Kentucky Department for Medicaid Services

Secretary for Health and Family Services Selections for Preferred Products

This is a summary of the final Preferred Drug List (PDL) selections made by the Secretary for Health and Family Services based on the November 19, 2009 Pharmacy and Therapeutics Advisory Committee (PTAC) Meeting.

Description of Recommendation P & T Vote Final Decision (s) Branded Products with Generic Components Passed Branded products with generic components will Clinical Criteria 10 For be approved if any of the following are true: 0 Against  Positive clinical response to the Branded products with generic components will prescribed active ingredient, and the be approved if any of the following are true: patient has an allergy to some  Positive clinical response to the component of the commercial product; prescribed active ingredient, and the OR patient has an allergy to some  Therapeutic failure of: component of the commercial o At least three (if available) product; OR medications containing the  Therapeutic failure of: same active ingredient; AND o At least three (if available) o The requested medication’s medications containing the corresponding generic (if a same active ingredient; AND generic is available) has been o The requested medication’s attempted and failed or is corresponding generic (if a contraindicated. generic is available) has been attempted and failed or is  Of Note: Products in convenience contraindicated. packaging (i.e. dose packs) will not be approved if there is a generic equivalent  Of Note: Products in convenience available in a stock bottle. packaging (i.e. dose packs) will not be approved if there is a generic equivalent available in a stock bottle. Branded Products with Generic Components Passed The following products will require prior Require prior authorization for the following 10 For authorization: products: 0 Against  Terbinex Kit®  Terbinex Kit®  NuCort®  NuCort® New Drugs to Market: Multaq® Passed Multaq® will pay unrestricted until the entire class Allow this product to pay unrestricted until the 9 For of antiarrhythmics can be reviewed for inclusion entire class of antiarrhythmics can be reviewed 0 Against on the KY PDL. for inclusion on the KY PDL. 1 Abstention New Drugs to Market: Effient™ Passed Effient™ will be preferred in the PDL category Place this product preferred in the PDL 9 For titled: Platelet Inhibitors. category titled: Platelet Inhibitors. 0 Against 1 Abstention Description of Recommendation P & T Vote Final Decision (s) New Drugs to Market: Sabril™ Passed Sabril™ will be preferred in the PDL category Place this product preferred in the PDL 10 For titled: Anticonvulsants: Second Generation; category titled: Anticonvulsants: Second 0 Against however, it will only be allowed for use in Generation; however, only allow for its use in infantile spasms via an ICD-9 override. infantile spasms via an ICD-9 override. Diagnosis ICD-9 Diagnosis ICD-9 Infantile Spasms 345.6 Infantile Spasms 345.6 345.60 345.60 345.61 345.61 New Drugs to Market: Colcrys® Passed Colcrys® will pay after trial and failure of generic Allow this product to pay after trial and failure 10 For colchicine products. of generic colchicine products. 0 Against New Drugs to Market: Onglyza™ Passed Onglyza™ will be non preferred in the PDL Place this product non preferred in the PDL 10 For category titled: DPP4-Inhibitors. category titled: DPP4-Inhibitors. 0 Against New Drugs to Market: Saphris® Passed Saphris® will be preferred in the PDL category Place this product preferred in the PDL 10 For titled: Antipsychotics: Atypical with the same category titled: Antipsychotics: Atypical with 0 Against diagnosis criteria as other agents in the class. the same diagnosis criteria as other agents in the class. New Drugs to Market: Extavia® Passed Extavia® will be non preferred in the PDL Place this product non preferred in the PDL 10 For category titled: Multiple Sclerosis Agents. category titled: Multiple Sclerosis Agents. 0 Against New Drugs to Market: Embeda™ Passed Embeda™ will be non preferred in the PDL Place this product non preferred in the PDL 6 For category titled: Narcotics: Long-Acting. category titled: Narcotics: Long-Acting. 