA, Concerta or Metadate CD.
Adult (18+): Adequate trial of formulary generic
methylphenidate ER/Metadate ER/Methylin ER
(generic Ritalin SR), with product being effective
but effect does not last through the needed
treatment period (ie, wears off too soon), OR
adequate trial with unsatisfactory result which is
a treatment failure due to no effect of the
following formulary and restricted formulary
medications: Formulary methylphenidate
ER/Methylin ER/Metadate ER (generic Ritalin SR)
and a long acting methylphenidate product (TAR
required for adults): methylphenidate ER
capsules (generic Ritalin LA) or methylphenidate
ER /OSM type tablets (generic Concerta) or
Metadate CD.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
ADHD-STRATTERA
Drugs included in
TAR Group
• atomoxetine
(STRATTERA)
Covered Use
For the treatment of
attention-deficit
hyperactivity disorder
(ADHD)
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
Required Medical
Age Restriction
Information
Prescriber notes and/or
pharmacy records
documenting previous
adequate trial with formulary
stimulant used in conjunction
with guanfacine (or
clonidine) OR notes
documenting
contraindications to
stimulant therapy, such as
history of stimulant
abuse/diversion by member
or family member residing in
the home.
Prescriber Restriction Coverage Duration
TBD
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Other Criteria
New Start approval is limited to those requests
which include documentation (eg, prescriber
notes, pharmacy profile) showing:
For Pediatric use (age less than 17): (1)
Adequate trial with unsatisfactory result with
guanfacine used in conjunction with stimulant.
(2) Stimulant trial must include formulary
methylphenidate and a subsequent trial of a long
acting formulary stimulant (generic Ritalin LA,
Concerta, Metadate CD, Adderall XR) after trial
and failure of formulary methylphenidate, OR (3)
Documentation is submitted showing history of
stimulant abuse/diversion by the patient or a
family member residing in the home.
Adult use (age 17 and older): (1)
Documentation of a history of abuse/diversion
by the patient, OR, (2) Adequate trial and
unsatisfactory result with formulary
methylphenidate, non-formulary
dextroamphetamine SR (Dexedrine Spansules),
mixed amphetamine salts XR (Adderall XR) AND
(3) Non-formulary Vyvanse (TAR required for
Adderall and Vyvanse, see these agents criteria
for use). Note: Approval is limited to once daily
dosing of a single strength -- round desired dose
to the nearest available milligram dose. Strattera
is available in 10, 18, 25, 40, 60, 80 and 100mg
capsules.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
ADHD-VYVANSE
ALDOSTERONE
RECEPTOR
ANTAGONISTS
(SARA).
Drugs included in
Covered Use
TAR Group
• lisdexamfet- amine For the treatment of
(VYVANSE)
attention-deficit
hyperactivity disorder
(ADHD)
• eplenerone
(INSPRA)
(1)hypertension, either as
monotherapy or in
combination with other
antihypertensive agents AND
(2)For the reduction of
cardiovascular mortality in
stable patients with left
ventricular systolic
dysfunction (ejection fraction
40% or leass) and clinical
evidence of heart failure
after an acute myocardial
infarction
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
Required Medical
Age Restriction
Information
Documentation (clinic notes
or pharmacy records)
demonstrating adequate trial
of formulary generic Adderall
XR AND a formulary longacting methylphenidate
product (eg, Concerta, Ritalin
LA, Metadate CD), OR
documentation in the
medical record of a need for
a product with lower abuse
potential is required due to a
history of stimulant
abuse/diversion by member
or family member residing in
the home.
Ages 0 through 20:
Subject to PHC CCS
screening and
referral for CCS
eligible conditions.
Not FDA approved
for pediatric use:
Submit safety and
efficacy clinical
studies for any
requests to be
reviewed on a caseby-case basis.
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
TBD
TBD
Other Criteria
Pediatric use (Ages 4-17): (1) History of abuse or
diversion in member or a family member, OR (2)
Adequate trial and unsatisfactory result with
formulary mixed amphetamine salts ER (generic
Adderall XR) AND (3) Adequate trial and
unsatisfactory result with formulary
methylphenidate products (generic Ritalin LA,
Concerta, Metadate CD).
Adults (Ages 18 and older): (1) History of abuse
or diversion in member or a family member, OR
(2) Adequate trial and unsatisfactory result with
formulary methylphenidate ER/Methylin
ER/Metadate ER (generic forms of Ritalin SR),
AND (3) Adequate trial and unsatisfactory result
with non-formulary dextroamphetamine SR
capsules (generic Dexedrine Spansules) or mixed
amphetamine salts ER (generic Adderall XR).
HTN: Documentation of trial and failure of
formulary antihypertensives.
CHF: Approved for post-MI use.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
ALZHEIMER'S
DISEASECHOLINESTERASE
INHIBITORS
Drugs included in
TAR Group
• galantamine
(RAZADYNE)
• rivastigmine
(EXELON)
Covered Use
For the treatment of
Alzeheimer's disease or
related dementia.
ALZHEIMER'S
• donepezil 23mg For the treatment of
Alzheimer's disease or
DISEASE- DONEPEZIL tab (ARICEPT)
23mg
related dementia.
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
Required Medical
Information
An updated MMSE or other
objective assessment tool is
required every 12 months.
An updated MMSE or other
objective assessment tool is
required every 12 months.
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Age Restriction
Prescriber Restriction Coverage Duration
Ages 0 through 20:
12 months
Subject to PHC CCS
screening and
referral for CCS
eligible conditions.
Not FDA approved
for pediatric use:
Submit safety and
efficacy clinical
studies for any
requests to be
reviewed on a caseby-case basis.
Other Criteria
Treatment of Alzheimer's Disease or related
dementia with a baseline MMSE score of
between 10 and 26 or evidence of Alzheimer's
Dementia with an alternate objective assessment
tool.
Not FDA approved
for pediatric use:
Submit clinical
safety and efficacy
studies for any
requests to be
reviewed on a caseby-case basis.
Treatment of Alzheimer's Disease or related
dementia with a baseline MMSE score of 3-14 or
evidence of Alzheimer's Dementia with an
alternate objective assessment tool, and trial and
failure of 10mg used for at least 3 months.
12 months
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
ALZHEIMER'S
DISEASE-NMDA
RECEPTORS
ANDROGENIC
AGENTSOXANDROLONE
Drugs included in
TAR Group
• memantine IR
(NAMENDA)
• oxandrolone
(NANDROLONE)
Covered Use
Mod-Sev. Alzheimer's
disease.
For the treatment of
cachexia, and as adjunct
therapy to promote weight
gain and protein anabolism
after weight loss following
extensive surgery, chronic
infections, or severe trauma,
after prolonged
administration of
corticosteroids, and in some
patients who without
definite pathophysiologic
reasons fail to gain or to
maintain normal weight.
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
Required Medical
Information
New Starts: Baseline and
current MMSE (or equivalent
assessment). Renewals: An
updated MMSE or other
assessment tool is required
every 12 months.
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Age Restriction
Prescriber Restriction Coverage Duration
Ages 0 through 20:
12 months
Subject to PHC CCS
screening and
referral for CCS
eligible conditions.
Not FDA approved
for pediatric use:
Submit safety and
efficacy clinical
studies for any
requests to be
reviewed on a caseby-case basis.
Height and weight from last 3 Ages 0 through 20:
clinic visits.
Subject to PHC CCS
screening and
referral for CCS
eligible conditions.
TBD
Other Criteria
A baseline MMSE score of between 3 and 14 or
evidence of Alzheimer's Dementia with an
alternate assessment tool is required. Treatment
of moderate to severe Alzheimer's Disease or
related dementia as single therapy or in
combination with an acetylcholinesterase
inhibitor.
Documentation of trial and failure with adequate
doses of megestrol.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
ANTIDEPRESANT OCD
ANTIDIABETICBIGUANIDES
SOLUTION
Drugs included in
TAR Group
• clomipramine
(ANAFRANIL)
• metformin oral
soln (RIOMET)
Covered Use
Obsessive compulsive
disorder uncontrolled with
first line agents.
For treatment of type 2
diabetes mellitus
uncontrolled by diet alone
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
Required Medical
Information
Continuing care requests
(from another plan):
pharmacy refill history or
clinic notes documenting
member history with the
medication.
Initial Rx: Documentation of
previous treatments and
responses. Reasons why
formulary alternatives for
OCD cannot be used.
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Age Restriction
Prescriber Restriction Coverage Duration
Ages 0-20: subject
TBD
to CCS review and
referral if the
behavioral health
status affects the
ability of member
or caregivers to
provide adequate
care for a CCS
approved
condition.
TBD
Other Criteria
New Starts: Member has been diagnosed by
specialist as having obsessive compulsive
disorder, and has failed adequate trial of or has
contraindications to formulary alternatives:
fluvoxamine, fluoxetine, paroxetine and
sertraline.
Continuing Care: For new or existing members
without significant claim history to show
continuation of care, TARs should include the
pharmacys refill history and/or clinic notes
documenting member history with the
medication. (Otherwise, if no evidence of
ongoing/consistent use, will be treated as a new
start). Even in cases of continuing care,
prescribers may be asked to consider formulary
options for therapy change.
Restricted to use in members with swallowing
difficulties and unable to use crushed tablets.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
ANTIINFECTIVE,
FURADANTIN
Drugs included in
TAR Group
• nitrofurantoin oral
soln. (FURADANTIN)
ANTIINFECTIVE, TCN • tetracycline oral
dosage forms
(SUMYCIN)
Covered Use
UTI (urinary tract infection)
treatment or suppression.
FDA and CDC recommended
uses when other antibiotics
are not appropriate (see
exclusions, other criteria).
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Required Medical
Exclusion Criteria
Age Restriction
Information
Infections other than urinary UTI diagnosis and workup,
tract infections (UTI).
including culture and
sensitivity reports. Member
medication allergies.
Failure to try other formulary
tetracyclines (both
doxycycline monohydrate
and minocycline) when
indicated. Lack of clinical
justification for TCN being
drug of choice when other
formulary oral antibiotics are
indicated and no
contraindications exist
(penicillins, sulfa,
cephalosporins and
macrolides). Culture and
sensitivity reports show
organism is resistant to
tetracycline.
Culture and Sensitivity lab
report, Patient Med Allergy
list if relevant, treatment
history for same infection
Ages 8 and older
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
Acute: 7-10 days.
Suppression: 3
months.
Other Criteria
Acute treatment: Limited to members with a
confirmed urinary tract infection diagnosis and
unable to use capsules (50-100mg), and
formulary antibiotics are not indicated based on
culture and sensitivities or member medication
allergy history. Suppression treatment: Limited
to members unable to use capsules,
documentation of failure or allergy to formulary
antibiotics and limited to 3 months of treatment
without further review. For renewals after 3
months: Include clinic notes documenting that
the benefits continue to outweigh the risks of
long-term nitrofurantoin treatment. Note:
Although rare, long-term use (over 6 months) is
associated with increased risk of potentially
serious and life-threatening pulmonary reactions.
Duration depends on Documentation of intolerance, allergy or
diagnosis and
insusceptibility to other formulary oral
treatment plan
antibiotics, 2 of which must be Minocycline and
Doxycycline Monohydrate. Penicillins, Sulfas,
Cephalosporins and Macrolides should all have
been considered, with one agent from each class
tried and failed, contraindicated or not indicated
for condition.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
ANTIINFECTIVEAMPHOTERICIN B
Drugs included in
TAR Group
• amphotericin B
liposome
(AMBISOME)
ANTIINFECTIVESCABICIDES
(NATROBA)
• spinosad
(NATROBA)
ANXIOLYTICS
• meprobamate
(EQUINIL, MILTOWN)
Covered Use
Exclusion Criteria
For the treatment of
aspergillosis in patients
refractory or intolerant to
conventional amphotericin B
therapy
• dronedarone
(MULTAQ)
Required Medical
Information
Clinic notes and or hospital
admit and discharge notes,
lab reports.
Age Restriction
Ages 0 through 20:
Subject to PHC CCS
screening and
referral for CCS
eligible conditions.
For the treatment of
pediculosis capitis (head lice
infestation) due to Pediculus
capitis
For the treatment of anxiety
APAP/SYMPATHOMI • isometh- dichloral- For the treatment of
METIC
APAP (MIDRIN,
Migraine and Tension
COMBINATIONS
MIGRAGESIC,
Headache.
NODOLOR)
• isomethephencaffeine- APAP
(PRODRIN)
ARRHYTHMIC
AGENTS
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
For reduction in the risk of
hospitalization for atrial
fibrillation in patients in sinus
rhythm with a history of
paroxysmal or persistent
atrial fibrillation (AF)
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
Infectious disease
TBD
consult may be
requested.
TBD
TBD
Documentation from medical Adults ages 18
record indicating previous
years and older
treatments tried and nature
of failure/contraindication.
Neurologists consultation
notes if member requires
more than 45 capsules per
month.
Ages 0 through 20:
Subject to PHC CCS
screening and
referral for CCS
eligible conditions.
Other Criteria
Trial and failure of Amphotericin B desoxycholate
or contraindication to use in patients with renal
impairment.
Documentation of trial and failure (or
contraindication) to Permethrin (Rx and OTC),
malathion (Ovide) and non-formulary benzyl
alcohol 5% (Ulesfia).
Trial and failure of buspirone, hydroxyzine or
failure with benzodiazepines.
3 MONTHS
Limited to members with contraindication or
history of prior use and documented failure with
formulary triptan (if migraine),
butalbital/caffeine w/ APAP or ASA (Fiorinal,
Fioricet) and NSAIDS. Requests exceeding
quantity #45 per month must be prescribed by a
neurologist and record must indicated member is
on an adequate prophylactic regimen as well.
TBD
Trial and failure or contraindication to
amiodarone.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
ASTHMA-IGE
BENLYSTA
Drugs included in
TAR Group
• omalizumab
(XOLAIR)
• belimumab
(BENLYSTA)
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Covered Use
Exclusion Criteria
For the prophylaxis of asthma
exacerbations and control of
symptoms of moderate to
severe persistent asthma that
is not controlled with inhaled
corticosteroids in patients
who have a positive skin test
or in vitro reactivity to a
perennial aeroallergen
For the treatment of active,
autoantibody-positive,
systemic lupus
erythematosus (SLE) in
combination with standard
therapy
Required Medical
Age Restriction
Information
Allergy or pulmonary clinic
members 12 years
notes, skin prick or RAST test of age and older
results
Required lab reports: CBC,
Creatinine, Sed Rate, Anti-DS
DNA, Complement (C3 and
C4). In the event that lab
results do not support the
diagnosis of active disease,
an in-office second opinion is
required. Requested dose
does not exceed the FDA
approved dose and frequency
per manufacturers labeling.
SELENA-SLEDAI score greater
than or equal to 6
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
Must be prescribed by TBD
an allergy or
pulmonary medicine
specialist
6 MONTHS
Other Criteria
Treatment of moderate to severe allergy related
asthma inadequately controlled with high-dose
inhaled corticosteroid in combination with a 2nd
asthma controller (LA beta-agonist or leukotriene
modifier) for at least 3 months. Must be
prescribed by an allergy or pulmonary medicine
specialist and member must have a documented
positive skin prick or RAST test to a perennial
aeroallergen.
Approval is limited to those requests for adult
members with SLE, which document: Active,
Antibody positive musculo-skeletal or cutaneous
systemic lupus erythematosus Member does not
have severe active lupus nephritis Member does
not have severe active CNS lupus Member is
currently receiving standard therapy such as
NSAIDs, corticosteroids, antimalarials(eg,
chloroquine, hydroxychloroquine) or
immunosuppressives (eg, cyclophosphamide,
azathioprine, mycophenolate or methotrexate),
and requires the equivalent of at least 10mg
prednisone per day in combination with either
azathioprine or mycophenolate. Treatment will
not be in combination with other biologics, nor in
combination with IV cyclophosphamideApproval
duration is limited to 6 months, with clinical
reassessment prior to renewal request. Renewals
are limited to those which document
improvement, including a 4 point reduction in
SELEN-SLEDAI from baseline.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
Drugs included in
TAR Group Name
TAR Group
BETA-3 ADRENERGIC • mirabegron
RECEPTOR AGONIST (MYRBETRIQ)
Covered Use
Exclusion Criteria
For the treatment of patients
with overactive bladder
(OAB) with symptoms of urge
urinary incontinence,
urgency, and urinary
frequency
BETA-AGONIST LONG • formoterol aerolizer COPD bronchospasm,
ACTING(FORADIL)
maintenance treatment.
RESPIRATORY
• salmeterol dpi
(SEREVENT)
BETA-AGONIST
SHORT ACTINGRESPIRATORY
• levalburerol HFA
(XOPENEX HFA)
BETA-AGONIST
SHORT ACTINGRESPIRATORY
NEBULIZER
SOLUTION
• levalbuterol hcl
nebulizer solution
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Levalbuterol HFA (Xopenex
HFA): Asthma rescue (acute)
treatment for acute
brnochospams.
Asthma rescue (acute)
treatment for acute
bronchospams.
Required Medical
Information
Asthma treatment, without
the use of inhaled
corticosteroid.
Age Restriction
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
TBD
Other Criteria
Requires documentation of trial and failure with
(or contraindications to) formulary/Step
oxybutynin ER or formulary/Step oxybutynin OTC
patch, formulary tolterodine LA (TAR required if
age less than 65) and preferred non-formulary
agent fesoterodine (Toviaz). Allow for members
with contraindications to anticholinergics (eg,
narrow angle glaucoma).
