Download September 2006 - Highmark Blue Shield

December 2007
________________________________________________
4th Quarter Update:
Highmark Drug Formulary
Enclosed is the 4th Quarter 2007 update to the Highmark Drug Formulary and pharmaceutical management
procedures. The Formulary and pharmaceutical management procedures are updated on a quarterly basis,
and the enclosed changes reflect the decisions made in September 2007 by our Pharmacy and Therapeutics
Committee. These updates are effective on the dates noted throughout this document.
As an added convenience, you can also search the Highmark Drug Formulary online at
http://highmark.formularies.com. This function allows you to search by the drug name or therapeutic class.
You can also find other helpful information regarding the prescription drug program from our online
Resource Center under the Pharmacy/Formulary Information link. (NaviNet® users: Simply click on the
Resource Center button for quick access to the Pharmacy/Formulary Information link.)
Formulary changes will be reflective of both the Highmark Select/Choice Formulary (formerly the
Highmark Closed/Incentive Formulary) and the Highmark Medicare-Approved Select/Choice Formulary.
For each section, please refer to the header description to obtain information specific to that formulary.
ƒ
Section I contains changes to the Highmark Select/Choice Formulary.
ƒ
Section II contains changes to the Highmark Medicare-Approved Select/Choice Formulary. The
Highmark Medicare-Approved Select/Choice Formulary can also be searched online at
http://highmark.medicare-approvedformularies.com.
If you have any questions, contact Provider Service or call Pharmacy Affairs, toll-free,
at 1-800-600-2227.
(over, please)
Highmark Drug Formulary Update
December 2007
Section I.
Highmark Select/Choice Formulary (Formerly Closed/Incentive Formulary)
A.
Changes to the Highmark Select/Choice Formulary
The Highmark Pharmacy and Therapeutics Committee has reviewed the medications listed in the following tables.
Please note that since the Highmark Select/Choice Formulary is a complete subset of the Open Formulary, all
medications added to the Select/Choice Formulary are automatically added to the Open Formulary. For your
convenience, you can search the Highmark Select/Choice Formulary online at http://highmark.formularies.com.
An electronic copy of the Highmark Select/Choice Formulary for use with a portable handheld device can be
downloaded free by visiting www.epocrates.com.
Table 1: Products Added (All products added to the formulary effective immediately unless otherwise
noted)
Brand Name
Generic Name
Comments
®
AndroGel §
testosterone 1% gel
A topically applied testosterone product for the
treatment of hypogonadism
Exelon® Patch
rivastigmine transdermal
An acetylcholinesterase inhibitor indicated for the
system
treatment of mild to moderate Alzheimer’s
dementia and mild to moderate dementia
associated with Parkinson’s disease
Exforge®
amlodipine/valsartan
A calcium channel blocker/angiotensin receptor
blocker combination for the treatment of
hypertension
FreeStyle Lite
blood glucose test strip
Multiple other blood glucose test strips are also
on the formulary.
Humatrope®§
somatropin
Norditropin® is also on the formulary.
™
Janumet
sitagliptin/metformin
A dipeptidyl peptidase-4 (DPP-4)
inhibitor/metformin combination for the treatment
of type II diabetes mellitus
Januvia™
sitagliptin
A dipeptidyl peptidase-4 (DPP-4) inhibitor for the
treatment of type II diabetes mellitus
Letairis™
ambrisentan
An endothelin receptor antagonist (ERA)
indicated for the treatment of pulmonary arterial
hypertension (PAH) (WHO Group 1) in patients
with WHO Class II or III symptoms to improve
exercise capacity and delay clinical worsening
§Effective Jan. 1, 2008
Table 2: Products Not Added*
Brand Name
Generic Name
Chantix™
varenicline
Divigel®
estradiol gel
Enablex®
darifenacin extended release
tablets
Comments
Bupropion and bupropion SR are on the
formulary.
Climara®, Estraderm® and Vivelle-Dot® are on the
formulary.
Detrol®, Detrol® LA, oxybutynin and oxybutynin
ER are on the formulary.
*Physicians may request coverage of these products using the Prescription Drug Medication Request Form, which can be found on Page 8 of the
2008 Highmark Drug Formulary book. You may also access the form online in Highmark’s Provider Resource Center, under Provider Forms; select
Miscellaneous Forms from the fly-out menu.
(continued)
2
A.
Changes to the Highmark Select/Choice Formulary (continued)
Table 2: Products Not Added* (continued)
Brand Name
Generic Name
Comments
Endometrin®
progesterone vaginal insert
Crinone® is on the formulary.
Extina®
ketoconazole foam
Topical forms of ketoconazole are on the
formulary.
®
Lybrel
levonorgestrel/ethynyl
Multiple oral contraceptives are on the formulary.
estradiol
Neupro®
rotigotine transdermal system
Selegiline, carbidopa-levodopa, Comtan®,
Mirapex® and Requip® are on the formulary.
®
VesiCare
solifenacin succinate
Detrol®, Detrol® LA, oxybutynin and oxybutynin
ER are on the formulary.
