PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Olumiant (baricitinib) BILLING CODE Must use valid NDC BENEF IT TYPE Pharmacy SIT EOF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Preferred Product) QUANTITY LIMIT 30 tabs for 30 days LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click He re Olumiant (baricitinib) is a pre fe rred product and will only be con sidered for coverage under the pharm acy benefit when the following criteria are met: Members mus t be c linically diagnosed with one of the following dis eas e states and meet their individual c riteria as s tated. RHEUMATOID ARTHRITIS (RA) For initial authorization: 1. Member is 18 year of age or older with moderate to severe active RA who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies ; AND 2. Must have a documented negative TB test (i.e., tuberculosis skin test (PPD), an interferon-r ele a s e assay (IGRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a rheumatologist; AND 4. Member must have tried and failed treatm ent with at least two non-biologic DMARDS (i.e., methotrexate, hydroxychloroquine, sulfasalazine, azathioprine, cyclosporine and leflunomide) or must have documented contraindication to all non-biologic DMARDS. Treatment trial duration with each non-biologic DMARD agent must have been at least 30 days ; AND 5. Medication is not being used in combination with other JAK inhibitors, biologic disease-m o dif y in g antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine . 6. Do sage allowed: 2 mg once daily . Note: Olumiant should be used with caution in member s who may be at increased risk of thrombosis. If member meets all the requirements listed above, the medication will be approved for 12 months. For r e a ut ho riza tion: 1. Must have been retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will be approved for a n a ddit ion a l 12 months. Care Source conside rs Olum iant (baricitinib) not m e dically ne ce ssary for the tre atment of the follow ing dise ase state s base d on a lack of robust clinical controlle d trials show ing supe rior e fficacy com pared to curre ntly av ailable tre atments: Alopecia ANCA associated vasculitis Asthma Cellulitis Dissecting scalp cellulitis Dry eye disease For use in combination with other TNF-inhibitors (i.e. Kineret, Enbrel, Remicade) Giant-cell arteritis Infectious uveitis Inflammatory bowel diseases (Crohn's disease and ulcerative colitis) Lupus perino Osteoarthr itis Prevention of organ transplant rejection Plaque psoriasis Recurrent pregnancy loss Relapsing polychondritis Sarcoidosis Sciatica Spondyloarthritis (other than ankylosing spondylitis) Takayasus arteritis Vogt-Koyanagi-Harada (VKH) disease DATE ACTION/DESCRIPTION 08/31/2018 New policy for Olumiant created. 02/26/2019 Status changed to preferred. Humira and Enbrel trials removed from criteria. TB test allowed to be done within 12 months prior to initiation of therapy; chest x-ray option removed. References added. Referenc es : 1. Olumiant [pac kage ins ert]. Indianapolis, IN: Lilly USA, LLC; May 2018. 2. Americ an College of Rheumatology . Guidelines for the management of rheumatoid arthritis: American College of Rheumatology Ad Hoc Committee on Clinical Guidelines . Arthritis Rheuma. 1996;39(5):713-723. 3. Singh JA, Furs t DE, Beharat A, et al. 2012 Update the 2008 American College of Rheumatology Rec ommendations for the Us e of Disease]Modifying Antirheumatic Drugs and Biologic Agents in the Treatment of Rheumatoid Arthritis. Arthritis Care Res (Hobok en). 2012;64(5):625-639. 4. Genov es e MC, et al. Baricitinib in Patients with Refractory Rheumatoid Arthritis. NEngl JMed. 2016 Mar 31;374(13):1243-52. 5. Tay lor PC, et al. Baric itinib v ersus Placebo or Adalimumab in Rheumatoid Arthritis . NEngl JMed. 2017 Feb 16;376(7):652-662. Effec tive date: 04/01/2019 Rev is ed date: 02/26/2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Kineret (anakinra) BILLING CODE Must use valid NDC code BENEF IT TYPE Pharmacy SIT EOF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) Alternative pr eferred products include Actemra, Enbrel, Cimzia, Kevzara, Olumiant and Xeljanz for RA QUANTITY LIMIT 28 syringes per 28 days LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click He re Kineret (anakinra) is a non-pre ferred product and will only be con sidered for coverage under the pharm acy benefit when the following criteria are met: Members mus t be c linically diagnosed with one of the following dis eas e states and meet their individual c riteria as s tated. CRY OPYRIN-ASSOCIATED PERIODIC SY NDROME (CAPS) For initial authorization: 1. Member must be diagnosed with Neonatal-Onset Multisystem Inflammatory Disease (NOMID); AND 2. Prescriber has submitted laboratory evidence of a genetic mutation in the Cold-Induced Auto-Inflammatory Syndrome 1 (CIAS1sometimes referred to as the NLRP3); AND 3. Medication must be prescribed by a rheumatologist or under recommendation of a rheumatologist or CAPS specialist; AND 4. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-r ele a s e assay (IGRA )) within 12 months prior to starting therapy. 5. Dosage allowed: Initial dose: Inject 1-2 mg/kg subcutaneously once daily in 1 or 2 divided doses; adjust dose in 0.5-1 mg/kg increments as needed. Usual maintenance dose: 3-4 mg/kg once daily (maximum of 8 mg/kg per day). If member meets all the requirements listed above, the medication will be approved for 12 months. For r e a ut ho riza tion: 1. Must have been retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will be approved for a n a ddit ion a l 12 months.RHEUMATOID ARTHRITIS (RA) For initial authorization: 1. Member must be 18 years of age or older with moderate to severe active RA; AND 2. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-r ele a s e assay (IGRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a rheumatologist; AND 4. Member must have tried and failed treatment with at least two non-biologic DMARDS (i.e. , methotrexate, hydroxychloroquine, sulfasalazine, azathioprine, cyclosporine and leflunomide) or must have documented contraindication to all non-biologic DMARDS. Treatment trial duration with each non-biologic DMARD agent must have been at least 30 days ; AND 5. Member has tried and failed treatment with at least two of the following: Actemra, Enbrel, Cimzia and Kevzara, Olumiant and Xeljanz . Treatment failure requires at least for 30 days of therapy with each drug. 6. Dosage allowed: Inject 100 mg subcutaneously once daily. If member meets all the requirements listed above, the medication will be approved for 12 months. For r e a ut ho riza tion: 1. Must have been retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will be app r ov e d f or an additional 12 months. Care Source conside rs Kine ret (anakinra) not m e dically ne ce ssary for the tre atment of the follow ing dise ase state s base d on a lack of robust clinical controlle d trials show ing supe rior e fficacy com pared to curre ntly av ailable tre atments: Ankylosing Spondylitis Anterior cruciate ligament injury Diabetes mellitus (type 1 and type 2) Familial Mediterranean fever Fatigue associated with Sjogrens syndrome Gout Heart failure (prevention of heart failure after acute MI) Inflammatory bowel disease Kawasaki disease Lupus arthritis Myopathy/myositis Non-neuropathic hereditary familial amyloidosis Osteoarthritis Pyoderma gangraenosum Reactive arthritis Systemic lupus erythematosus DATE ACTION/DESCRIPTION 05/15/2017 New policy for Kineret created. Policy SRx-0042 archived. List of diagnoses considered not medically necessary was added. 02/26/2019 Humira was removed from criteria; Actemra, Cimzia, Kevzara, Olumiant and Xeljanz for RA added to trial agents list. TB test allowed to be done within 12 months prior to initiation of therapy; chest x-ray option removed. Referenced added. Referenc es : 1. Kineret [pac k age insert]. Stock holm, Sweden: Swedish Orphan Biovitrum AB; May, 2016. 