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Step Therapy Criteria
Paramount Medicare Enhanced Formulary 2011
Formulary ID 11110, Ver 23. CMS Approved 10-25-2011. Last Updated: 10-05-2011
ANTIDEPRESSANT THERAPY
Products Affected
•
•
•
•
•
•
•
•
•
Celexa
Cymbalta
Effexor
Effexor Xr
Lexapro
Luvox Cr
Paxil
Paxil Cr
Pexeva
•
•
•
•
•
•
•
•
•
Pristiq
Prozac
Prozac Weekly
Rapiflux
Savella
Savella Titration Pack
Venlafaxine Hcl Er TB24
Viibryd
Zoloft
Details
Criteria
If the patient has tried a Step 1 drug, then authorization for a Step 2 drug
may be given. Step 1 Drug(s): Citalopram Hbr, Fluoxetine Hcl,
Fluoxetine DR, Fluvoxamine Maleate, Paroxetine Hcl, Paroxetine ER, or
Sertraline Hcl. Step 2 Drug(s): Cymbalta, Celexa, Effexor, Effexor Xr,
Lexapro, Luvox Cr, Paxil, Paxil Cr, Pexeva, Pristiq, Prozac, Prozac
Weekly, Rapiflux, Savella, Venlafaxine ER, Viibryd, Zoloft. Number of
days for claims review for select or first line drugs: 130 days. History
effective date: 130 days prior to effective date. Grandfathering: 130 days.
Grandfathering includes all SSRI/SNRI products as well as second-line
drugs listed above. On-line Pharmacy Message: "Use generic
SSRI/SNRIs first". Override allowed: Yes. Override NCPCP number: 75.
This step therapy program applies to new utilizers only.
ANTIDEPRESSANTS - BUPROPION
Products Affected
•
•
Aplenzin
Wellbutrin Sr
•
Wellbutrin XL
Details
Criteria
If the patient has tried a Step 1 drug, then authorization for a Step 2 drug
may be given. Step 1 Drug(s): Budeprion Sr, Budeprion Xl, Bupropion
Hcl Sr. Step 2 Drug(s): Aplenzin, Wellbutrin XL, Wellbutrin SR. Number
of days for claims review for select or first line drugs: 130 days. History
effective date: 130 days prior to effective date. Grandfathering: 130 days.
On-line Pharmacy Message: "Use generic bupropion XR/XL first".
Override allowed: Yes. Override NCPCP number: 75. This step therapy
program applies to new utilizers only. Authorization may be given for a
step 2 drug if the patient is currently taking the requested agent.
2
ANTIDEPRESSANTS - SARAFEM
Products Affected
•
Sarafem
Details
Criteria
If the patient has tried a Step 1 drug, then authorization for a Step 2 drug
may be given. Step 1 Drug(s): Fluoxetine Hcl. Step 2 Drug(s): Sarafem.
Number of days for claims review for select or first line drugs: 130 days.
History effective date: 130 days prior to effective date. Grandfathering:
130 days. On-line Pharmacy Message: "Use generic fluoxetine first".
Override allowed: Yes. Override NCPCP number: 75. This step therapy
program applies to new utilizers only. Authorization may be given for
step 2 Sarafem if the patient is currently taking the requested agent.
3
ANTIHISTAMINE THERAPY
Products Affected
•
•
•
•
•
Allegra
Cetirizine Hcl SYRP
Clarinex
Clarinex Reditabs
Clarinex-d 12 Hour
•
•
•
•
Clarinex-d 24 Hour
Fexofenadine Hcl
Levocetirizine Dihydrochloride
Xyzal
Details
Criteria
OTCs: "LORATADINE", "LORATADINE HIVES RELIEF",
"CETIRIZINE HCL", "LORATADINE-D 12HR" or "24HR",
"CETIRIZINE HCL/PSEUDOEPHEDRINE HCL ER", "CETIRIZINE
HCL CHILDRENS ALLERGY". If the patient has tried a Step 1 drug,
then authorization for a Step 2 drug may be given. Step 1 Drug(s): OTC
Cetirizine Hcl, OTC Loratadine. Step 2 Drug(s): Fexofenadine,
Cetirizine Syr 5mg/5ml. Step 3 Drug(s): Allegra, Allegra-D 12 Hour,
Allegra-D 24 Hour, Clarinex, Clarinex-D 12 Hour, Clarinex-D 24 Hour,
Levocetirizine, Xyzal. Number of days for claims review for select or
first line drugs: 130 days. History effective date: 130 days prior to
effective date. Grandfathering: 130 days. On-line Pharmacy Message:
"Generic OTC cetirizine or loratadine 1st". Override allowed: Yes.