12 months
COPD: No additional criteria required other than
documented diagnosis. Asthma: Use only as
additional therapy when patient not adequately
controlled on long term asthma control with an
inhaled corticosteroid. If request is for patient on
inhaled corticosteroid, use of formulary
Symbicort or Dulera should be initially
considered.
Clinical documentation of
failure/intolerance to
Ventolin HFA with a spacer.
12 months
Limited to rescue treatment in members with
asthma.
Clinical documentation of
failure/intolerance to
Ventolin HFA with a spacer,
albuterol nebulizer and
failure with non-formulary
levalbuterol (Xopenex HFA)
with spacer. Provider may be
requested to consider side
effect management such as
vial trial of albuterol
nebulizer solution.
12 months
Limited to rescue treatment in members with
asthma.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
BETA-AGONIST/
CORTICOSTEROID
COMBINATIONSRESPIRATORY
Drugs included in
TAR Group
• fluticasone/
salmeterol dpi
(ADVAIR DISKUS)
• fluticasone/
salmeterol hfa
(ADVAIR HFA)
Covered Use
Limited to the treatment of
confirmed diagnosis of either
Asthma or COPD that has not
responded to formulary
alternatives.
BILE ACID
SEQUESTRANTS
• colestipol
(COLESTID)
• colesevelam
(WELCHOL)
For the treatment of primary
hypercholesterolemia
BIOLOGICS FOR RA
• anakinra (KINERET) For the treatment of
• abetacept
moderate to severe
(ORENCIA)
rheumatoid arthritis.
• infliximab
(REMICADE)
• golimumab
(SIMPONI, SIMPONI
ARIA)
BISPHOSPHONATES
• ibandronate oral Treatment or prevention of
(BONIVA tablets) post-menopausal
Osteoporosis
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
Treatment of respiratory
symptoms due to illness
other than Asthma or COPD
Required Medical
Information
Clinic notes which document:
(1) adequate trial of
formulary alternatives (see
""Other Criteria""), (2) that
the member has adhered to
the treatment plan and
demonstrated appropriate
use of the device, (3)
spirometry results and (4)
symptom assessment.
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Age Restriction
Prescriber Restriction Coverage Duration
Ages under 21 will
TBD
be screened for
CCS eligibility and
referral when
appropriate. For
members under 21
already enrolled in
CCS for a chronic
respiratory
condition, CCS is
primary in all
counties except
Marin, Napa,
Solano and Yolo.
Other Criteria
Requires adequate trial and failure with both
formulary/STEP agents Dulera and Symbicort.
Note the Step requirements for Dulera and
Symbicort: Prior use of inhaled corticosteroid
without long-acting beta-agonist), clinic notes
(see required Medical Information) and
spirometry results.
Documentation of failure or
contraindication to
cholestyramine powder
(labs).
TBD
Limited to those who have tried and failed
formulary cholestyramine powder (generic
Questran, Questran Light).
Disease Activity Score, lab
For members 18
reports, imaging reports and yrs or older
clinic notes as needed to
document severity, disease
activity/progression or
otherwise support medical
necessity.
TBD
Trial and failure of at least 3 month trials of
Enbrel and Humira (anti-TNF therapies) and
Xeljanz (JAK inhibitor).
TBD
Limited to use in postmenopausal women (the
only FDA approved indication), who have tried
and failed (or have contraindications to)
formulary alendronate.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
Drugs included in
TAR Group Name
Covered Use
TAR Group
BISPHOSPHONATES- • risedronate DR
Osteoporosis
ATELVIA/BINOSTO
(ATELVIA)
• alendronate
effervescent
(BINOSTO)
• ibandronate
prefilled syringes
(BONIVA INJECTION)
BISPHOSPHONATES- • zolendronic acid
RECLAST
5mg/100ml infusion
(RECLAST)
Osteoporosis
BISPHOSPHONATES- • Risedronate tabs
ACTONEL
(ACTONEL)
For the treatment and
prevention of osteoporosis in
postmenopausal women,
men with osteoporosis, men
and women with
glucocorticoid-induced
osteoporosis, and Pagets
disease.
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
Required Medical
Information
Requires BMD T-score of
-2.5 or below.
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Age Restriction
Prescriber Restriction Coverage Duration
Not FDA approved
TBD
for pediatric use
Other Criteria
Limited to the treatment and prevention of
osteoporosis in postmenopausal women, men
with osteoporosis, men and women with
glucocorticoid-induced osteoporosis, and Pagets
disease. Member must have tried and failed (or
have contraindications to) formulary alendronate
and non-formulary-preferred oral ibandronate
(generic Boniva, TAR required).
Not FDA approved
for pediatric use
TBD
Limited to the treatment and prevention of
osteoporosis in postmenopausal women, men
with osteoporosis, glucocorticoid induced
osteoporosis and Pagets disease. Requires BMD
T-score of -2.5 or below. Member must have
tried and failed (or have contraindications to)
formulary alendronate and non-formularypreferred oral ibandronate (generic Boniva, TAR
required).
TBD
Limited to the treatment and prevention of
osteoporosis in postmenopausal women, men
with osteoporosis, men and women with
glucocorticoid-induced osteoporosis, and Pagets
disease. Member must have tried and failed (or
have contraindications to) formulary alendronate
and non-formulary-preferred oral ibandronate
(generic Boniva, TAR required).
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
BLOOD GLUCOSEMONITORS, STRIPS
BOTILINUM TOXIN
TYPE A-BOTOX
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Drugs included in
TAR Group
• non-formulary DM
test strips
• non-formulary DM
test machines, kits
Note: Non-formulary
includes any
manufacturer other
than Abbott
Diagnostic products
(ie, other than
Freestyle, Freestyle
Lite, Freestyle
Freedom, InsulLinx,
Precision X-tra &
Optium).
Required Medical
Covered Use
Exclusion Criteria
Information
As an aid to disease
Long-term care DM screening
management for patients
orders (use house supply).
diagnosed with diabetes,
requiring regular and ongoing
testing to monitor blood
sugar.
• onabotulinumtoxin A (BOTOX)
As stated in Criteria
Age Restriction
Non-medical use (cosmetic). Clinic notes documenting
See criteria
responses to first/second line
treatments tried and failed.
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
TBD
Other Criteria
Trial and failure of preferred system (Freestyle,
etc by Abbott) with medical justification why
preferred system cannot be used. Non-formulary
authorizations are limited to the same quantity
restrictions as formulary: twice daily testing for
members not on insulin, 4 times daily testing for
members on insulin. Note: Testing limits are
waived if TAR is for gestational DM or for
diabetic members who become pregnant. For
skilled nursing facility members: requests for
less than one time daily use as evidence by TAR,
refill history and or physician orders are not a
covered benefit (use house supply for screening
requirements).
Specialist in the field,
depending on
diagnosis
(dermatology,
neurology,
ophthalmology)
Treatment of: (1) Upper limb spasticity in adults,
(2) Cervical dystonia in adults to reduce the
severity of abnormal head position and neck
pain, (3) Severe axillary hyperhidrosis,
inadequately managed by topical agents, (4)
Blepharospasm with dystonia in patients over 12
yrs of age, (5) Strabismus in patients over 12 yrs,
(6) Prophylaxis of headaches in adults with
chronic migraine (15 or more per mo. and lasting
4 hrs or more). In addition, HA treatment
requires: (a) Request must be from neurology,
(b) Trial and failure of at least 2 formulary
agents: TCA, beta-blocker, valproate or calcium
channel blocker.
TBD
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
BPH-CIALIS
Drugs included in
TAR Group
• tadalafil 5mg
tablets (CIALIS
5mg)
Covered Use
For the treatment of the
signs and symptoms of
benign prostatic hyperplasia
(BPH)--limited to 5mg dose
only
BRILINTA
• ticagrelor tablets
(BRILINTA)
For arterial
thromboembolism
prophylaxis in patients with
acute coronary syndrome
(ACS-unstable angina, acute
myocardial infarction),
including in patients
undergoing percutaneous
coronary intervention (PCI)
CALCIMIMETICSENSIPAR
• cinacalcet tablets
(SENSIPAR)
For the treatment of
hyperparathyroidism AND For
the treatment of
hypercalcemia in patients
with parathyroid carcinoma
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Required Medical
Exclusion Criteria
Information
Note: This drug is not
Urologist consult
covered for the treatment of
impotence or erectile
dysfunction, per Federal
Regulation and State
Operating Instruction letter
as of 1/1/06. It is a violation
of Federal and State
regulations to submit
requests for BPH treatment if
in fact the patient is being
treated for impotence/ED.
Recent relevant lab reports
Age Restriction
Adults
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
Prescribed by or on
TBD
recommendation of a
urologist.
Other Criteria
Limited to: (1) 5mg dose only, (2) The treatment
of benign prostatic hyperplasia (BPH), (3)
Previous treatment failure following adequate
trials with alpha blocker (doxazosin, terazosin or
alfuzosin) and tamsulosin, alone AND in
combination with formulary finasteride, (4)
Member has been evaluated by an urologist.
TBD
Trial and failure of (or contraindication to)
formulary clopidogrel or prasugrel. Must meet
FDA approved recommendation for use, which is
to reduce the rate of thrombotic cardiovascular
events in patients with acute coronary syndrome
(ACS-including unstable angina, non ST elevation
MI or ST elevation MI)
TBD
Criteria includes: (1)For dialysis members with
uncontrolled severe secondary
hyperparathyroidism despite maximal doses of
vitamin D sterols who are either not candidates
for parathyroidectomy, or who have failed
parathyroidectomy. (2)For dialysis members with
persistent hypercalcemia on vitamin D sterol and
off all calcium-containing products and on low
calcium dialysate or (3)For members with
parathyroid cancer.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
CALCIUM
REGULATORPARATHYROID
HORMONES
Drugs included in
TAR Group
• teriparatide SQ
injection (FORTEO
prefilled pen)
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Covered Use
Exclusion Criteria
Treatment of postmenopausal female with
history of osteoporosis with
high risk for fracture. Male
with primary or hypogonadal
osteoporosis with high risk
for fracture.
Required Medical
Information
Age Restriction
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
Other Criteria
1 year per TAR, with 1 Trial and failure of oral formulary
renewal; maximum
bisphosphonate alendronate (Fosamax) required.
recommended
treatment duration is
2 years for lifetime.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
CANNABINOIDS
Drugs included in
TAR Group
• dronabinol
(MARINOL)
CHELATING AGENTSYPRINE
• trientine hcl
(SYPRINE)
Covered Use
Treatment of anorexia
associated weight loss for
members with HIV/AIDS OR
Treatment of
nausea/vomiting in members
with HIV/AIDS (to improve
tolerance to antiretroviral
treatment) OR Treatment of
nausea/vomiting in members
undergoing cancer
chemotherapy.
For the treatment of Wilsons
disease (hepatolenticular
degeneration)
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
Including but not limited to:
(1) Non-FDA approved uses,
such as analgesia, nausea
secondary to opioid
analgesics, or doses
exceeding the FDA approved
dosing in the package
labeling, (2) those who are
underweight as their normal
baseline (constitutionally thin
individuals) and (4) HIV
members refusing
antiretroviral treatment.
Required Medical
Age Restriction
Information
TAR should included baseline Adult use only.
and current height and
weight and labs relevant to
nutritional status (albumin,
CBC). If weight loss is
sudden, indicate percentage
lost in the last 30 days and
provide the last 3 clinic
weights with dates. Include
clinic notes documenting
responses to formulary
alternatives. For HIV/AIDS
patients, viral load is also
required.
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
6 months
TBD
Other Criteria
For Anorexia: Limited to members with a BMI of 18.0
or less, OR BMI greater than 18.0 but less than or
equal to 22 with documented rapid weight loss,
defined as weight loss of 10% or more in a one month
period. Requires documentation that member is
unresponsive to megestrol suspension and his/her
HIV is under control, that is, weight loss has continued
despite (a) therapeutic doses of megestrol and (b)
ARV (antiretroviral) treatment with undetectable viral
load/stable HIV status. Must also document that
weight loss is not due to other remediable causes
such as malabsorption or hypogonadism. Members
refusing antiretroviral treatment are not eligible for
dronabinol based on weight loss. 6 month trial
required, with reevaluation prior to continuation.
RENEWALS: Discontinue if BMI is within normal
range, unless there are other signs of malnutrition
such as low albumin. If no response at 6 months (BMI
unchanged), request RD consult.
For nausea & vomiting: Members undergoing cancer
chemotherapy PHC requires trial and failure with
conventional antiemetic treatment, including
formulary promethazine, prochlorperazine,
ondansetron (Zofran), aprepitant (Emend) and nonformulary granisetron (Kytril).Members with HIV PHC requires trial and failure with formulary
antiemetics (ondansetron, promethazine,
prochlorperazine) as well as regimen adjustments as
appropriate when nausea and vomiting is drug
induced (such as opioid induced).
Trial and failure of penicillamine.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
CIMZIA
Drugs included in
TAR Group
• certolizumab
(CIMZIA)
COLCHICINE (Colcrys) • colchicine
(COLCRYS)
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Covered Use
Exclusion Criteria
For the treatment of
moderately to severely active
rheumatoid arthritis and for
the treatment of Crohn's
disease
Familial Mediterranean
Fever, Acute Gout, Chronic
Gout
Required Medical
Age Restriction
Information
Specialists clinic notes
documenting disease course,
previous therapies tried and
responses, current evaluation
(lab and imaging reports as
appropriate), treatment plan.
RA: Include Disease Activity
Score.
Familial Mediterranean
Fever: Confirmed diagnosis
(submit clinic work-up).
Acute Gout: Documented
contraindications to NSAIDS,
or documentation of prior
use and reason for failure
with NSAIDS. Chronic Gout:
Documentation of
contraindication or reasons
for failure with probenecid,
colchicine/probenecid
(Colbenemid) AND
allopurinol.
Claims of CRF/CKD: include
EGFR. Requests for
maintenance with 2 tabs per
day require clinic notes
assessing member response
and number of outbreaks
with compliant 1 tablet per
day dosing.
Ages under 21 will
be screened for
CCS eligibility and
referral when
appropriate. For
members under 21
already enrolled in
CCS for a chronic
respiratory
condition, CCS is
primary in all
counties except
Marin, Napa,
Solano and Yolo.
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
Appropriate specialist TBD
TBD
Other Criteria
RHEUMATOID ATHRITIS: Enbrel and Humira are
the preferred anti-TNF agents. Trial and failure
of at least 3 month trials of Enbrel, Humira (antiTNF therapies) and Xeljanz (JAK inhibitor).
Requires Disease Activity Score. Crohn's
DISEASE: Evaluation by appropriate specialist
with inadequate response to conventional
therapy. Adalimumab (Humira) is the preferred
anti-TNF agent.
Familial Mediterranean Fever: Approved for up
to a maximum dose of 4 tablets per day Acute
Gout: Approved for the following recommended
dosage: 2 tablets at first sign of gout, followed
by 1 tablet 1 hour later (3 tablets per acute
attack). Limited to 9 tablets per month (covering
3 attacks per month), unless medical history
demonstrates a higher frequency of attacks.
Chronic Gout: Limited to once daily dosing.
Requests for maintenance with 2 tabs per day
require clinic notes assessing member response
and number of outbreaks with compliant 1 tablet
per day dosing.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
COLON ANTIINFLAMMATORY/
SALICYLATE
CORTICOTROPINACTHAR GEL
Drugs included in
TAR Group
• balsalazide
disodium (GIAZO)
• repository
corticotropin gel
injection (H.P.
ACTHAR GEL)
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Covered Use
Exclusion Criteria
Balsalazide (Giazo):
(1)Lack of evidence of active
Treatment of mildly to
disease. (2)Female
moderately active ulcerative
colitis in male patients 18
years of age and older.
For adrenocortical
insufficiency diagnosis, or for
situations considered
responsive to corticosteroiid
treatment per the FDA
approved indications, when
corticosteroids have failed.
Required Medical
Age Restriction
Prescriber Restriction Coverage Duration
Information
GI specialists notes providing 18 years and older GI
8 weeks
documentation of disease
history & current status,
previous treatments used
and patients response to
treatment(s). Renewal
requests require clinic note
indicating current disease
activity.
Diagnostic use: submit TAR
to PHC Utilization
Management department.
Treatment use: Submit clinic
notes which include details of
the clinical course, specific
responses to prior
treatments, current
treatment plan, other
possible treatment options,
all specialist consult notes.
Appropriate specialist TBD
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Other Criteria
Limited to the short-term treatment of active
ulcerative colitis in male members, with a
documented history of failure to formulary
balsalazide 750mg (Colazal) and formulary
mesalamine (Delzicol). Must be prescribed by or
recommended by a GI specialist. Renewals
dependent upon current active disease state, as
product is not indicated for maintenance.
Diagnostic testing use: Trial and failure of
cosyntropin. Treatment of clnicial situations
responsive to corticosteroids require trial and
failure to formulary corticosteroids (e.g.,
cortisone, hydrocortisone, dexamethasone or
prednisone).