4 Against New Drugs to Market: Invega ® Sustenna™ Passed Invega® Sustenna™ will be preferred in the PDL Place this product preferred in the PDL 10 For category titled: Antipsychotics: Atypical with category titled: Antipsychotics: Atypical with 0 Against the same diagnosis criteria as other agents in the the same diagnosis criteria as other agents in the class. class. New Drugs to Market: Bepreve™ Passed Bepreve™ will be non preferred in the PDL Place this product non preferred in the PDL 10 For category titled: Ophthalmic Antihistamines. category titled: Ophthalmic Antihistamines. 0 Against New Drugs to Market: Intuniv™ Passed Intuniv™ will be preferred with appropriate Place this product preferred with appropriate 9 For quantity limits and similar prior approval criteria quantity limits and similar prior approval 0 Against in the PDL category titled: Antihyperkinesis criteria in the PDL category titled: 1 Abstention Agents. Antihyperkinesis Agents. Description of Recommendation P & T Vote Final Decision (s) New Drugs to Market: Valturna® Passed Valturna® will be non preferred with similar Place this product preferred with similar 8 For approval criteria in the PDL category titled: approval criteria in the PDL category titled: 1 Against Direct Renin Inhibitors. Direct Renin Inhibitors if cost neutral to other 1 Abstention agents in the category. New Drugs to Market: Stelara™ Passed Stelara™ will be non preferred in the PDL Place this product non preferred in the PDL 10 For category titled: Immunomodulators with the category titled: Immunomodulators with the 0 Against following clinical criteria: following clinical criteria: Stelara™ will be approved if both of the Stelara™ will be approved if both of the following are true: following are true:  Trial and failure of two of the following  Trial and failure of two of the following therapies: therapies: o Methotrexate o Methotrexate o Cyclosporine o Cyclosporine o Oral retinoid o Oral retinoid o Topical corticosteroids o Topical corticosteroids o Phototherapy/UV light o Phototherapy/UV light o Coal tar preparation o Coal tar preparation  No less than a one month trial and failure  No less than a one month trial and of one preferred product that is indicated failure of one preferred product that is for psoriasis. indicated for psoriasis. New Drugs to Market: Onsolis™ Passed Onsolis™ will be non preferred in the PDL Place this product non preferred in the PDL 10 For category titled: Narcotics: Fentanyl Buccal category titled: Narcotics: Fentanyl Buccal 0 Against Products with similar prior approval criteria and Products with similar prior approval criteria and quantity limits as other agents in the class. quantity limits as other agents in the class. Description of Recommendation P & T Vote Final Decision (s) Immunomodulators Passed Selected Preferred Agent (s) 1. DMS to select preferred agent (s) based on 10 For Enbrel® economic evaluation; however, at least two 0 Against Humira® self administrable products should be preferred. 2. Agents not selected as preferred will be considered non preferred and require trial and failure of preferred product (s) with a FDA-approved indication for the requested diagnosis. 3. All agents in the category should be approved for their FDA-approved indications only. 4. DMS to allow continuation of therapy if there is a paid claim in the past 90 days. 5. Maintain quantity limits on agents within the category according to their maximum recommended dose, taking into consideration any escalating doses needed during initial therapy. 6. For any new chemical entity in the Immunomodulator class, require a PA until reviewed by the P&T Advisory Committee. Immunomodulator Clinical Criteria Passed Immunomodulator Clinical Criteria 10 For Drug Diagnosis Prior Therapy 0 Against Drug Diagnosis Prior Therapy Orencia® Rheumatoid Trial and failure of 1 Orencia® Rheumatoid Trial and failure of 1 (abatacept) arthritis DMARD (abatacept) arthritis DMARD Juvenile Trial and failure of 1 Juvenile Trial and failure of 1 Idiopathic DMARD Idiopathic DMARD Arthritis (JIA) Arthritis (JIA) Humira® Rheumatoid Trial and failure of 1 Humira® Rheumatoid Trial and failure of 1 (adalimumab) Arthritis DMARD (adalimumab) Arthritis DMARD Juvenile Trial and failure of 1 Juvenile Trial and failure of 1 Idiopathic DMARD Idiopathic DMARD Arthritis (JIA) Arthritis (JIA) Ankylosing None Ankylosing None Spondylitis Spondylitis Plaque Trial and failure of two of the Plaque Trial and failure of two of the Psoriasis following therapies: Psoriasis following therapies:  Methotrexate  Methotrexate  Cyclosporine  Cyclosporine  Oral retinoid  Oral retinoid  Topical corticosteroids  Topical corticosteroids  Phototherapy/UV light  Phototherapy/UV light  Coal tar preparations  Coal tar preparations Crohn’s Failure of conventional Crohn’s Failure of conventional Disease therapy of at least one agent Disease therapy of at least one agent in at least 2 of the following in at least 2 of the following classes (not all inclusive): classes (not all inclusive):  5-ASA agents –  5-ASA agents – examples: Mesalamine examples: Mesalamine (Pentasa, Asacol, (Pentasa, Asacol, Rowasa) Rowasa)  Corticosteroids –  Corticosteroids – examples: Cortenema, examples: Cortenema, Prednisone Prednisone  Immunosuppressives–  Immunosuppressives– examples: examples: Azathioprine (Imuran), Azathioprine (Imuran), 6-Mercaptopurine 6-Mercaptopurine (Purinethol) (Purinethol) Psoriatic Trial and failure of one of the Psoriatic Trial and failure of one of the Arthritis following treatment: Arthritis following treatment:  Oral NSAID  Oral NSAID  Methotrexate alone  Methotrexate alone  Intra-articular  Intra-articular corticosteroid corticosteroid Amevive® Plaque Trial and failure of two of the Amevive® Plaque Trial and failure of two of the (alefacept) Psoriasis following therapies: (alefacept) Psoriasis following therapies:  Methotrexate  Methotrexate  Cyclosporine  Cyclosporine  Oral retinoid  Oral retinoid  Topical corticosteroids  Topical corticosteroids  Phototherapy/UV light  Phototherapy/UV light  Coal tar preparations  Coal tar preparations Kineret® Rheumatoid Trial and failure of 1 Kineret® Rheumatoid Trial and failure of 1 (anakinra) Arthritis DMARD (anakinra) Arthritis DMARD Cimzia® Rheumatoid Trial and failure of 1 Cimzia® Rheumatoid Trial and failure of 1 (certolizumab Arthritis DMARD (certolizumab Arthritis DMARD pegol) Crohn’s Failure of conventional pegol) Crohn’s Failure of conventional Disease therapy of at least one agent Disease therapy of at least one agent in at least 2 of the following in at least 2 of the following classes (not all inclusive): classes (not all inclusive):  5-ASA agents –  5-ASA agents – examples: Mesalamine examples: Mesalamine (Pentasa, Asacol, (Pentasa, Asacol, Rowasa) Rowasa)  Corticosteroids –  Corticosteroids – examples: Cortenema, examples: Cortenema, Prednisone Prednisone  Immunosuppressives–  Immunosuppressives– examples: examples: Azathioprine (Imuran), Azathioprine (Imuran), 6-Mercaptopurine 6-Mercaptopurine (Purinethol) (Purinethol) Enbrel Rheumatoid Trial and failure of 1 Enbrel Rheumatoid Trial and failure of 1 (etanercept) Arthritis DMARD (etanercept) Arthritis DMARD Juvenile Trial and failure of 1 Juvenile Trial and failure of 1 Idiopathic DMARD Idiopathic DMARD Arthritis (JIA) Arthritis (JIA) Ankylosing None Ankylosing None Spondylitis Spondylitis Plaque Trial and failure of two of the Plaque Trial and failure of two of the Psoriasis following therapies: Psoriasis following therapies:  Methotrexate  Methotrexate  Cyclosporine  Cyclosporine  Oral retinoid  Oral retinoid  Topical corticosteroids  Topical corticosteroids  Phototherapy/UV light  Phototherapy/UV light  Coal tar preparations  Coal tar preparations Psoriatic Trial and failure of one of the Psoriatic Trial and failure of one of the Arthritis following treatment: Arthritis following treatment:  Oral NSAID  Oral NSAID  Methotrexate alone  Methotrexate alone  Intra-articular  Intra-articular corticosteroid corticosteroid Simponi™ Rheumatoid Trial and failure of 1 Simponi™ Rheumatoid Trial and failure of 1 (golimumab) Arthritis DMARD (golimumab) Arthritis DMARD Ankylosing None Ankylosing None Spondylitis Spondylitis Psoriatic Trial and failure of one of the Psoriatic Trial and failure of one of the Arthritis following treatment: Arthritis following treatment:  Oral NSAID  Oral NSAID  Methotrexate alone  Methotrexate alone  Intra-articular  Intra-articular corticosteroid corticosteroid Remicade® Rheumatoid Trial and failure of 1 Remicade® Rheumatoid Trial and failure of 1 (infliximab) Arthritis DMARD (infliximab) Arthritis