Override NCPCP number: 75.
4
BISPHOSPHONATES
Products Affected
•
•
•
Actonel
Atelvia
Boniva TABS
•
•
Fosamax
Fosamax Plus D
Details
Criteria
If the patient has tried a Step 1 drug, then authorization for a Step 2 drug
may be given. Step 1 Drug(s): Alendronate Sodium. Step 2 Drug(s):
Actonel, Actonel With Calcium, Atelvia, Boniva. Fosamax, Fosamax Plus
D. Number of days for claims review for select or first line drugs: 130
days. History effective date: 130 days prior to effective date.
Grandfathering: 130 days. On-line Pharmacy Message: "Use generic
alendronate first". Override allowed: Yes. Override NCPCP number: 75.
Authorization may be given for Fosamax oral solution for adult patients
with a gastrostomy tube, who cannot swallow, or who have difficulty
swallowing tablets. Authorization may be given for Fosamax oral solution
for children who require an oral solution.
5
BRANDED NSAID THERAPY
Products Affected
•
•
•
•
•
•
•
•
•
•
•
Anaprox
Anaprox Ds
Arthrotec 50
Arthrotec 75
Cataflam
Clinoril
Daypro
Ec-naprosyn
Feldene
Flector
Mobic
•
•
•
•
•
•
•
•
•
•
•
Nalfon
Naprelan TB24 375MG, 500MG,
750MG
Naprosyn
Pennsaid
Ponstel
Sprix
Vimovo
Voltaren GEL
Voltaren TBEC
Voltaren-xr
Zipsor
Details
Criteria
If the patient has tried two Step 1 drugs, then authorization for a Step 2
drug may be given. Step 1 Drug(s): Diclofenac Potassium, Diclofenac
Sodium, Diflunisal, Etodolac, Fenoprofen Calcium, Flurbiprofen,
Ibuprofen, Indomethacin, Ketoprofen, Ketorolac Tromethamine,
Meclofenamate Sodium, Mefenamic Acid, Meloxicam, Nabumetone,
Naproxen, Naproxen Sodium, Oxaprozin, Piroxicam, Sulindac, Tolmetin
Sodium. Step 2 Drug(s): Anaprox, Anaprox Ds, Arthrotec 50, Arthrotec
75, Cambia, Cataflam, Clinoril, Daypro, Ec-Naprosyn, Feldene, Flector,
Indocin, Indocin Sr, Mobic, Nalfon, Naprelan, Naprosyn, Pennsaid,
Ponstel, Sprix, Voltaren, Voltaren-XR, Vimovo, Zipsor. Number of days
for claims review for select or first line drugs: 130 days. History effective
date: 130 days prior to effective date. Grandfathering: 130 days. On-line
Pharmacy Message: "Use 2 generic NSAIDs first". Override allowed:
Yes. Override NCPCP number: 75. Post effective date coverage rule:
120 days. Allow continuous users of second line drugs who have met first
line criteria. Authorization for a step 2 drug may be given if the patient
has tried two unique generic prescription strength non-steroidal antiinflammatory drugs (NSAIDs) for the current condition. Authorization
may be given for Flector or Voltaren Gel for patients with difficulty
swallowing or cannot swallow. Authorization may be given for Voltaren
Gel for patients with a chronic musculoskeletal pain condition (eg,
osteoarthritis) in 3 or fewer joints/sites (ie, hand, wrist, elbow, knee,
ankle, or foot each count as 1 joint/site) who are at risk of NSAIDassociated toxicity (eg, previous gastrointestinal [GI] bleed, history of
peptic ulcer disease, impaired renal function, cardiovascular disease,
6
hypertension, heart failure, elderly patients with impaired hepatic
function, or those taking concomitant anticoagulants).
