PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Ilaris (canakinumab) BILLING CODE Must use valid NDC code BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Preferred Product) QUANTITY LIMIT 2 per 28 days LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Ilaris (canakinumab) is a preferred product and will only be con sidered for coverage under the pharmacy benefit when the following criteria are met: Members must be clinically diagnosed with one of the following disease states and meet their individual criteria as stated. CRYOPYRIN-ASSOCIATED PERIODIC SYNDROME (CAPS) For initial authorization: 1. Member must be 4 years of age or older; AND 2. Member must be diagnosed with Familial Cold Autoinflammatory Syndrome (FCAS) OR Muckle-Wells Syndrome; AND 3. Prescriber has submitted laboratory evidence of a genetic mutation in the Cold-Induced Auto-Inflammatory Syndrome 1 (CIAS1 sometimes referred to as the NLRP3); AND 4. Medication must be prescribed by a rheumatologist or under recommendation of a rheumatologist or CAPS specialist; AND 5. 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. 6. Dosage allowed: 150 mg for body weight > 40 kg; 2 mg/kg for body weight 15 kg and 40 kg. For children 15 to 40 kg with an inadequate response, the dose can be increased to 3 mg/kg. Administer subcutaneously every 8 weeks. If member meets all the requirements listed above, the medication will be approved for 12 months. For reauthorization: 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 an additional 12 months.FAMILIAL MEDITERRANEAN FEVER (FMF) For initial authorization: 1. Members Physicians Global Assessment (PGA) Disease Activity score is 2 documented in chart notes with key signs and symptoms of FMF: abdominal pain, skin rash, chest pain, arthralgia/arthritis; AND 2. Members C-reactive protein (CRP) > 10 mg/L is documented in chart notes; AND 3. Member has documentation of at least one flare per month; AND 4. 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. 5. Dosage allowed: Body weight 40 kg: starting dose is 2 mg/kg every 4 weeks. The dose can be increased to 4 mg/kg every 4 weeks if the clinical response is not adequate. Body weight > 40 kg: starting dose is 150 mg every 4 weeks. The dose can be increased to 300 mg every 4 weeks if the clinical response is not adequate. If member meets all the requirements listed above, the medication will be approved for 12 months. For reauthorization: 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 an additional 12 months. HYPERIMMUNOGLOBULIN DSYNDROME (HIDS)/MEVALONATE KINASE DEFICIENCY (MKD) For initial authorization: 1. Members Physicians Global Assessment (PGA) Disease Activity score is 2 documented in chart notes with key signs and symptoms of HIDS/MKD: abdominal pain; lymphadenopathy, aphthous ulcers; AND 2. Members C-reactive protein (CRP) > 10 mg/L is documented in chart notes; AND 3. Member has documentation of 3 febrile acute flares within a 6 month period; AND 4. 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. 5. Dosage allowed: Body weight 40 kg: starting dose is 2 mg/kg every 4 weeks. The dose can be increased to 4 mg/kg every 4 weeks if the clinical response is not adequate. Body weight > 40 kg: starting dose is 150 mg every 4 weeks. The dose can be increased to 300 mg every 4 weeks if the clinical response is not adequate. If member meets all the requirements listed above, the medication will be approved for 12 months. For reauthorization: 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 an additional 12 months. SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) For initial authorization: 1. Member must be 2 years of age or older; 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 rheumatologist; AND 4. Member must have active systemic juvenile idiopathic arthritis, as indicated by arthri tis involving two or more joints AND one or more of the following: a) Evanescent erythematous rash; b) Fever for at least two weeks; c) Generalized lymphadenopathy; d) Hepatomegaly or splenomegaly; e) Pericarditis, pleuritic, or peritonitis; AND 5. Member must have inadequate response to ALL of the following: a) Glucocorticoid injection; b) Methotrexate; c) NSAIDs after a 12-week trial. 