DMARD Ankylosing None Ankylosing None Spondylitis Spondylitis Plaque Trial and failure of two of the Plaque Trial and failure of two of the Psoriasis following therapies: Psoriasis following therapies:  Methotrexate  Methotrexate  Cyclosporine  Cyclosporine  Oral retinoid  Oral retinoid  Topical corticosteroids  Topical corticosteroids  Phototherapy/UV light  Phototherapy/UV light  Coal tar preparations  Coal tar preparations Crohn’s Failure of conventional Crohn’s Failure of conventional Disease therapy of at least one agent Disease therapy of at least one agent in at least 2 of the following in at least 2 of the following classes (not all inclusive): classes (not all inclusive):  5-ASA agents –  5-ASA agents – examples: Mesalamine examples: Mesalamine (Pentasa, Asacol, (Pentasa, Asacol, Rowasa) Rowasa)  Corticosteroids –  Corticosteroids – examples: Cortenema, examples: Cortenema, Prednisone Prednisone  Immunosuppressives–  Immunosuppressives– examples: examples: Azathioprine (Imuran), Azathioprine (Imuran), 6-Mercaptopurine 6-Mercaptopurine (Purinethol) (Purinethol) Ulcerative Trial and failure of one of the Ulcerative Trial and failure of one of the Colitis following treatments: Colitis following treatments:  Corticosteroid  Corticosteroid  Immunosuppressant  Immunosuppressant Fistulizing None Fistulizing None Crohn’s Crohn’s Disease Disease Psoriatic Trial and failure of one of the Psoriatic Trial and failure of one of the Arthritis following treatment: Arthritis following treatment:  Oral NSAID  Oral NSAID  Methotrexate alone  Methotrexate alone  Intra-articular  Intra-articular corticosteroid corticosteroid Stelara™ Plaque Trial and failure of two of the Stelara™ Plaque Trial and failure of two of the (ustekinumab) Psoriasis following therapies: (ustekinumab) Psoriasis following therapies:  Methotrexate  Methotrexate  Cyclosporine  Cyclosporine  Oral retinoid  Oral retinoid  Topical corticosteroids  Topical corticosteroids  Phototherapy/UV light  Phototherapy/UV light  Coal tar preparations  Coal tar preparations

Non preferred products will require no less than Non preferred products will require no less than a a one month trial and failure of one preferred one month trial and failure of one preferred product which is approved for the same product which is approved for the same diagnosis. diagnosis. Description of Recommendation P & T Vote Final Decision (s) Topical Immunomodulator Passed Selected Preferred Agent (s) 1. DMS to select preferred agent (s) based on 10 For Elidel® economic evaluation; however, at least one 0 Against Protopic® topical immunomodulator should be preferred. 2. Agents not selected as preferred will be considered non preferred and require PA. 3. For any new chemical entity in the Topical Immunomodulators, require a PA until reviewed by the P&T Advisory Committee. Multiple Sclerosis Agents Passed Selected Preferred Agent (s) 1. DMS to select preferred agent (s) based on 9 For Avonex® economic evaluation; however, at least 0 Against Avonex® Administration Pack glatiramer, one interferon β-1b and one 1 Abstention Betaseron® interferon β-1a product should be preferred. Copaxone® 2. Agents not selected as preferred will be Rebif® considered non preferred and require PA. 3. DMS to allow continuation of therapy if there is a paid claim in the past 90 days. 4. All agents in the category will have no higher than a tier 2 copay regardless of PDL status. 5. Place quantity limits on these products based on maximum recommended dose. 6. For any new chemical entity in the Multiple Sclerosis Agents class, require a PA and quantity limit until reviewed by the P&T Advisory Committee. Calcium Channel Blockers (DHP) Passed Selected Preferred Agent (s) 1. DMS to select preferred agent (s) based 9 For Afeditab CR® on economic evaluation; however, at least 1 Against amlodipine three unique chemical entities, one of which felodipine ER should be amlodipine, should be preferred. isradipine 2. Agents not selected as preferred will be nicardipine considered non preferred and require PA. nifedipine 3. For any new chemical entity in the nifedipine SA/ER Calcium Channel Blocker (DHP) class, nimodipine require a PA until reviewed by the P&T Advisory Committee. Description of Recommendation P & T Vote Final Decision (s) ACE