Xyzal®
levocetirizine
Fexofenadine is on the formulary.
Zyflo CR ™
zileuton extended release
Accolate® and Singulair® are on the formulary.
*Physicians may request coverage of these products using the Prescription Drug Medication Request Form, which can be found on Page 8 of the
2008 Highmark Drug Formulary book. You may also access the form online in Highmark’s Provider Resource Center, under Provider Forms; select
Miscellaneous Forms from the fly-out menu.
Table 3: Products to be Removed* from the Formulary (effective Jan. 1, 2008, unless otherwise
noted)
Brand Name
Comments
Generic Name
MetroGel® 1%¶
metronidazole
Generic metronidazole gel is on the formulary.
Testim®
testosterone 1% gel
Xalatan®
latanoprost
Genotropin®
somatropin
somatropin
Multiple testosterone products are on the
formulary.
Travatan®, Travatan® Z™ and Lumigan® are on the
formulary.
Humatrope® and Norditropin® are on the
formulary.
Humatrope and Norditropin are on the formulary.
Nutropin AQ
somatropin
Humatrope and Norditropin are on the formulary.
Nutropin Depot®
somatropin
Humatrope and Norditropin are on the formulary.
Protropin®
somatrem
Humatrope and Norditropin are on the formulary.
Serostim®
somatropin
Humatrope and Norditropin are on the formulary.
Tev-Tropin®
somatropin
Humatrope and Norditropin are on the formulary.
Nutropin®
®
*Physicians may request coverage of these products using the Prescription Drug Medication Request Form, which can be found on Page 8 of the
2008 Highmark Drug Formulary book. You may also access the form online in Highmark’s Provider Resource Center, under Provider Forms; select
Miscellaneous Forms from the fly-out menu.
¶Effective July 1, 2008
B.
Updates to the Prior Authorization Program
1.
Letairis™ (ambrisentan)
Effective Nov. 1, 2007, Letairis was added to Highmark’s pulmonary arterial hypertension prior
authorization policy. Letairis is an endothelin receptor antagonist indicated for the treatment of pulmonary
arterial hypertension (WHO Group 1) in patients with WHO Class II or III symptoms to improve exercise
capacity and delay clinical worsening.
(continued)
3
B.
Updates to the Prior Authorization Program (continued)
1.
Letairis™ (ambrisentan) (continued)
When a benefit, ambrisentan may be approved when all of the following criteria are met:
• A diagnosis of pulmonary hypertension is substantiated by results from Doppler echocardiography
and/or direct measurement of pulmonary arterial pressure (Pulmonary arterial hypertension is
defined as a mean pulmonary arterial pressure of > or = 25 mmHg, with a pulmonary capillary
wedge pressure of <15 mmHg), AND
• Ambrisentan is prescribed under the supervision of a cardiologist or pulmonologist, AND
• Ambrisentan is to be used for the treatment of pulmonary arterial hypertension (WHO Group I) in
members with WHO functional Class II or III symptoms, AND
• Ambrisentan may be used alone or in combination with calcium channel blockers, angiotensin
converting enzyme (ACE) inhibitors, diuretics, digoxin and anticoagulants, but will not be covered
when used concomitantly with bosentan (Tracleer™), sildenafil (Revatio™), epoprostenol sodium
(Flolan®), treprostinil sodium (Remodulin™) or iloprost (Ventavis®), due to the lack of clinical data
to support combination therapy with these agents.
As there is no established criterion or algorithm for the transitioning of patients from one PAH drug product
to another (e.g., sildenafil to bosentan), the use of two agents concomitantly may be authorized for a period
of up to one month to accommodate potential overlapping titration schedules when changing therapy from
one drug product to another. As stated above, coverage will not be provided for the use of two agents
(bosentan, ambrisentan, sildenafil, epoprostenol, iloprost, treprostinil) as maintenance combination therapy
for PAH.
If approved, authorization may be granted for a period of up to one year.
2.
Humira® (adalimumab)
Effective Sept. 5, 2007, the prior authorization criteria for Humira was revised to allow for use as a first-line
agent in the treatment of moderate to severe active rheumatoid arthritis. When a benefit, coverage for
adalimumab may be approved if members meet the following criteria:
• The member should be under the supervision of a rheumatologist or gastroenterologist, AND
• The member is currently not using another biological DMARD [e.g., etanercept (Enbrel), anakinra
(Kineret), etc.], AND
• Adalimumab is to be used in reducing the signs and symptoms and inhibiting the progression of
structural damage in adults with moderate to severe active rheumatoid arthritis, OR
• Adalimumab is to be used in reducing the signs and symptoms of active arthritis in patients with
psoriatic arthritis, OR
• Adalimumab is to be used in reducing the signs and symptoms of patients with ankylosing
spondylitis, OR
• Adalimumab is to be used in reducing the signs and symptoms of patients with Crohn’s Disease
who have failed two alternative therapies or monotherapy with Remicade.
If approved, authorization may be granted for a period of up to one year.
3.