6. Dosage allowed: 4 mg/kg (with a maximum of 300 mg) for members with a body weight 7.5 kg. Administer subcutaneously every 4 weeks. If member meets all the requirements listed above, the medication will be approved for 12 months. For reauthorization: 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 an additional 12 months. TUMOR NECROSIS FACTOR RECEPTOR ASSOCIATED PERIODIC SYNDROME (TRAPS) For initial authorization: 1. Members Physicians Global Assessment (PGA) Disease Activity score is 2 documented in chart notes with key signs and symptoms of TRAPS: abdominal pain, skin rash, musculoskeletal pain, eye manifestations; AND 2. Members C-reactive protein (CRP) > 10 mg/L is documented in chart notes; AND 3. Member has documentation of at least 6 flares per year; AND 4. Must have a documented negative TB test (i.e., tuberculosis skin test (P PD), an interferon-release assay (IGRA)) within 12 months prior to starting therapy. 5. Dosage allowed: Body weight 40 kg: starting dose is 2 mg/kg every 4 weeks. The dose can be increased to 4 mg/kg every 4 weeks if the clinical response is not adequate. Body weight > 40 kg: starting dose is 150 mg every 4 weeks. The dose can be increased to 300 mg every 4 weeks if the clinical response is not adequate. If member meets all the requirements listed above, the medication will be approved for 12 months.For reauthorization: 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 an additional 12 months. CareSource considers Ilaris (canakinumab) not medically necessary for the treatment of the following disease states based on a lack of robust clinical controlled trials showing superior efficacy compared to currently available treatments: Acute coronary syndromes Adult-onset Still's disease Atherosclerosis Chronic obstructive pulmonary disease Gout/gouty arthritis Heart failure Inflammatory dermatosis Majeed syndrome Ocular diseases Rheumatoid arthritis Schnitzler syndrome Type 1 and type 2 diabetes DATE ACTION/DESCRIPTION 05/09/2017 New policy for Ilaris created. Policy SRx-0042 archived. For CAPS diagnosis: laboratory evidence requirement of a genetic mutation added. Diagnose s of TRAPS, HIDS/MKD and FMF were added. List of diagnoses considered not medically necessary added. 07/14/2017 Documentation of negative TB test was added to all diagnosis. 03/20/2019 TB test allowed to be done within 12 months prior to initiation of therapy; chest x-ray option removed. References: 1. Ilaris [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; December, 2016 2. Shinkai K, McCalmont TH, Leslie KS. Cryopyrin-associated periodic syndromes and autoinflammation. Clin Exp Dermatol. 2008;33(1):1-9. 3. Lachmann HJ, Kone-Paut I, Kuemmerle-Deschner JB, et al; Canakinumab in CAPS Study Group. Use of canakinumab in the cryopyrin-associated periodic syndrome. NEngl JMed. 2009;360(23):2416-2425. 4. American College of Rheumatology. Guidelines for the management of rheumatoid arthritis: Americ an College of Rheumatology Ad Hoc Committee on Clinical Guidelines. Arthritis Rheuma. 1996;39(5):713-723. 5. Ringold S, Weiss PF, Beukelman T, et al. 2013 Update of the 2011 American College of Rheumatology Recommendations for the Treatment of Juvenile Idiopathic Arthritis. Recommendations for the Medical Therapy of Children With Systemic Juvenile Idiopathic Arthritis and Tuberculosis Screening Among Children Receiving Biologic Medications Vol. 65, No. 10, October 2013, pp 2499 2512. Effective date: 07/01/2019 Revised date: 03/20/2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Harvoni (ledipasvir/sofosbuvir) BILLING CODE Must use valid NDC code BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) Alternative preferred products include Mavyret and Sofosbuvir/velpatasvir (generic for Epclusa) QUANTITY LIMIT 28 for a 28 day supply LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Harvoni (ledipasvir/sofosbuvir) is a non-preferred product and will only be considered for coverage under the pharmacy benefit when the following criteria are met: Members must be clinically diagnosed with one of the following disease states and meet their individual criteria as stated. HEPATITIS C (without cirrhosis or with compensated cirrhosis (Child-Turcotte-Pugh Class A)) For initial authorization: 1. Member who is 12-17 years of age must tried and failed course of treatment with Mavyret (Dates and HCV RNA values must be documented in chart notes) OR i f member is 18 years of age and older must tried and failed courses of treatment with Sofosbuvir/velpatasvir (generic for Epclusa) and Mavyre t (Dates and HCV RNA values must be documented in chart notes) ; AND 2. Member is treatment-nave with genotype 1, 4, 5 or 6 (laboratory documentation required); AND 3. Medication must be prescribed by a board certified hepatologist, gastroenterologist, infectious disease specialist or a nurse practitioner working with the above specialists; AND 4. Members documented viral load taken within 6 months of beginning therapy and submitted with chart notes; AND 5. Member does not have moderate to severe hepatic impairment (Child-Turcotte-Pugh Band C). 