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
CUBICIN
Drugs included in
TAR Group
• daptomycin
lypholized powder
sdv (CUBICIN
INJECTION)
Covered Use
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
FDA and CDC recommended
Prescribing for Pneumonia,
uses when other antibiotics are left-sided infective
not appropriate (see exclusions, endocarditis or infections in
other criteria). FDA indications: which IV treatment is not
Complicated skin and skin
indicated.
structure infections:
Complicated skin and skin
structure infections (cSSSI)
caused by susceptible isolates of
the following Gram-positive
bacteria: Staphylococcus aureus
(including methicillin-resistant
isolates), Streptococcus
pyogenes, Streptococcus
agalactiae, Streptococcus
dysgalactiae subsp. equisimilis,
and Enterococcus faecalis
(vancomycin-susceptible
isolates only). Bacteremia:
Staphylococcus aureus
bloodstream infections
(bacteremia), including those
with right-sided infective
endocarditis, caused by
methicillin-susceptible and
methicillin-resistant isolates.
Required Medical
Information
Culture and Sensitivity lab
report(s), Patient Med Allergy
list if relevant, treatment
history for same infection,
clinic notes (or hospital admit
and discharge) with
assessment and plan
Age Restriction
Prescriber Restriction
Ages under 21 may
require CCS
screening and
referral, if
pharmacy is not
able to bill CCS
with a SAR (applies
to all counties
except Marin,
Napa, Solano and
Yolo).
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Coverage Duration
Duration depends on
diagnosis and
treatment plan
Other Criteria
Medi-Cal: Complicated skin and skin structure
infections: Documentation of trial and failure (or
contraindication) to oral antibiotics appropriate
to treat condition. Formulary oral antibiotics
which may be useful for cellulitis include:
Doxycycline Monohydrate, Minocycline,
SMZ/TPM (Septra DS), Erythromycin, Penicillins
and Cephalosporins. Culture and Sensitivity
reports must be provided when appropriate.
MRSA when IV treatment is indicated: Failure
with vancomycin. An Infectious Disease consult
may be required.Healthy Kids: As above, and in
addition, case is reviewed for CCS eligibility and
referral initiated if appropriate, or provider is
redirected to CCS billing if SAR coverage is
already present.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
CYMBALTA
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Drugs included in
Covered Use
Exclusion Criteria
TAR Group
• duloxetine capsules For the treatment of:
(CYMBALTA)
(1)major depression, (2)pain
associated with diabetic
neuropathy or fibromyalgia,
(3)chronic musculoskeletal
pain (e.g., chronic low back
pain and chronic pain due to
osteoarthritis).
DENAVIR
• penciclovir
(DENAVIR)
Recurrent Herpes labialis
(cold sores)
DERMATOLOGICALDM ULCER
• becaplemin gel
(REGRANEX)
For the treatment of lower
extremity diabetic
neuropathic ulcers (e.g.,
diabetic foot ulcer) that
extend into the
subcutaneous tissue or
beyond and have an
adequate blood supply to
support healing.
Required Medical
Age Restriction
Information
DEPRESSION Continuing Care:
For new member without
significant claim history to
show continuation of care,
TARs should include refill
history from pharmacy
and/or clinic notes
documenting members
history with the medication.
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
TBD
12 months
Clinic notes with care plan.
Wound care specialist TBD
(including DPM)
Other Criteria
New Starts, limited to treatment of:
(1)DEPRESSION: Prior authorization is considered
for members in whom multi-drug resistance is
apparent following failure with multiple
therapeutic trials: Must have failure to remission
with 4 prior agents (SSRI, SNRI, Mirtazapine,
Venlafaxine, Bupropion, MAO-I (carve-out), alone
and/or in combination, also adjunctive cognitive
therapy, consideration of Lithium, T3,
aripiprazole (carve-out). A Psychiatric Consult is
required for re-evaluation of diagnosis.
Submission of PHQ9 Score is required: Prior
Authorization allowed with psychiatrist
confirmation of diagnosis and PHQ9 greater than
14. Prior Authorization allowed for nonpsychiatrist if psychiatrist is not available for
consult and PHQ9 geater than 20 and other
criteria have been met. (2)DIABETIC
NEUROPATHY OR FIBROMYALGIA: For members
who have tried and failed gabapentin AND
tricyclic antidepressants. (3) CHRONIC
Requires documentation of previous trial and
failure of (or contraindication to) a formulary oral
antiviral agent which is indicated for herpes
labialis (cold sores): famciclovir, valacyclovir.
Treatment of lower-extremity diabetic
neuropathic ulcers that extend into the
subcutaneous tissue or beyond and have an
adequate blood supply, in addition to
debridement, pressure relief, and infection
control.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
DESMOPRESSIN
NASAL SPRAYS
DOXYCYCLINEPERIOSTAT 20MG
Drugs included in
TAR Group
• desmopressin
0.01mg/spray
(DDAVP SPRAY)
• desmopressin
0.1mg/ml solution
(DDAVP RHINAL
TUBE)
• desmopressin
0.15mg/spray
(STIMATE)
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Covered Use
Exclusion Criteria
DDAVP generic spray, rhinal Diagnosis of Bedwetting or
tube(soln)--For the
Primary Nocturnal Enuresis
management of patients with
Central Cranial Diabetes
Insipidus. STIMATE--For
bleeding prophylaxis (e.g.,
surgical bleeding) in patients
with hemophilia A or mild to
moderate von Willebrand
disease (vWd) type 1 with
factor VIII activity greater
than 5%.
• doxycycline hyclate Adjunct therapy to scaling
20mg (PERIOSTAT)
and root planing for adults
with periodontitis.
Required Medical
Information
Verified diagnosis of either
CENTRAL CRANIAL DIABETES
INSIPIDUS (for DDAVP
product) or for VON
WILLEBRAND DISEASE (for
Stimate) or for HEMOPHILIA
A (for Stimate).
NOTE: DDAVP nasal products
are no longer recommended
by the FDA for the treatment
of primary nocturnal
enuresis.
Treatment plan, expected
end date, schedule of
planned procedure visits
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Age Restriction
Prescriber Restriction Coverage Duration
0-20: Ages under
TBD
21 will be
screened for CCS
eligibility, with
referral when
appropriate. For
members under 21
already enrolled in
CCS, claims are
submitted to CCS
in all counties
except Marin,
Napa, Solano and
Yolo.
Over 18
DDS, DMD
Other Criteria
DDAVP Nasal Spray (0.01mg/spray) and DDAVP
Rhinal Tube (0.1mg/ml solution) are approved
for the indication of central cranial diabetes
insipidus.
STIMATE Nasal Spray (0.15mg/spray) is approved
soley for the indication of hemophilia A and Von
Willebrand disease.
TBD
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
ENBREL
Drugs included in
TAR Group
• Eternacept kit,
syringes (ENBREL)
Covered Use
Rheumatoid Arthritis,
Psoriasis
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
Required Medical
Information
Specialists clinic notes
documenting disease course,
previous therapies tried and
responses, current evaluation
(lab and imaging reports as
appropriate), treatment plan.
RA (Rheumatoid Arthritis):
Include Disease Activity
Score.
Age Restriction
Ages 0 through 20:
Subject to PHC CCS
screening and
referral for CCS
eligible conditions.
Prescriber Restriction Coverage Duration
Rheumatologist, or
TBD
Dermatologist for
plaque psoriasis.
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Other Criteria
RHEUMATOID ARTHRITIS: Formulary oral
DMARDS: Methotrexate, Leflunomide,
Sulfasalazine, Hydroxchloroquine. New Starts,
for members with RA who have inadequate
response (disease progression to or remains at
mod-high activity level) to TRIPLE combination
therapy with formulary oral DMARDs (minimum
3 month trial) in the following situations: (1)
New RA diagnosis, less than 6 months, but with
High Disease Activity with or without poor
prognostic factor(s) (2) New RA diagnosis, less
than 6 months, with moderate disease activity
but with poor prognostic factors (3) RA with
current Mod-High disease activity but initially
diagnosed and treated less than 6 months ago
for low, moderate or high disease activity and
without poor prognostic factors (4) RA for more
than 6 months with low disease activity with
poor prognostic factors and (5) RA for more than
6 months with mod-high disease activity, with or
without poor prognostic factors. PLAQUE
PSORIASIS: Limited to members with (1)
Involvement of greater than 10% of body surface
area (2)Evaluation by an appropriate specialist
and (3) Trial and failure with at least 3 formulary
plaque psoriasis therapies. Note: Request must
follow FDA approved dosing of 50mg twice
weekly for 3 months followed by a reduction to a
maintenance dose of 50mg/week.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
ENTERAL
NUTRITIONAL
Drugs included in
TAR Group
All enteral nutrition
products (eg,
ENSURE, GLUCERNA,
JEVITY, NEOCATE,
PEDIASURE)
Covered Use
Standard (intact
macronutrients): Medically
necessary nutritional therapy
when regular foods cannot
support needs, as outlined in
PHC Policy.
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
Enteral nutrition products
used orally as a convenient
alternative to preparing and
/or consuming regular solid
or pureed foods.
Required Medical
Age Restriction
Information
Documented medical
None
diagnosis, nutritional
evaluation notes with clinical
indicators supporting
nutritional risk, BMI, wt , diet
status, dated within 3 month
of TAR submission, and for
children include growth
charts.
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
None
Up to 31 day supply
per Rx fill. TAR auth
duration determined
on case-by-case basis
per PHC policy
Other Criteria
FOR ORAL (1)Medical diagnosis - Severe Swallowing
or chewing difficulty due to cancer (mouth, throat,
esophagus), injury (head or neck), chronic
neurological disorders, and severe craniofacial
anomalies. (2)Documented medical diagnosis AND
inability to meet nutritional needs with dietary
adjustment of regular or altered-consistency (soft or
pureed) foods. a)documented nutritional risk.
b)anthropometric measures (for adults 21 years and
older) one of these: 1)involuntary wt loss 10 percent
/6 months. 2)involuntary wt loss 7.5 percent/3
months. 3)involuntary wt loss 5 percent/1 month.
4)BMI less than 18.5kg/m2. (3)Documented chronic
diagnostic condition and inability to meet nutritional
needs with dietary adjustment of regular or alteredconsistency (soft or pureed foods) and documented
clinical indicators must be identified and support
patient is nutritionally at risk. (4)Transitioning from
TPN to enteral feeding to an oral diet. (5)Children
under 21 years of age-documented clinical signs and
symptoms: a)Anthropometric status indicators
(stunting, wasting or underweight) of nutritional risk.
b)Standard and modified growth charts to document
nutritional need and patient deficiency. FOR TUBE
FEEDING (no change)Treatment for members with a
functioning gastrointestinal tract who, due to
pathology or nonfunction of the structures that
normally permit food to reach the digestive tract,
requires tube feedings to provide sufficient nutrients
to maintain weight and strength commensurate with
the members general condition. LTC/SNF residents:
OTC products are not a covered benefit.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
ENZYME-XIAFLEX
ERYTHROPOETINSEPOGEN AND
PROCRIT
Drugs included in
TAR Group
• clooagenase
clostridium
histolyticum injection
(XIAFLEX)
• epoetin alpha
(EPOGEN, PROCRIT)
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Covered Use
Exclusion Criteria
For the treatment of
Dupuytrens contracture with
a palpable cord
For the treatment of anemia
secondary to Chronic Kidney
Disease (CKD), malignancy,
chemotherapy,
myelodysplastic disease, antiretroviral therapy for HIV
infected patients, antiHepatitis-C treatment
(ribavirin). Also for
increasing blood count prior
to elective, non-cardiac, nonvascular surgery when the
patient is unable or unwilling
to donate autologous blood.
New to treatment with Hgb over
stated upper limit in these
situations: CKD 10.5,
Malignancy/MDS 10.0, elective
non-vascular/non-cardiac
surgery 12.0, Anti-retrovirals for
HIV patients 10.0, Hepatitis-C
treatment 10.0. Excluded for
CKD anemia if EGFR is not less
than 60. Also excluded when
anemia is known or suspected
to be due a correctable cause
such as iron deficiency,
infectious or inflammatory
process, occult blood loss,
hematologic disease (eg,
thalassemia), vitamin
deficiencies, or hemolysis.
Continuing care (renewal)
exclusions: Hgb greater than
11.0 for HIV, Hep-C use and CKD
without documented dose
reduction (unless ongoing dose
is 1000 units/wk or less). For
oncology, excluded for greater
than 10.0 and for pre-elective
surgery use, Hgb greater than
12.
Required Medical
Information
Clinic Notes from specialist
New starts, all etiologies:
Iron studies, CBC. CKD: EGFR
(also iron studies and CBC).
Ribavirin induced: Evidence
of failure to respond to
ribavirin dose reduction with
2 weeks of dose change.
Renewals: Updated Hgb,
HCT. CKD: Evidence of dose
reduction if Hgb over 12.
Documentation required
every 3-4 months for CKD
and Oncology use. For HIV
and Hep C, documentation is
required every 2 weeks.
Age Restriction
Ages 0 through 20:
Subject to PHC CCS
screening and
referral for CCS
eligible conditions.
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
TBD
Dependent upon
etiology
Other Criteria
Limited to use in adult with Dupuytrens
contracture AND: (1) a palpable cord. (2)
Evidence of discomfort/functional impairment of
hand interferes with ADLs. (3) Physical findings
of either contracture at MCP joint greater than
30 degrees flexion or contracture at PIP joint
greater than 20 degrees flexion. (4) Prescriber
has completed the required Xiaflex training
program - Risk Evaluation and Mitigation
Strategy (REMS)
Any preexisting iron deficiencies must be
resolved prior to starting treatment. CKD: Start
if Hgb 10.5 or less, maintain with Hgb 11.0 or
less. For CKD with HgB between 11.0 and 12.0, a
25% dose reduction is required, unless dose is
already at 1000 units/wk or less. ONCOLOGY: for
patients receiving cancer chemotherapy and for
those with MDS (not receiving chemotherapy):
Hgb less than 10.0 in the last 30 days. For
patients with hematologic malignancies in the
absence of chemotherapy: trial and failure of
conventional treatment for anemia. MEMBERS
ON ANTIRETROVIRALS FOR HIV: Considered on a
case-by-case basis for those with Hgb less than
10.0, limited to a 2 week supply per TAR.
MEMBERS ON HEP-C TREATMENT (RIBAVIRIN):
Must have failed to respond to a ribavirin dose
reduction of 200mg/day within 2 weeks, initial
Hgb less than 10.0, renewal Hgb less than 11.0.
Limited to a 2 week supply per TAR.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
FENTANYL CITRATE ALL DOSAGE FORMS
(FILM/ LOZENGE/
LOLLIPOP/ BUCCAL
TABLETS)
FENTANYL
TRANSDERMAL
PATCH
Drugs included in
Covered Use
TAR Group
• fentanyl citrate,
Cancer pain, as described in
non-injectable forms Criteria section
(eg, ACTIQ, FENTORA,
LAZANDA, ONSOLIS,
SUBLIMAZE,
SUFENTA)
• fentanyl patches
(DURAGESIC)
Around-the-clock pain
control
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
Opioid-naive patients (taking
less than the equivalent of
60mg morphine per day for
at lease one week)
Required Medical
Information
Requested doses 100mcg/hr
or greater require:
A)Diagnosis of cancer pain, or
B)Pain management consult
(either as a visit or PCP can
confer over the phone w/
specialist), AND C) urine tox
screen, cures report and
opioid use agreement.
Please note fentanyl
transdermal is
contraindicated and not
approved for opiate nave
patients: Opiate nave is
defined as taking less than
the equivalent of 60mg/day
oral morphine for at least
one week.
Age Restriction
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
TBD
TBD
Other Criteria
Limited to the treatment for the management of
break-through cancer pain in members with
malignancies who are already receiving and who
are already tolerant to opioid therapy for their
underlying cancer pain. There must also be
documented evidence that other more
appropriate and cost effective short-acting
opioids have been tried and failed. Limit of 4
doses per day. Requests must be accompanied
by documentation ofan appropriate evaluation
and management plan in the medical record.
Consultation with a PHC contractedpain
management consultant may be required.
Limited to the treatment of severe pain for:
(1)Members with a diagnosis of cancer, or (2)
Members requiring a non-oral route of
medication or (3) Requested dose is less than
100mcg/hr and member has had an adequate
trial with failure of morphine-LA and methadone.
Requested doses 100mcg/hr or more require: (1)
Diagnosis of cancer pain, or (2) Pain management
consult (either as a visit or PCP can confer over
the phone w/ specialist), AND (3) A urine tox
screen, cures report and opioid use agreement.
NOTE: For all DXs (including CA, initial fills are
limited to every 72 hour application (10 per 30
days).
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
FIBRIC ACID
DERIVATIVES
FILGRASTIMNEUPOGEN/
NEULASTA
Drugs included in
TAR Group
• fenofibric acid,
choline fenofibrate
• fenofibrate
nanocrystals
(TRICOR)
• filgrastim
(NEUPOGEN)
• pegfilgrastim
(NEULASTA)
GAUCHER'S DISEASE- • miglustat
ZAVESCA
(ZAVESCA)
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Covered Use
Exclusion Criteria
For use as an adjunct to diet
for the treatment of adult
patients with severe
hypertriglyceridemia and in
adult patients with primary
hypercholesterolemia or
mixed dyslipidemia.
For treatment of neutropenia
due to chemotherapy,
hepatitis-C treatment,
congenital diagnosis, cyclic
neutropenia or idiopathic
neutropenia. Prevention of
neutropenia in certain
situations (see criteria).
For the treatment of mild to
moderate type 1 Gauchers
disease in patients for whom
enzyme replacement therapy
is not an option
Required Medical
Information
Include with TAR: current
and past Lab reports
(especially any that
document history of severe
neutropenia secondary to
chemotherapy), specific
chemo regimen, memberspecific risk factors for
developing neutropenia.