Nexavar® (sorafenib)
Effective Sept. 5, 2007, the prior authorization criteria for Nexavar was revised to include coverage when
used for the treatment of hepatocellular carcinoma. These revisions were made in response to recent updates
to the NCCN practice guidelines for hepatobiliary cancers.
(continued)
4
B.
Updates to the Prior Authorization Program (continued)
3.
Nexavar® (sorafenib) (continued)
When a benefit, sorafenib may be approved when all of the following criteria are met:
• Sorafenib is to be prescribed under the supervision of an oncologist/hematologist.
• Sorafenib is to be used for the treatment of advanced renal cell carcinoma after treatment with at
least one other prior systemic therapy, OR
• Sorafenib is to be used for the treatment of hepatocellular carcinoma.
Use of sorafenib for disease states outside of these indications should be denied based on the lack of clinical
data to support its effectiveness and safety in other conditions.
If approved, authorization may be granted for a period of up to one year.
C.
Updates to the Managed Prescription Drug Coverage (MRxC) Program
1.
Lyrica™ (pregabalin)
Effective Sept. 5, 2007, the Managed Prescription Drug Coverage (MRxC) policy for Lyrica was revised to
allow for coverage when used for the treatment of fibromyalgia. When a benefit, coverage for pregabalin
for the treatment of fibromyalgia may be approved if members meet the following criteria:
• The member has a documented diagnosis of fibromyalgia as determined by clinical notes including,
but not limited to, confirmation of widespread bilateral pain both above and below the waist for >3
months duration AND the presence of at least 11 of 18 specific tender points AND documented
fibromyalgia-related symptoms (e.g., fatigue, sleep disturbance, neurologic symptoms and/or
exercise intolerance), AND
• The member has a documented trial and failure of at least two additional agents used to treat
fibromyalgia (e.g., tricyclic agents, cyclobenzaprine, SSRIs), one of which must be a tricyclic agent
or cyclobenzaprine.
If approved, authorization may be granted for a period of up to one year.
2.
Subutex® (buprenorphine) and Suboxone® (buprenorphine and naloxone)
Effective Sept. 5, 2007, the Managed Prescription Drug Coverage (MRxC) policy for Subutex and
Suboxone sublingual tablets was revised. Subutex and Suboxone are classified as Schedule III controlled
substances and are indicated for the treatment of opioid dependence. Subutex is used as a single agent for
the initial treatment (induction) of opioid dependence, and Suboxone is used following the initial phase of
therapy. When a benefit, coverage for Subutex and Suboxone may be approved if members meet the
following criteria:
Subutex:
Subutex may be covered for a five-day supply (160 mg) of medication within the last 90 days for the
induction treatment of opioid dependence. Authorization for an additional coverage period can be approved
for female members who are pregnant and require treatment for opioid dependence for the duration of their
pregnancy (up to nine months of treatment, at which time the member can be transitioned to treatment with
the combination tablet). Otherwise, Subutex will not be covered for long-term therapy.
Suboxone:
Suboxone may be approved if a member meets the following criteria:
• The prescribed dose of Suboxone does not exceed 720mg/30 days (24mg/day).
Members who meet the criteria as outlined above will receive automatic authorization at the level of the
(continued)
5
C.
Updates to the Managed Prescription Drug Coverage (MRxC) Program (continued)
2.
Subutex® (buprenorphine) and Suboxone® (buprenorphine and naloxone) (continued)
Suboxone: (continued)
pharmacy without documentation of additional information. Claims will adjudicate automatically with no
prior authorization required. For members who do not meet the criteria noted previously, the dispensing
pharmacist will be prompted that prior authorization is required. Prior authorization criteria include the
following:
• The member is being treated for opioid dependence by a physician certified in addiction medicine,
AND
• The patient is enrolled in at least one ancillary service (e.g., psychiatric, counseling, behavioral
education), AND
• The prescribed dose of Suboxone does not exceed 24mg/day.
Upon receiving authorization for payment of claims for Suboxone, claims for opioid-containing products
will reject at the point of sale if the member has a claim for Subutex or Suboxone in their pharmacy claims
history within the past 120 days. Authorization for coverage of an opioid claim will be provided if the
member has a documented acute pain condition (e.g., acute traumatic injury) in which treatment with other
agents would cause insufficient pain control, or if the member requires treatment for pain related to a
terminal illness. If approved, authorization may be granted for a period of up to one year.
D.
Quantity Level Limit Additions
Effective Sept. 5, 2007, the following products were added to Highmark’s Quantity Level Limit (QLL)
program.
Table 4: Additions to the QLL program
Brand Name
Generic Name
Up to 34 Days’ Supply
35-90 Days’ Supply
Limit (retail)
Limit (retail or mail)
Elestrin™ 144 gm
estradiol 0.06% gel
1 metered pump
3 metered pumps
E.
Updates to Highmark’s Formulary policies
1.