7
COX II THERAPY
Products Affected
•
Celebrex
Details
Criteria
If the patient has tried two Step 1 drugs, then authorization for a Step 2
drug may be given. Step 1 Drug(s): Diclofenac Potassium, Diclofenac
Sodium, Diflunisal, Etodolac, Fenoprofen Calcium, Flurbiprofen,
Ibuprofen, Indomethacin, Ketoprofen, Ketorolac Tromethamine,
Meclofenamate Sodium, Mefenamic Acid, Meloxicam, Nabumetone,
Naproxen, Naproxen Sodium, Oxaprozin, Piroxicam, Sulindac, Tolmetin
Sodium. Step 2 Drug(s): Celebrex. Number of days for claims review for
select or first line drugs: 130 days. History effective date: 130 days prior
to effective date. Grandfathering: 130 days. On-line Pharmacy Message:
"Use 2 generic NSAIDs first". Override allowed: Yes. Override NCPCP
number: 75. Post effective date coverage rule: 120 days. Allow
continuous users of second line drugs who have met first line criteria.
This step therapy program will exclude participants with a claims history
of warfarin (Coumadin) within the last 130 days. Authorization for
Celebrex may be given for patients who are currently taking chronic
systemic corticosteroid therapy, warfarin (Coumadin), clopidogrel
(Plavix), chronic aspirin therapy, or low molecular weight heparins.
Authorization for Celebrex may be given for patients with reduced
platelet counts or other coagulation disorders. Authorization for Celebrex
may be given for patients with familial adenomatous polyposis (FAP) or
attenuated adenomatous polyposis coli (AAPC) who have adenomatous
colorectal polyps. Authorization for Celebrex may be given if used for
the treatment of cancer as part of a cancer-chemotherapy regimen (e.g., in
combination with chemotherapeutic agents). Authorization for Celebrex
may be given for patients who have had a documented upper
gastrointestinal bleed from a duodenal or gastric ulcer. Authorization for
Celebrex may be given for patients with a past hypersensitivity,
anaphylactic or allergic-type reaction (e.g., erythema, hives, urticaria,
angioedema) to aspirin or NSAIDs. Authorization for Celebrex may be
given to patients with aspirin-sensitive asthma (also known as aspirininduced asthma, aspirin-exacerbated respiratory disease) or NSAIDinduced asthma.
8
INTRANASAL STEROIDS
Products Affected
•
•
•
•
Beconase Aq
Flonase
Nasacort Aq
Nasonex
•
•
•
Omnaris
Rhinocort Aqua
Veramyst
Details
Criteria
If the patient has tried a Step 1 drug, then authorization for a Step 2 drug
may be given. Step 1 Drug(s): Flunisolide, Fluticasone Propionate,
Triamcinolone. Step 2 Drug(s): Beconase Aq, Flonase, Nasacort Aq,
Nasonex, Omnaris, Rhinocort Aqua, Veramyst. Number of days for
claims review for select or first line drugs: 130 days. History effective
date: 130 days prior to effective date. Grandfathering: 130 days. On-line
Pharmacy Message: "Use generic nasal steroid first". Override allowed:
Yes. Override NCPCP number: 75.
9
LEUKOTRIENE INHIBITOR THERAPY
Products Affected
•
•
Accolate
Singulair
•
Zafirlukast
Details
Criteria
OTCs: "LORATADINE", "LORATADINE HIVES RELIEF",
"CETIRIZINE HCL", "LORATADINE-D 12HR" OR "24HR",
"CETIRIZINE HCL/PSEUDOEPHEDRINE HCL ER", "CETIRIZINE
HCL CHILDRENS ALLERGY". If the patient has tried two Step 1 drugs,
then authorization for a Step 2 drug may be given. Step 1 Drug(s):
Intranasal flunisolide, fluticasone propionate, Beconase, Nasacort AQ,
Nasonex, Omnaris, Rhinocort, or Veramyst plus either OTC cetirzine,
OTC loratadine, fexofenadine, or Clarinex. Step 2 Drug(s): Singulair,
Accolate. This step therapy program will exclude participants with a
claims history of inhaled beta 2 agonists or inhaled corticosteroids within
the last 130 days. Number of days for claims review for select or first line
drugs: 130 days. History effective date: 130 days prior to effective date.