Age Restriction
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
TBD
Other Criteria
Trial and failure of formulary fenofibrateavailable as 67mg, 134mg and 200mg micronized
fenofibrate capsules and 54mg and 160mg
tablets (non-micronized).
Prescribed by an
oncologist
TBD
Treatment in members with neutropenia
secondary to chemotherapy when prescribed by
an oncologist, and prophylaxis treatment in
chemotherapy regimens and patient factors that
are associated with a high risk of febrile
neutropenia (20% or more) as summarized in
NCCN Practice Guidelines in Oncology-v.1.2007
(which includes members with a history of
chemo-induced neutropenia) and in members
with congenital neutropenia, cyclic neutropenia,
or idiopathic neutropenia. Ref: Myeloid Growth
Factors: National Comprehensive Cancer
Network (NCNN) practice guidelines in Oncology
V.1.2008. For HCV treated members:
Neutropenia defined as absolute neutrophil
count (ANC) less than 500/mm3 (Grade 4)
associated with interferon treatment in HCV and
a higher than average risk of infection (eg,
cirrhosis, HIV/HCV co-infection and patients
posttransplant on immunosuppressants). QTY
limit of 1 week supply. Ref: UpToDate Online
2010.
TBD
Use restricted to Gaucher disease
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
GI- IRRITABLE
BOWEL SYNDROME
Drugs included in
TAR Group
• alosetron tablets
(LOTRONEX)
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Covered Use
Exclusion Criteria
For the treatment of severe,
chronic, diarrheapredominant irritable bowel
syndrome (IBS).
GI-CROHN'S DISEASE • budesonide enteric For mild to moderate Crohn's
capsules (ENTOCORT) disease involving the ileum
and/or ascending colon
GOUT-XANTHINE
OXIDASE INHIB.
• febuxostat
(ULORIC)
GROWTH FACTOR-1 • mecasermin
HORMONES
(INCRELEX)
Required Medical
Information
Age Restriction
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
TBD
Other Criteria
Trial and failure of an antispasmodic agent and a
bulking agent.
Initial: 2 months.
Indicated for treatment of mild to moderate
Renewal: 2- 3
active Crohn's disease involving the ileum and/or
months (see criteria). ascending colon in members with trial and failure
or contraindication to prednisone/prednisolone
and currently on maintenance mesalamine. Not
indicated for maintenance to prevent relapse.
Limited to 9mg (3 capsules) per day for the first 816 weeks, followed by dose not to exceed
6mg/day (2 capsules) for up to 3 months (with
taper to complete cessation).
Symptomatic Gout
Patient-specfic reasons why
allopurinol cannot be used at
maximum therapeutic doses
(send labs if renal
failure/compromise present).
Adults (safety and
efficacy in ages
under 18 have not
been established).
12 months
Requires trial and failure of (or contraindication
to) formulary allopurinol at maximum doses.
Severe primary IGF-1
deficiency or GH depletion
with neutralizing antibiotics
Pediatric Endocrinology or
Nephrology clinic notes,
relevant lab work.
Less than 18 years Pediatric
of age. Ages 0
endocrinologist or
through 20:
nephrologist
Subject to PHC CCS
screening and
referral for CCS
eligible conditions.
12 months
For treatment of severe primary IGF-1 deficiency
or growth hormone gene depletion with
neutralizing antibiotics in a person less than 18
years old and confirmed by pediatric
endocrinologist or nephrologist.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Drugs included in
TAR Group Name
TAR Group
GROWTH HORMONE • somatropin
- OTHER
(GENOTROPIN,
HUMATROPE,
NUTROPIN, etc)
• somatrem
(PROTROPIN)
Covered Use
Exclusion Criteria
Treatment of Growth
Hormone Deficiency, Chronic
Renal Insufficiency (CRI) and
Non-mosaic Turner Syndrome
(TS) in members under the
age of 21
GROWTH HORMONE • Somatropin
- SEROSTIM
(SEROSTIM)
HIV associated wasting when
specified criteria is met.
Required Medical
Information
Endocrinology clinic notes,
relevant lab reports (GH
response), growth rate data.
BMI history, Nutritional
Evalualation, documented
weight loss as specified in
Other Criteria section.
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Age Restriction
Prescriber Restriction Coverage Duration
Limited to
TBD
Members under
the age of 21.
Subject to PHC CCS
screening and
referral for CCS
eligible conditions.
TBD
Other Criteria
Requests for GHD must meet one of the
following criteria: (1) A diminished peak serum
GH response below 7ng/ml to at least 2
provocative stimuli: (2) A diminished peak serum
GH response between 7-12ng/ml with a growth
rate of 4.5cm or less per yr for girls 0-10 years
and boys 0-12 years: (3) Growth less than 8-10cm
per year at puberty.
5% BCM loss within the preceding 6 months.
BCM less than 35% of total body weight for men
or 23% for women and BMI less than 27kg/m2.
BMI less than 25kg/m2 and a 10% unintentional
weight loss within the preceding 12 months or
7.5% unintentional weight loss within the
preceding 6 months. Treatment must be reevaluated after 4 weeks and 8 weeks of therapy
for a maximum duration of 12 weeks of initial
therapy. A nutritional evaluation by a
Registered Dietician is also required. For
complete policy see HS Policy No. RC100435.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
HEMATOPOIETICARANESP
Drugs included in
TAR Group
• darbepoetin
(ARANESP)
Covered Use
For the treatment of anemia
secondary to Chronic Kidney
Disease (CKD), malignancy,
chemotherapy,
myelodysplastic disease, antiretroviral therapy for HIV
infected patients, antiHepatitis-C treatment
(ribavirin). Also for
increasing blood count prior
to elective, non-cardiac, nonvascular surgery when the
patient is unable or unwilling
to donate autologous blood.
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Required Medical
Information
New to treatment with Hgb over New starts, all etiologies:
stated upper limit in these
Iron studies, CBC. CKD:
situations: CKD 10.5,
EGFR (also iron studies and
Malignancy/MDS 10.0, elective CBC). Ribavirin induced:
non-vascular/non-cardiac
Evidence of failure to
surgery 12.0, Anti-retrovirals for
respond to ribavirin dose
HIV patients 10.0, Hepatitis-C
reduction with 2 weeks of
treatment 10.0. Excluded for
CKD anemia if EGFR is not less dose change.
Renewals: Updated Hgb,
than 60. Also excluded when
HCT.
CKD: Evidence of dose
anemia is known or suspected
reduction if Hgb over 12.
to be due a correctable cause
such as iron deficiency,
Documentation required
infectious or inflammatory
every 3-4 months for CKD
process, occult blood loss,
and Oncology use. For HIV
hematologic disease (eg,
and Hep C, documentation is
thalassemia), vitamin
required every 2 weeks.
Exclusion Criteria
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Age Restriction
Prescriber Restriction Coverage Duration
Ages 0 through 20:
Dependent upon
etiology
Subject to PHC CCS
screening and
referral for CCS
eligible conditions.
deficiencies, or hemolysis.
Continuing care (renewal)
exclusions: Hgb greater than
11.0 for HIV, Hep-C use and CKD
without documented dose
reduction (unless ongoing dose
is 25mcg every other week or
less). For oncology, excluded for
greater than 10.0 and for preelective surgery use, Hgb
greater than 12.
HEPATITIS B
• adefovir (HEPSERA)
• entacavir
(BARACLUDE)
• telbivudine
(TYZEKA)
For the treatment of chronic
hepatitis B infection in
patients with evidence of
active viral replication and
either evidence of persistent
elevations in serum
aminotransferases (AST or
ALT) or histologically active
disease
Requests must include
baseline HBeAg status:
HBeAg positive then submit
HBeAb status. If HBeAg
negative, include HBsAg
status. Also include baseline
and current HBV DNA viral
load.
Gastroenterologist,
HIV or liver specialist
TBD
Other Criteria
Any preexisting iron deficiencies must be
resolved prior to starting treatment. CKD: Start
if Hgb 10.5 or less, maintain with Hgb 11.0 or
less. For CKD with Hgb between 11.0 and 12.0, a
25% dose reduction is required, unless dose is
already at 25mcg every other wk or less.
ONCOLOGY: for patients receiving cancer
chemotherapy and for those with MDS (not
receiving chemotherapy): Hgb less than 10.0 in
the last 30 days. For patients with hematologic
malignancies in the absence of chemotherapy:
trial and failure of conventional treatment for
anemia. Starting dose of 2.25mcg/kg per week.
MEMBERS ON ANTIRETROVIRALS FOR HIV:
Considered on a case-by-case basis for those
with Hgb less than 10.0, limited to a 2 week
supply per TAR. MEMBERS ON HEP-C
TREATMENT (RIBAVIRIN): Must have failed to
respond to a ribavirin dose reduction of
200mg/day within 2 weeks, initial Hgb less than
10.0, renewal Hgb less than 11.0. Limited to a 2
week supply per TAR
Treatment of chronic Hepatitis B virus in adults
who have been evaluated by a
gastroenterologist, HIV or liver specialist with
evidence of active viral replication, active disease
or evidence of persistent elevation of ALT / AST.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
HEPATITIS C
NUCLEOTIDE
ANALOG NS5B
POLYMERASE
INHIBITOR
Drugs included in
TAR Group
• sofosbuvir
(SOVALDI)
Covered Use
HCV Genotype 1, 2, 3
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
Required Medical
Information
HCV TAR information form,
Metavir F3-4, and required
documents (see Other
Criteria section).
Age Restriction
Adults only (18
years and older).
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
Hepatologist, GI ,
12-24 weeks
infectious dz ,
according to criteria
specialists or
experience in HCV
treatment
Other Criteria
Limited to combination treatment in conjunction
with ribavirin or ribavirin and peginterferon (or
simeprevir*). TAR must include completed
Hepatitis treatment form, and Metavir F3-4.
Required documentation listed on treatment
form to include copies of laboratory results,
ultrasound/ biopsy reports, AUDIT C screening
form, PHQ2/9 screening form, Utox, HIV test,
Hepatitis A,B tests demonstrating immunity or
vaccination, women of child bearing agepregnancy test if used with RBV *. TAR must be
submitted with entire packet of documents to
PHC specialty pharmacy, DIPLOMAT. *Refer to
California Department of Health Care Services
Utilization and Treatment Policy for Simeprevir
and Sofosbuvir in the Management of Hepatitis
C.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
HEPATITIS C
THERAPY PEGINTERFERON
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Drugs included in
Covered Use
Exclusion Criteria
TAR Group
• peginterferon alpha- For the treatment of chronic
2A (PEGASYS)
hepatitis C infection
• peginterferon alpha2B (PEGINTRON)
Required Medical
Age Restriction
Information
All types: TAR must include
the following, along with a
completed Hepatitis
treatment form: 1) Member
has been evaluated by a
gastroenterologist or a
hepatologist. 2) copy of liver
biopsy demonstrating stage 2
or greater fibrosis or a Fibro
Test (Fibro Sure) score of
0.75 or greater. 3) copy of
recent CBC, Chem Panel, HCV
VL, ultrasound report, HIV
test in last 6 months. 4) most
recent clinical notes detailing
the plans for HCV treatment
and the members health
status.
Prescriber Restriction Coverage Duration
Hepatologist, GI ,
TBD
infectious dz ,
specialists or
experience in HCV
treatment
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Other Criteria
Genotypes 2 and 3: Must be part of combination
treatment with ribavirin. Treatment duration
limited to 24 weeks.
Genotype 1: In combination with ribavirin and a
protease inhibitor.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Drugs included in
TAR Group Name
Covered Use
Exclusion Criteria
TAR Group
HEPATITIS C
• ribavirin 400mg,
For the treatment of chronic
THERAPY- RIBAVIRIN 600mg & dosepaks
hepatitis C infection
(REBETROL, RIBAPAK,
RIBASPHERE)
Note that 200mg is
on formulary, PA may
be required due to
step edit
requirements
Required Medical
Information
All Types: TAR must include
the following, along with a
Hepatitis treatment form: 1)
Member has been evaluated
by a gastroenterologist or a
hepatologist. 2) copy of liver
biopsy demonstrating stage 2
or greater fibrosis or a Fibro
Test (Fibro Sure) score of
0.75 or greater. 3) copy of
recent CBC, Chem Panel, HCV
VL, ultrasound report, HIV
test in last 6 months. 4) most
recent clinical notes detailing
the plans for HCV treatment
and the members health
status.
Genotypes 2 and 3: Must be
part of combination
treatment with
peginterferon. Treatment
duration limited to 24 weeks.
Genotype 1: In combination
with peginterferon and a
protease inhibitor.
Age Restriction
Ages 0-20: PHC
screening and
referral for CCS
eligible
condition(s).
Prescriber Restriction Coverage Duration
Hepatologist, GI ,
TBD
infectious dz ,
specialists or
experience in HCV
treatment
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Other Criteria
Documentation of trial and failure of (or
contraindication to) formulary ribavirin 200mg
capsules or tablets.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
HORMONE
REPLACEMENTESTROGENIC AGENTS
HORMONESESTROGEN/
PROGESTIN
COMBINATIONS
Drugs included in
TAR Group
• conjugated
estrogen tablets
(PREMARIN)
• synthetic
conjugated
estrogens, B tablets
(ENJUVIA)
• conjugated
estrogens/
medroxyprogesterone (PREMPHASE,
PREMPRO)
HTN-ALPHA AGONIST • clonidine patches
TRANSDERMAL
(CATAPRES TTS)
PATCH
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Covered Use
Exclusion Criteria
For estrogen replacement
therapy in premenopausal
women with estrogen
deficiency and for high-dose
estrogen trans-gender
hormone treatment.
Required Medical
Age Restriction
Information
Documentation of reasons
why formulary estradiol
cannot be used. For
transgender requests: Must
also include documentation
that request is for medical
reasons rathe than purely
cosmetic (ie, failure to treat
would result in psychological
harm).
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
TBD
For the treatment of
moderate to severe
symptoms associated with
menopause.
For the treatment of
hypertension.
Other Criteria
For moderate to severe vasomotor symptoms of
menopause, with documentation of trial and
failure with formulary oral and transdermal
estradiol (in combination with
medroxyprogesterone). For the treatment of
vulvar or vaginal atrophy with documentation of
trial and failure of formulary estradiol and
Premarin Cream. For trans-gender change new
starts: documentation of trial and failure with
high dose estradiol. For trans-gender change
Continuing care: treatment authorized if it is
prescribed for medically necessary reasons (not
cosmetic use) and discontinuing would cause
great psychological harm.
For moderate to severe vasomotor symptoms of
menopause with documentation of trial and
failure with formulary oral and transdermal
estradiol (in combination with
medroxyprogesterone). For the treatment of
vulvar/vaginal atrophy with documentation of
trial and failure of formulary estradiol and
Premarin Cream.
TBD
Treatment for members with hypertension and
have a documented trial and failure with oral
clonidine.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
HTN-ARB AND
COMBO
Drugs included in
Covered Use
Exclusion Criteria
TAR Group
With or without
For the treatment of
HCTZ:
hypertension, either alone or
• azilsartan (EDARBI, in combination with other
EDARBICHLOR)
antihypertensive agents
• candesartan
(ATACAND, ATACANDHCT)
• eprosartan
(TEVETEN, TEVETENHCT)
• olmesartan
(BENICAR, BENICARHCT)
• telmisartan
(MICARDIS, MICARDISHCT)
• valsartan (DIOVAN,
DIOVAN-HCT)
HTN-BETA BLOCKERS • nebivolol
(BYSTOLIC)
HTN-DIRECT RENIN
INHIBITORS
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
• aliskiren
(TEKTURNA)
For the treatment of
hypertension either alone or
in combination with other
agents
For the treatment of
hypertension either alone or
in combination with other
agents
Required Medical
Information
Age Restriction
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
TBD
Other Criteria
Must have trial and failure of, or contraindication
to, a formulary ACE inhibitor, formulary losartan
AND formulary/STEP agent irbesartan.
TBD
Patients with hypertension requiring 2 or more
classes of antihypertensives AND trial and failure
of 2 or more formulary beta-blockers.
TBD
Use limited to inadequately controlled
hypertension on three formulary medications.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
HUMIRA
Drugs included in
TAR Group
• adalimumab
(HUMIRA)
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Covered Use
Exclusion Criteria
Rheumatoid Arthritis,
Psoriasis and Crohn's Disease
as described in criteria.
Required Medical
Information
Specialists clinic notes
documenting disease course,
previous therapies tried and
responses, current evaluation
(lab and imaging reports as
appropriate), treatment plan.
RA (Rheumatoid Arthritis):
Include Disease Activity
Score.
Age Restriction
Ages 0 through 20:
Subject to PHC CCS
screening and
referral for CCS
eligible conditions.
Prescriber Restriction Coverage Duration
Rheumatologist for
TBD
the treatment of
rheumatoid arthritis.
Appropriate specialist
for the treatment of
plaque psoriasis and
crohns disease.
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Other Criteria
RHEUMATOID ARTHRITIS: Same criteria as Enbrel:
Formulary oral DMARDS: Methotrexate, Leflunomide,
Sulfasalazine, Hydroxchloroquine. New Starts, for
members with RA who have inadequate response
(disease progression to or remains at mod-high
activity level) to TRIPLE combination therapy with
formulary oral DMARDs (minimum 3 month trial) in
the following situations: (1) New RA diagnosis, less
than 6 months, but with High Disease Activity with or
without poor prognostic factor(s) (2) New RA
diagnosis, less than 6 months, with moderate disease
activity but with poor prognostic factors (3) RA with
current Mod-High disease activity but initially
diagnosed and treated less than 6 months ago for
low, moderate or high dz activity and without poor
prognostic factors (4) RA for more than 6 months with
low disease activity with poor prognostic factors and
(5) RA for more than 6 monts with mod-high disease
activity, with or without poor prognostic factors.