Direct Renin Inhibitors
This policy pertains to the products categorized as direct renin inhibitors. Aliskeren (Tekturna®) is currently
the only product available within this therapeutic category. Aliskeren is indicated for the treatment of
hypertension. It may be used alone or in combination with other antihypertensive agents. Most exposure to
date is with diuretics and an angiotensin receptor blocker (ARB), valsartan. Use with maximal doses of
ACE inhibitors has not been adequately studied. Significant benefits over currently available products
within the class of ACE inhibitors or ARBs are unclear. Effective Sept. 5, 2007, when a benefit, coverage
for Aliskeren may be approved if members meet the following criteria:
• The agent must be used for an FDA-approved indication.
• The member must have tried (see third bullet) and failed at least two formulary agents within either
or both of the following class of drugs: ACE inhibitor or angiotensin receptor blocker (ARB).
• An “adequate therapeutic trial” consists of using an ACE inhibitor or ARB at recommended doses
for at least a two-week period (unless the member experiences an intolerable side effect due to drug
therapy within that time frame). “Drug therapy failure” consists of not achieving the desired
therapeutic goal, development of an intolerable side effect due to drug therapy or development of
hypersensitivity reaction to the drug product. The length of therapy with the formulary products and
the reason for treatment failure should be documented.
(continued)
6
E.
1.
•
•
Updates to Highmark’s Formulary policies (continued)
Direct Renin Inhibitors (continued)
If failure of an agent was due to an adverse effect related to the ACE inhibitor or ARB class (e.g.,
head and neck angioedema), then the use of Aliskeren is a relative contraindication. A request will
not be considered in this instance due to the risk to the member.
A request based on the reasoning that “the member is currently stable and cannot be switched to
another agent” will not be considered legitimate unless the member has tried and failed two
formulary products (as listed previously).
Section II.
Highmark Medicare-Approved Select/Choice Formulary
A.
Changes to the Highmark Medicare-Approved Select/Choice Formulary
The Highmark Pharmacy and Therapeutics Committee has reviewed the medications listed in the following tables.
As a reminder, the Highmark Medicare-Approved Select/Choice Formulary applies only to Highmark Medicare
Advantage and BlueRxSM members. For your convenience, you can search the Highmark Medicare-Approved
Select/Choice Formulary online at http://highmark.medicare-approvedformularies.com.
Table 1: Products Added (All products added to the formulary effective immediately unless otherwise
noted)
Brand Name
Generic Name
Comments
®
Androgel §
testosterone gel
A topical testosterone product
Azopt®§
brinzolamide
A carbonic anhydrase inhibitor used to treat openangle glaucoma
Exelon® Patch
rivastigmine
An acetylcholinesterase inhibitor indicated
transdermal system
for the treatment of mild to moderate Alzheimer’s
dementia and mild to moderate dementia associated
with Parkinson’s disease
®
Exforge
amlodipine/valsartan
A calcium channel blocker/angiotensin receptor
blocker combination for the treatment of hypertension
Famvir®§
famciclovir
An oral antiviral agent for the treatment of herpes
zoster (shingles) and herpes simplex infections
™
Janumet
sitagliptin/metformin
A dipeptidyl peptidase-4 (DPP-4) inhibitor/metformin
combination for the treatment of type II diabetes
mellitus
Januvia™
sitagliptin
A dipeptidyl peptidase-4 (DPP-4) inhibitor for the
treatment of type II diabetes mellitus
™
Letairis ¶
ambrisentan
An endothelin receptor antagonist (ERA) indicated for
the treatment of pulmonary arterial hypertension
(PAH) (WHO Group 1) in patients with WHO Class II
or III symptoms to improve exercise capacity and
delay clinical worsening
®
Lexapro §
escitalopram oxalate
A selective serotonin reuptake inhibitor (SSRI) for the
treatment of depression and generalized anxiety
disorder
lidocaine/prilocaine§
lidocaine/prilocaine
A local anesthetic combination for topical use
Lovaza™§
omega-3-acid ethyl
An adjunct to diet to reduce triglyceride (TG) levels in
esters
adult patients with very high (>500 mg/dL)
triglyceride levels
§Effective Jan. 1, 2008
¶Effective March 1, 2008
7
A.
Changes to the Highmark Medicare-Approved Select/Choice Formulary (continued)
Table 2: Products Not Added*
Brand Name
Generic Name
Comments
Chantix™
varenicline
Bupropion and bupropion SR are on the formulary.
Divigel®
estradiol gel
Climara®, Estraderm® and Vivelle-Dot® are on the
formulary.
®
Endometrin
progesterone vaginal insert
Crinone® is on the formulary.
Extina®
ketoconazole foam
Topical forms of ketoconazole are on the formulary.
Lybrel®
levonorgestrel/ethynyl
Multiple oral contraceptives are on the formulary.
estradiol
®
Neupro
rotigotine transdermal
Selegiline, carbidopa-levodopa, Comtan®, Mirapex®
system
and Requip® are on the formulary.
Xyzal®
levocetirizine
Fexofenadine is on the formulary.
Zyflo CR ™
zileuton extended release
Accolate® and Singulair® are on the formulary.