2. Americ an College of Rheumatology . Guidelines for the management of rheumatoid arthritis: American College of Rheumatology Ad Hoc Committee on Clinical Guidelines . Arthritis Rheuma. 1996;39(5):713-723. 3. Ringold S, Weis s PF, Beukelman T, et al. 2013 Update of the 2011 Americ an College of Rheumatology Rec ommendations for the Treatment of Juvenile Idiopathic Arthritis . Rec ommendations for the Medic al Therapy of Children With Sy s temic Juvenile Idiopathic Arthritis and Tuberc ulosis Screeni ng Among Children Rec eiv ing Biologic Medic ations Vol. 65, No. 10, October 2013, pp 2499 2512. 4. Shink ai K, McCalmont TH, Leslie KS. Cry opyrin-as sociated periodic s yndromes and autoinflammation. Clin Ex p Dermatol. 2008;33(1):1-9. 5. Sc ott IC, et al. A randomised trial evaluating anak inra in early ac tiv e rheumatoid arthritis. Clin Exp Rheumatol. 2016 Jan-Feb;34(1):88-93. 6. Fleis c hmann RM, et al. Safety of extended treatment with anakinra in patients with rheumatoid arthritis . Ann Rheum Dis . 2006;65(8):1006-12. 7. Gall oway JB, et al. The risk of s erious infections in patients rec eiv ing anak inra for rheumatoid arthritis: res ults from the Britis h Society for Rheumatology Biologics Regis ter. Rheumatology (Oxford). 2011 Jul;50(7):1341-2. Effec tive date: 04/01/2019 Rev is ed date: 02/26/2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Kevzara (sarilumab) BILLING CODE Must use valid NDC code BENEF IT TYPE Pharmacy SIT EOF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Preferre d Product) QUANTITY LIMIT 200 mg for 28 days LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click He re Kevzara (sarilumab) is a pre ferred product and will only be considered for coverage under the pharm acy benefit when the following criteria are met: Members mus t be c linically diagnosed with one of the following dis eas e states and meet their individual c riteria as s tated. RHEUMATOID ARTHRITIS (RA) For initial authorization: 1. Member must be 18 years of age or older with moderate to severe active RA ; AND 2. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-r ele a s e assay (IGRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a rheumatologist; AND 4. Member has at least 8 tender and 6 swollen joints at baseline; AND 5. Member must have tried and failed treatment with at least two non-biologic DMARDS (i.e. , methot rexate, hydroxychloroquine, sulfasalazine (pregnancy category B) , and leflunomide) or must have documented contraindication to all non-biologic DMARDS. Treatment trial duration with each non-biologic DMARD agent must have been at least 30 days . 6. Dosage allowed: 200 mg once every two weeks given as a subcutaneous injection. If member meets all the requirements listed above, the medication will be approved for 12 months. For r e a ut ho riza tion: 1. Must have been retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will b e a ppr ov e d f or an additional 12 months. Care Source conside rs Ke v zara (sarilumab) not m e dically necessary for the tre atment of the follow ing dise ase state s base d on a lack of robust clinical controlle d trials show ing supe rior e fficacy com pared to curre ntly av ailable tre atments: Adult-onset Still disease Ankylosing spondylitis Crohn s disease Giant cell arteritis Neuromyelitis optica Polymyalgia rheumatic a Psoriatic arthritis Relapsing polychondritis Systemic lupus erythematosus Systemic sclerosis-associated myopathy/polyarthritis Systemic vasculitis Takayasu arteritis Tumor necrosis fac tor receptor associated periodic syndrome (TRAPS) Uveitis DATE ACTION/DESCRIPTION 06/20/2017 New policy for Kevzara created. 02/26/2019 Status changed to preferred. Humira and Enbrel trials removed from criteria. Initial and reauthorization length placed for 12 months. ANC level requirement removed. TB test allowed to be done within 12 months prior to initiation of therapy; chest x-ray option removed. Referenc es : 1. Kev z ara [pac kage ins ert]. Bridgewater, NJ : SANO FI-AV ENT IS U.S. LLC; May 2017. 2. Genov es e MC. Sarilumab Plus Methotrexate in Patients With Ac tive Rheumatoid Arthritis and Inadequate Res pons e to Methotrexate: Res ults of a Phas e III Study. Arthritis Rheumatol. 2015 Jun;67(6):1424-37. 3. United States Food and Drug Administration. Kevzara ( s arilumab) injec tion. Available at: https ://www.acc es sdata.fda.gov/drugs atfda_docs /nda/2017/761037Orig1s000TOC.cfm. Ac cessed on 2/13/19. Effec tive date: 04/01/2019 Rev is ed date: 02/26/2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Ilumya (tildrakizumab-asmn) BILLING CODE J3590 BENEF IT TYPE Medical SIT EOF SERVICE ALLOWED Outpatient/Office COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) Alternative preferred products include Cimzia, Cosentyx, Enbrel, Otezla and Siliq QUANTITY LIMIT 100 mg every 12 weeks after 4th we ek LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click He re Ilumya (tildrakizumab-asmn) is a non-pre ferred product and will only be considered for coverage under the m e dical benefit when the following criteria are met: Members mus t be c linically diagnosed with one of the following dis eas e states and meet their individual c riteria as s tated. PLAQUE PSORIASIS (PsO) For initial authorization: 1. Member must be 18 years of age or older with a diagnosis of moderate-to-seve re chronic PsO ; AND 2. Member must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-release assay (IGRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a dermatologist or rheumatologist; AND 4. Member has PsO for 6 months or longer; AND 5. Mem ber is not receiving Ilumya in combination with other systemic therap ies (e.g., Enbrel, Humira, Cimzia, Simponi, Xeljanz, Otezla, etc. ) or phototherapy ; AND 6. Member s PsO involving 10% or more of the body surface area (BSA) , or BSA l ess than 10% if there is sensitive area involvement (hands, feet, face, or genitals); AND 7. Member s Psoriasis Area a nd Severity Index (PASI) score 12; AND 8. Member has tried and failed to respond to treatment with at least one of the following: a) a) At least 30 days of photochemotherapy (i.e. , psoralen plus ultraviolet A therapy); b) b) At least 30 days of phototherapy (i.e. , UVB light therapy, Excimer laser treatments (tanning beds emit mostly UVA light and therefore would not meet this criteria)); c) c) At least a 4 week trial with topical antipsoriatic agents (i.e. , anthralin, calcipotriene, coal tar, corticosteroids, tazarotene); AND 9. Member has tried and failed to respond to treatment with traditional first-line oral/systemic therapies (i.e. , cyclosporine, methotrexate, ac itretin) for at least 30 days ; AND 10. Member has tried and failed treatment with at least two of the following: Cimzia, Cosentyx, Enbrel, Otezla and Siliq. Treatment failure requires at least for 30 days of therapy with each drug. 11. Dosage allowed: 100 mg subcutaneous ly at Weeks 0, 4, and every twelve weeks thereafter , and should only be administered by a healthcare provider. If member meets all the requirements listed above, the medication will be approved for 12 months.For r e a ut ho riza tion: 1. Member must have been retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of si gns and symptoms of disease (e.g., documented members PASI score improvement, etc.). If member meets all the reauthorization requirements above, the medication will be approved for a n a ddit ion a l 12 months. Care Source considers Ilumya (tildrakizumab-as m n) not m edically necessary for the tre atment of the following disease state s base d on a lack of robust clinical controlle d trials show ing supe rior e fficacy com pared to curre ntly av ailable tre atments: Active infections Ankylosing spondylitis Asthma Cellulitis Crohn s Disease Dissecting scalp cellulitis For use in combination with other TNF-inhibitors (i.e. , Humira, Kineret, Enbrel, Remicade) Giant-cell arteritis Infectious uveitis Juvenile idiopathic arthritis Lupus perino Osteoarthritis Psoriatic Ar thritis Recurrent pregnancy loss Relapsing polychondritis Rheumatoid arthritis Sarcoidosis Sciatica Spondyloarthritis (other than ankylosing spondylitis) Takayasu s arteritis Ulcerative Colitis Vogt-Koyanagi D ATE ACTION/DESCRIPTION 09/13/2018 New policy for Ilumya created. 