NOTES: Humira may be considered after Enbrel
failure. Limited to every other week dosing. Failure
to control disease at QOW (every other week) should
have consideration of other therapy with alternative
mechanism of action (eg, Xeljanz).
PLAQUE PSORIASIS- Plaque Psoriasis involving greater
than 10% of body surface area in members who have
been evaluated by an appropriate specialist. Crohn's
DISEASE- Evaluation by appropriate specialist with
inadequate response to conventional therapy
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
HYALURONIC ACID
DERIVATIVES
Drugs included in
TAR Group
• hyaluronate sodium
(GEL-ONE, HYALGAN,
SUPARTZ)
IMMUNE GLOBULIN • immune globulin IV
(eg, BIVIGAM,
FLEBOGAMMA,
GAMMAGARD,
GAMUNEX,
HIZENTRA, PRIVIGEN)
Covered Use
For the treatment of knee
osteoarthritis pain when
criteria are met.
Immunodeficiency Syndrome
(supporting labs required),
Idiopathic
Thrombocytopenia, B-cell
Chronic Lymphocytic
Leukemia, Kawasaki Disease,
Bone Marrow transplant,
Guillain-Barre Syndrome or
Chronic Inflammatory
Demyelinating
Polyneuropathy (CIDP).
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Required Medical
Exclusion Criteria
Information
Brands other than Supartz or BMI, Clinic Notes from
Hyalgan are not covered.
Orthopedic or Pain
Management Specialist
Consultation notes and
treatment plan from
appropriate specialist,
relevant lab reports
Age Restriction
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
Ortho or Pain
Approval limited to
Management
one treatment series
per knee per year.
Other Criteria
Treatment of Osteoarthritis of the knee in which
each of the following are met: (1) Members who
have been evaluated by an appropriate
specialist. (2) Documentation of trial and failure
of, or contraindication to, at least 2 prescription
strength NSAIDs at adequate doses for 3 months
each of consistent usage. (3) If intolerant to
NSAIDs, must have 3 month trial of topical NSAID
(TAR required) and formulary tramadol. (4) Trial
and failure of physical therapy. (5)
Documentation of at least 3 intra-articular
steroid injections within the last year or
documentation of complete lack of response to
less than 3 injections. (6) Renewals: weight gain
(if any) relative to starting weight must not
exceed 5% or 10lbs, whichever is less.
Approvable Hyaluronic acid derivatives are Brand
Supartz or Hyalgan. PHC will only approve the
preferred products if patient meets criteria for
viscosupplementation therapy. Other products
are not covered.
Prescribed by
TBD
appropriate specialists
for the disease state,
or by PCP with a
specialist consultation
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
Drugs included in
TAR Group Name
TAR Group
INCRETIN MIMETICS • exenatide ER
(BYDUREON)
injection
(BYDUREON)
Covered Use
For the treatment of type 2
diabetes mellitus in
combination with diet and
exercise
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
Required Medical
Information
HgA1C lab report, drawn
within the last 90 days.
Age Restriction
Prescriber Restriction Coverage Duration
Criteria waived for
Initial: 3 months.
board certified
endocrinologist
Criteria waived for
board certified
endocrinologist
INCRETIN MIMETICS • exenatide (BYETTA) For the treatment of type 2
(BYETTA/VICTOZA) • liraglutide
diabetes mellitus in
(VICTOZA)
combination with diet and
exercise
HgA1C lab report, drawn
within the last 90 days and
current BMI
18 and older
INFANT FORMULAS
Specialist clinic notes such as
GI or RD, legible growth
charts (current CDC growth
charts are recommended),
premature infant status
(gestational age), allergies,
relevant lab reports.
0-1 yr (may be
extended for
preemie catch-up
growth).
• medically necessary
infant formulary not
otherwise covered by
WIC (eg, ENFACRE,
GOODSTART, ISOMIL,
NUTRAMIGEN,
SIMILAC ADVANCE)
When medically indicated for
members unable to maintain
adequate nutrition with WIC
program formulas.
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Other Criteria
Must have trial and failure to preferred/nonformulary Byetta (TAR required for Byetta).
Byetta initial TAR Criteria: For new start:
Prescribed by endocrinologist, or (1) trial and
failure of metformin and insulin, and (2) HgA1C
7.0-10.0 in the last 90 days, and (3) BMI equal to
or greater than 40 with failure of conventional
weight loss therapy. Initial approval is for 3
months then reassess.
Initial approval is for For new start: Prescribed by endocrinologist, or
3 months then
(1) trial and failure of metformin and insulin, and
reassess.
(2) HgA1C 7.0-10.0 in the last 90 days, and (3)
BMI equal to or greater than 40 with failure of
conventional weight loss therapy. Initial approval
is for 3 months then reassess. For renewal:
Prescribed by endocrinologist, or HgA1C at target
(less than 8.0) or documentation of greater than
3% weight loss in 3 months. HK: Not FDA
approved for use in ages less than 18 (submit
safety/efficacy pediatric studies for case-by-case
review).
TBD
Include rationale as to why WIC eligible formulas
cannot be used. WIC eligible formulas are the
standard Enfamil infant formulas: Premium,
Gentlease, AR, ProSobee.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
INHALED
CORTICOSTEROIDS
(NEBULIZED)
INSULIN ADJUNCT
THERAPY-SYMLIN
Drugs included in
TAR Group
• budesonide neb.
soln. (PULMICORT)
• pramlintide
(SYMLINPEN,
SYMLIN)
Covered Use
For maintenance &
prophylaxis of asthma in
young children.
For the adjunct treatment of
type 1 diabetes mellitus and
type 2 diabetes mellitus
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
(1)Diagnosis other than
asthma. (2)Age greater than
4 yrs old
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Required Medical
Age Restriction
Prescriber Restriction Coverage Duration
Information
Clinic notes documenting
Less than or equal
12 Months
patient trial and response to to age 4
formulary inhaled
corticosteroids with spacer
(waived if recommended by
specialist and diagnosis of
asthma).
TBD
Other Criteria
On recommendation of pulmonologist or
allergist, OR following failure with formulary
inhaled corticosteroid used in conjunction with a
spacer (PHC may request a referral to a
specialist).
Use as adjunct in Type 1 diabetics who use
mealtime insulin and who failed optimal insulin
therapy. Use in Type 2 diabetics as an adjunct
who use mealtime insulin and who failed optimal
insulin therapy with or without oral agents.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
Drugs included in
TAR Group Name
Covered Use
TAR Group
IRON REPLACEMENT • iron dextran
For the treatment of iron(INFED)
deficiency anemia.
• iron sucrose
(VENOFER)
• ferric
carboxymaltose
(INJECTAFER)
• ferumoxytol IV
(FERAHEME)
• sodium ferric
gluconate complex IV
(FERRLECIT, NULECIT)
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
Required Medical
Age Restriction
Information
Venofer and Infed are the
preferred choice for IV use.
Required medical
information include: (1).
Documentation of trial and
failure to adequate doses of
oral iron along with nature of
failure. (2). Required
laboratory evidence of iron
deficiency
anemia:hemoglobin/hematoc
rit, ferritin, serum iron,
transferrin/TIBC, percent
saturation of
transferrin/TIBC. (3).
Appropriate specialist notes
depending on etiology. (4).
Dialysis status. (5). Requests
for HIGH molecular weight
iron dextran (DexFerrum)
must include rationale why
preferred non formulary
products cannot be used, due
to increased risks associated
with the high molecular
weight product.
Prescriber Restriction Coverage Duration
TBD
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Other Criteria
Venofer and Infed are the preferred choice for IV
use. Requires the followings: 1). Laboratory
evidence of iron deficiency anemia(characterized
by low levels of hemoglobin/hematocrit,ferritin,
serum iron, increased levels of transferrin/TIBC,
low percent saturation of transferrin/TIBC).2).
Trial and failure with adequate doses of oral iron
supplementation.3). Dialysis patients unable to
maintain iron balance do not require failure of
oral iron. Requests for IV iron therapy inpatients
with HD-CKD on epoetin therapy should have
TSAT less than 30%.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
LA-OPIOID
Drugs included in
TAR Group
• hydrocodone ER
(ZOHYDRO)
Covered Use
Treatment of severe pain in
opioid tolerant terminal
cancer patients when pain
requires around-the-clock
opioid-level pain control and
alternative long-acting
opioids are contraindicated
or inadequate.
LIDODERM
• lidocaine patches
(LIDODERM)
For the treatment of
postherpetic neuralgia
LYRICA
• pregabalin (LYRICA) Fibromyalgia, Postherpetic
Neuralgia, Diabetic Peripheral
Neuropathy, Neuropathic
Pain associated with spinal
cord injury
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
(1) Not opioid tolerant.
(2)Not terminally ill. (3)PRN
use or any SIG other than
routine dosing (dosed every
12 hours, at same dose every
day) to maintain steady
blood levels ATC.
(4)Concurrent use of
benzodiazepines or other
soporifics. (5)Rx/TAR is for
undifferentiated pain.
(6)Severe or acute Asthma.
(7)Hypercarbia. (8)Known or
suspected paralytic ileus.
(9)Hypersensitivity to
hydrocodone. (10)Significant
respiratory depression.
Required Medical
Information
Clinic notes adequately
documenting: (1)Previous
pain regimens used and
members response to
treatments. (2)Any known
contraindications to
formulary alternatives.
(3)Specialists notes regarding
members current health
status and prognosis.
(4)UTOX within 30 days prior
to treatment initiation, and
periodically upon PHC
request.Additional
documentation: (1)Member
has agreed to abstain from
alcohol during treatment
with Zohydro ER. (2)Member
will be monitored closely for
s/sx respiratory depression
during the first 72hrs of
initiation and with each dose
increase
Age Restriction
18 years and over.
Ages 18-20 will be
referred to CCS if
not already
enrolled.
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
Board certified in
14 days supply
oncology or pain
authorized per fill.
management.
Other Criteria
Member is enrolled in PHC Hospice. Members
enrolled in a non-PHC Hospice must obtain any
comfort meds (including pain medications) from
the hospice plan rather than PHC. Must have
adequate documentation supporting the medical
necessity of the use of this product to treat
chronic pain in a terminally ill member and that
other long-acting opioids are either
contraindicated or have failed. Unless
contraindicated, member must have tried/failed
formulary methadone and morphine (longacting) as well as non-formulary fentanyl patches
and OxyContin (TAR required for fentanyl
patches and OxyContin, criteria must be met).
Duration of TAR auth to be determined on a caseby-case basis, based on prognosis.
Confirmed diagnosis of
postherpetic neuralgia.
TBD
Limited to the FDA approved indication only
(postherpetic neuralgia).
Clinic notes documenting
responses to first/second line
treatments tried and failed,
with treatment plan for
pregablin (titration schedule
if new start), specialists
consult notes if any.
TBD
Diagnosis other than seizures: Documentation of
adequate trial and failure with formulary
gabapentin and a TCA (tricyclic antidepressant,
used for nerve pain) is required. (Seizure dx is
case-by-case, submit specific type of seizures,
other medications used concurrently and
previously).
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
MAKENA
Drugs included in
TAR Group
• hydroxyprogesterone injection
(MAKENA)
MEGLITINIDESPRANDIN
• repaglinide
(PRANDIN)
MESALAMINE-ORAL
• mesalamine DR
tablets (ASACOL HD,
LIALDA)
• mesalamine CR
capsules (PENTASA)
Covered Use
To reduce the risk of preterm
birth in women with a
singleton pregnancy (single
fetus) who have a history of
singleton spontaneous
preterm birth.
For the treatment of type 2
diabetes mellitus
uncontrolled by diet and
exercise alone
Active ulcerative colitis (to
induce remission).
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
Multiple gestations (more
than one fetus) or other risk
factors for preterm birth.
Start earlier than week 16 or
later than week 20. End date
week 37 or later. Active liver
disease, history of breast
cancer, uncontrolled HTN.
Required Medical
Age Restriction
Information
Documented history of prior
singleton spontaneous
preterm birth (delivery at less
than 37 weeks gestation).
Treatment start date, end
date and the corresponding
gestational week numbers.
GI consult notes, disease
status (active vs maintenance
of remission) and reaons why
formulary Delzicol brand of
Mesalamine 400mg DR at
doses up to 2.4g per day
cannot be used.
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
Obstetricians only (OB, Exact duration is
OBGYN).
dependent on start
date.
Not FDA approved Must be prescribed by
for pediatric use. or recommended by GI
Older adolescent specialist.
use will be
screened for CCS
eligibility, with
referral if
appropriate.
Other Criteria
Limited to use by prescriber specializing in
obstetrics. Member with a single fetus and
documented history of spontaneous preterm
delivery of singleton fetus. Treatment to start
between 16 and 20 weeks, end before week 37.
12 months
Must have documentation of trial and failure to
formulary nateglinide (generic Starlix)
Initial (Active
Disease): 2 mo.
Refills: Case-by-case,
see criteria.
Must be prescribed by GI specialist or
recommended via GI consult note. Limited to
the treatment of moderately active ulcerative
colitis, in order to induce remission, for duration
of up to 6-8 weeks, for members unresponsive to
maximum doses of mesalamine 400mg DR
(Delzicol, max 2.4g/day). For maintenance
dosing, prescription should revert back to
formulary mesalamine 400mg DR. For
maintenance requests with trial and failure to
maintenance dosing with Delzicol, periodic dose
reductions should be attempted.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
MSB: PA CRITERIA
and BRAND POLICY
REQUIREMENTS
Drugs included in
TAR Group
Any NON-formulary
brand product for
which a NONformulary generic is
available
Covered Use
Case-Specific
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
PHC Criteria for use and/or
PHC Brand Policy not met.
Required Medical
Age Restriction
Information
PHC Policy MPRP4033 states
the following will be
provided: Documentation
from the member Rx profile
or clinician progress notes
that the member has had a
previous trial of both generic
and therapeutic alternatives
in the last 180 days,
justification why the member
cannot use the generic and
justification why the member
cannot use a therapeutic
alternative. If the member is
unable to use a generic due
to an adverse event, an FDA
MedWatch form completed
by the prescriber,
documenting the event, may
be required.
Prescriber Restriction Coverage Duration
Appropriate specialist TBD (Limited to 30
consult may be
day supply per fill).
requested.
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Other Criteria
See generic equivalent entry for drug-specific
requirements. Must meet both PHC PA criteria
for the generic drug entity and PHC brand policy
MPRP4033.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
MSB: BRAND POLICY
(FORMULARY
GENERIC)
Drugs included in
Covered Use
TAR Group
Any NON-formulary Case-specific
brand product for
which a FORMULARY
GENERIC is available
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
Required Medical
Age Restriction
Information
PHC Policy MPRP4033 states
the following will be
provided: Documentation
from the member Rx profile
or clinician progress notes
that the member has had a
previous trial of both generic
and therapeutic alternatives
in the last 180 days,
justification why the member
cannot use the generic and
justification why the member
cannot use a therapeutic
alternative. If the member is
unable to use a generic due
to an adverse event, an FDA
MedWatch form completed
by the prescriber,
documenting the event, may
be required.
Prescriber Restriction Coverage Duration
TBD
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Other Criteria
See formulary generic equivalent entry for
generic requirements/restrictions.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
MULTIPLE
SCLEROSIS, 1st LINE
AGENTS
Drugs included in
TAR Group
• dimethyl fumarate
(TECFIDERA)
• glatiramer acetate
(COPAXONE)
• interferon beta-1a
(AVONEX, REBIF)
• iatiramer acetate
(COPAXONE)
• teriflunomide
(AUBAGIO)
MUSCLE RELAXANTS • carisoprodol
(SOMA)
• orphenadrine
(NORFLEX)
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Covered Use
Exclusion Criteria
For the treatment of
Diagnosis other than Multiple
relapsing-remitting multiple sclerosis(MS).
sclerosis to reduce the
frequency of relapses & slow
accumulation of physical
disability. Efficacy has been
shown for several agents
even when initiated after
first clinical episode when
MRI has features consistent
with MS.
For treatment of
musculoskeletal pain
associated with acute, painful
musculoskeletal conditions
Required Medical
Information
New Starts, MS Diagnosis
Confirmed: Clinical
evaluation by neurologist,
imaging reports, lab
reports.Renewal, confirmed
Dx/Continuing Care:
Documentation supporting
the diagnosis of multiple
sclerosis. For new starts this
would include neurology
consult notes, imaging and
lab reports. TAR renewals
require annual assessment by
neurologist. New Starts,
Clinical Dx based on
Initial/Isolated Episode:
Completed Neurologist
evaluation, diagnostic plan
(which tests are
pending/scheduled). Initial
Renewal after the
above:Subsequent imaging,
lab reports and any follow-up
clinic notes must accompany
the request to continue
treatment.
