ANTIDEPRESSANTS - BUPROPION
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1 Step Therapy Paramount Medicare Formulary 2012 Formulary ID 12112, Version 22. CMS Approved ANTIDEPRESSANTS - BUPROPION Aplenzin may be given. Step 1 Drug(s): Budeprion Sr, Budeprion Xl, Bupropion Hcl Sr. Step 2 Drug(s): Aplenzin. Authorization may be given for a step 2 drug if the patient is currently taking the requested agent. This step therapy program applies to new utilizers only.
2 ANTIDEPRESSANTS - SARAFEM Sarafem may be given. Step 1 Drug(s): Fluoxetine DR, Fluoxetine Hcl, Rapiflux, Selfemra. Step 2 Drug(s): Sarafem. Authorization may be given for step 2 Sarafem if the patient is currently taking the requested agent. This step therapy program applies to new utilizers only. 2
3 ANTIDEPRESSANTS - SNRI Cymbalta Pristiq If the patient has tried a Step 1 drug, then authorization for a drug in Step 2 drug may be given. Step 1 Drug(s): Venlafaxine Hcl, Venlafaxine Hcl Er. Step 2 Drug(s): Cymbalta, Pristiq. Patients who have taken a step 2 SNRI at any time in the past and discontinued its use may receive authorization to restart the step 2 SNRI (whichever they used in the past), without a trial of a step 1 agent. Authorization may be given for a step 2 SNRI if the patient is currently taking the requested agent. Authorization may be given for Cymbalta or Pristiq, without a trial of a step 1 agent, if the patient is a child or adolescent aged 18 years or less, or the patient has symptoms of suicidal ideation. Authorization may be given for Cymbalta, without a trial of a step 1 agent, if the patient (men or women) has symptoms of stress urinary incontinence. Authorization may be given for Cymbalta without a trial of a step 1 agent, if the patient has symptoms of fibromyalgia or diabetic peripheral neuropathic pain. Authorization may be given for Cymbalta, without a trial of a step 1 agent, if the patient has symptoms of chronic musculoskeletal pain (eg, chronic low back pain or chronic pain due to osteoarthritis). Step 1 drug use before Step 2 drug use is not required for any Step 2 drug labeled indications not part of Step 1 drug labeled indications. This step therapy program applies to new utilizers only. 3
4 ANTIDEPRESSANTS - SSRI Lexapro Viibryd TABS Luvox Cr If the patient has tried two Step 1 drugs, then authorization for a drug in Step 2 drug may be given. Step 1 Drug(s): Citalopram Hbr, Escitalopram, Fluoxetine Dr, Fluoxetine Hcl, Fluvoxamine Maleate, Paroxetine Hcl, Paroxetine Hcl Er, Rapiflux, Selfemra, Sertraline Hcl. Step 2 Drug(s): Lexapro, Luvox Cr, Viibryd. Patients who have taken Lexapro, Luvox Cr, or Viibryd at any time in the past and discontinued its use may receive authorization to restart Lexapro, Luvox Cr, or Viibryd (whichever they used in the past). Authorization may be given for a step 2 SSRI if the patient is currently taking the requested agent. Authorization may be given for Lexapro or Luvox Cr if the patient is a child or adolescent aged 18 years or less, or has suicidal ideation. Authorization may be given for Lexapro for use in the management of generalized anxiety disorder (GAD) for patients who have tried paroxetine HCl immediate release. Authorization may be given for Lexapro for patients who have tried citalopram hbr and who may have a clinically significant drug interaction with fluoxetine dr, fluoxetine hcl, fluvoxamine maleate, sertraline hcl, or paroxetine hcl. This step therapy program applies to new utilizers only. 4