Reclast®
zoledronic acid
An I.V. bisphosphonate for the treatment of
osteoporosis
Torisel™
temsirolimus
Intravenous medication for the treatment of
advanced renal cell carcinoma
*Physicians may request coverage of these products using the Prescription Drug Medication Request Form, which can be found on Page 8 of the
2008 Highmark Drug Formulary book. You may also access the form online in Highmark’s Provider Resource Center, under Provider Forms; select
Miscellaneous Forms from the fly-out menu.
Table 3: Products Removed* From the Formulary (effective Jan. 1, 2008)
Brand Name
Generic Name
Comments
Aromasin®
exemestane
Femara® and Arimidex® are on the formulary.
Carisoprodol
carisoprodol
Ciloxan®
ciprofloxacin
This medication has been identified as a drug to
avoid in the elderly.
Generic is on the formulary.
etidronate disodium
Generic is on the formulary.
Effexor
venlafaxine HCl
Generic is on the formulary.
Flonase®
fluticasone propionate
Generic is on the formulary.
Floxin Ophthalmic
ofloxacin
Generic is on the formulary.
Isopto Carbachol
Isopto Carbachol
This product is no longer available.
Phenylephrine HCl/
Promethazine HCl
Primaxin®
Phenylephrine HCl/
Promethazine HCl
Imipenem-Cilastatin
Cough/cold preparations are not covered under
Medicare Part D.
Merrem® is on the formulary.
Pseudoephedrine
HCl/brompheniramine
maleate
Pseudoephedrine
HCl/brompheniramine
maleate capsule,
sustained action
Pseudoephedrine
HCl/brompheniramine
maleate
Pseudoephedrine
HCl/brompheniramine
maleate capsule, sustained
action
Cough/cold preparations are not covered under
Medicare Part D.
Didronel
®
®
®
Cough/cold preparations are not covered under
Medicare Part D.
*Physicians may request coverage of these products using the Prescription Drug Medication Request Form, which can be found on Page 8 of the
2008 Highmark Drug Formulary book. You may also access the form online in Highmark’s Provider Resource Center, under Provider Forms; select
Miscellaneous Forms from the fly-out menu.
(continued)
8
A.
Changes to the Highmark Medicare-Approved Select/Choice Formulary (continued)
Table 3: Products Removed* From the Formulary (effective Jan. 1, 2008) (continued)
Brand Name
Generic Name
Comments
Pseudoephedrine
HCl/carbinoxamine
malate tablet,
sustained action
Pseudoephedrine
HCl/chlorpheniramine
maleate capsule,
sustained action
Urocit-K®
Zoloft
®
Pseudoephedrine
HCl/carbinoxamine malate
tablet, sustained action
Cough/cold preparations are not covered under
Medicare Part D.
Pseudoephedrine
HCl/chlorpheniramine
maleate capsule, sustained
action
potassium citrate
Cough/cold preparations are not covered under
Medicare Part D.
sertraline HCl
Generic is on the formulary.
Generic is on the formulary.
*Physicians may request coverage of these products using the Prescription Drug Medication Request Form, which can be found on Page 8 of the
2008 Highmark Drug Formulary book. You may also access the form online in Highmark’s Provider Resource Center, under Provider Forms; select
Miscellaneous Forms from the fly-out menu.
Table 4: Tiering Changes
Beginning in 2008, Medicare Advantage and BlueRxSM members will have a Medicare-Approved Choice
(Incentive) Formulary design. For these members, the medications listed in the table below will be covered
as Non-Preferred Brands (Tier 3). For members with a Medicare-Approved Select (Closed) Formulary, the
products in this table are covered as Preferred Brands (Tier 2).
Therapeutic Chapter
Brand Name
Generic Name
Autonomic & CNS Drugs, Neurology, & Psych
Antivertigo & antiemetic drugs
Emend1
Aprepitant
Antiparkisonism agents
Comtan
Entacapone
Anticonvulsants
Lyrica1
Pregabalin
Miscellaneous antidepressants
Cymbalta1
Duloxetine
Effexor XR
Venlafaxine HCL
Aripiprazole
Miscellaneous antipsychotics
Abilify
Aripiprazole ODT
Abilify Disc-melt
Paliperidone
Invega
Olanzapine
Zyprexa
Olanzapine
Zyprexa Zydis
Cardiovascular, Hypertension & Lipids
Coagulation therapy
Aggrenox
Aspirin/dipyridamole
Lipid/cholesterol-lowering agents
Omacor
Omega-3 acid ethyl esters
Immunology, Vaccines & Biotechnology
Interferons
Betaseron1
Interferon beta-1b
Musculoskeletal & Rheumatology
Osteoporosis therapy
Boniva IV only
Ibandronate
Respiratory, Allergy, Cough & Cold
Miscellaneous pulmonary agents
Zyflo
Zileuton
1. Authorization Required
B.
Updates to the Prior Authorization Program
1.
Letairis™ (ambrisentan)
Effective March 1, 2008, Letairis will be added to Highmark’s pulmonary arterial hypertension prior
authorization policy for Medicare Advantage and BlueRx members. Letairis is an endothelin receptor
(continued)
9
B.
Updates to the Prior Authorization Program (continued)
1.