Etiology, if known (eg, MS,
DDD, Spinal cord injury)
Age Restriction
Prescriber Restriction
Ages 20 years and Neurologist
younger are
subject to CCS
review
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Coverage Duration
1 yr when adequate
documentation is
received which meets
criteria for ongoing
use
Other Criteria
Limited to the treatment of Multiple Sclerosis for
members who have been evaluated by a
neurologist. Requests which document that the
member continues to benefit from therapy are
approved on a yearly basis. For neurologists
wishing to initiate treatment following
presentation of first clinical episode, prior to
completion of objective workup for definitive
diagnosis: A one time authorization will be
considered based on the clinical evidence
submitted along with the plan for further
diagnostic work-up (see Required Medical
Documentation).
TBD
Limited to short-term (acute) use only, per FDA
approved indication. Ongoing use requires failure
of at least 3 formulary muscle relaxants:
baclofen, cyclobenzaprine, methocarbamol,
tizanidine (tablets only), chlorzoxazone.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
NARCOLEPSY
Drugs included in
TAR Group
• modafanil
(PROVIGIL)
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Covered Use
Exclusion Criteria
Treatment of narcolepsy or
for daytime sleepiness due to
sleep apnea unresponsive to
1st line therapy such as CPAP
NASAL
ANTIHISTAMINECORTICOSTEROID
COMBINATIONS
• azelastine/
fluticasone
(DYMISTA)
For the treatment of
symptoms associated with
seasonal allergic rhinitis in
patients who require
treatment with azelastine
and fluticasone in ages 12
and older.
NASAL
ANTIHISTAMINES
• azelastine 200mcg
(ASTEPRO 0.15%)
• olopatadine nasal
spray(PATANASE
0.6%)
For the treatment of
symptoms associated with
allergic rhinitis: seasonal and
perennial in ages 6 years and
older.
Failure to document
adequate trial of formulary
alternatives as required by
criteria.
Required Medical
Information
Relevant clinic notes,
including sleep studies or
neurology consults.
Age Restriction
Adults
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
TBD
Other Criteria
Limited to 30 tablets per month.
Clinic notes documenting
12 years and older None
patients trial and response to
formulary nasal
corticosteroids AND
azelastine 137mcg nasal
spray.
Initial: 1 month.
Renewal: 12 months
Clinic notes documenting
6 years and older
patients trial and response to
formulary oral antihistamine
and nasal corticosteroids
AND azelastine 137mcg nasal
spray may be requested if
claim history shows no prior
use of formulary first line and
2nd line agents.
1 yr with adequate
Documentation of trial and failure (or
documentation which intolerance) of a nasal corticosteroid used
meets criteria for use. concurrently with a formulary oral antihistamine,
AND documentation of failure with trial of
azelastine 137mcg nasal spray (generic Astelin),
used concurrently with a formulary
antihistamine.
None
Requires documentation of treatment failure of
or intolerance to 2 intranasal steroid products,
one of which must be formulary fluticasone, used
in combination with formulary/step agent
intranasal azelastine 137mcg (generic Astelin)
and a formulary oral antihistamine.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
NASAL
CORTICOSTEROIDS
Drugs included in
TAR Group
• beclomethasone
(BECONASE AQ,
QNASL)
• budesonide
(RHINOCORT AQUA)
• mometasone
(NASONEX)
• ciclesonide
(OMNARIS,
ZETONNA)
• fluticasone furoate
(VERAMYST)
Covered Use
Nasal symptoms of allergic
rhinitis, both seasonal and
perennial.
NIACIN-STATIN
COMBINATIONS
• Niacin XRLovastatin
Hypercholesterolemia
NICOTINE
• nicotine inhaler
(NICOTROL INHALER)
• nicotine nasal spray
(NICOTROL NS)
For use as an aid in the
treatment of nicotine
withdrawal following
cessation of smoking
NON-CALCIUM
• lanthanum
PHOSPHATE BINDERS carbonate chewable
tabs(FOSRENOL)
• sevelamer hcl
tablets (RENAGEL)
• sevelamer
carbonate susp.,
pwd., tabs (RENVELA)
For the treatment of
hyperphosphatemia in
patients with end stage renal
disease (ESRD), in dialysis
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Required Medical
Exclusion Criteria
Information
Failure to include clinic notes Clinic notes documenting
as required by criteria.
patient trial and response to
at least 2 of formulary nasal
corticosteroids.
Current lab reports which
include: serum Phosphate,
Calcium, Creatinine, EGFR.
Other: If calcium binders are
contraindicated due to
elevated calcium &/or the
presence of vascular or soft
tissue calcification, that
information should be
included with TAR.
Age Restriction
Per individual
product's FDA
indication.
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
None
1 year with adequate
documentation which
meets criteria for use
Other Criteria
Requires documentation of trial and failure or
intolerance to 2 formulary intranasal steroid
agents with concurrent use of a formulary
antihistamine. Rhinocort Aqua may be approved
for patients who are pregnant. Need to provide
member due date. Formulary nasal ICS:
fluticasone (generic Flonase), flunisolide (generic
Nasarel) and triamcinolone (Nasacort Allergy
OTC. Formulary antihistamines: loratadine,
cetirizine, and with step requirement also
fexofenadine (requires previous trial of
loratadine or cetirizine).
TBD
Not for initial treatment. Request must include
documentation of adequate trial and failure of
niacin or formulary statins alone (lovastatin,
fluvastatin, atorvastatin, simvastatin, pravastatin)
Note: Children
and Adolescents:
Safety and efficacy
have not been
established.
TBD
Trial and failure of nicotine gum and nicotine
patches.
Ages 20 years and None
younger are
subject to CCS
eligibility review
and referral.
1 yr when adequate
documentation is
received which meets
criteria for ongoing
use
For control of hyperphosphatemia in dialysis
members who are unresponsive to calcium based
phosphate binder therapy (formulary calcium
acetate or calcium carbonate) in amounts
exceeding 1,500 mg total elemental calcium
content 1500mg is provided by: PhosLo: 9 per
day. Tums E-X 750mg: 5 per day
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
NON-FORMULARY
AGENTS
Drugs included in
Covered Use
TAR Group
Any non-formulary
Case-Specific
request which is an
FDA approved
product but for which
no drug or categoryspecific PHC TAR
criteria has yet been
established (case-bycase review)
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
Required Medical
Age Restriction
Information
Non-Formulary. TAR must
include accurate diagnosis as
provided by PRESCRIBER and
include all necessary/relevant
clinical documentation to
support medical justification
(clinic notes, lab reports,
specialist consults, imaging
reports, etc).
Prescriber Restriction Coverage Duration
Appropriate specialist TBD
consult may be
requested.
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Other Criteria
Non-formulary, TAR required. Submit diagnosis
and reasons why formulary and preferred nonformulary products cannot be used.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
NS3/4A SERINE
PROTEASE
INHIBITORS
NSAIDS-TOPICAL
Drugs included in
Covered Use
TAR Group
• simeprevir (OLYSIO) HCV Genotype 1
• diclofenac gel
(VOLTAREN GEL)
For the treatment of
osteoarthritis.
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
Mild liver disease (equivalent
to Metavir F0-2 except those
with serious extra-hepatic
manifestations or post liver
transplant, Q80K
polymorphism positive for
simeprevir based
regimenGT1
Required Medical
Age Restriction
Information
HCV tar information form,
Adults only (18
Metavir F3-4, and required
years and older).
documents. Must meet
interferon-ineligible criteria
and DHCS investigational use
criteria
(sofosbuvir/simeprevir
regimens). Simeprevir based
regimen needs justification
why preferred sofosbuvir
based regimen cannot be
used.
Drug Interactions:
Metabolized by CYP3A-strong
inducers or inhibitors not
recommended eg.
(carbamazepine, phenytoin,
phenobarbital,
oxcarbazepine) macrolides,
azole antifungals,
dexamethasone, ketolides,
antimycobacterials
(rifampin), milk thistle, St.
johns wort, HIV protease
inhibitors, cobicistat
containing antiretrovirals.
Contraindications to oral
NSAIDS (if any), from patient
medical records.
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
Hepatologist, GI ,
12 weeks according
infectious dz ,
to criteria
specialists or
experience in HCV
treatment
TBD
Other Criteria
Limited to combination treatment in conjunction
with sofosbuvir +/-ribavirin or ribavirin and
peginterferon (without Q80K polymorphism).
TAR must include completed Hepatitis treatment
form, and Metavir F3-4. Required
documentation listed on treatment form to
include copies of laboratory results, ultrasound/
biopsy reports, AUDIT C screening form, PHQ2/9
screening form, Utox, HIV test, Hepatitis A,B
tests demonstrating immunity or vaccination,
women of child bearing age-pregnancy test if
used with RBV *. TAR must be submitted with
entire packet of documents to PHC specialty
pharmacy, DIPLOMAT.Investigational-drug
criteria must be adhered to for off-label
uses.*Refer to California Department of Health
Care Services Utilization and Treatment Policy for
Simeprevir and Sofosbuvir in the Management of
Hepatitis C.
Documentation of trial and failure of 2 formulary
NSAIDS, one of which must be oral diclofenac.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
NSAIDSTRANSDERMAL
Drugs included in
TAR Group
• diclofenac patch
(FLECTOR)
Covered Use
For the topical treatment of
acute pain due to injury
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
Required Medical
Age Restriction
Information
Contraindications to oral
NSAIDS (if any), from patient
medical records.
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
TBD
Other Criteria
Trial and failure of 2 formulary agents for acute
pain such as diclofenac, meloxicam, etodolac,
salsalate, ibuprofen, naproxen and trial and
failure of Voltaren gel. Not FDA approved for
chronic use.
NUEDEXTA
• dextromethorphan/quinidine
tablets 20mg/30mg
(NUEDEXTA)
For the treatment of
pseudobulbar affect (PBA)
18 years and older Neurologist
TBD
Limited to the treatment of Pseudobulbar Affect
(PBA) in members who have been evaluated by a
neurologist and only have episodic outbursts of
crying or laughing which are involuntary and are
incongruent with the members emotional state.
Must rule out depression or other emotional
events, manifested as either intermittent or
prolonged crying episodes. Treatment of other
emotional labilities is not FDA indicated. Notes:
(A)Studies to support the effectiveness of
Nuedexta were performed in patients with ALS
(amyotrophic lateral sclerosis) and MS (Multiple
Sclerosis). (B)Nuedexta has not been shown to
be effective in the types of emotional lability
that occur in Alzheimer's disease and other
dementias. (C)PBA occasionally spontaneously
improves, therefore patients should be
periodically reassessed for the need for
continued treatment.
OAB EXTENDED
RELEASE AGENTS
• darifenacin ER
(ENABLEX)
• trospium
(SANCTURA,
SANCTURA XR)
• solifenacin
(VESICARE)
For the treatment of an
overactive bladder (OAB)
with symptoms of urinary
frequency, urinary urgency,
or urge-related urinary
incontinence
Not indicated for
pediatric use.
TBD
Requires documentation of trial and failure with
(or contraindications to) formulary/Step
oxybutynin ER or formulary/Step oxybutynin OTC
patch, formulary tolterodine LA (TAR required if
ages is less than 65) and preferred non-formulary
agent fesoterodine (Toviaz).
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
Drugs included in
TAR Group Name
TAR Group
OAB EXTENDED
• fesoterodine
RELEASE PREFERRED ER(TOVIAZ)
AGENTS
OAB IMMEDIATE
RELEASE AGENTS
• tolterodine IR
(DETROL)
Covered Use
For the treatment of an
overactive bladder (OAB)
with symptoms of urinary
frequency, urinary urgency,
or urge-related urinary
incontinence
For the treatment of an
overactive bladder (OAB)
with symptoms of urinary
frequency, urinary urgency,
or urge-related urinary
incontinence
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
Required Medical
Information
Age Restriction
Not indicated for
pediatric use.
Safety and efficacy
has not been
established in
children.
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
TBD
TBD
Other Criteria
PHC's preferred non-formulary agent. Requires
documentation of trial and failure with (or
contraindications to) formulary/Step oxybutynin
ER or formulary/Step oxybutynin OTC patch and
formulary tolterodine LA (TAR required if age less
than 65 years old).
Limited to the treatment of overactive bladder
(in adults) with documentation of failure of PHC
preferred urinary anticholinergics: formulary
oxybutynin ER or OTC patch and non-formulary
fesoterodine (prior authorization required). After
initial trial for tolerance and efficacy of
tolterodine, conversion to single dose LA tablets
will be requested.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
Drugs included in
Covered Use
TAR Group
• omega-3 acid ethyl For use as an adjunct to diet
esters (LOVAZA)
to reduce
hypertriglyceridemia (i.e.,
defined as TG blood
concentrations 500 mg/dl or
greater)
ONCOLOGY, AXITINIB • axitinib (INLYTA)
FDA Indication: For the
treatment of advanced renal
cell cancer after failure of 1
prior systemic therapy.
TAR Group Name
OMEGA 3 FATTY
ACIDS-LOVAZA
OPHTHALMICCYCLOSPORINE
• cyclosporin ophth.
drops (RESTASIS)
Reduced tear production
associated with
keratoconjunctivitis sicca or
vision threatening dry eye
disease
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
Required Medical
Information
Triglyceride lab reports
Treatment naive. Cancers
other than advanced renal
cell.
Oncology notes detailing
treatment history and
response to treatment.
Objective measure of tear
production is helpful
(Schirmers).
Age Restriction
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
TBD
Ages under 21 will Oncologist
be screened for
CCS eligibility and
referral when
appropriate. For
members under 21
already enrolled in
CCS, claims are
submitted to CCS
in all counties
except Marin,
Napa, Solano and
Yolo.
Evaluation and
prescription by
ophthalmologist or
optometrist
Other Criteria
For the treatment of hypertriglyceridemia with
12 hour fasting TG greater than 500mg/dl. Trial
and failure of niacin, formulary statins and
fenofibrate
TBD
Limited to the treatment of advance renal cell
cancer, with documentation of failure (defined as
intolerance requiring discontinuation or disease
progression) with a previous systemic therapy
that is FDA approved for the treatment of
advanced renal cell cancer. Approvals will be for
a 2 week supply per fill, dispensed by Diplomat
Specialty Pharmacy.
TBD
Restricted to use for patients whose tear
production is decreased due to ocular
inflammation associated with
keratoconjunctivitis sicca or vision threaatening
dry eye disease, who have failed artificial tears
and/or Lacrisert.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
Drugs included in
TAR Group Name
TAR Group
OPIOID ANALGESICS - • morphine sulfate
LONG ACTING
ER 12-24HR pelletcaps (KADIAN)
• morphine sulfate
ER 24HR multiphase
pellet-caps (AVINZA)
• tapentadol ER
tablets (NUCYNTA
ER)
• oxymorphone ER
tablets (OPANA ER)
OPIOID ANALGESICS - • oxymorphone
SHORT ACTING
(OPANA)
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Covered Use
Exclusion Criteria
For the management of
moderate to severe pain in
patients requiring
continuous, around-the-clock
opioid therapy for an
extended period of time.
For moderate pain or severe
pain.
Required Medical
Information
Trial and failure or
contraindication to use of
morphine sulfate sustainedrelease tablets (generic MS
Contin), methadone and nonformulary fentanyl patches,
at equi-analgesic doses.
Requests must be
accompanied by
documentation of an
appropriate evaluation and
management plan in the
medical record. Consultation
with pain management
consultant may be required.
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Age Restriction
Prescriber Restriction Coverage Duration
Not FDA approved
TBD
for ages less than
18 years old
Details of previous trials of
Not FDA approved
formulary alternatives (doses, for ages less than
results).
18 years old
TBD
Other Criteria
Trial and failure or contraindication to use of
morphine sulfate sustained-release tablets
(generic MS Contin), methadone and nonformulary fentanyl patches, at equi-analgesic
doses.
For Avinza: This formulation is a 24h pelleted
capsule and the package labeling states it should
not be dosed any more often than once ever 24
hours. Therefore there will be no exception to
the criteria limit of once daily dosing. If multiple
daily dosing is required, alternative products
should be considered.
Trial and failure of, or contraindication to, use of
formulary morphine, oxycodone/APAP,
oxycodone, hydromorphone, levorphanol and
non-formulary meperidine.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
ORAL
ANTICOAGULANTS
OXYBUTYNIN GEL
Drugs included in
TAR Group
• apixaban tabs
(ELIQUIS)
• dabigatran capsules
(PRADAXA)
• rivaroxaban tablets
(XARELTO, other than
formulary/code 1
10mg)
• oxybutynin gel
(GELNIQUE)
Covered Use
For Nonvalvular atrial
fibrillation and DVT/PE
treatment & prevention of
recurrence.
For the treatment of an
overactive bladder (OAB)
with symptoms of urinary
frequency, urinary urgency,
or urinary incontinence due
to involuntary detrusor
muscle contractions (includes
neurogenic bladder)
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
Required Medical
Information
Confirmed diagnosis of
Nonvalvular atrial fibrillation.
Clinic notes (and labs)
showing adequate trial of
warfarin and response.
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Age Restriction
Prescriber Restriction Coverage Duration
Ages 0 through 20:
TBD
Subject to PHC CCS
screening and
referral for CCS
eligible conditions.
Not FDA approved
for pediatric use:
Submit safety and
efficacy clinical
studies for any
requests to be
reviewed on a caseby-case basis.
Other Criteria
Atrial Fibrillation: 1) Limited to Nonvalvular atrial
fibrillation. 2) Documentation of an adequate
trial and failure to, or contraindication to
warfarin. Note: Cha2ds2vasc score may be
requested. Guidelines suggest anticoagulation
for score of 2 and greater. For score of 1, may
also consider no anticoagulation, aspirin or these
agents.