02/26/2019 Humira trial removed from criteria; Cimzia, Cosentyx, Otezla and Siliq added to trial agents list. TB test allowed to be done within 12 months prior to initiation of therapy; chest x-ray option removed. Reauthorization criteria on documented members PASI score improvement incorporated into general chart noted documentation requirements. Static Physicians Global Assessment (sPGA) score removed. Ulcerative Colitis added to not covered diagnosis. BSA less than 10% allowed if there is sensitive area involvement. Referenc es : 1. Ilumy a [pac kage insert]. Whitehous e Station, NJ :Merck & Co., Inc., March, 2018. 2. Menter A, Korman NJ , Elmets CA, et al. Guidelines of care for the management of psoriasis and ps oriatic arthritis. Sec tion 6. Guidelines of c are for the treatment of ps orias is and ps oriatic arthritis: Cas e-based pres entations and ev idenc e-bas ed c onclusions. Journal of the American A cademy of Dermatology, Volume 65, Issue 1, 137 174. 3. Hs u S, Papp KA, Lebwohl MG, et al. Cons ensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012 Jan;148(1):95-102. 4. Clinic alTrials .gov. Identifier NCT01225731. A Study to Determine the Optimal Dos e of Tildrak izumab (SCH 900222/MK-3222) for the Treatment of Moderate-to-s evere Chronic Plaque Psoriasis (P05495) (MK-3222-003). Av ailable at: ht tps :/ /cl inicaltrials.gov /ct2/show/NCT01225731?term=tildrak izumab&rank =1. Ac cessed on Marc h 26, 2018. 5. Ed. Lebwohl MG, et al. Treatment of Skin Disease: Comprehens iv e Therapeutic Strategies. 5th ed. Philadelphia, PA: Saunders ; 2018. 6. Bolognia JL, et al. Dermatology . 4th ed. Philadelphia, PA: Saunders ; 2018. 7. Feldman SR. Treatment of ps oriasis. In: UpToDate. Waltham, MA: UpToDate; 2018. Effec tive date: 04/01/2019 Rev is ed date: 02/26/2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Humira (adalimumab) BILLING CODE Must use valid NDC code BENEF IT TYPE Pharmacy SIT EOF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) Alternative preferred product s include Actemra, Cimzia, Cosentyx, Enbrel, Kevzara, Olumiant, Otezla, Siliq and Xeljanz QUANTITY LIMIT 4 per 28 days LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click He re Humira (adalimumab) is a non-pre ferred product and will only be con sidered for coverage under the pharm acy benefit when the following criteria are met: Members mus t be c linically diagnosed with one of the following dis eas e states and meet their individual c riteria as s tated. ANKY LOSING SPONDYLITIS (AS) For initial authorization: 1. Member must be 18 years of age or older; AND 2. Member m ust have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-release assay (IGRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a rheumatologist; AND 4. Member has had back pain for 3 months or more that began before the age of 50; AND 5. Current imaging results show inflammation of one or both of the sacroiliac joints; AND 6. Member shows at least one of the following signs or symptoms of Spondyloarthritis: a) Arthritis ; b) Elevated serum C-reactive protein; c) Inflammation at the tendon, ligament or joint capsule insertions ; d) Positive HLA-B27 test ; e) Limited chest expansion; f) Morning stiffness for 1 hour or more; AND 7. Member meets at least o ne of the following scenarios: a) Member has Axial (spinal) disease; b) Member has peripheral arthritis without axial invol vement and has tried and failed treatment with methotrexate or sulfasalazine. Treatment failure requires at least 30 days of therapy without an adequate response; AND 8. Member has tried and failed to respond to treatment with at least two prescription NSAIDs taken at t he maximum recommended dosages. Treatment failure requires at least 30 days of therapy with each NSAID without an adequate response; AND9. Member must have tried and failed treatment with at least two of the following: Enbrel, Cimzia and Cosentyx. Treatment failure requires at least for 30 days of therapy with each drug. 10. Dosage allowed: 40 mg subcutaneously every other week . If member meets all the requirements listed above, the medication will b e a ppr ov e d f or 1 2 mon t h s. For r e a ut ho riza tion: 1. Member must be retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will b e a ppr ov e d f or an additional 12 months. CROHNS DISEASE (CD) For initial authorization: 1. Member is 6 years of age or older with moderate to severe active CD; AND 2. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-r ele a s e assay (IGRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a gastroenterologist; AND 4. Member has had a documented trial and inadequate response to at least one of the following: 6-mercaptopurine, azathioprine, methotrexate or corticosteroids for at least 30 days ; OR 5. Member has severe disease, as indicated by at least one of the following: a) Esophageal or gastroduodenal disease; b) Extensive small-bowel disease involving more than 100 cm; c) History of colonic resection; d) History of two or more small-bowel resections; e) Perianal or rectal disease. 6. Dosage allowed: Adult dose: 160 mg subcutaneously on day one, then 80 mg 2 week later, then 40 mg every other week beginning on day 29; Pediatric dose: 17 kg (37 lbs. ) to
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Entyvio (vedolizumab) BILLING CODE J3380 (1 unit = 1 mg) BENEF IT TYPE Medical SIT EOF SERVICE ALLOWED Office/Outpatient Hospital COVERAGE REQUIREMENT SPrior Authorization Required (Non-Preferred Product) Alternative preferred product for Crohns Disease includes Cimzia; for Ulcerative Colitis-Xeljanz QUANTITY LIMIT 300 units/mg per infusion LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click He re Entyvio (vedolizumab) is a non-pre ferred product and will only be con sidered for coverage under the m e dical benefit when the following criteria are met: Members mus t be c linically diagnosed with one of the following dis eas e states and meet their individual c riteria as s tated. CROHNS DISEASE (CD) For initial authorization: 1. Member is 18 years of age or older with moderate to severe active CD with Crohns Disease Activity Index (CDAI) of 220-450; AND 2. Member have had a documented history of a n inadequate response with, lost response to, or were intolerant to one of the following: a) A tumor necrosis factor ( TNF) blocker (e.g., Remicade, Cimzia, etc.) ; b) Immunomodulator (e.g., 6-mercaptopurine, azathioprine) ; c) Corticosteroids ( or demonstrated dependence on corticosteroids ); AND 3. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-r ele a s e assay (IGRA)) within 12 months prior to starting therapy; AND 4. Medication must be prescri bed by a gastroenterologist. 5. Dosage allowed: 300 mg intravenously at 0, 2, and 6 weeks, then 300 mg intravenously every 8 weeks thereafter. Note: Therapy s hould be discontinued in member s who show no evidence of therapeutic benefit by week 14. If member meets all the requirements listed above, the medication will b e a ppr ov e d f or 12 months. For r e a ut ho riza tion: 1. Must have been retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will b e a ppr ov e d f or an additional 12 months . ULCERATIVE COLITIS (UC) For initial authorization: 1. Member is 18 years of age or older with m oderately to severely active UC as defined by Mayo score of 6 or greater with an endoscopy subscore of 2 or 3; AND 2. Member have had a documented history of a n inadequate response with, lost response to, or were intolerant to one of the following: a) A tumor necrosis factor (TNF) blocker (e.g., Remicade, Cimzia, etc.); b) Immunomodulator (e.g., 6-mercaptopurine, azathioprine) ; c) Corticosteroids ( or demonstrated dependence on corticosteroids ); d) Salicylates (e.g. , Asacol HD, Lialda, Pentasa, Delzicol, mesalamine, etc.); AND 3. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-r ele a s e assay (IGRA)) within 12 months prior to starting therapy; AND 4. Medication must be prescri bed by a gastroenterologist. 5. Dosage allowed: 300 mg intravenously at 0, 2, and 6 weeks, then 300 mg intravenously every 8 weeks thereafter. Note: Therapy should be discontinued in patients who show no evidence of therapeutic benefit by week 14. If member meets all the requirements listed above, the medication will b e a ppr ov e d f or 1 2 months. For r e a ut ho riza tion: 1. Must have been retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will be app r ov e d f or a n a ddit ion a l 12 months. Care Source conside rs Enty vio (v e dolizumab) not m e dically ne cessary for the tre atment of the follow ing dise ase state s base d on a lack of robust clinical controlle d trials show ing supe rior e fficacy com pared to curre ntly av ailable tre atments: Active infections Ankylosing Spondylitis Asthma Cellulitis Dissecting scalp cellulitis For use in combination with other TNF-inhibitors (i.e., Humira, Kineret, Enbrel, Remicade) Giant-cell arteritis Infectious uveitis Lupus perino Osteoarthritis Plaque Psoriasis Psoriatic Arthritis Relapsing polychondritis Rhe umatoid Arthritis Sarcoidosis Sciatica Spondyloarthritis (other than ankylosing spondylitis) Takayasus arteritis Vogt-Koyanagi DATE ACTION/DESCRIPTION 05/15/2017 New policy for Entyvio created. Policy SRx-0041 archived. For both diagnoses CD and UC: TNF inhibitor Humira wa s listed as required trial. Trials length changed to 30 days for each drug trial due to KY MCD regulations List of diagnoses considered not medically necessary was added. 02/26/2019 Humira removed from required trials. TB test allowed to be done within 12 months prior to initiation of therapy; chest x-ray option removed. Initial authorization length increased to 12 months. Inadequate response to trial agents combined under members history; CDAI and Mayo scoring requirement added; severity factors for CD removed from requirements. Referenc es : 1. Enty v io [package ins ert]. Deerfield, IL: Takeda Pharmaceutic als America, Inc.; May 2014. 2. Feagan, BG, Rutgeerts , P, Sands, BE, et al. Vedolizumab as induc tion and maintenance therapy for ulc erative c olitis . The New England journal of medicine. 2013 Aug 22;369(8):699-710. PMID: 23964932. 3. Sands , BE, Feagan, BG, Rutgeerts , P, et al. Effects of Vedolizumab Induction Therapy for Patients With Crohn’s Dis eas e in Whom Tumor Nec ros is Factor Antagonis t Treatment Had Failed. Gastroenterology. 2014 May 21. PMID: 24859203. 4. Sandborn, WJ , Feagan, BG, Rutgeerts , P, et al. Vedolizumab as induc tion and maintenance therapy for Crohn’s dis eas e. The New England journal of medicine. 2013 Aug 22;369(8):711-21. PMID: 23964933. 5. Terdiman JP, Grus s CB, Heidelbaugh JJ, Sultan S, Falck-Ytter YT; AGA Ins titute Clinic al Prac tice and Quality Management Committee. Americ an Gastroenterologic al As sociation Institute guideline on t he us e of thiopurines, methotrex ate, and anti-TNF-biologic drugs for the induction and maintenanc e of remiss ion in inflammatory Crohn's dis eas e. Gas troenterology. 2013 Dec ;145(6):1459-63. 6. Sandborn, W., Binion, D., Persley, K., Atreja, A., & Kos ins ki, L. (2014). AGA Institute Guidelines for the Identific ation, As sessment and Initial Medical Treatment in Crohn's Dis ease: Clinic al Dec ision Support Tool. AGA Ins titute. Retrieved August 14, 2015, from www.gastro.org/IBDc arepathway. Effec tive date: 04/01/2019 Rev is ed date: 02/26/2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Enbrel (etanercept) BILLING CODE Must use valid NDC code BENEF IT TYPE Pharmacy SIT EOF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Preferred Product) QUANTITY LIMIT 8 per 28 days LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click He re Enbrel (etanercept) is a pre fe rred product and will only be con sidered for coverage under the pharm acy benefit when the following criteria are met: Members mus t be c linically diagnosed with one of the following dis eas e states and meet their individual c riteria as s tated. ANKY LOSING SPONDYLITIS (AS) For initial authorization: 1. Member must be 18 years of age or older with active AS; AND 2. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-r ele a s e assay (IGRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a rheumatologist; AND 4. Member has had back pain for 3 months or more that began before the age of 50; AND 5. Current imaging results show an inflammation of one or both of the sacroiliac j oints; AND 6. Member shows at least one of the following signs or symptoms of Spondyloarthritis: a) Arthritis; b) Elevated serum C-reactive protein; c) Inflammation at the tendon, ligament or joint capsule insertions; d) Positive HLA-B27 test; e) Limited chest expansion; f) Mo rning stiffness for 1 hour or more; AND 7. Member meets at least o ne of the following scenarios: a) Member has Axial (spinal) disease; b) Member has peripheral arthritis without axial involvement and has tried and failed treatment with methotrexate or sulfasalazine. Treatment failure requires at least 30 days of therapy without an adequate response; AND 8. Member has tried and failed to respond to treatment with at least two prescription NSAIDs taken at the maximum recommended dosages. Treatment failure requires at least 30 days of therapy with each NSAID without an adequate response. 9. Dosage allowed: Inject 50 mg subcutaneously once weekly. Prior to any dosages or dosing freq uencies greater than listed, medical necessity documentation must be supplied to justify coverage. If member meets all the requirements listed above, the medication will be approved for 12 months. For r e a ut ho riza tion: 1. Member must be retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reautho rization requirements above, the medication will be approved for a n a ddit ion a l 12 months. JUV ENILE IDIOPATHIC ARTHRITIS (JIA) For initial authorization: 1. Member must be 2 years of age or older with moderate to severe active JIA; AND 2. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-r ele a s e assay (IGRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a rheumatologist; AND 4. Member shows at least one of the following signs or symptoms: a) Four or fewer joints involved with inadequate response to systemic corticosteroids (prednisone, cortisone, methylprednisolone, etc.) AND systemic immunosuppressants (azathioprine, cyclosporine, etc.) AND NSAID treatment for at least 30 days ; b) Five or more joints involved and inadequate response to methotrexate. 5. Dosage allowed: For members
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Cosentyx (secukinumab) BILLING CODE Must use valid NDC code BENEF IT TYPE Pharmacy SIT EOF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Preferred Product) QUANTITY LIMIT 1 per 28 days (after loading dose) LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click He re Cosentyx (secukinumab) is a pre ferred product and will only be con sidered for coverage under the pharm acy benefit when the following criteria are met:Members mus t be c linically diagnosed with one of the following dis eas e states and meet their individual c riteria as s tated. ANKY LOSING SPONDYLITIS (AS) For initial authorization: 1. Member must be 18 years of age or older; AND 2. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-r ele a s e assay (I GRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a rheumatologist; AND 4. Member has had back pain for 3 months or more that began before the age of 50; AND 5. Current imaging results show an inflammation of one or both of the sacroiliac joints; AND 6. Member shows at least one of the following signs or symptoms of Spondyloarthritis: a) Arthritis; b) Elevated serum C-reactive protein; c) Inflammation at the tendon, ligament or joint capsule insertions; d) Positive HLA-B27 test; e) Limited chest expansion; f) Morning stiffness for 1 hour or more; AND 7. Member meets at least o ne of the following scenarios: a) Member has Axial (spinal) disease; b) Member has peripheral arthritis without axial involvement and has tried and failed treatment with methotrexate or sulfasalazine. Treatment failure requires at leas t 30 days of therapy without an adequate response; AND 8. Member has tried and failed to respond to treatment with at least two prescription NSAIDs taken at the maximum recommended dosages. Treatment failure requires at least 30 days of therapy with each NSAID without an adequate response. 9. Dosage allowed: With a loading dosage is 150 mg at weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter; without a loading dosage is 150 mg every 4 weeks. If member meets all the requirements listed above, the medication will be approved for 12 months.For r e a ut ho riza tion: 1. Member must be retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will b e a ppr ov e d f or an additional 12 months. PLAQUE PSORIASIS (PsO) For initial authorization: 1. Member must be 18 years of age or older; AND 2. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-r ele a s e assay (I GRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a rheumatologist or dermatologist; AND 4. Member has PsO involves 10% or more of the members body surface area; AND 5. Members Psoriasis Area and Severity Index (PASI) score is greater than or equal to 12; AND 6. Member has tried and failed to respond to treatment with at least one of the following: a) At least 30 days of photochemotherapy (i.e. , psoralen plus ultraviolet A therapy); b) At least 30 days of phototherapy (i.e. , UVB light therapy, Excimer laser treatments) (tanning beds em it mostly UVA light and therefore would not meet this criteria). c) At least a 4 week trial with topical antipsoriatic agents (i.e. , anthralin, calcipotriene, coal tar, corticosteroids, tazarotene); AND 7. Member has tried and f ailed to respond to treatment with traditional first-line oral/systemic therapies (i.e. , cyclosporine, methotrexate, aci tretin) for at least 30 days. 8. Dosage allowed: 300 mg by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 followed by 300 mg every 4 weeks. If member meets all the requirements listed above, the medication will b e a ppr ov e d f or 1 2 mon t h s. For r e a ut ho riza tion: 1. Must have been retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease (e.g., documented members PASI score improvement, etc.). If member meets all the reauthorization requirements above, the medication will be app r ov e d f or an additional 12 months. PSORIATIC ARTHRITIS (PsA) For initial authorization: 1. Member must be 18 years of age or older; AND 2. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-r ele a s e assay (I GRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a rheumatologist or dermatologist; AND 4. Member meets at least o ne of the following scenarios: a) Member has pr edominantly axial disease (i.e. , sacroiliitis or spondylitis) as indicated by radiographic evidence; OR b) Member has shown symptoms of predominantly axial disease (i.e., sacroiliitis or spondylitis) for more than 3 months (i.e., limited spinal range of motion, spinal morning stiffness for more than 30 minutes) AND has tried and failed to respond to treatment with at least 2 prescription NSAIDs taken at the maximum recommended dosages. Treatment failure requires at least 30 days of therapy with each NSAID without an adequate response; OR c) Member has predominately non-axial disease (e.g., peripheral synovitis or dactylitis or nail involvement) and has tried and failed to respond to treatment with at least 30-da y trial of methotrexate and NSAID taken at the maximum recommended dosages (if unable to tolerate or has contraindication to methotrexate than 30-d ay trial of sulfasalazine or azathioprine or cyclosporine). 5. Dosage allowed: With a loading dosage is 150 mg at weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter; without a loading dosage is 150 mg every 4 weeks. If member meets all the requirements listed above, the medication will b e a ppr ov e d f or 1 2 mon t h s. For r e a ut ho riza tion: 1. Must have been retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will be app r ov e d f or an additional 12 months. Care Source considers Cosentyx (secukinumab) not medically necessary for the tre atment of the follow ing dise ase state s base d on a lack of robust clinical controlle d trials show ing supe rior e fficacy com pared to curre ntly av ailable tre atments: Active infections Asthma Cellulitis Crohns Disease Dissecting scalp cellulitis For use in combination with other TNF-inhibitors (i.e. , Humira, Kineret, Enbrel, Remicade) Giant-cell arteritis Infectious uveitis Lupus perino Osteoarthritis Recurrent pregnancy loss Relapsing polychondritis Sa rcoidosis Sciatica Spondyloarthritis (other than ankylosing spondylitis) Takayasus arteritis Vogt-Koyanagi D ATE ACTION/DESCRIPTION 05/08/2017 New policy for Cosentyx created. Policies SRx-0043 achieved. New diagnoses of AS and PsA with criteria were added. For diagnosis of PsO : immunosuppressive criterion was separated from phototherapies and topical agents trials ; TNF inhibitors Humira and Enbre l were listed as required trials; Psoriasis Area and Severity Index (PASI) score requirement was added. List of diagnoses considered not medically necessary was added. 02/26/2019 Status changed to preferred. Trials of Humira and Enbrel removed from criteria. Clarifications entered for AS and PsA on NSAIDs trial length. References updated. TB test allowed to be done within 12 months prior to initiation of therapy; chest x-ray option removed. Symptoms of back pain for AS extended till before age of 50. Other drugs options allowed for PsA if there is an intolerance or contraindication to methotrexate. Immuno suppressant therapies changed to treatment of traditional first-line oral/systemic therapies. Reauthorization criteria on documented members PASI score improvement incorporated into general chart noted documentation requirements. Referenc es : 1. Cos enty x [package ins ert]. East Hanover, NJ :Novartis Pharmac euticals Corporation; 2015. Access ed on May 1, 2017. 2. Menter A, Gottlieb A, Feldman SR, et al. Guidelines of c are for the management of ps oriasis and ps oriatic arthritis : Section 1. Overview of ps orias is and guidelines of care for the treatment of psoriasis with biologics. JAm Ac ad Dermatol. 2008 May ;58(5):826-50. 3. Gottlieb A, Korman NJ, Gordon KB, et al. Guidelines of care for the management of psoriasis and ps oriatic arthritis : Section 2. Ps oriatic arthritis: ov erv iew and guidelines of care for treatment with an emphas is on the biologic s . JAm Acad Dermatol. 2008 May;58(5):851-64. 4. Menter A, Korman NJ , Elmets CA, Feldman SR, Gelfand JM, Gordon KB,et al. Guidelines of c are for the management of ps orias is and ps oriatic arthritis. Section 3. Guidelines of c are for the management and treatment of ps orias is with topical therapies. JAm Acad Dermatol. 2009 Apr;60(4):643-59. 5. Menter A, Korman NJ , Elmets CA, et al. Guidelines of care for the management of psoriasis and ps oriatic arthritis: s ec tion 4. Guidelines of c are for the management and treatment of psoriasis with traditional sy stemic agents. JAm Ac ad Dermatol. 2009 Sep;61(3):451-85. 6. Menter A, Korman NJ , Elmets CA, Feldman SR, Gelfand JM, Gordon KB, et al. Guidelines of care for the management of ps orias is and ps oriatic arthritis: Section 5. Guidelines of c are for the treatment of ps oriasis with phototherapy and photoc hemotherapy. JAm Ac ad Dermatol. 2010 Jan;62(1):114-35. 7. Menter A, Korman NJ , Elmets CA, Feldman SR, Gelfand JM, Gordon KB, Guidelines of c are for the management of ps orias is and ps oriatic arthritis: s ection 6. Guidelines of c are for the treatment of psorias is and ps oriatic arthritis : c ase-bas ed presentations and ev idence-based c onclusions. JAm Acad Dermatol. 