Letairis™ (ambrisentan) (continued)
antagonist indicated for the treatment of pulmonary arterial hypertension (WHO Group 1) in patients with
WHO Class II or III symptoms to improve exercise capacity and delay clinical worsening. When a benefit,
ambrisentan may be approved when all of the following criteria are met:
• A diagnosis of pulmonary hypertension is substantiated by results from Doppler echocardiography
and/or direct measurement of pulmonary arterial pressure (Pulmonary arterial hypertension is
defined as a mean pulmonary arterial pressure of > or = 25 mmHg, with a pulmonary capillary
wedge pressure of <15 mmHg), AND
• Ambrisentan is prescribed under the supervision of a cardiologist or pulmonologist, AND
• Ambrisentan is to be used for the treatment of pulmonary arterial hypertension (WHO Group I) in
members with WHO functional Class II or III symptoms, AND
• Ambrisentan may be used alone or in combination with calcium channel blockers, angiotensin
converting enzyme (ACE) inhibitors, diuretics, digoxin and anticoagulants, but will not be covered
when used concomitantly with bosentan (Tracleer™), sildenafil (Revatio™), epoprostenol sodium
(Flolan®), treprostinil sodium (Remodulin™) or iloprost (Ventavis®), due to the lack of clinical data
to support combination therapy with these agents.
The pulmonary arterial hypertension prior authorization policy has also been revised to allow for short-term
combination therapy for PAH. As there is no established criterion or algorithm for the transitioning of
patients from one PAH drug product to another (e.g., sildenafil to bosentan), the use of two agents
concomitantly may be authorized for a period of up to one month to accommodate potential overlapping
titration schedules when changing therapy from one drug product to another. As stated above, coverage will
not be provided for the use of two agents (bosentan, ambrisentan, sildenafil, epoprostenol, iloprost,
treprostinil) as maintenance combination therapy for PAH.
If approved, authorization may be granted for a period of up to one year.
2.
Humira® (adalimumab)
Effective Sept. 5, 2007, the prior authorization criteria for Humira was revised for Medicare Advantage and
BlueRxSM members to allow for use as a first-line agent in the treatment of moderate to severe active
rheumatoid arthritis. When a benefit, coverage for adalimumab may be approved if members meet the
following criteria:
• The member should be under the supervision of a rheumatologist or gastroenterologist, AND
• The member is currently not using another biological DMARD [e.g., etanercept (Enbrel), anakinra
(Kineret), etc.], AND
• Adalimumab is to be used in reducing the signs and symptoms and inhibiting the progression of
structural damage in adults with moderate to severe active rheumatoid arthritis, OR
• Adalimumab is to be used in reducing the signs and symptoms of active arthritis in patients with
psoriatic arthritis, OR
• Adalimumab is to be used in reducing the signs and symptoms of patients with ankylosing
spondylitis, OR
• Adalimumab is to be used in reducing the signs and symptoms of patients with Crohn’s Disease
who have failed two alternative therapies or monotherapy with Remicade.
If approved, authorization may be granted for a period of up to one year.
10
B.
Updates to the Prior Authorization Program (continued)
3.
Nexavar® (sorafenib)
Effective Sept. 5, 2007, the prior authorization criteria for Nexavar was revised for Medicare Advantage
and BlueRxSM members to include coverage when used for the treatment of hepatocellular carcinoma. These
revisions were made in response to recent updates to the NCCN practice guidelines for hepatobiliary
cancers. When a benefit, sorafenib may be approved when all of the following criteria are met:
• Sorafenib is to be prescribed under the supervision of an oncologist/hematologist.
• Sorafenib is to be used for the treatment of advanced renal cell carcinoma after treatment with at
least one other prior systemic therapy, OR
• Sorafenib is to be used for the treatment of hepatocellular carcinoma.
Use of sorafenib for disease states outside of these indications should be denied based on the lack of clinical
data to support its effectiveness and safety in other conditions.
If approved, authorization may be granted for a period of up to one year.
C.
Updates to the Managed Prescription Drug Coverage (MRxC) Program
1.
Lyrica™ (pregabalin)
Effective Sept. 5, 2007, the Managed Prescription Drug Coverage (MRxC) policy for Lyrica was revised
for Medicare Advantage and BlueRx members to allow for coverage when used for the treatment of
fibromyalgia. When a benefit, coverage for pregabalin for the treatment of fibromyalgia may be approved if
members meet the following criteria:
• The member has a documented diagnosis of fibromyalgia as determined by clinical notes including,
but not limited to, confirmation of widespread bilateral pain both above and below the waist for >3
months duration AND the presence of at least 11 of 18 specific tender points AND documented
fibromyalgia-related symptoms (e.g., fatigue, sleep disturbance, neurologic symptoms and/or
exercise intolerance), AND
• The member has a documented trial and failure of at least two additional agents used to treat
fibromyalgia (e.g., tricyclic agents, cyclobenzaprine, SSRIs), one of which must be a tricyclic agent
or cyclobenzaprine.
If approved, authorization may be granted for a period of up to one year.
2.