5 ANTIDEPRESSANTS - SSRI_REVISED Lexapro Viibryd Luvox Cr If the patient has tried two Step 1 drugs, then authorization for a drug in Step 2 drug may be given. Step 1 Drug(s): Citalopram Hbr, Escitalopram, Fluoxetine Dr, Fluoxetine Hcl, Fluvoxamine Maleate, Paroxetine Hcl, Paroxetine Hcl Er, Rapiflux, Selfemra, Sertraline Hcl. Step 2 Drug(s): Lexapro, Luvox Cr, Viibryd. Patients who have taken Lexapro, Luvox Cr, or Viibryd at any time in the past and discontinued its use may receive authorization to restart Lexapro, Luvox Cr, or Viibryd (whichever they used in the past). Authorization may be given for a step 2 SSRI if the patient is currently taking the requested agent. Authorization may be given for Lexapro or Luvox Cr if the patient is a child or adolescent aged 18 years or less, or has suicidal ideation. Authorization may be given for Lexapro for use in the management of generalized anxiety disorder (GAD) for patients who have tried paroxetine HCl immediate release. Authorization may be given for Lexapro for patients who have tried citalopram hbr and who may have a clinically significant drug interaction with fluoxetine dr, fluoxetine hcl, fluvoxamine maleate, sertraline hcl, or paroxetine hcl. This step therapy program applies to new utilizers only. 5
6 ANTIHISTAMINE THERAPY Levocetirizine Dihydrochloride OTCs: "LORATADINE", "LORATADINE HIVES RELIEF", "CETIRIZINE HCL", "CETIRIZINE SYRUP", "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. Step 2 Drug(s): Levocetirizine. 6
7 BISPHOSPHONATES Actonel Ibandronate Sodium Fosamax SOLN may be given. Step 1 Drug(s): Alendronate Sodium. Step 2 Drug(s): Actonel, Fosamax SOLN. Authorization may be given for Actonel for use in the management of Paget s disease if the patient has already started therapy with Actonel. 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. 7
8 BISPHOSPHONATES_REVISED Actonel Ibandronate Sodium Fosamax SOLN may be given. Step 1 Drug(s): Alendronate Sodium. Step 2 Drug(s): Actonel, Fosamax SOLN, Ibandronate. Authorization may be given for Actonel for use in the management of Paget s disease if the patient has already started therapy with Actonel. 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. 8
9 BRANDED NSAID THERAPY Arthrotec 50 Pennsaid Arthrotec 75 Voltaren GEL Flector 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, Diclofenac Sodium DR, EC, ER, and XR, Etodolac, Etodolac ER, Fenoprofen Calcium, Flurbiprofen, Ibuprofen, Indomethacin, Indomethacin ER, Ketoprofen, Ketorolac Tromethamine, Meclofenamate Sodium, Mefenamic Acid, Meloxicam, Nabumetone, Naproxen, Naproxen DR, Naproxen Sodium, Oxaprozin, Piroxicam, Sulindac, Tolmetin Sodium. Step 2 Drug(s): Arthrotec 50, Arthrotec 75, Flector, Pennsaid, Voltaren Gel. Authorization for a step 2 drug, may be given if the patient has tried two unique generic prescription strength non-steroidal anti-inflammatory drugs (NSAIDs) for the current condition. Authorization may be given for Flector, Pennsaid, or Voltaren Gel for patients with difficulty swallowing or cannot swallow. Authorization may be given for Pennsaid or 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 NSAID-associated toxicity (eg, previous gastrointestinal [GI] bleed, history of peptic ulcer disease, impaired renal function, cardiovascular disease, hypertension, heart failure, elderly patients with impaired hepatic function, or those taking concomitant anticoagulants). 9
10 INTRANASAL STEROIDS Nasonex may be given. Step 1 Drug(s): Flunisolide, Fluticasone Propionate. Step 2 Drug(s): Nasonex. Authorization may be given for Nasonex if it is being used in the prevention of nasal symptoms associated with seasonal allergic rhinitis or for the treatment of nasal polyps in adults. 10
11 INTRANASAL STEROIDS_REVISED Nasonex may be given. Step 1 Drug(s): Flunisolide, Fluticasone Propionate. Triamcinolone. Step 2 Drug(s): Nasonex. Authorization may be given for Nasonex if it is being used in the prevention of nasal symptoms associated with seasonal allergic rhinitis or for the treatment of nasal polyps in adults. 11
12 LEUKOTRIENE INHIBITOR THERAPY Singulair Zafirlukast OTCs: "LORATADINE", "LORATADINE HIVES RELIEF", "CETIRIZINE HCL", "CETIRIZINE SYRUP", "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, Nasonex, plus either OTC cetirzine, OTC loratadine, or levocetirizine. Step 2 Drug(s): Singulair, Zafirlukast 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:
13 LEUKOTRIENE INHIBITOR THERAPY_REVISED Singulair Zafirlukast OTCs: "LORATADINE", "LORATADINE HIVES RELIEF", "CETIRIZINE HCL", "CETIRIZINE SYRUP", "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, triamcinolone, Nasonex, plus either OTC cetirzine, OTC loratadine, or levocetirizine. Step 2 Drug(s): Singulair, Zafirlukast 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:
14 LEUKOTRIENE INHIBITOR THERAPY_REVISED Montelukast Sodium CHEW Singulair Montelukast Sodium TABS Zafirlukast OTCs: "LORATADINE", "LORATADINE HIVES RELIEF", "CETIRIZINE HCL", "CETIRIZINE SYRUP", "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, triamcinolone, Nasonex, plus either OTC cetirzine, OTC loratadine, or levocetirizine. Step 2 Drug(s): Montelukast, Singulair, Zafirlukast 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:
15 LONG ACTING OPIOIDS Embeda Oxycontin Opana Er (crush Resistant) may be given. Step 1 Drug(s): Morphine Sulfate ER. Step 2 Drug(s): Embeda, Opana ER, Oxycontin. Authorization may be given for OxyContin if the patient is unable to tolerate or has a drug allergy noted with morphine sulfate. Authorization may be given for OxyContin if the patient has renal insufficiency. Authorization may be given for OxyContin if the patient is pregnant. Authorization may be given for Embeda if the patient cannot swallow or has difficulty swallowing. 15
16 LONG ACTING OPIOIDS_REVISED Embeda Oxycontin Opana Er (crush Resistant) may be given. Step 1 Drug(s): Morphine Sulfate ER. Oxymorphine ER. Step 2 Drug(s): Embeda, Opana ER, Oxycontin. Authorization may be given for OxyContin if the patient is unable to tolerate or has a drug allergy noted with morphine sulfate. Authorization may be given for OxyContin if the patient has renal insufficiency. Authorization may be given for OxyContin if the patient is pregnant. Authorization may be given for Embeda if the patient cannot swallow or has difficulty swallowing. 16
17 OPHTHALMIC PROSTAGLANDINS Lumigan Travatan Z may be given. Step 1 Drug(s): Latanoprost. Step 2 Drug(s): Lumigan, Travatan. 17
18 PPI THERAPY Dexilant Omeprazole CPDR Lansoprazole Omeprazole/sodium Bicarbonate Lansoprazole Odt OTCs: "OMEPRAZOLE" and "LANSOPRAZOLE". If the patient has tried a Step 1 drug, then authorization for a Step 2 drug may be given. Step 1 Drug(s): OTC, Pantoprazole Sodium. Step 2 Drug(s): Dexilant, Lansoprazole, Lansoprazole ODT, Omeprazole, Omeprazole-Sodium Bicarbonate. Authorization may be given for Lansoprazole (ODT tablets) for patients with a feeding tube (eg, nasogastric tube, gastric tube). Authorization may be given for a Step 2 agent for children less than 2 years old. 18
19 SEDATIVE HYPNOTICS Lunesta Zolpidem Tartrate Er Rozerem may be given. Step 1 Drug(s): Zaleplon, Zolpidem Tartrate. Step 2 Drug(s): Lunesta, Rozerem, Zolpidem ER. 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. 19
20 TEKTURNA Tekturna Tekturna Hct may be given. Step 1 Drug(s): Amlodipine Besylate-benazepril, Avalide, Avapro, Benazepril Hcl, Benazepril-hydrochlorothiazide, Captopril, Captopril-hydrochlorothiazide, Diovan, Diovan HCT, Enalapril Maleate, Enalapril-hydrochlorothiazide, Fosinopril Sodium, Fosinoprilhydrochlorothiazide, Lisinopril, Lisinopril-hydrochlorothiazide, Losartan Potassium, Losartan-Hydrochlorothiazide, Moexipril Hcl, Moexiprilhydrochlorothiazide, Perindopril erbumine, Quinapril Hcl, Quinaprilhydrochlorothiazide, Ramipril, Trandolapril. Step 2 Drug(s): Tekturna, Tekturna HCT. Authorization for a step 2 drug may be given if the patient tried an angiotensin converting enzyme (ACE) inhibitor or ACE inhibitor combination product in the past. Authorization for a step 2 drug may be given if the patient tried an angiotensin receptor blocker (ARB) or ARB combination product in the past (they are not required to have a trial with an ACE inhibitor). 20