2011 Jul;65(1):137-74. 8. Hs u S, Papp KA, Lebwohl MG, et al. Cons ensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012 Jan;148(1):95-102. 9. Braun J , et al. Sec ukinumab s hows s ustained effic acy and low s tructural progress ion in ank ylosing s pondylitis: 4-y ear res ults from the MEASURE 1 s tudy. Rheum. Key 375. 10. Bis s onnette R, et al. Secukinumab demonstrates high s ustained efficacy and a fav orable s afety profile through 5 y ears of treatment in moderate to s evere ps oriasis. JEur Acad Dermatol Venereol. 2018 Sep;32(9):1507-1514. 11. Meas e PJ , et al. Sec ukinumab Provides Sustained Improv ements in the Signs and Sy mptoms of Active Psoriatic Arthritis through 3 Years : Efficacy and Safety Results from a Phas e 3 Trial. Ann Rheum Dis. 2017;76:952-953. 12. Baeten D, et al. Sec ukinumab, interleuk in-17A inhibition in anky los ing s pondylitis. NEngl JMed. 2015;373:2534-48. 13. Mc Innes IB, et al. Sec ukinumab, a human anti-interleukin-17A monoc lonal antibody , in patients with ps oriatic arthritis (FUTURE 2): a randomis ed, double-blind, plac ebo-c ontrolled, phas e 3 trial. Lanc et. 2015;386(9999):1137-1146. 14. Reic h K, et al. Sec ukinumab, a fully human anti-interleukin-17A monoclonal antibody , ex hibits minimal immunogenic ity in patients with moderate-to-severe plaque ps oriasis. Br JDermatol. 2017;176:752-58. Effec tive date: 04/01/2019 Rev is ed date: 02/26/2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Cimzia (certolizumab pegol) BILLING CODE For medical J0717 (1 unit = 1 mg) Must use valid NDC code for self-administered product BENEF IT TYPE Pharmacy or Medical SIT EOF SERVICE ALLOWED Outpatient/Office/Home COVERAGE REQUIREMENT SPrior Authorization Required (Preferred Product) QUANTITY LIMIT 1200 per 28 days LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click He re Cimzia (certolizumab pegol) is a pre fe rred product and will only be considered for coverage under the pharm acy or m e dical benefit when the following criteria are met: Members mus t be c linically diagnosed with one of the following dis eas e states and meet their individual c riteria as s tated. ANKY LOSING SPONDYLITIS (AS) For initial authorization: 1. Member must be 18 years of age or older; AND 2. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-r ele a s e assay (I GRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a rheumatologist; AND 4. Member has had back pain for 3 months or more that began before the age of 50; AND 5. Member shows at least one of the following signs or symptoms of Spondyloarthritis: a) Arthritis; b) Elevated serum C-reactive protein; c) Inflammation at the tendon, ligament or joint capsule insertions; d) Positive HLA-B27 test; e) Limited chest expansion; f) Morning stiff ness or post rest stiffness for 1 hour or more; g) Increased occiput to wall distance; AND 6. Member meets at least o ne of the following scenarios: a) Member has Axial (spinal) disease; b) Member has peripheral arthritis without axial involvement and has tried and failed treatment with methotrexate or sulfasalazine. Treatment f ailure requires at least 30 days of therapy without an adequate response; AND 7. Member has tried and failed to respond to treatment with at least two prescription NSAIDs taken at the maximum recommended dosages. Treatment failure requires at least 4 weeks of therapy with each NSAID w ithout an adequate response. 8. Dosage allowed: Inject 400 mg subcutaneously once a week at weeks 0, 2, and 4 and then 200 mg every other week or 400 mg every four weeks. If member meets all the requirements listed above, the medication will b e a ppr ov e d f or 1 2 mon t h s. For r e a ut ho riza tion: 1. Must have been retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will b e a ppr ov e d f or an additional 12 months . CROHNS DISEASE (CD) For initial authorization: 1. Member is 18 years of age or older with moderate to severe active CD; AND 2. Must have a documented negat ive TB test (i.e., tuberculosis skin test (PPD), an interferon-r ele a s e assay (I GRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a gastroenterologist; AND 4. Member has had a documented trial (for at least 30 day s) and inadequate response to 6-mercaptopurine, azathioprine, methotrexate or corticosteroids; OR 5. Member has severe disease, as indicated by at least one of the following: a) Esophageal or gastroduodenal disease; b) Extensive small-bowel disease involving more than 100 cm; c) History of colonic resection; d) History of two or more small-bowel resections; e) Perianal or rectal disease. 6. Dosage allowed: Inject 400 mg subcutaneously once a week at weeks 0, 2, and 4 and then 400 mg every four weeks. If member meets all the requirements listed above, the medication will b e a ppr ov e d f or 1 2 mon t h s. For r e a ut ho riza tion: 1. Must have been retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will be app r ov e d f or an additional 12 months . PLAQUE PSORIASIS (PsO) For initial authorization: 1. Member must be 18 years of age or older; AND 2. Must have a documented negative TB test (i.e., tuberculosis skin test (PPD), an interferon-r ele a s e assay (I GRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a rheumatologist or dermatologist; AND 4. Member has PsO for 6 months or longer; AND 5. Member has PsO involves 10% or more of the body surface area (BSA); AND 6. Members Psoriasis Area and Severity Index (PASI) score is greater than or equal to 12; AND 7. Member has tried and failed to respond to treatment with at least one of the following: a) At least 30 days of photochemotherapy (i.e., psoralen plus ultraviolet A therapy);b) At least 30 days of phototherapy (i.e., UVB light therapy, Excimer laser treatments; tanning beds emit mostly UVA light and therefore would not meet this criteria); c) At least a 4 week trial with topical antipsoriatic agents (i.e. , anthralin, calcipotriene, coal tar, corticosteroids, tazarotene); AND 8. Member has tried and failed to respond to treatment with traditional first-line oral/systemic therapies (i.e. , cyclosporine, methotrexate, aci tretin) for at least 30 day s. 9. Dosage allowed: 400 mg (given as 2 subcutaneous injections of 200 mg each) every other week. For some members (with body weight 90 kg), a dose of 400 mg (given as 2 subcutaneous injections of 200 mg each) initially and at Weeks 2 and 4, followed by 200 mg every other w eek may be considered. If member meets all the requirements listed above, the medication will be approved for 12 months. For r e a ut ho riza tion: 1. Member must be retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease (e.g., documented members PASI score improvement, etc.). If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months. PSORIATIC ARTHRITIS (PsA) For initial authorization: 1. Member must be 18 years of age or older; AND 2. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-r ele a s e assay (I GRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a rheumatologist or dermatologist; AND 4. Member meets at least o ne of the following scenarios: a) Member has pr edominantly axial disease (i.e. , sacroiliitis or spondylitis) as indicated by radiographic evidence; b) Member has shown symptoms of pr edominantly axial disease (i.e., sacroiliitis or spondylitis) for more than 3 months (i.e. , limited spinal range of motion, s pinal morning stiffness for more than 30 minutes) AND has tried and failed to respond to treatment with at least 2 prescription NSAIDs taken at the maximum recommended dosages. Treatment failure requires at least 4 weeks of therapy with each NSAID without an adequate response; c) Member has predominately non-axial disease (e.g., peripheral synovitis or dactylitis or nail involvement) and has tried and failed to respond t o treatment with at least 30-da y s trial of methotrexate and NSAID taken at the maximum recommended dosages (if unable to tolerate or has contraindication to methotrexate than 30-d ay trial of sulfasalazine or azathioprine or cyclosporine). 