6. Dosage allowed: One tablet once daily for 12 weeks, see Appendix A below for details. Note: Members life expectancy must be no less than one year due to non-liver related comorbidities. Please submit fibrosis score and drug screening with prior authorization. If member meets all the requirements listed above, the medication will be approved for 12 weeks, see Appendix A below. For reauthorization or for retreatment: 1. Member must be in compliance with ALL other initial criteria and be treatment-experienced with genotype 1, 4, 5 or 6 (laboratory documentation required) ; AND 2. Prescriber must submit completed Supplemental Form Hepatitis Cfor KY Medicaid with reauthorization request (see Appendix Bbelow); AND 3. Member is compliant with drug therapy regimen by paid pharmacy claims; AND4. Member has documented current monthly negative urine drug and alcohol screens for 3 consecutive months (laboratory documentation required); AND 5. If the member has a recent history (within the past 6 months) of alcohol or substance abuse, the following is required: a) Documentation that the member has completed or is participating in a recovery program, receiving alcohol or substance abuse counseling services, or s eeing an addiction specialist as part of HCV treatment; AND b) Documentation that the member is not actively participating in illicit substance use or alcohol abuse with confirmatory laboratory testing (e.g., urine drug screen); AND 6. Member has evidence of liver fibrosis stage 3 or 4 confirmed by liver biopsy, or elastography only (lab chart notes required) unless one of the following (fibrosis stage F0-4 covered): a) Hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation); b) Pos t liver transplantation; c) Extrahepatic disease (i.e., kidney disease: proteinuria, nephrotic syndrome or membranoproliferative glomerulonephritis; cryoglobulinemia with end-organ manifestations (e.g., vasculitis)); d) HIV or HBV coinfection. 7. Dosage allowed: One tablet once daily for 12-24 weeks, see Appendix A below for details. Note: Members life expectancy must be no less than one year due to non-liver related comorbidities. If member meets all the reauthorization requirements above, the medication will be approved for 12-24 weeks, see Appendix A below. CareSource considers Harvoni (ledipasvir/sofosbuvir) not medically necessary for the treatment of the diseases that are not listed in this document. DATE ACTION/DESCRIPTION 05/09/2017 New policy for Harvoni created. Criteria coverage was adjusted for age, alternative products were indicated. Hep Btest requirement was added. Drug and alcohol screens for 3 consecutive months required for all regardless of abuse history. Evidence of liver fibrosis exceptions was expanded. Reauthorization requirement of 2 consecutive values of HCV RNA 25 IU per mL during the post-treatment period and documented reason of treatment failure were added. 11/22/2017 Substance abuse program information is no longer required. Criterion on absence of moderate to severe liver impairment was added. 12/07/2017 Criterion of life expectancy not less than one year due to non-liver related comorbidities removed from criteria and added in a form of the note. Hepatitis Btesting is no longer required. 03/07/2018 Criteria revised based on new requirements from Kentucky Department of Medicaid Services. Documentation of fibrosis level and current monthly negative urine drug and alcohol screens for 3 consecutive months are no longer required for initial authorization for treatment-nave members. Reauthorizati on criteria added for treatment-experienced members. New Appendix added (Supplemental Form Hepatitis Cfor KY Medicaid). 05/01/2019 Sofosbuvir/velpatasvir (generic for Epclusa) trial added for adult members; Mavyret trial added for members 12-17 years of age. References: 1. Harvoni [package Insert]. Foster City, CA: Gilead Sciences, Inc.; November, 2017. 2. Mavyret [Package insert]. North Chicago, IL: AbbVie Inc.; August 2017. 3. Hepatitis CInformation | Division of Viral Hepatitis | CDC. (2015, May 31). Retrieved from https://www.cdc.gov/hepatitis/hcv/index.htm. 4. American Association for the Study of Liver Diseases and the Infectious Diseases Society of America (AASLD) and Infectious Diseases Society of America (IDSA). HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C; 2017. Available at: https://www.hcvguidelines.org/. 