21 TEKTURNA_REVISED Tekturna Tekturna Hct may be given. Step 1 Drug(s): Amlodipine Besylate-benazepril, Avalide, Avapro, Benazepril Hcl, Benazepril-hydrochlorothiazide, Captopril, Captopril-hydrochlorothiazide, Diovan, Diovan HCT, Enalapril Maleate, Enalapril-hydrochlorothiazide, Eprosartan, Fosinopril Sodium, Fosinoprilhydrochlorothiazide, Lisinopril, Lisinopril-hydrochlorothiazide, Losartan Potassium, Losartan-Hydrochlorothiazide, Moexipril Hcl, Moexiprilhydrochlorothiazide, Perindopril erbumine, Quinapril Hcl, Quinaprilhydrochlorothiazide, Ramipril, Trandolapril. Step 2 Drug(s): Tekturna, Tekturna HCT. Authorization for a step 2 drug may be given if the patient tried an angiotensin converting enzyme (ACE) inhibitor or ACE inhibitor combination product in the past. Authorization for a step 2 drug may be given if the patient tried an angiotensin receptor blocker (ARB) or ARB combination product in the past (they are not required to have a trial with an ACE inhibitor). 21
22 TOPICAL IMMUNOMODULATOR THERAPY Elidel Protopic may be given. Step 1 Drug(s): Ala-cort, Alclometasone Dipropionate, Amcinonide, Augmented Betamethasone Dipropionate, Betamethasone Dipropionate, Betamethasone Valerate, Clobetasol Emollient, Clobetasol Propionate, Clobetasol E, Desonide, Desoximetasone, Diflorasone Diacetate, Fluocinolone Acetonide, Fluocinonide, Fluocinonide Emollient, Fluocinonide E, Fluticasone Propionate, Halobetasol Propionate, Hydrocortisone, Hydrocortisone Butyrate, Hydrocortisone Valerate, Mometasone Furoate, Nystatin-Triamcinolone, Prednicarbate, Triamcinolone Acetonide, Triamcinolone Acetonide in Absorbase, Triderm. Step 2 Drug(s): Elidel, Protopic. Authorization may be given for Elidel or Protopic, if the patient has tried one 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 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 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). 22
23 ULORIC Uloric may be given. Step 1 Drug(s): Allopurinol. Step 2 Drug(s): Uloric. Authorization may be given for Uloric if the patient has tried allopurinol at any time in the past. Authorization may be given for Uloric if the patient has renal insufficiency or decreased renal function. Authorization may be given for Uloric if the patient is receiving concomitant medications that have significant drug-drug interactions with allopurinol, which are not noted with Uloric (eg, cyclosporine, chlorpropamide). 23
24 ZETIA Vytorin TABS 10MG; 10MG, 10MG; Zetia 20MG may be given. Step 1 Drug(s): Advicor, Caduet, Crestor, Lipitor, Lovastatin, Pravastatin Sodium, Simcor, Simvastatin. Step 2 Drug(s): Vytorin 10 mg, Vytorin 20 mg, Zetia. 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/muscle-metabolism-related disorder (eg, myositis, McArdle disease). 24
25 ZETIA_REVISED Vytorin TABS 10MG; 10MG, 10MG; Zetia 20MG may be given. Step 1 Drug(s): Advicor, Atorvastatin, Caduet, Crestor, Juvisync, Lipitor, Lovastatin, Pravastatin Sodium, Simcor, Simvastatin. Step 2 Drug(s): Vytorin 10 mg, Vytorin 20 mg, Zetia. 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/muscle-metabolismrelated disorder (eg, myositis, McArdle disease). 25
26 INDEX A Actonel... 7, 8 ANTIDEPRESSANTS - BUPROPION... 1 ANTIDEPRESSANTS - SARAFEM... 2 ANTIDEPRESSANTS - SNRI... 3 ANTIDEPRESSANTS - SSRI... 4 ANTIDEPRESSANTS - SSRI_REVISED ANTIHISTAMINE THERAPY... 6 Aplenzin... 1 Arthrotec Arthrotec B BISPHOSPHONATES... 7 BISPHOSPHONATES_REVISED BRANDED NSAID THERAPY... 9 C Cymbalta... 3 D Dexilant E Elidel Embeda... 15, 16 F Flector... 9 Fosamax... 7, 8 I Ibandronate Sodium... 7, 8 INTRANASAL STEROIDS INTRANASAL STEROIDS_REVISED L Lansoprazole Lansoprazole Odt LEUKOTRIENE INHIBITOR THERAPY LEUKOTRIENE INHIBITOR THERAPY_REVISED LEUKOTRIENE INHIBITOR THERAPY_REVISED Levocetirizine Dihydrochloride... 6 Lexapro... 4, 5 LONG ACTING OPIOIDS LONG ACTING OPIOIDS_REVISED Lumigan Lunesta Luvox Cr... 4, 5 M Montelukast Sodium N Nasonex... 10, 11 O Omeprazole Omeprazole/sodium Bicarbonate Opana Er (crush Resistant)... 15, 16 OPHTHALMIC PROSTAGLANDINS Oxycontin... 15, 16 P Pennsaid... 9 PPI THERAPY Pristiq... 3 Protopic R Rozerem S Sarafem... 2 SEDATIVE HYPNOTICS Singulair... 12, 13, 14 26
27 T TEKTURNA... 20, 21 Tekturna Hct... 20, 21 TEKTURNA_REVISED TOPICAL IMMUNOMODULATOR THERAPY Travatan Z U ULORIC V Viibryd... 4, 5 Voltaren... 9 Vytorin... 24, 25 Z Zafirlukast... 12, 13, 14 ZETIA... 24, 25 ZETIA_REVISED Zolpidem Tartrate Er
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