5. Dosage allowed: Inject 400 mg subcutaneously once a week at weeks 0, 2, and 4 and then 200 mg every other week or 400 mg every four weeks. If member meets all the requirements listed above, the medication will b e a ppr ov e d f or 1 2 mon t h s. For r e a ut ho riza tion: 1. Must have been retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization r equirements above, the medication will be app r ov e d f or an additional 12 months . RHEUMATOID ARTHRITIS (RA) For initial authorization: 1. Member must be 18 years of age or older with moderate to severe active RA; AND 2. Must have a documented negative TB test (i.e. , tuberculosis skin test (PPD), an interferon-r ele a s e assay (I GRA)) within 12 months prior to starting therapy; AND 3. Medication must be prescribed by a rheumatologist; AND 4. Member must have tried and failed treatment with at least two non-biologic DMARDS (i.e. , methotrexate, hydroxychloroquine, sulfasalazine, azathioprine, cyclosporine and leflunomide) or must have documented contraindication to all non-biologic DMARDS. Treatment trial duration with each non-biologic DMARD agent must have been at least 30 day s. 5. Dosage allowed: Inject 400 mg subcutaneously once a week at weeks 0, 2, and 4 and then 200 mg every other week thereafter. If member meets all the requirements listed above, the medication will b e a ppr ov e d f or 1 2 mon t h s. For r e a ut ho riza tion: 1. Must have been retested for TB with a negative result within the past 12 months; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease. If member meets all the reauthorization requirements above, the medication will be app r ov e d f or an additional 12 months. Care Source considers Cim zia (ce rtolizumab pe gol) not m e dically ne cessary for the tre atment of the following disease state s base d on a lack of robust clinical controlle d trials show ing supe rior e fficacy com pared to curre ntly av ailable tre atments: Active infections Asthma Cellulitis Dissecting scalp cell ulitis For use in combination with other TNF-inhibitors (i.e. , Humira, Kineret, Enbrel, Remicade) Giant-cell arteritis Guttate psoriasis Infectious uveitis Lupus perino Osteoarthritis Recurrent pregnancy loss Relapsing polychondritis Sarcoidosis Sciatica Spondyloarthritis (other than ankylosing spondylitis) Takayasus arteritis Vogt-Koyanagi DATE ACTION/DESCRIPTION 05/08/2017 New policy for Cimzia created. Policies SRx-0041 and SRx-0042 achieved. New diagnosis of AS with criteria was added. For diagnosis of CD: TNF inhibitor Humira and corticosteroids trial s were added. For PsA: TN Finhibitors Humira and Enbrel were listed as required trials. For RA: non-biologic DMARDS we re listed, and TN Finhibitors Humira and Enbrel were listed as required trials. Li st of diagnose s considered not medically necessary was added. 08/15/2018 Exception to pregnant member or those who a r e planning on becoming pregnant or a r e currently breastfeeding was added to each diagnosis in TNF requirement criterion. New indication of Plaque Psoriasis added. A requirement to have documented radiographic change involving the sacroiliac joints for diagnosis of AS was removed, and criteria of increased occiput to wall distance and post rest stiffness were added. Drug tria ls length were clarified as 4 weeks in length with each NSAID and 30 days in length with each Enbrel and Humira. 02/26/2019 Status changed to preferred. Humira and Enbrel trials removed from criteria; references edited. Initial authorization length increased to 12 months for PsO. TB test allowed to be done within 12 months prior to initiation of therapy; chest x-ray option removed. Symptoms of back pain for AS extended till before age of 50. Other drugs options allowed for PsA if there is an intolerance or contraindication to methotrexate. Immunosuppressant therapies changed to treatment of traditional first-line oral/systemic therapies. Reauthorization criteria on documented members PASI score improvement incorporated into general chart noted documentation requirements. Referenc es : 1. Cimz ia [pres c r ibing information]. Smyrna, GA: UCB, Inc.; May 2018. 2. Menter A, Gottlieb A, Feldman SR, et al. Guidelines of c are for the management of ps oriasis and ps oriatic arthritis : Section 1. Overview of ps orias is and guidelines of care for the treatment of psoriasis with biologics. JAm Ac ad Dermatol. 2008 May ;58(5):826-50. 3. Gottlieb A, Korman NJ, Gordon KB, et al. Guidelines of care for the management of psoriasis and ps oriatic arthritis : Section 2. Ps oriatic arthritis: ov erv iew and guidelines of care for treatment with an emphas is on the biologic s . JAm Acad Dermatol . 2008 May;58(5):851-64. 4. Menter A, Korman NJ , Elmets CA, Feldman SR, Gelfand JM, Gordon KB,et al. Guidelines of c are for the management of ps orias is and ps oriatic arthritis. Section 3. Guidelines of c are for the management and treatment of ps orias is with topical therapies. JAm Acad Dermatol. 2009 Apr;60(4):643-59. 5. Menter A, Korman NJ , Elmets CA, et al. Guidelines of care for the management of psoriasis and ps oriatic arthritis: s ec tion 4. Guidelines of c are for the management and treatment of psoriasis wit h traditional sy stemic agents. JAm Ac ad Dermatol. 2009 Sep;61(3):451-85. 6. Menter A, Korman NJ , Elmets CA, Feldman SR, Gelfand JM, Gordon KB, et al. Guidelines of care for the management of ps orias is and ps oriatic arthritis: Section 5. Guidelines of c are f or the treatment of ps oriasis with phototherapy and photoc hemotherapy. JAm Ac ad Dermatol. 2010 Jan;62(1):114-35. 7. Menter A, Korman NJ , Elmets CA,Feldman SR, Gelfand JM, Gordon KB, Guidelines of care for the management of ps orias is and ps oriatic arthritis: s ection 6. Guidelines of c are for the treatment of psorias is and ps oriatic arthritis : c ase-bas ed presentations and ev idence-based c onclusions. JAm Acad Dermatol. 2011 Jul;65(1):137-74. 8. Singh, J ., et.al.,(2012). 2012 Update of the 2008 American College of Rheumatology Rec ommendations for the Us e of Dis eas e-Modify ing Anti-rheumatic Drugs and Biologic Agents in the Treatment of Rheumatoid Arthritis. Arthritis Care & Res earc h, 64(5), 625-639. doi:10.1002/acr.21641. 9. Beuk elman T, Patk ar NM, Saag KG, et al. 2011 American College of Rheumatology rec ommendations for the treatment of juv enile idiopathic arthritis: initiation and s afety monitoring of therapeutic agents for the treatment of arthritis and s y s temic features. Arthritis Care Res . (Hobok en). 2011 Apr;63(4) :465-82. 10. Saag KG, Teng GG, Patkar NM, et al. American College of Rheumatology 2008 Rec ommendations for the Us e of Non-biologic and Biologic Disease-Modifying Anti-rheumatic Drugs in Rheumatoid Arthritis . Arthritis Care & Res earc h. Arthritis Rheum 2008;59( 6):762-84. 11. Lic htens tein GR, Hanauer SB, Sandborn WJ , Practice Parameters Committee of American College of Gas troenterology . Management of Crohn's disease in adults. American Journal of Gastroenterology 2009;104(2):465-83; quiz 464, 484. DOI: 10.1038/ajg.2008.168. (Reaffirmed 2014 Oc t) 12. Sandborn, W., Binion, D., Persley, K., Atreja, A., & Kos ins ki, L. (2014). AGA Institute Guidelines for the Identific ation, As sessment and Initial Medical Treatment in Crohn's Dis ease: Clinic al Dec ision Support Tool. AGA Institute. Retrieved August 14, 2015, from www.gastro.org/IBDc arepathway . 13. Kraus e ML, Amin S, Makol A. Us e of DMARDs and biologic s during pregnanc y and lac tation in rheumatoid arthritis : what the rheumatologist needs to k now. Therapeutic Adv ances in Musc ulos kelet al Disease. 2014;6(5):169-184. doi:10.1177/1759720X14551568. 14. Clows e ME, Wolf DC, Frger F, et al. Pregnanc y Outc omes in Subjects Exposed to Certoliz umab Pegol. The Journal of Rheumatology . 2015;42(12):2270-2278. doi: 10.3899/jrheum.140189. 