5. Afdhal, N. (2012). Fibroscan (Transient Elastography) for the Measurement of Liver Fibrosis. Gastroenterology & Hepatology, 8(9), 605-607. Effective date: 07/01/2019 Revised date: 05/01/2019 Appendix A. Treatment Duration Genotype Pediatric Patient Population 12 Years of Age and Older or Weighing at Least 35 Kg Regimen and Duration Genotype1 Treatment-nave without cirrhosis or with compensated cirrhosis (Child-Pugh A) Harvoni 12 weeks Treatment-experienced without cirrhosis Harvoni 12 weeks Treatment-experienced with compensated cirrhosis (Child-Pugh A) Harvoni 24 weeks Genotype 4, 5, or 6 Treatment-nave and treatment-experienced, without cirrhosis or with compensated cirrhosis (Child-Pugh A) Harvoni 12 weeksAppendix B. Supplemental Form Hepatitis Cfor KY Medicaid 1. Prescriber must answer ALL of the following questions with prior authorization submission: a) Is retreatment necessary due to treatment failure or reinfection? b) Was the member compliant (e.g., few to no missed doses) with previous Direct-Acting Antiviral ( DAA) therapy? If not, why? c) Were there any additional factors that led to DAA treatment failure? If so, describe these factors and how they have been addressed or are no longer relevant. 2. Member has been evaluated for potential clinically significant drug interactions. Please see package insert for details: http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf. 3. Provider attests that: a) Member is willing and able to comply with the requirements of the proposed retreatment plan; AND b) Any factors that may have led to noncompliance with previous treatment(s) have been addressed; AND c) Member has received education regarding risk behaviors (e.g., IV drug use) associated with HCV infection. Prescribers name: Signature: Date:
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Galafold (migalastat) BILLING CODE Must use valid NDC code BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) QUANTITY LIMIT 14 capsules per 28 days LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Galafold (migalastat ) is a non-preferred product and will only be considered for coverage under the pharmacy benefit when the following criteria are met: Members must be clinically diagnosed with one of the following disease states and meet their individual criteria as stated. FABRY DISEASE For initial authorization: 1. Member is 1 8 years of age or older; AND 2. Medication must be prescr ibed by or in consultation with a nephrologist, cardiologist, metabolic or genetic specialist; AND 3. Member has diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data documented in chart notes ; AND 4. Member has a documented baseline level of plasma globotriaosylsphingosine (lyso-GL3) or urinary globotriaosylceramide (GL-3) ; AND 5. Member does not have ANY of the following: a) Severe renal impairment or end-stage renal disease requiring dialysis ; b) History of organ transplant; c) NYHA Class III or IV heart disease; d) Currently pregnant or breast-feeding; e) Planned concomitant treatment with enzyme replacement therapy (e.g., Fabrazyme) . Note: if approved, PA request for Galafold will result in termination of Fabrazyme authorization. 6. Dosage allowed: 123 mg every other day . If member meets all the requirements listed above, the medication will be approved for 3 months. For reauthorization: 1. Member has responded to therapy with chart notes documenting one of the following: a) Achieved and maintains at least a 20% reduction in plasma globotriaosylsphingosine (lyso-GL3) levels; OR b) Achieved and maintains at least a 20% reduction in urinary globotriaosylceramide (GL-3). If member meets all the reauthorization requirements above, the medication will be approved for an additional 6 months. CareSource considers Galafold (migalastat) not medically necessary for the treatment of the diseases that are not listed in this document. DATE ACTION/DESCRIPTION 05/20/2019 New policy for Galafold created. References: 1. Benjamin ER, et al . The validation of pharmacogenetics for the identification of Fabry patients to be treated with migalastat. Genetics in m edicine. 2017 Apr;19(4):430. 2. ClinicalTrials.gov. Identifier NCT01218659. Study to compare the efficacy and safet of oral AT1001 and enzyme replacement therapy in patients with fabry disease. Available: clinicaltrials.gov/ct2/show/NCT01218659. 3. ClinicalTrials.gov. Identifier NCT00925301. Study of the effects of oral AT1001 (migalastat hydrochloride) in patients with fabry disease. Available: clinicaltrials.gov/ct2/show/NCT0 0925301. 4. Desnick R, et al. Fabry disease, an under-recognized multisystemic disorder: expert recommendations for diagnosis, management, and enzyme replacement therapy. Annals of internal medicine. 2003 Feb 18;138(4):338 46. 5. Ellaway C. Paediatric f abry dise ase. Transl p ediatr. 