Grandfathering: 130 days. On-line Pharmacy Message: "Nas ster+OTC
cetirizine or lorat 1st". Override allowed: Yes. Override NCPCP number:
75.
10
PPI THERAPY
Products Affected
•
•
•
•
•
Aciphex
Dexilant
Nexium
Pantoprazole Sodium
Prevacid
•
•
•
•
Prevacid Solutab
Prilosec CPDR
Protonix
Zegerid
Details
Criteria
OTCs: "OMEPRAZOLE" and "LANSOPRAZOLE". If the patient has
tried a Step 1 drug, then authorization for a Step 2 drug may be given. If
the patient has tried a Step 2 drug, then authorization for a Step 3 drug
may be given. Step 1 Drug(s): OTC, omeprazole, or lansoprazole. Step 2
Drug(s): pantoprazole. Step 3 Drug(s): Aciphex, Dexilant, Nexium,
Prevacid, Prilosec, Protonix, Zegerid. Number of days for claims review
for select or first line drugs: 130 days. History effective date: 130 days
prior to effective date. Grandfathering: 130 days. Injectables are not
included in the drug groups nor in the look back period. On-line
Pharmacy Message: "Use generic OTC PPI first". Override allowed: Yes.
Override NCPCP number: 75. Post effective date coverage rule: Allow
pantoprazole for Plavix users. Allow continuous users of second line
drugs who have met first line criteria. Authorization may be given for
lansoprazole SoluTabs for patients with a feeding tube (eg, nasogastric
tube, gastric tube). Authorization may be given for lansoprazole
SoluTabs for children less than 2 years old.
11
SEDATIVE HYPNOTICS
Products Affected
•
•
•
•
Ambien
Ambien Cr
Edluar
Lunesta
•
•
•
•
Rozerem
Silenor
Sonata
Zolpimist
Details
Criteria
If the patient has tried a Step 1 drug, then authorization for a Step 2 drug
may be given. Step 1 Drug(s): Zaleplon, Zolpidem Tartrate. Step 2
Drug(s): Ambien, Ambien CR, Edular, Lunesta, Rozerem, Silenor,
Sonata, Zolpimist. Number of days for claims review for select or first
line drugs: 130 days. History effective date: 130 days prior to effective
date. Grandfathering: 130 days. On-line Pharmacy Message: "Use generic
zolpidem IR or generic zaleplon 1st". Override allowed: Yes. Override
NCPCP number: 75. Rozerem will be covered for members equal to or
over the age of 65 years. For those under 65 years of age, the step therapy
will apply. Authorization for Rozerem may be given if the patient has a
documented history of addiction to controlled substances. Authorization
for Edluar may be given if the patient has difficulty swallowing or cannot
swallow tablets.
12
TOPICAL IMMUNOMODULATOR THERAPY
Products Affected
•
Elidel
•
Protopic
Details
Criteria
If the patient has tried a Step 1 drug, then authorization for a Step 2 drug
may be given. Step 1 Drug(s): Ala-cort, Alclometasone Dipropionate,
Amcinonide, Augmented Betamethasone, Betamethasone Dipropionate,
Betamethasone Valerate, Beta-val, Clobetasol Emollient, Clobetasol
Propionate, Del-beta, Desoximetasone, Diflorasone Diacetate,
Fluocinolone Acetonide, Fluocinonide, Fluocinonide Emollient,
Fluticasone Propionate, Halobetasol Propionate, Hydrocortisone,
Hydrocortisone Butyrate, Hydrocortisone Valerate, Mometasone Furoate,
Nystatin/Triamcinolone, Prednicarbate, Triamcinolone Acetonide,
Triderm, Step 2 Drug(s): Elidel, Protopic. Number of days for claims
review for select or first line drugs: 60 days. History effective date: 130
days prior to effective date. Grandfathering: 130 days. On-line Pharmacy
Message: "Use generic Rx topical steroid first". Override allowed: Yes.