Inhibitors Passed Selected Preferred Agent (s) 1. DMS to select preferred agent (s) based 10 For benazepril on economic evaluation; however, at least 0 Against captopril three unique chemical entities should be enalapril preferred. Lisinopril and ramipril must be lisinopril among the preferred agents. quinapril 2. Agents not selected as preferred will be ramipril considered non preferred and require PA. 3. For any new chemical entity in the ACE Inhibitor class, require a PA until reviewed by the P&T Advisory Committee. ACE Inhibitor + Diuretic Combinations Passed Selected Preferred Agent (s) 1. DMS to select preferred agent (s) based on 10 For benazepirl/HCTZ economic evaluation; however, at least three 0 Against captopril/HCTZ unique chemical entities should be preferred. enalapril-HCTZ Lisinopril/HCTZ and ramipril/HCTZ must lisinopril/HCTZ be among the preferred agents. quinapril/HCTZ 2. Agents not selected as preferred will be Quinaretic® considered non preferred and require PA. 3. For any new chemical entity in the ACEI + Diuretic Combination class, require a PA until reviewed by the P&T Advisory Committee. Antibiotic Agents for Acne Passed Selected Preferred Agent (s) 1. Rename this category Miscellaneous Topical 9 For BenzaClin® Treatments for Acne. 0 Against Benzamycin® 2. DMS to select preferred agent (s) based on benzoyl peroxide economic evaluation; however, at least benzoyl peroxide/clindamycin multiple generic formulations of benzoyl benzoyl peroxide/erythromycin peroxide and one topical antibiotic agent for clindamycin acne should be preferred. erythromycin 3. Agents not selected as preferred will be salicylic acid considered non preferred and require PA. sodium sulfacetamide 4. For any new chemical entity in the sodium sulfacetamide/sulfur Miscellaneous Topical Treatments for Acne class, require a PA until reviewed by the P&T Advisory Committee. Description of Recommendation P & T Vote Final Decision (s) Topical Retinoids Passed Selected Preferred Agent (s) 1. DMS to select preferred agent (s) based on 9 For Avita® economic evaluation; however, at least 0 Against Differin® tretinoin should be preferred. Epiduo™ 2. Agents not selected as preferred will be Retin-A Micro® considered non preferred and require PA. tretinoin 3. For any new chemical entity in the Topical Retinoid class, require a PA until reviewed by the P&T Advisory Committee. Oral Retinoids Passed Selected Preferred Agent (s) 1. DMS to select preferred agent (s) based on 9 For Amnesteem® economic evaluation; however, at least 0 Against Claravis® acitretin and isotretinoin should be preferred. Soriatane CK® 2. Agents not selected as preferred will be Sotret® considered non preferred and require PA. 3. For any new chemical entity in the Oral Retinoid class, require a PA until reviewed by the P&T Advisory Committee. Isotretinoin Clinical Criteria Passed Since the iPLEDGE system already restricts the Since the iPLEDGE system already restricts the 9 For use of these products, the prior authorization use of these products, allow them to be subject 0 Against criteria will be removed. to the general PDL criteria if one is chosen to be preferred over another. Thiazolidinediones Passed Selected Preferred Agent (s) 1. DMS to select preferred agent (s) based 7 For Actos® on economic evaluation; however, at least 2 Against Avandia® pioglitazone and rosiglitazone should be preferred. 2. Continue quantity limits based on maximum recommended dose. 3. Agents not selected as preferred will be considered non preferred and require PA. 4. For any new chemical entity in the Diabetes: Thiazolidinediones class, require a PA until reviewed by the P&T Advisory Committee. Description of Recommendation P & T Vote Final Decision (s) Thiazolidinedione Combinations Passed Selected Preferred Agent (s) 1. DMS to select preferred agent (s) based on 9 For Actoplus Met™ economic evaluation; however, at least two 0 Against Avandamet® combination products containing metformin Duetact™ should be preferred. 2. Continue quantity limits based on maximum recommended dose. 3. Agents not selected as preferred will be considered non preferred and require PA. 4. For any new chemical entity in the Diabetes: Thiazolidinediones Combination class, require a PA until reviewed by the P&T Advisory Committee.