DVT/PE treatment: Documentation of an
adequate trial and failure to, or contraindication
to warfarin.
Not indicated for
pediatric use.
Requires documentation of trial and failure with
(or contraindications to) formulary/Step
oxybutynin ER or formulary/Step oxybutynin OTC
patch, formulary tolterodine LA (TAR required if
age is less than 65) and preferred non-formulary
agent fesoterodine (Toviaz). For members with
inability to swallow oral dosage forms: trial and
failure of formulary/step oxybutynin OTC patch.
TBD
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
PAH-ADCIRCA
PAH-ERA
Drugs included in
TAR Group
• tadalafil 20mg
tablets (ADCIRCA)
• ambrisentan tablets
(LETAIRIS)
• bosentan tablets
(TRACLEER)
Covered Use
Pulmonary HypertensionPhosphodiesterase 5
inhibitors are limited to
treatment of Pulmonary
Arterial Hypertension (PAH)
with etiology World Health
Organization (WHO) Group 1
and WHO or New York Heart
Association (NYHA)
functional class II or more
Coverage of Endothelin
Receptor Antagonists (ERA) is
limited to Pulmonary Arterial
Hypertension (PAH) with
etiology World Health
Organization (WHO) Group 1
and WHO or New York Heart
Association (NYHA)
functional class II or more.
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
Evidence of use of an illicit
drug known to cause
pulmonary hypertension
(positive random tox
screen).New Starts: Failure
to adequately document why
preferred agent, sildenafil
20mg (Revatio) cannot be
used
Required Medical
Information
Heart catheterization results,
Vasoreactivtity test results (if
done), WHO Group number
(etiology) and WHO or NYHA
Functional Class number
(functional assessment).
Specialists notes including
assessment and treatment
plan. Random urine tox
screen is required for all
patients new to tadalafil
treatment. Repeat random
tox screen required for
renewals (at least yearly)
when etiology is WHO group
I/drug induced.
Heart catheterization results,
vasoreactivtity test results (if
done), WHO Group number
(etiology) and WHO or NYHA
Functional Class number
(functional assessment).
Specialist notes including
assessment and treatment
plan. If WHO Group 1, drug
induced: urine tox screen
may be requested (include
with TAR if already available).
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Age Restriction
Ages under 21
require screening
for CCS eligibility
with referrals
when appropriate.
Prescriber Restriction
Prescribed by or on
recommendation of
Pulmonologist or
Cardiologist
Coverage Duration
6 fills/ 6months per
TAR (30 day supply
limit) when criteria
has been met.
Other Criteria
New Starts (new to tadalafil therapy): Must have
adequate trial and failure or contraindication
documented to preferred PDE-inhibitor,
sildenafil 20mg (Revatio). In addition: Right
heart cath must have been performed prior to
initiation of advanced treatment. For members
with a positive vasoreactivity test in the patient
history, documentation of failure or
contraindication to calcium channel blocker is
required. If drug-induced PAH, member must be
off offending agent (a periodic random tox
screen may be requested). Please note that this
drug is not covered for the treatment of
impotence or erectile dysfunction, per Federal
Regulation and State Operating Instruction letter
as of 1/1/06. It is a violation of Federal and State
regulations to submit requests for PAH
treatment if in fact the patient is being treated
for impotence/ED.
Ages under 21
require screening
for CCS eligibility
with referrals
when appropriate.
Prescribed by or on
recommendation of
Pulmonologist or
Cardiologist
TBD
Right heart cath must be performed prior to
initiation of advanced treatment. For members
with a positive vasoreactivity test in the patient
history, documentation of failure or
contraindication to calcium channel blocker is
required. Trial and failure of (or contraindication
to) sildenafil or tadalafil is required. For druginduced PAH, member must be off the offending
agent(s), periodic urine tox screen may be
requested.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
Drugs included in
TAR Group Name
TAR Group
PAH- PROSTACYCLIN • epoprostenol IV
(FLOLAN)
• epoprostenol
inhalation (VELETRI)
• treprostinil IV/SQ
(REMODULIN)
• treprostinil
inhalation (TYVASO)
Covered Use
Epoprostenol, Treprostinil
Sodium, Treprostinil (Flolan,
Veletri, Remodulin, Tyvaso):
Pulmonary Arterial
Hypertension, with etiology
WHO Group I and
functional/symptom WHO
Class (or NYHA Class) III or
more.
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
Members with drug-induced
PAH: evidence that the
offending agent continues to
be in use is reason to exclude
coverage.
Required Medical
Information
WHO (World Health
Organization) Group
(identifies etiology), WHO
Class or NYHA Class
(identifies
functional/symptom severity,
Cardiologist or Pulmonologist
clinic notes which include
heart cath, vasoreactivity test
if included at time of cath,
result of prior use of calcium
channel blockers (if
vasoreactivity positive). For
functional class III,
documentation of responses
to both a PDE-5 inhibitor
(sildenafil or tadalafil) AND
an endothelial receptor
antagonist (bosentan or
ambrisentan).
Age Restriction
Ages 0-20: TAR
review includes
screening for CCS
eligibility and
referral to CCS
when appropriate.
Prescriber Restriction Coverage Duration
Prescribed by
TBD
Cardiologist or
Pulmonologist.
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Other Criteria
Must be prescribed by a cardiologist or a
pulmonologist. Limited to WHO Group 1 and
WHO Class III or greater. For Drug-Induced PAH,
a tox-screen may be requested at any time.
Right Heart cath must be performed prior to
intiation of advanced treatment, such as Flolan
or Remodulin. Members who have had a
positive vasoreactivity test during heart cath
must have a trial of a calcium channel
blocker/CCB (include results of CCB use with
TAR). WHO/NYHA Class III requires previous trial
of Sildenafil (Revatio) or tadalafil (Adcirca) and
bosentan (Tracleer) or ambrisentan (Letairis).
TAR must include response (or contraindication)
to those agents as well (waived for documented
Class IV).
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
Drugs included in
TAR Group Name
TAR Group
PAH-PROSTACYCLIN • iloprost inhalation
II
(VENTAVIS)
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Covered Use
Exclusion Criteria
For the treatment of
pulmonary hypertension
(pulmonary arterial
hypertension WHO Group 1)
to improve a composite
endpoint consisting of
exercise tolerance, symptoms
(NYHA Class), and lack of
deterioration
Required Medical
Age Restriction
Information
(A)For PAH with etiology
WHO group 1 and WHO or
NYHA functional class III or
more. (B)If drug-induced
PAH, member must be off
the offending agent(s). Urine
tox screen may be requested.
(C)Functional Class III: Trial
and failure of (or
contraindication to) both a
PDE-5 inhibitor (sildenafil or
tadalafil) AND an endothelial
receptor antagonist
(bosentan or ambrisentan)
AND preferred inhaled
prostacyclin analog
treprostinil (Tyvaso).
Prescriber Restriction Coverage Duration
Prescribed by
TBD
Cardiologist or
Pulmonologist
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Other Criteria
(A) Right heart cath must be performed prior to
initiation of advanced treatment. (B)If positive
vasoreactivity test in pt. history, documentation
of trial and failure of (or contraindication to)
calcium channel blockers is required.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Required Medical
Information
Heart catheterization results,
Vasoreactivtity test results (if
done), WHO Group number
(etiology) and WHO or NYHA
Functional Class number
(functional assessment).
Specialists notes including
assessment and treatment
plan. If WHO Group 1, drug
induced: urine tox screen
may be requested (include
with TAR if already available).
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
TAR Group Name
PAH-REVATIO
Drugs included in
TAR Group
• sildenafil 20mg
tablets (REVATIO)
PARKINSON'S
DISEASE-AZILECT
• rasagiline (AZILECT) For the treatment of
Parkinson's disease
Diagnosis of Parkinsons
Disease and documentation
of failure or contraindication
to carbidopa/levodopa
treatment.
TBD
Trial and failure of first line adjunct therapy to
carbidopa/levodopa treatment in Parkinson's
Disease.
PLATELET
INHIBITORSAGGRENOX
• dipyridamole/ ASA
200mg/25mg ER
capsules
Reasons why clopidogrel
(Plavix), or dipyridamole and
ASA cannot be used.
TBD
Prophylactic treatment for reduction of
atherosclerotic events in member who have
failed on or intolerant to generic dipyridamole
and aspirin or Plavix
Covered Use
Exclusion Criteria
Pulmonary HypertensionPhosphodiesterase 5
inhibitors are limited to
treatment of Pulmonary
Arterial Hypertension (PAH)
with etiology World Health
Organization (WHO) Group 1
and WHO or New York Heart
Association (NYHA)
functional class II or more.
For stroke prophylaxis in
patients who have sustained
a previous transient ischemic
attack (TIA) or completed
ischemic stroke due to
thrombosis.
Age Restriction
Ages under 21
require screening
for CCS eligibility
with referrals
when appropriate.
Prescriber Restriction Coverage Duration
Prescribed by or on
TBD
recommendation of
Pulmonologist or
Cardiologist
Other Criteria
Right heart cath must be performed prior to
initiation of advanced treatment. For members
with a positive vasoreactivity test in the patient
history, documentation of failure or
contraindication to calcium channel blocker is
required. If drug-induced PAH, member must be
off offending agent (a periodic random tox
screen may be requested). Please note that this
drug is not covered for the treatment of
impotence or erectile dysfunction, per Federal
Regulation and State Operating Instruction letter
as of 1/1/06. It is a violation of Federal and State
regulations to submit requests for PAH
treatment if in fact the patient is being treated
for impotence/ED. Healthy Kids: In addition to
the above, CCS screening will be included with
TAR review, with referral if appropriate.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
PPI
PREVACID SOLUTAB
Drugs included in
TAR Group
• dexlansopra- zole
caps (DEXILANT)
• omeprazole-sodium
bicarbonate caps,
pwd (ZEGERID)
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Covered Use
Exclusion Criteria
For symptomatic treatment Non-FDA approved dose or
of erosive GERD (erosive
duration
esophagitis) and non-erosive
GERD, including treatment of
pyrosis (heartburn) related to
GERD.
• lansoprazole
Per FDA Indications (Facts
Non-FDA approved dose or
soluble tablet
and Comparisons), Key:
duration
(PREVACID SOLUTAB) D=Dexlansoprazole,
E=Esomeprazole,
L=Lansoprazole,
O=Omeprazole,
P=Pantoprazole,
R=Rabeprazole. Duodenal
Ulcer: L, O, R. H. Pylori: E, L,
O, R (in combination with
antibiotics). Gastric ulcer: E,
L, O. Erosive Esophagitis: D,
E, L, O, P, R. GERD (adult): D,
E, L, O, P, R. GERD (child): E,
L, O, R. Hypersecretory: E, L,
O, P, R.
Required Medical
Age Restriction
Information
Documentation of patientAdults (18+)
specific diagnosis, current
status of condition, expected
duration of treatment,
treatment history (including
doses, duration and reasons
for failure). GI consult notes
if any.
Documentation of patientspecific diagnosis, current
status of condition, expected
duration of treatment,
treatment history (including
doses, duration and reasons
for failure). GI consult notes
if any.
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
Other Criteria
None
See Other Criteria for Limited to the treatment of FDA approved
specific duration
conditions and unresponsive to trials of
formulary lansoprazole, omeprazole (Rx or OTC),
rabeprazole, pantoprazole AND formulary/STEP
Nexium 24 hour OTC at MAXIMUM doses.
Requested dose and duration must be consistent
with package labeling and nationally recognized
treatment guidelines. BID or 2 QD dosing
requires trial and failure 1 QD dosing (with total
daily dose still being consistent with package
labeling or national treatment guidelines).
Coverage duration: Healing of erosive esophagitis
up to 8 weeks. Maintenance of erosive
esophagitis and symptomatic relief of heartburn
up to 6 months. Symptomatic GERD for 4 weeks.
None
TBD
Reserved for members unable to swallow
capsules. Must have documentation of trial and
failure of both formulary lansoprazole
suspension and lansoprazole capsules sprinkled
on food. Note: package labeling for Prevacid
Capsules includes tube administration
instructions.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
PROLIA
PROMETRIUM
Drugs included in
TAR Group
• denosumab
injection (PROLIA)
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Covered Use
Exclusion Criteria
Women: Postmenopausal
osteoporosis or members
receiving an aromatase
inhibitor for breast cancer.
Men: Osteoporosis or
members receiving androgen
deprivation therapy for
prostate cancer.
• progesterone,
Endometrial hyperplasia,
micronized, capsules secondary amenorrhea
(PROMETRIUM)
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Required Medical
Age Restriction
Prescriber Restriction Coverage Duration
Information
Documentation is to include: Not FDA approved
TBD
BMD T-score, risk factors
for pediatric use
(such as low trauma fracture
history, chronic oral
corticosteroids), cancer
status (if any), other
medications tried and
reasons for failure.
TBD
Other Criteria
For Members with Osteoporosis (Men and
Postmenopausal Women), the following is
required: (1) A documented history of
osteoporotic fracture(s), or at least 2 risk factors,
such as: (a)History of multiple recent low trauma
fractures, (b)BMD T-Score of -2.5 or below,
(c)Chronic corticosteroid use. (2)Previous trial
and failure (or contraindications) with other
available osteoporosis therapy, including
formulary alendronate and at least one nonformulary bisphosphonate (of the non-formulary
oral agents, ibandronate/generic Boniva is
preferred).
For members receiving Androgen Deprivation
Therapy for Prostate CA, the following is
required: (1) Cancer must be non-metastatic
disease. (2) Member has had bilateral
orchiectomy. (3) Member on Lupron or other
GnRH analog for 12 months or more (shorter
treatment will not affect bone mass).
For members receiving Aromatase Inhibitor for
Breast CA, the following is required: (1) Requires
BMD T-Score of -1.0 or below AND Previous trial
and failure (or contraindication) with formulary
alendronate and non-formulary/preferred
ibandronate (generic Boniva, oral).
Note: Not all patients will require treatment, and
bisphosphonates are the preferred treatment per
UpToDate.
Trial and failure of, or contraindication to
formulary medroxyprogesterone or formulary
progesterone injection. (Rx Qty limit 12/month).
Medically accepted off-label uses considered on
a case-by-case basis.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
RIFAXIMIN
RITUXAN
Drugs included in
TAR Group
• rifaximin tablets
(XIFAXAN)
• rituximab IV
(RITUXAN)
Covered Use
Xifaxan 200mg: For the
treatment of patients 12 or
older with travelers diarrhea
caused by noninvasive strains
of Escherichia coli.
Xifaxan 550mg: For reducing
the risk of overt hepatic
encephalopathy recurrence
in adults 18 and older.
For rheumatoid arthritis in
combination with
methotrexate (not first-line
treatment, see other criteria
section).
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
Per FDA labeling, Xifaxan
should not be used for
diarrhea complicated by
fever or blood in the stool or
diarrhea due to pathogens
other than E. coli.
Required Medical
Information
Documentation should
include: specific diagnosis
consistent with dosing
requested (inconsistencies
may delay review), history of
HE events requiring
hospitalization, current status
of disease, previous
treatments tried (with doses
and reasons for failure),
MELD score if available. Note
that Xifaxan has not been
studied in patients with
MELD over 25 (there is
increased systemic exposure
with more severe hepatic
dysfunction. See package
labeling for warnings and
precautions, specific
populations and clinical
pharmacology).
Rheumatologist notes, lab
reports, disease activity
score, documentation of
previous treatments (dose,
duration, reasons for failure).
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Age Restriction
Prescriber Restriction Coverage Duration
200mg: 12 and
TBD
older. 550mg: 18
and older.
TBD
Other Criteria
Travelers Diarrhea: Treatment of members age
12 and older with a previous trial and failure of
ciprofloxacin or azithromycin. Limited to 200mg
strength, maximum #9 tablets.
Hepatic Encephalopathy (HE): Prevention or
treatment of HE recurrence in patients 18 years
or older who have had an adequate trial and
failure of lactulose. Limited to 550mg tablets,
#60.
(1) Trial and failure of at least 3 month trials of
Enbrel and Humira (anti-TNF therapies) AND
Orencia and xeljanz(non-TNF inhibitor). (2)
Must be used with methotrexate (MTX)(or in
case of MTX intolerance/side effect-use
leflunomide). (3) Requires Disease Activity
Score.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
SEDATIVEHYPNOTICS
SERMS-EVISTA
Drugs included in
TAR Group
• ramelteon tabs
(ROZEREM)
• temazepam caps,
non-formulary
strengths (RESTORIL
7.5mg, 22mg)
• triazolam tabs
(HALCION)
Covered Use
For the treatment of
insomnia
• raloxifene (EVISTA) 1. Treatment and prevention
of osteoporosis in
postmenopausal women. 2.
Reduction of risk of invasive
breast cancer in
postmenopausal women with
osteopororisis. 3. Reduction
of risk of invasive breast
cancer in postmenopausal
women at high risk of
invasive breast cancer.
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
Required Medical
Information
Age Restriction
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
TBD
TBD
Other Criteria
Trial and failure of non-drug treatment of chronic
insomnia and formulary agents: zolpidem
(Ambien), zaleplon (Sonata), temazepam 15,
30mg, flurazepam.
For osteoporosis, trial and failure of formulary
alendronate (Fosamax) or documented
contraindication to use of alendronate. Prior
authorization approved for FDA approved
indication of reduction in risk of invasive breast
cancer in postmenopausal women with
osteoporosis or in postmenopausal women at
high risk of invasive breast cancer.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
SNRI
Drugs included in
Covered Use
TAR Group
• vortioxetine tablets For the treatment of major
(BRINTELLIX)
depressive disorder.