2016; 5(1): 37-42. 6. Fabrazyme [package insert]. Cambridge, MA: Genzyme Corporation; May 2010. 7. Galafold [prescribing information]. Cranbury, NJ: Amicus Therapeutics U.S., Inc. 2018 August. 8. Germain D, et al. Treatment of Fabrys disease with the pharmacologic chaperone migalastat. New England Journal of Medicine. 2016 Aug 11;375(6):545-55. 9. Germain DP, et al. Pharmacological chaperone therapy by active-site-specific chaperones in Fabry disease: in vitro and preclinical studies. Int JClin Pharmacol Ther. 2009;47 Suppl 1:S111-7. 10. Hopkin R, et al. The management and treatment of children with Fabry disease: A United States-based perspective. Molecular genetics and metabolism. 2016 Feb 1;117(2):104-13. 11. Hughes D, et al. Oral pharmacological chaperone migalastat compared with enzyme replacement therapy in Fabry disease: 18-month results from the randomised phase III ATTRACT study. Journal of medical genetics. 2017 Apr 1;54(4):288-96. 12. National institute for health and care e xcellence. Migalastat for treating Fabry disease. 2017 Feb. Available from : nice.org.uk/guidance/hst4/chapter/1-Recommendations. 13. Ortiz A, et al. Fabry disease revisited: management and treatment recommendations for adult patients. Molecular genetics and metabolism. 2018 Apr 1;123(4):416-27. 14. Wang R, et al. Lysosomal storage diseases: diagnostic confirmation and management of presymptomatic individuals. Genetics in Medicine. 2011 May;13(5):457. 15. Wanner C, et al. European expert consensus statement on therapeutic goals in Fabry disease. Molecular genetics and metabolism. 2018 Jun 12. Effective date: 07/01/2019 Revised date: 05/20/2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Firdapse (amifampridine) BILLING CODE Must use valid NDC code BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) Alternati ve preferred product includes p yridostigmine QUANTITY LIMIT 240 tablets per 30 days LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Firdapse (amifampridine ) is a non-preferred product and will only be con sidered for coverage under the pharmacy benefit when the following criteria are met: Members must be clinically diagnosed with one of the following disease states and meet their individual criteria as stated. LAMBERT-EATON MYASTHENIC SYNDROME (LEMS) For initial authorization: 1. Member 18 years of age or older; AND 2. Medication must be prescr ibed by or in consultation with a neurologist; AND 3. Member has diagnosis of Lambert-Eaton myasthenic syndrome (LEMS) confirmed by documentation of diagnostic test results including one of the following: a) Repetitive nerve s timulation (RNS) testing showing reproducible post-exercise increase in compound muscle action potential (CMAP) amplitude of at least 60 percent compared with pre-exercise baseline value or a similar increment on high-frequency repetitive nerve stimulation without exercise; AND b) Positive anti-P/Q type voltage-gated calcium channel antibody test; AND 4. Member must have a documented baseline ECG in the last 12 months demonstrating QT interval
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Exondys 51 (eteplirsen) BILLING CODE J1428 (1 unit = 10 mg) BENEFIT TYPE Medical SITE OF SERVICE ALLOWED Office/Outpatient/Home COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) QUANTITY LIMIT based on weight LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Exondys 51 (eteplirsen) is a non-preferred product and will only be considered for coverage under the medical benefit when the following criteria are met: Members must be clinically diagnosed with one of the following disease states and meet their individual criteria as stated. DUCHENNE MUSCULAR DYSTROPHY (DMD) For initial authorization: 1. Member has confirmed mutation of a DMD gene that is amenable to exon 51 skipping (chart/lab notes required); AND 2. Member is currently taking a corticosteroid or has contraindication to corticosteroids; AND 3. Chart notes submitted confirming that the member is ambulatory and walking independently (e.g., without side-by-side assist, cane, walker, wheelchair, etc.) prior to beginning Exondys 51 therapy . 4. Dosage allowed: 30 milligrams per kilogram of body weight once weekly. If member meets all the requirements listed above, the medication will be approved for 6 months. For reauthorization: 1. Member must be in compliance with all other initial criteria; AND 2. Chart notes submitted with members status reviewed within 30 days prior to reauthorization request confirming that the member remains ambulatory and walks independently (e.g., without side-by-side assist, cane, walker, wheelchair, etc.). If member meets all the reauthorization requirements above, the medication will be approved for an additional 6 months. CareSource considers Exondys 51 (eteplirsen) not medically necessary for the treatment of the diseases that are not listed in this document. DATE ACTION/DESCRIPTION 11/29/2016 Last revision of the policy. 