Override NCPCP number: 75. Authorization may be given for Elidel or
Protopic, if the patient has tried one generic prescription strength topical
corticosteroid for atopic dermatitis or eczema in the previous 60 days.
Authorization for Protopic or Elidel may be given for patients with a
dermatologic condition on or around the eyes, eyelids or genitalia.
Authorization for Protopic or Elidel may be given for patients with the
following conditions after a trial of a prescription strength generic topical
corticosteroid: lichen planus, seborrheic dermatitis, chronic hand
dermatitis, cutaneous lupus erythematosus or dermatomyositis or discoid
lupus erythematosus, psoriasis, and vitiligo. Authorization for Protopic
may be given for patients with the following conditions after a trial of a
prescription strength generic topical corticosteroid: dyshidrotic palmar
eczema, pyoderma gangrenosum, orofacial or perineal Crohn’s disease,
erosive pustular dermatosis, chronic cutaneous graft-vs-host disease
(GVHD), chronic actinic dermatitis, allergic contact dermatitis, and
bullous pemphigoid. Authorization may be given for Elidel or Protopic,
for steroid-induced rosacea if the patient has tried two therapies for
rosacea (e.g., azelaic acid, topical metronidazole, topical tretinoin
products, oral antibiotics [e.g., tetracycline, metronidazole, doxycycline,
minocycline, clarithromycin], or oral isotretinoin). Authorization may be
given for Protopic, for severe uremic pruritus if the patient has tried two
other therapies for this condition (e.g., emollients, capsaicin, topical
corticosteroids, ultraviolet B irradiation).
13
14
ZETIA
Products Affected
•
Vytorin TABS 10MG; 10MG, 10MG;
20MG
•
Zetia
Details
Criteria
If the patient has tried a Step 1 drug, then authorization for a Step 2 drug
may be given. Step 1 Drug(s): 40 mg or greater of the following:
Advicor, Altoprev, Caduet, Lescol, Lescol Xl, Lipitor, Lovastatin,
Mevacor, Pravachol, Pravastatin Sodium, Simcor, Simvastatin, Zocor. At
least 20 mg of Crestor. Livalo. Step 2 Drug(s): Zetia, Vytorin 10 10,
Vytorin 10 20. Number of days for claims review for select or first line
drugs: 130 days. History effective date: 130 days prior to effective date.
Grandfathering: 130 days. On-line Pharmacy Message: "Titrated dose
HMG first". Override allowed: Yes. Override NCPCP number: 75.
Authorization for Zetia may be given if the patient is taking or will be
taking a medication that has a significant drug interaction with any of the
HMG-CoA reductase inhibitors [statins] (eg, cyclosporine, fibrates, niacin
more than 1 g/day, itraconazole, ketoconazole, erythromycin,
clarithromycin, HIV protease inhibitors, nefazodone, amiodarone, and
verapamil). Authorization of Zetia may be given if the patient has severe
renal impairment (creatinine clearance of 30 mL/minute or less).
Authorization of Zetia may be given if for management of homozygous
familial sitosterolemia. Authorization of Zetia may be given for use in
pregnant woman. Authorization of Zetia may be given if the patient has
active liver disease or unexplained persistent elevations of serum
transaminases. Exceptions are NOT recommended for Zetia for use in
patients with moderate or severe hepatic insufficiency. Authorization for
Zetia may be given for use in patients who have been previously
diagnosed with myopathy or rhabdomyolysis (either medication-related or
not medication related) OR the patient has an underlying muscle/musclemetabolism-related disorder (eg, myositis, McArdle disease).