Subutex® (buprenorphine) and Suboxone® (buprenorphine and naloxone)
Effective Sept. 5, 2007, the Managed Prescription Drug Coverage (MRxC) policy for Subutex and
Suboxone sublingual tablets was revised for Medicare Advantage and BlueRx members. Subutex and
Suboxone are classified as Schedule III controlled substances and are indicated for the treatment of opioid
dependence. Subutex is used as a single agent for the initial treatment (induction) of opioid dependence, and
Suboxone is used following the initial phase of therapy. When a benefit, coverage for Subutex and
Suboxone may be approved if members meet the following criteria:
Subutex:
Subutex may be covered for a five-day supply (160 mg) of medication within the last 90 days for the
induction treatment of opioid dependence. Authorization for an additional coverage period can be approved
for female members who are pregnant and require treatment for opioid dependence for the duration of their
pregnancy (up to nine months of treatment, at which time the member can be transitioned to treatment with
the combination tablet). Otherwise, Subutex will not be covered for long-term therapy.
(continued)
11
C.
Updates to the Managed Prescription Drug Coverage (MRxC) Program (continued)
2.
Subutex® (buprenorphine) and Suboxone® (buprenorphine and naloxone) (continued)
Suboxone:
Suboxone may be approved if a member meets the following criteria:
• The prescribed dose of Suboxone does not exceed 720mg/30 days (24mg/day).
Members who meet the criteria as outlined above will receive automatic authorization at the level of the
pharmacy without documentation of additional information. Claims will adjudicate automatically with no
prior authorization required. For members who do not meet the criteria above, the dispensing pharmacist
will be prompted that prior authorization is required. Prior authorization criteria include the following:
• The member is being treated for opioid dependence by a physician certified in addiction medicine,
AND
• The patient is enrolled in at least one ancillary service (e.g., psychiatric, counseling, behavioral
education), AND
• The prescribed dose of Suboxone does not exceed 24mg/day.
Upon receiving authorization for payment of claims for Suboxone, claims for opioid-containing products
will reject at the point of sale if the member has a claim for Subutex or Suboxone in their pharmacy claims
history within the past 120 days. Authorization for coverage of an opioid claim will be provided if the
member has a documented acute pain condition (e.g., acute traumatic injury) in which treatment with other
agents would cause insufficient pain control or if the member requires treatment for pain related to a
terminal illness. If approved, authorization may be granted for a period of up to one year.
D.
Updates to Highmark’s Formulary policies
1.
Direct Renin Inhibitors
This policy pertains to the products categorized as direct renin inhibitors. Aliskeren (Tekturna®) is currently
the only product available within this therapeutic category. Aliskeren is indicated for the treatment of
hypertension. It may be used alone or in combination with other antihypertensive agents. Most exposure to
date is with diuretics and an angiotensin receptor blocker (ARB), valsartan. Use with maximal doses of
ACE inhibitors has not been adequately studied. Significant benefits over currently available products
within the class of ACE inhibitors or ARBs are unclear. Effective Sept. 5, 2007, when a benefit, coverage
for Aliskeren may be approved for Medicare Advantage and BlueRxSM members if the following criteria are met:
• The agent must be used for an FDA-approved indication.
• The member must have tried (see third bullet) and failed at least two formulary agents within either
or both of the following class of drugs: ACE inhibitor or angiotensin receptor blocker (ARB).
• An “adequate therapeutic trial” consists of using an ACE inhibitor or ARB at recommended doses
for at least a two-week period (unless the member experiences an intolerable side effect due to drug
therapy within that time frame). “Drug therapy failure” consists of not achieving the desired
therapeutic goal, development of an intolerable side effect due to drug therapy or development of
hypersensitivity reaction to the drug product. The length of therapy with the formulary products and
the reason for treatment failure should be documented.
• If failure of an agent was due to an adverse effect related to the ACE inhibitor or ARB class (e.g.,
head and neck angioedema), then the use of Aliskeren is a relative contraindication. A request will
not be considered in this instance due to the risk to the member.
• A request based on the reasoning that “the member is currently stable and cannot be switched to
another agent” will not be considered legitimate unless the member has tried and failed two
formulary products (as listed above).
2.
Tiering Exceptions
This policy applies to all Medicare Part D members who have a prescription drug benefit design with three
or more tiers. Effective Sept. 5, 2007, the provider must document an adequate trial and/or failure of the
(continued)
12
D.
Updates to Highmark’s Formulary policies (continued)
2.
Tiering Exceptions (continued)
majority of the preferred medications before a tiering exception would be granted to non-preferred
medications in the same drug class/category. When a benefit, a tiering exception may be approved if the
following criteria are met:
• If the tiering exception request is for a non-preferred, multi-source brand product and the generic is
available on preferred, approval will be granted if:
-- The member had an adequate trial and/or failed the generic medication plus two other
available preferred medications within the same therapeutic class/category, OR
-- The member had an adequate trial and/or failed the generic and each available preferred
medication if a given therapeutic class/category has less than three available preferred
medications.
• If the tiering exception request is for a non-preferred, single-source brand product, approval will be
granted if:
-- The member had an adequate trial and/or failed three preferred medications within the same
therapeutic class/category, OR
-- The member had an adequate trial and/or failed each available preferred medication if a given
therapeutic class/category has less than three available preferred medications.