• desvenlafaxine
tablets (PRISTIQ,
KHEDEZLA)
• vilazodone tablets
(VIIBRYD)
SNRIS-SAVELLA
• milnacipran tabs
(SAVELLA)
For the treatment of
fibromyalgia
SSRIS-PAXIL CR
• paroxetine ER 24hr For the treatment of major
tablets (PAXIL CR)
depression
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
Required Medical
Age Restriction
Information
PHQ9 score (Patient Health 18 years and older
Questionaire). Continuing
Care: For new member to
PHC, without significant claim
history to show continuation
of care, TARs should include
the refill history from
pharmacy and/or clinic notes
documenting members
history with the medication.
Documentation of previous
treatments used (including
dose, duration and
response).
Adults only. The
use of Savella in
pediatric patients
is not
recommended per
the manufacturer.
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
Psychiatric evaluation TBD
required unless PHQ9
is greater than 20 and
a psychiatrist is not
readily available for
consult.
Other Criteria
New Starts: Prior authorization is considered for
members in whom multi-drug resistance is
apparent following failure with multiple
therapeutic trials: Must have failure to remission
with 4 prior agents (SSRI, SNRI, Mirtazapine,
Venlafaxine, Bupropion, MAO-I (carve-out), alone
and/or in combination, also adjunctive cognitive
therapy, consideration of Lithium, T3,
aripiprazole (carve-out). A Psychiatric Consult is
required for re-evaluation of diagnosis.
Submission of PHQ9 Score is required: Prior
Authorization allowed with psychiatrist
confirmation of diagnosis and PHQ9 greater than
14. Prior Authorization allowed for nonpsychiatrist if psychiatrist is not available for
consult and PHQ9 greater than 20 and other
criteria have been met.
Continuing Care: For new members without
significant claim history to show continuation of
care, TARs should include the pharmacys refill
history and/or clinic notes documenting member
history with the medication.
TBD
Limited to the treatment of Fibromyalgia with
trials and failures of a TCA, gabapentin and
pregabalin.
TBD
New Starts: For treatment in members who have
failed or have contraindications to 2 formulary
SSRIs: fluoxetine, paroxetine, sertraline or
citalopram.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
STATINS
STATINS WITH
EZETIMIBE
Drugs included in
TAR Group
• fluvastatin ER tabs
(LESCOL XL)
• pitavastatin tabs
(LIVALO)
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Covered Use
Exclusion Criteria
For the treatment of
hypercholesterolemia,
hyperlipoproteinemia, and or
hypertriglyceridemia as an
adjunct to dietary control.
• simvastatin/
For use as an adjunctive
ezetimibe (VYTORIN) therapy to diet for patients
with primary (heterozygous
familial and nonfamilial)
hypercholesterolemia or
mixed hyperlipoproteinemia.
Required Medical
Information
Age Restriction
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
TBD
TBD
Other Criteria
Must have trial and failure of simvastatin,
fluvastatin 80mg/day (40mg BID), lovastatin
80mg, pravastatin 80mg AND atorvastatin 80mg.
Trial and failure or contraindication to at least 2
formulary statins, one of which must be
atorvastatin.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
STATINS-CRESTOR
SYNAGIS
Drugs included in
TAR Group
• rosuvastatin tabs
(CRESTOR)
• palivizumab
injection (SYNAGIS)
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Covered Use
Exclusion Criteria
For the treatment of
hypercholesterolemia,
hyperlipoproteinemia, and or
hypertriglyceridemia as an
adjunct to dietary control.
For respiratory syncytial virus
(RSV) infection prophylaxis to
prevent serious infection of
the lower respiratory tract in
pediatric patients at high risk
of RSV disease, including
those with hemodynamically
significant congenital heart
disease
(1)Incomplete Synagis
Enrollment form. (2)Infants
born grather than 29 wks
without documentation of
significant chronic lung
disease, congenital heart
disease,
neuromuscular/other
anomaly impairing upper
airway clearance or severe
immunodeficiency. (3)Infants
born before 29 wks who are
older than 12 months at the
start of RSV season.
Required Medical
Age Restriction
Information
Clinical documentation of
failure (inadequate control)
or contraindications (allergies
or intolerable side effects) to
formulary alternatives.
Diplomat Pharmacy (PHC
contracted specialty pharmacy)
is to complete and submit the
Synagis Enrollment form which
includes: CCS status,
Gestational age, birth weight,
current weight, presence of
congenital heart disease,
presence of chronic respiratory
conditions, congenital
respiratory anomolies,
additional risk factors relating to
prematurity, number of siblings
at home, other medications, etc,
as well as dosing info, projected
growth/dosing needs. To
support diagnosis of chronic
lung disease, must include:
(1)Diagnosis of Chronic Lung
Disease of prematurity AND
(2)Documentation that member
continues to require medical
support (chronic corticosteroid
therapy, bronchodilator
therapy, or supplemental
oxygen) during the six month
period before the start of RSV
season.
Per criteria/policy
(dependent upon
gestational age at
birth, age at start
of RSV season and
other risk factors
present)
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
12 months
Other Criteria
Require trial and failure (or contraindications) to
at least 2 of the following, one of which must be
atorvastatin: simvastatin (any strength),
fluvastatin 40mg, lovastatin 40mg, pravastatin
80mg, or atorvastatin 80mg. Doses less than
40mg/day are limited to 1/2 tablet per day (15
per month).
For children enrolled
in CCS: must be
prescribed by a CCS
paneled physician.
For prophylaxis of RSV in Infants who are: (1)
Born before 29 weeks, 0 days of gestation who
are younger than 12 months at the start of RSV
season. (2) Younger than 12 months with CLD of
prematurity, defined as gestational age less than
32week/0d and required greater than 21% O2 for
28 days or more after birth. (3) Aged 12-24
months with CLD of prematurity AND continue to
require medical support during the 6mo period
prior to RSV season. (4) children 12months or
younger with hemodynamically significant
congenital heart disease (including those with
acyanotic disease & receiving Rx to control CHF &
will require surgical intervention, moderate to
sevever PAHT, acyanotic disease and request is
made in conjunction with a pediatric cardiologist.
(5) children younger than 24 months who
undergo cardiac transplant during the RSV
season. In addition, certain scenarios are
evaluated on a case-by-case basis: (1) children
less than 12 months with neuromuscular disease
or congenital anomaly which impairs ability to
clear secretions from the upper airway. (2)
Infants & children with severe
immunodeficiencies. For complete policy, see HS
Policy Number MPRC4025.
Per current CDC
recommendations
(usually not to exceed
5 doses or the end of
RSV season).
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
TESTOSTERONE
Drugs included in
TAR Group
• testosterone,
transdermal forms
(eg, ANDRODERM,
ANDROGEL, AXIRON,
FORTESTA, VOGELXO,
etc)
• testosterone
cypionate injection
(DEPOTESTOSTERONE)
• testosterone
enanthate injection
(DELATESTRYL)
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Covered Use
Exclusion Criteria
Injection (cypionate and
enanthate): treatment for
male members with
confirmed diagnosis of
primary or secondary
hypogonadism. Other (patch,
gel, pellet, cream): Same as
above, but limited to those
members who have failed
injection therapy (or have
contraindications).
Required Medical
Information
New to therapy: Current
testosterone lab reports,
drawn prior to 9am, within
the last 90 days and prior to
initiation of treatment.
Continuation of care
requests: the baseline
testosterone lab reports,
drawn prior to initiation of
treatment, upon which
diagnosis of hypogonadism
was based.
Age Restriction
Prescriber Restriction Coverage Duration
TBD
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Other Criteria
Treatment for male members 18 years of age or
older diagnosed with primary or secondary hypogonadism: (A )Lab confirmed low testosterone
level, drawn before 9am, within 90 days of
request must be provided for initiation of new
therapy. OR (B) A baseline lab before treatment
was started is required for those members new
to PHC who are currently on therapy. Patches,
gel, cream and pellet dosage forms require a trial
and failure of, or contraindication to, injectable
testosterone.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
TOPICAL
ANTIFUNGALS
Drugs included in
TAR Group
• ciclopirox 8% nail
soln (PENLAC NAIL
LACQUER)
TOPICAL ANTIVIRAL
CREAM
• acyclovir cream
(ZOVIRAXZ)
Limited to the treatment of
recurrent herpes labialis (cold
sores)
TOPICAL ANTIVIRAL
OINTMENT
• acyclovir oint.
(ZOVIRAX)
Limited to the treatment of
Herpes genitalis or
mucocutaneous Herpes
simplex infections in
immunocompromised
patients.
TOPICAL IMMUNOSUPPRESSIVEPROTOPIC
• tacrolimus oint.
0.01%
For the treatment of atopic
dermatitis
TOPICAL
PEDICULICIDE I
• benzyl alcohol 5%
(ULESFIA)
For the topical treatment of
pediculosis capitis (head lice
infestation) due to Pediculus
capitis in patients 6 months
of age and older.
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Covered Use
Exclusion Criteria
For the topical treatment of
mild to moderate
onychomycosis of fingernails
and toenails without lunula
involvement, due to
Trichophyton rubrum in
immunocompetent patients
Required Medical
Age Restriction
Information
Reasons why oral terbinafine
(Lamisil) cannot be used and
documentation of: pain,
impairment of normal daily
activities, and planned nail
removal at frequent intervals
by a healthcare professional.
Documention failure of
adequate trial with formulary
oral antiviral agents, or
documentation of
contraindication to oral
antivirals.
FDA approved for
ages 2 yrs and
older for 0.03%
and ages over
15yrs or older for
0.1%
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
Treatment may be
authorized up to 48
weeks
Other Criteria
Treatment of onychomycosis in members for
whom oral Lamisil is contraindicated and
member must be experiencing pain that
interferes with normal activity or be
immunocompromised. Treatment may be
authorized up to 48 weeks with documentation
of removal of the unattached, infected nail, as
frequently as monthly, by a health care
professional
TBD
Documention of trial and failure or
contraindications to preferred antiviral agents
indicated for herpes labialis (cold sores):
famciclovir, valacyclovir and non-formulary
preferred topical penciclovir (Denavir).
TBD
Requires trial and failure of (or contraindication
to) formulary oral antivirals (acyclovir,
famciclovir, valacyclovir).
TBD
Treatment of moderate-to-severe atopic
dermatitis for members who are intolerant to
alternative conventional therapies, and for when
alternative, conventional therapies are deemed
inadvisable because of potential risks. Protopic
0.03% is formulary for ages 5 and under with
limit 30g/Rx.
TBD
Trial and failure or contraindication to
permethrin or malathion.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
TOPICAL ROSACEA
AGENTS
Drugs included in
TAR Group
• metronidazole 1%
topical gel
(METROGEL 1%)
TRIPTANS-NON ORAL • zolmitriptan nasal
spray (ZOMIG)
Covered Use
For the treatment of acne
rosacea
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
Required Medical
Information
Age Restriction
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
TBD
Other Criteria
Trial and failure of formulary metronidazole
0.75% gel
For the acute treatment of
migraine with or without
aura
Reasons why member cannot
use sumatriptan nasal spray
or zolmitriptan oral/ODT. For
requests exceeding 1 unit per
month (6 doses): neurology
consult notes.
TBD
Documentation of trial and failure of formulary
sumatriptan nasal spray and Zolmitriptan ODT
(TAR required). Request limited to 1 unit per
month (6 doses). Requests exceeding 1 per
month will require documentation that member
has had a consult with a neurologist and is
receiving adequate prophylactic therapy.
TRIPTANS-ORAL
• almotriptan tabs
(AXERT)
• frovatriptan tabs
(FROVA)
• eletriptan
tabs (RELPAX)
For the treatment of acute
migraine headache attacks
with or without aura
Documentation of trial and
failure of formulary
sumatriptan, and rizatriptan
oral tablets, as well as
preferred-Non-Formulary
agent Zolmitriptan (TAR
required).
TBD
Requests are limited to #12/month. Requests
exceeding #12 per month will require
documentation that member has had a consult
with a neurologist and is receiving adequate
prophylactic therapy.
TRIPTANS-ORAL
PREFERRED
• zolmitriptan tablets For the treatment of acute
(ZOMIG)
migraine headache attacks
• zolmitriptan ODT
with or without aura
(ZOMIG ZMT)
Documentation of trial and
failure of formulary
sumatriptan and rizatriptan.
TBD
Requests are limited to #12/month. Requests
exceeding #12 per month will require
documentation that member has had a consult
with a neurologist and is receiving adequate
prophylactic therapy.
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
TYKERB
Drugs included in
TAR Group
• lapatinib (TYKERB)
Covered Use
Adjunctive 2nd line
treatment of breast cancer
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
Required Medical
Information
Oncology notes detailing
treatment history and
response to treatment.
Age Restriction
Prescriber Restriction
Ages under 21 will Oncologist
be screened for
CCS eligibility and
referral when
appropriate. For
members under 21
already enrolled in
CCS, claims are
submitted to CCS
in all counties
except Marin,
Napa, Solano and
Yolo.
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Coverage Duration
Limited to 2 week
supply (#70 or #84)
for the first 2 months
of therapy
Other Criteria
For members also taking capecitabine (Xeloda):
Limited to those who have: (1)Advanced or
metastatic breast cancers that overexpress HER2.
(2)Previously received an anthracycline, a taxane
and trastuzumab (with disease progression on
the latter before initiation of Tykerb). Limit 5 per
day. For members also taking letrozole (Femara):
Limited to those who have: (1)Postmenopausal
disease. (2)HER2 overexpression. (3)Hormonal
therapy is indicated. Limit 6 per day.
VANCOMYCIN
• vacomycin oral
For the treatment of
capsules (VANCOCIN) pseudomembranous colitis
due to Clostridium difficile
Documented failure of
metronidazole.
TBD
Limited to use in gastrointestinal infections due
to Clostridium difficile (C. diff.) with trial and
failure of metronidazole. Notes: (1) Not
systemically absorbed (therefore not indicated
for systemic infections) and (2) Compounded oral
solution is preferred for therapy anticipated to
be greater than 5 days.
VRE-LINEZOLID
• linezolid (ZYVOX)
Culture and sensitivity
reports, any relevant clinical
notes available such as
hospital admit/discharge
note or infectious disease
consult.
TBD
Use limited to VRE. Note: for non-VRE
infections, including MRSA, formulary
alternatives are available.
For the treatment of
infections due to vancomycinresistant enterococci (VRE).
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.
EFFECTIVE DATE: JANUARY 1, 2015
TAR Group Name
WEIGHT LOSS STIMULANT BASED
AGENTS
XELJANZ
Drugs included in
TAR Group
• benzphetamine
tabs (DIDREX)
• diethlypropion tabs
(TENUATE)
• phendimetrazine
tabs (BONTRIL)
• phentermine tabs
(ADIPEX-P)
• tofacitinib tablets
(XELJANZ)
Covered Use
Limited to adults with
baseline BMI 30 or more, or
BMI 27 with hypertension,
dyslipidemia, coronary heart
disease, diabetes or sleep
apnea.
For the treatment of adult
patients with moderately to
severely active rheumatoid
arthritis (RA) who have had
an inadequate response or
intolerance to methotrexate
as monotherapy or in
combination with
methotrexate or other
nonbiologic diseasemodifying antirheumatic
drugs (DMARDs).
TREATMENT AUTHORIZATION (TAR) CRITERIA GUIDELINES
Exclusion Criteria
Including, but not limited to:
Failure to document
continued benefit (weight
gain or no weight reduction
over a 3 month prior auth
period), evidence of potential
health risk/contraindication
such as abnormal EKG,
uncontrolled hypertension,
symptoms of pulmonary
arterial hypertension or other
evidence that suggest risks
may outweigh benefits.
Failure to incorporate nondrug treatment/lifestyle
changes (supervised diet and
exercise) with medical
treatment.
Required Medical
Age Restriction
Information
New TARS require current
Adults only (18
HT, WT, BP and clinic notes and older).
as described in Other Criteria
section. Renewals require
HT, updated WT and BP and
clinic notes as described in
Other Criteria section.
Nutritional consult may be
requested.
Specialist clinic notes
documenting disease course,
previous therapies tried and
responses (including Enbrel
or Humira), current
evaluation (lab and imaging
reports as appropriate),
treatment plan, Disease
Activity Score.
PARTNERSHIP HEALTHPLAN OF CALIFORNIA
Prescriber Restriction Coverage Duration
Must not be outside 3 months
scope of usual practice
(eg, not approved for
DDS, OD, or
physician/PA
specialties unpracticed
in the areas of general
medicine and
cardiovascular
screening, such as
Ophthalmology or
Psychiatry.
TBD
Other Criteria
Clinic notes showing failure to supervised diet
and exercise, failure of formulary OTC Orlistat,
and that the member will continue with diet and
exercise while on drug treatment. Renewals:
documentation of ongoing benefit and that the
benefits outweigh risks. Note that assistance
with TOPS enrollment can be obtained through
PHC Member Services Department.
Requires diagnosis of rheumatoid arthritis,
meeting PHC criteria for biologics per
Enbrel/Humira criteria, but with clinic notes
documenting trial and failure of (or
contraindication to) Enbrel or Humira (dosed
every other week).
Note that criteria apply to the drug entity specified by the generic name, and that brand (trade) names are shown for reference or example only; additional criteria apply to brand requests when generic is available.