15
INDEX
A
D
Accolate ............................................................. 10
Aciphex ............................................................. 11
Actonel ................................................................ 5
Allegra ................................................................. 4
Ambien .............................................................. 12
Ambien Cr ......................................................... 12
Anaprox ............................................................... 6
Anaprox Ds .......................................................... 6
ANTIDEPRESSANT THERAPY ................................ 1
ANTIDEPRESSANTS - BUPROPION ......................... 2
ANTIDEPRESSANTS - SARAFEM ............................ 3
ANTIHISTAMINE THERAPY .................................. 4
Aplenzin .............................................................. 2
Arthrotec 50 ......................................................... 6
Arthrotec 75 ......................................................... 6
Atelvia ................................................................. 5
Daypro ................................................................ 6
Dexilant .............................................................11
B
Beconase Aq ........................................................ 9
BISPHOSPHONATES .............................................. 5
Boniva ................................................................. 5
BRANDED NSAID THERAPY .................................. 6
C
Cataflam .............................................................. 6
Celebrex............................................................... 8
Celexa .................................................................. 1
Cetirizine Hcl ....................................................... 4
Clarinex ............................................................... 4
Clarinex Reditabs ................................................. 4
Clarinex-d 12 Hour .............................................. 4
Clarinex-d 24 Hour .............................................. 4
Clinoril ................................................................ 6
COX II THERAPY ................................................. 8
Cymbalta ............................................................. 1
E
Ec-naprosyn ........................................................ 6
Edluar ................................................................12
Effexor ................................................................ 1
Effexor Xr ........................................................... 1
Elidel..................................................................13
F
Feldene................................................................ 6
Fexofenadine Hcl ................................................ 4
Flector ................................................................. 6
Flonase ................................................................ 9
Fosamax .............................................................. 5
Fosamax Plus D .................................................. 5
I
INTRANASAL STEROIDS....................................... 9
L
LEUKOTRIENE INHIBITOR THERAPY .................10
Levocetirizine Dihydrochloride ........................... 4
Lexapro ............................................................... 1
Lunesta...............................................................12
Luvox Cr ............................................................. 1
M
Mobic .................................................................. 6
N
Nalfon ................................................................. 6
Naprelan.............................................................. 6
Naprosyn ............................................................. 6
Nasacort Aq ........................................................ 9
Nasonex .............................................................. 9
16
Omnaris ............................................................... 9
Silenor................................................................12
Singulair .............................................................10
Sonata ................................................................12
Sprix ................................................................... 6
P
T
Pantoprazole Sodium ......................................... 11
Paxil .................................................................... 1
Paxil Cr ................................................................ 1
Pennsaid .............................................................. 6
Pexeva ................................................................. 1
Ponstel ................................................................. 6
PPI THERAPY ..................................................... 11
Prevacid ............................................................. 11
Prevacid Solutab ................................................ 11
Prilosec .............................................................. 11
Pristiq .................................................................. 1
Protonix ............................................................. 11
Protopic ............................................................. 13
Prozac .................................................................. 1
Prozac Weekly ..................................................... 1
TOPICAL IMMUNOMODULATOR THERAPY .........13
R
Xyzal................................................................... 4
Rapiflux ............................................................... 1
Rhinocort Aqua .................................................... 9
Rozerem............................................................. 12
Z
Nexium .............................................................. 11
O
S
Sarafem................................................................ 3
Savella ................................................................. 1
Savella Titration Pack .......................................... 1
SEDATIVE HYPNOTICS ....................................... 12
V
Venlafaxine Hcl Er .............................................. 1
Veramyst ............................................................. 9
Viibryd ................................................................ 1
Vimovo ............................................................... 6
Voltaren .............................................................. 6
Voltaren-xr .......................................................... 6
Vytorin ...............................................................15
W
Wellbutrin Sr....................................................... 2
Wellbutrin XL ..................................................... 2
X
Zafirlukast ..........................................................10
Zegerid ...............................................................11
ZETIA.................................................................15
Zipsor.................................................................. 6
Zoloft .................................................................. 1
Zolpimist ............................................................12
17