• Approvals will not be granted for a tiering exception request for a preferred, single-source brand
product.
• No tiering exception will be made for those drugs placed on the specialty tier.
• A request based on the reasoning that “the patient is currently stable and cannot be switched to
another agent” will not be considered legitimate unless the patient has tried and failed the required
number of preferred products (see first and second bullets, above).
• If a specific policy for a medication or therapeutic category/indication is established, then the
medication or therapeutic category/indication policy would supersede the tiering exception policy.
• No exceptions will be made for requests of non-preferred combination products that are currently
available as separate preferred agents.
E.
1.
Updates to Recent Formulary Changes
In the 1st Quarter 2007 Formulary Update, Noroxin® was listed as a medication to be removed from
the formulary. Noroxin will remain on the Highmark Medicare-Approved Select/Choice Formulary.
2.
In the 1st Quarter 2007 Formulary Update, Levaquin® was listed as a medication to be added to the
formulary (effective May 1, 2007). Levaquin will not be added to the Highmark Medicare-Approved
Select/Choice Formulary.
3.
In the 3rd Quarter 2007 Formulary Update, Je-Vax® and Imovax® were listed as medications to be
added to the formulary, effective June 2007. Je-Vax and Imovax will be added to the Highmark
Medicare-Approved Select/Choice Formulary effective Jan. 1, 2008.
F.
Specialty Drug Tier Program
Specialty drugs are very high-cost and unique drugs as defined by the Centers for Medicare and Medicaid
Services. These drugs may incur a coinsurance based on their negotiated price. Because of this, the cost
may vary slightly due to pricing changes in the drug. Drugs in the specialty tier apply to Highmark
Medicare Advantage, BlueRxSM and Highmark Health Insurance Company members. Please refer to the
following list for products included in the Specialty Drug Tier program.
(continued)
13
F.
Specialty Drug Tier Program (continued)
Table 5: Products Included in the Specialty Drug Tier Program
Product Name
Accutane
Humira
Regranex
Actimmune
Humira Pen
Remicade
Actiq
Immune Globulin
Revlimid
Adagen
Increlex
Ribapak
Aldurazyme
Infergen
Ribasphere
Alferon N
Innohep
Ribatab
Anadrol-50
Intron A
Ribavirin
Apokyn
Invirase
Rilutek
Aptivus
Iressa
Risperdal Consta
Aralast
Iveegam En
Rituxan
Aranesp
Kaletra
Roferon-A
Aranesp Albumin Free
Kineret
Saizen
Aredia
Kytril
Sandostatin
Arixtra
Leukine
Sandostatin LAR
Atripla
Leuprolide Acetate
Sensipar
Avonex
Lovenox
Serostim
Avonex Administration Pack
Lupron
Somavert
Baraclude
Lupron Depot
Soriatane
Betaseron
Lupron Depot-Ped
Sprycel
Buphenyl
Matulane
Sucraid
Carimune
Mepron
Sutent
Carimune Nf Nanofiltered
Mesnex
Synarel
Cerezyme
Myozyme
Tarceva
Colistimethate Sodium
Naglazyme
Targretin
Coly-Mycin M Parenteral
Neulasta
Tev-Tropin
Copaxone
Neumega
Thalomid
Copegus
Neupogen
Tracleer
Cubicin
Nexavar
Truvada
Cytovene
Nimotop
Tygacil
D.H.E. 45
Norditropin
Valcyte
Declomycin
Norditropin Nordiflex
Vancocin
Elaprase
Novantrone
Velcade
Elitek
Nutropin
Venoglobulin-S
14
Section III.
Miscellaneous Updates
A.
Zyrtec® to be Available Over the Counter
Within the next few months, all forms of the prescription, non-sedating antihistamine Zyrtec will become
available over the counter. This change will apply to Zyrtec tablets, Zyrtec chewable tablets, Zyrtec syrup
and Zyrtec-D 12 Hour® extended-release tablets. The exact date of the prescription to over-the-counter
switch has not yet been announced by the manufacturer. However, it will most likely occur in January 2008,
shortly after the prescription patent expiration date of Dec. 25, 2007.
B.
Correction
The relative cost of Humatrope® is incorrectly listed as $2,000-$2,500 on page 72 of the 2008 Highmark
Drug Formulary book. The correct relative cost of this product is $1,000-$1,500.
Highmark is a registered mark of Highmark Inc. BlueRx is a service mark of the Blue Cross and Blue Shield Association, an association of
independent Blue Cross and Blue Shield Plans.
Highmark Senior Resources Inc., a subsidiary of Highmark Inc., has a contract with the Federal government to administer Medicare Prescription
Drug Coverage in the states of Pennsylvania and West Virginia.
NaviNet is a registered trademark of NaviMedix, Inc. NaviMedix, Inc. is an independent company that does not provide Highmark Blue Shield
products or services. NaviMedix, Inc. is solely responsible for the products and services that it provides and that are referenced in this bulletin.
15