10/16/2017 Policy converted into new format. No changes in criteria. 05/20/2019 Criteria on members ambulatory status and independent walking ability added to initial authorization and reauthorization parts of the policy. References: 1. Exondys 51 [Package Insert]. Cambridge, MA: Sarepta Therapeutics, Inc.; September 2016. 2. Sarepta Therapeutics. An Open-Label, Multi-Center Study to Evaluate the Safety and Tolerability of Eteplirsen in Patients With Advanced Stage Duchenne Muscular Dystrophy. NLM Identifier: NCT02286947. 3. Sarepta Therapeutics. Confirmatory Study of Eteplirsen in DMD Patients (PROMOVI). NLM Identifier: NCT02255552. 4. Sarepta Therapeutics. An Open-Label, Multi-Center Study to Evaluate the Safety and Tolerability of Eteplirsen in Early Stage Duchenne Muscular Dystrophy. NLM Identifier: NCT02420379. Effective date: 07/01/2019 Revi sed date: 05/20/2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Sofosbuvir/velpatasvir (generic for Epclusa) BILLING CODE Must use valid NDC code BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Preferred Product) Alternative preferred product includes Mavyret QUANTITY LIMIT 28 for a 28 day supply LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Sofosbuvir/velpatasvir (generic for Epclusa) is a preferred product and will only be considered for coverage under the pharmacy benefit when the following criteria are met: Members must be clinically diagnosed with one of the following disease states and meet their individual criteria as stated. HEPATITIS C (without cirrhosis or with compensated cirrhosis (Child-Turcotte-Pugh Class A)) For initial authorization: If request is for brand name Epclusa, please follow policy Medical Necessity for DAW on CareSource webpage. 1. Member is treatment-nave without cirrhosis or with compensated cirrhosis (Child-Turcotte-Pugh Class A); AND 2. Member must be 18 years of age or older; AND 3. Member has genotype 1, 2, 3, 4, 5 or 6 (laboratory documentation required); AND 4. Medication must be prescribed by a board certified hepatologist, gastroenterologist, infectious disease specialist or a nurse practitioner working with the above specialists; AND 5. Members documented viral load taken within 6 months of beginning therapy and submitted with chart notes . 6. Dosage allowed: One tablet once daily for 12 weeks. Note: Members life expectancy must be no less than one year due to non-liver related comorbidities . Please submit fibrosis score and drug screening with prior authorization. If member meets all the requirements listed above, the medication will be approved for 12 weeks. For reauthorization or for retreatment: 1. Member must be in compliance with ALL other initial criteria and be treatment-experienced without cirrhosis or with compensated cirrhosis (Child-Turcotte-Pugh Class A); AND 2. Prescriber must submit completed Supplemental Form Hepatitis Cfor KY Medicaid with reauthorization request (see Appendix A below); AND 3. Member is compliant with drug therapy regimen by paid pharmacy claims; AND4. Member has documented current monthly negative urine drug and alcohol screens for 3 consecutive months (laboratory documentation required); AND 5. If the member has a recent history (within the past 6 months) of alcohol or substance abuse, the following is required: a) Documentation that the member has completed or is participating in a recovery program, receiving alcohol or substance abuse counseling services, or seeing an addiction specialist as part of HCV treatment; AND b) Documentation that the member is not actively participating in illicit substance use or alcohol abuse with confirmatory laboratory testing (e.g., urine drug screen); AND 6. Member has evidence of liver fibrosis stage 3 or 4 confirmed by liver biopsy, or elastography only (lab chart notes required) unless one of the following (fibrosis stage F0-4 covered): a) Hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation); b) Post liver transplantation; c) Extrahepatic disease (i.e., kidney disease: proteinuria, nephrotic syndrom e or membranoproliferative glomerulonephritis; cryoglobulinemia with end-organ manifestations (e.g., vasculitis)); d) HIV or HBV coinfection. 