15. Clows e ME, Frger F, Hwang C, et al. Minimal to no trans fer of c ertoliz umab pegol into breast milk: res ults from CRADLE, a pros pec tive, pos tmarketing, multicentre, pharmacokinetic s tudy. Annals of the Rheumatic Dis eases 2017;76:1890-1896. 16. Hs u S, Papp KA, Lebwohl MG, et al. Cons ensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012 Jan;148(1):95-102. 17. Clinic alTrials .gov. Identifier: NCT02326298. An Effic acy and Safety Study of Two Dose Lev els of Certoliz umab Pegol (CZP) in Subjec ts With Plaque Psorias is (P SO) (CI MP ASI-1). Available at:https ://clinicaltrials.gov/ct2/show/NCT02326298?term=NCT02326298&rank=1. 18. Clinic alTrials .gov. Identifier: NCT02326272. A Study to Ev aluate the Efficac y and Safety of Two Dos e Levels of Certoliz umab Pegol (CZP) in Subjects With Plaque Psorias is (PSO) (CIMPASI-2). Av ailable at: https ://clinicaltrials.gov/ct2/show/NCT02326272?term=NCT02326272&rank=1. 19. Clinic alTrials .gov. Identifier: NCT02346240. Efficacy and Safety Study of Certolizumab Pegol (CZP) Vers us Ac tiv e Comparator and Plac ebo in Subjects With Plaque Psoriasis (PSO) (CIMPACT).Available at: https ://clinicaltrials.gov/ct2/show/NCT02346240?term=NCT02346240&rank=1. 20. Harrold LR, et al. One-y ear ris k of s erious infec tion in patients treated with c ertolizumab pegol as c ompared with other TNF inhibitors in a real-world s etting: data from a national U.S. rheumatoid arthritis registry. Arthritis Res Ther. 2018 Jan 2;20(1):2. 21. By k erk VP, et al Update on the s afety profi le of c ertolizumab pegol in rheumatoid arthritis: an integrated analys is from c linic al trials. Ann Rheum Dis. 2015 Jan;74(1):96-103. 22. Bello S, et al. FRI0190 Safety of c ertolizumab pegol in rheumatoid arthritis patients with prev ious hepatitis b v irus ex pos ure. Ann Rheum Dis . 2013;72:A436. 23. Mariette X, et al. The incidence of tuberculosis in patients treated with c ertolizumab pegol ac ross indications: impac t of bas eline sk in tes t res ults, more s tringent s creening c riteria and geographic region. RMD Open. 2015 Apr 28;1(1):e000044. Effec tive date: 04/01/2019 Rev is ed date: 02/26/2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Amevive (alefacept) BILLING CODE J0215 (1 unit = 0.5 mg) BENEF IT TYPE Medical SIT EOF SERVICE ALLOWED Outpatient/Office COVERAGE REQUIREMENT SPrior Authorization Required (Non-Preferred Product) Alternative preferred products include Cimzia, Cosentyx, Enbrel, Otezla, and Siliq QUANTITY LIMIT 60 mg per 30 days LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click He re Amevive (alefacept) is a non-preferred product and will only be con sidered for coverage under the m e dical benefit when the following criteria are met: Members mus t be c linically diagnosed with one of the following dis eas e states and meet their individual c riteria as s tated. PLAQUE PSORIASIS (PsO) For initial authorization: 1. Member must be 18 years of age or older; AND 2. Medication must be prescribed by a rheumatologist or dermatologist; AND 3. Members CD4 count is documented in chart notes, and it is greater than 250 cells/microliter; AND 4. Member has moderate to severe chronic PsO for one year or over , and it involves 10% or more of the body surface area (BSA); AND 5. Members baseline of Psoriasis Area and Severity Index (PASI) score documented in chart notes ; AND 6. Member has tried and failed to respond to treatment with at least one of the following: a) At least 4 weeks of photochemotherapy (i.e. , psoralen plus ultraviolet A therapy); b) At least 4 weeks of phototherapy (i.e. , UVB light ther apy, Excimer laser treatments; tanning beds emit mostly UVA light and therefore would not meet this criteria); c) At least a 4 week trial with topical antipsoriatic agents (i.e. , anthralin, calcipotriene, coal t a r , corticosteroids, tazarotene); AND 7. Member has tried and failed to respond to treatment with traditional first-line oral/systemic therapies (i.e. , cyclosporine, methotrexate, aci tretin) for at least 4 week s; AND 8. Member has tried and failed treatment with at least two of the following: Cimzia, Cosentyx, Enbrel, Otezla and Siliq . Treatment failure requires at least for 30 days of therapy with each drug. 9. Dosage allowed: IV: 7.5 mg once weekly for 12 weeks ; IM: 15 mg once weekly for 12 weeks. If member meets all the requirements listed above, the medication will be approved for 3 months. For r e a ut ho riza tion: 1. Member must be in compliance with all other initial criteria; AND 2. Chart notes have been provided that show the member has shown improving signs and symptoms of disease; AND 3. Members CD4 count is greater than 250 cells/microliter; AND 4. PASI score improvement of 50% from baseline documented in chart notes. If member meets all the reauthorization requirements above, the medic a t ion will b e a ppr ov e d f or a ddit ion a l 12 months. Care Source conside rs Am evive (ale facept) not m e dically ne ce ssary for the tre atment of the follow ing dise ase state s base d on a lack of robust clinical controlle d trials show ing supe rior e fficacy com pared to curre ntly av ailable tre atments: Active infections Ankylosing spondylitis Asthma Cellulitis Crohns Disease Dissecting scalp cellulitis For use in combination with other TNF-inhibitors (i.e. , Humira, Kineret, Enbrel, Remicade) Giant-cell arteritis Infectious uveitis Lupus perino Osteoarthritis Psoriatic arthritis Recurrent pregnancy loss Relapsing polychondritis Rheumatoid arthritis Sarcoidosis Sciatica Spondyloarthritis (other than ankylosing spondylitis) Takayasus arteritis Vogt-Koyanagi DATE ACTION/DESCRIPTION 07/18/2017 New policy for Amevive created. 02/26/2019 Humira trial removed from criteria; Cimzia, Cosentyx, Otezla and Siliq added to trial agents list. Immunosuppressant therapies changed to treatment of traditional first-line oral/systemic therapies. Referenc es : 1. Amev iv e [package ins ert]. Astellas Pharma US, Inc: Deerfield, IL; May, 2011. 2. Menter A, Korman NJ , Elmets CA, et al. Guidelines of care for the management of psoriasis and ps oriatic arthritis. Sec tion 6. Guidelines of c are for the treatment of ps orias is and ps oriatic arthritis: Cas e-based pres entations and ev idenc e-bas ed c onclusions. Journal of the American Academy of Dermatology, Volume 65, Issue 1, 137 174. 3. Hs u S, Papp KA, Lebwohl MG, et al. Cons ensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012 Jan;148(1):95-102. 4. Amev iv e. Lex i-Drugs. Lexicomp. Wolters Kluwer Health, Inc. Riv erwoods, IL. Av ailable at: http://online.lexi.c om. Ac c es sed May 24, 2017. 5. Krueger GG, Papp KA, Stough DB, et al. A randomized, double-blind, plac ebo-controlled phase IIIs tudy ev aluating efficac y and tolerability of 2 c ourses of alefacept in patients with chronic plaque psoriasis. JAm Acad Dermatol 2002;47:821-833. 6. Lebwohl M, Chris tophers E, Langley R, et al. An international, randomized, double-blind, plac ebo controlled phas e 3 trial of intramus c ular alefacept in patients with c hronic plaque psoriasis. Arch Dermatol 2003;139(6):791-793. 7. Gottlieb AB, et al. Safety obs ervations in 12095 patients with ps orias is enrolled in an international registry (PSOLAR): ex perience with infliximab and other s y stemic and biologic therapies. JDrugs Dermatol. 2014 Dec ;13(12):1441-8. 8. Sbidian E, et al. Sy stemic pharmacological treatments for c hronic plaque psoriasis: a network metaanaly sis. Coc hrane Databas e Sy st Rev . 2017;12:CD011535. 9. Nas t A, et al. European S3-Guideline on the s ystemic treatment of ps oriasis v ulgaris Update Apremilast and Sec uk inumab-EDF in c ooperation with EADV and IPC. JEur Acad Dermatol Venereol. 2017;31(12):1951. 10. Smith CH, et al. British Association of Dermatologists guidelines for biologic therapy for psorias is 2017. Br JDermatol. 2017;177(3):628. Effec tive date: 04/01/2019 Rev is ed date: 02/26/2019
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