7. Dosage allowed: One tablet once daily for 12 weeks. Note: Members life expectancy must be no less than one year due to non-liver related comorbidities . If member meets all the requirements listed above, the medication will be approved for 12 weeks. HEPATITIS CWITH DECOMPENSATED CIRRHOSIS (Child-Turcotte-Pugh Class Bor C) For initial authorization: 1. Member is treatment-nave with decompensated cirrhosis (Child-Turcotte-Pugh Class Bor C) who may or may not be a candidate for liver transplantation, including those with hepatocellular carcinoma; AND 2. Member must be 18 years of age or older; AND 3. Member has genotype 1, 2, 3, 4, or 6 (laboratory documentation required); AND 4. Member will be prescribed sofosbuvir/velpatasvir in combination with ribavirin (if ribavirin ineligible must submit documentation of one of the following results obtained within the past month: neutrophils
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Dupixent (dupilumab) BILLING CODE Must use valid NDC code BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) QUANTITY LIMIT up to 600 mg per month after loading dose LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Dupixent (dupilumab) is a non-preferred product and will only be considered for coverage under the pharmacy benefit when the following criteria are met: Members must be clinically diagnosed with one of the following disease states and meet their individual criteria as stated. MODERATE-TO-SEVERE ATOPIC DERMATITIS For initial authorization: 1. Member must be 12 years of age or older; AND 2. Medication must be prescribed by a dermatologist, allergist or immunologist; AND 3. Members atopic dermatitis involving 10% or more of the body surface area (BSA); AND 4. Documented members Eczema Area and Severity Index (EASI) score is 16 (on a scale of 0-72) submitted with chart notes; AND 5. Member has documented trial and failure of or contraindication to at least two medium potency to very-high potency topical corticosteroids (e.g., Elocon (mometasone furoate), Sy nalar (fluocinolone acetonide), Lidex (fluocinonide)) for at least 3 months ; AND 6. Member has tried and failed to respond to phototherapy treatment (i.e., UV-A, UV-B, a combination of both, psoralen plus UV-A (PUVA), or UV-B1 (narrow-band UV-B)) for at least 12 weeks (Note: tanning beds or outdoor exposure are not true and appropriate substitutes for true UVB or PUVA therapy and therefore would not meet this criteria) .* * If member does n ot have access to light therapy two oral immunomodulatory agents should be used as alternative treatment option (that includes one agent from criterion 7) ; AND 7. Member has documented trial and failure of or contraindication to at least one oral immunomodulatory agent (cyclosporine, methotrexate, azathioprine, or mycophenolate mofetil); AND 8. Member has documented trial and failure of or contraindication to one of the following: a) Eucrisa and/or Elidel (pimecrolimus); b) Protopic (tacrolimus); AND 9. Member is not receiving Dupixent in combination with another biologic medication for the treatment of atopic dermatitis (e.g., Xolair (omalizumab), Rituxan/ (rituximab), Enbrel /Erelzi (etanercept), Remica de/Inflectra/Renflexis (infliximab)). 10. Dosage allowed: Initial dose of 600 mg (two 300 mg injections in different injection sites), followed by 300 mg given every other week. If member meets all the requirements listed above, the medication will be approved for 6 months. For reauthorization: 1. Member must be in compliance with all other initial criteria; AND 2. Documented members EASI score improvement; AND 3. Member is not receiving Dupixent in combination with another biologic medication for the treatment of atopic dermatitis (e.g., Xolair (omalizumab), Rituxan (rituximab), Enbrel /Erelzi (etanercept), Remicade/Inflectra/Renflexis (infliximab)). If member meets all the reauthorization requirements above, the medication will be approved for an additional 6 months. MODERATE-TO-SEVERE PERSISTENT ASTHMA For initial authorization: 1. Member must be 12 years of age or older; AND 2. Member has diagnosis of moderate-to-severe persistent asthma with an eosinophilic phenotype ( basel ine peripheral blood eosinophil level 150 cells/L within the past 6 weeks or h istory of blood eosinophils greater than or equal to 300 cells/L ) OR with oral cortico steroid dependent asthma; AND 3. Medication must be prescribed by a pulmonologist, immunologist or allergist for the diagnosis of asthma; AND 4. Member has at least two documented severe asthma exacerbation within last year; AND 5. Members asthma has been inadequately controlled after 3 month of conventional treatment including one of the following: a) Medium to high doses of inhaled corticosteroids and long acting beta 2-agonists; b) High dose inhaled corticosteroid and a Leukotriene Receptor Antagonists; OR 6. Member is requiring any of the following despite adherent use of conventional therapy: a) Oral/systemic corticosteroid treatment (or increase in dose if already on oral corticosteroid); b) Urgent care visit or hospital admission; c) Intubation; AND 7. Medication is being used as the add-on maintenance treatment to conventional therapies for asthma (i.e., ICS, LABA, etc.); AND 8. Medication is not used in combinati on with Nucala (mepolizumab), Cinqair (reslizumab) , Xolair (omalizumab) or Fasenra (benralizumab). 9. Dosage allowed: I nitial dose of 400 mg (two 200 mg injections) followed by 200 mg given every other week, or an initial dose of 600 mg (two 300 mg injections) followed by 300 mg given every other week . For member s requiring concomitant oral corticosteroids start with an initial dose of 600 mg followed by 300 mg given every other week . If member meets all the requirements listed above, the medication will be approved for 16 weeks. For reauthorization: 1. Medication is not being used as monotherapy for asthma; AND 2. Member must be in compliance with all other initial criteria; AND 3. Chart notes have been provided that show the member has demonstrated improvement during 16 weeks of medication therapy: a) Decreased frequency of emergency department visits; OR b) Decreased frequency of hospitalizations due to asthma symptoms; OR c) Increase in percent predicted FEV1 from pretreatment baseline; OR d) Improved functional ability (i.e., decreased effect of asthma on ability to exercise, function in sch ool or at work, or quality of sleep); OR e) Decreased utilization of rescue medications; OR f) Reduction in exacerbations or corticosteroid dose. If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months. CareSource considers Dupixent (dupilumab) not medically necessary for the treatment of the following disease states based on a lack of robust clinical controlled trials showing superior efficacy compared to currently available treatments: Allergic broncho-pulmonary aspergillosis Allergic conditions without asthma Allergic rhinitis Bullous pemphigoid Cholinergic urticaria and urticaria of other known causes Chronic idiopathic urticaria (CIU) Contact dermatitis (irritant or allergic) Cutaneous T-cell lymphoma Eosinophilic esophagitis Eosinophilic gastroenteritis Eosinophilic granulomatosis with polyangiitis (EGPA/Churg-Strauss Syndrome) Eosinophilic pneumonia Erythroderma of other causes Food allergy (e.g., peanut allergy) Ichthyoses Immune deficiency diseases Initial therapy for allergic asthma Insulin allergy Latex allergy Nasal polyposis Non-allergic (non-atopic) asthma Photosensitivity dermatosis Psoriasis Scabies Seborrheic dermatitis Subcutaneous immunotherapy, adjunct Vibratory angioedema DATE ACTION/DESCRIPTION 06/12/2017 New policy for Dupixent created. 05/22/2019 New indication of Moderate-to-Severe Persistent Asthma added. For Atopic Dermatitis: age requirements expanded (covered for 12 years old members and older); topical corticosteroids use required for at least 3 months; clarification on tanning beds for UV exposure entered; step therapy for topical calcineurin inhibitors revised. References: 1. Dupixent [package insert]. Tarrytown, NY; Regene ron Pharmaceuticals, Inc.: March, 2019. 2. Atopic dermatitis clinical guideline (2017). In American Academy of Dermatology. Retrieved from https://www.aad.org/practicecenter/quality/clinical-guidelines/atopic-dermatitis . 3. Eichenfield LF, Tom WL, Chamlin SL e t al. Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis. JAm Acad Dermatol. 2014; 70(1):338-51. 4. Sidbury R, Davis DM, Cohen DE, et al. Guidelines of care for the management of atopic dermat itis: Section 3. Management and treatment with phototherapy and systemic agents. JAm Acad Dermatol. 2014 Aug;71(2):327-49. 5. Montes-Torres A, Llamas-Velasco M, Prez-Plaza A et al. Biological Treatments in Atopic Dermatitis. J. Clin. Med. 2015, 4, 593-613. 6. Chung KF, Wenzel SE, Brozek JL, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. The European respiratory journal. 2014;43(2):343-373. 7. Kuehn BM. Fevipiprant shows promise for severe, refractory asthma. Meds cape. 2016 Aug 11. http://www.medscape.com/viewarticle/867344. 8. Mayer Knutsen R. Novartis aims to bring first oral asthma drug to market in two decades. Medical Marketing & Media. 2017 Mar 22. http://www. mmm-online.com/pipeline/novartis-nvs-first-to-marke t-oral-asthma-respiratory-drug-in-two-decades/article/645364. 9. IPD Analytics. New Drug Approval. Dupixent (dupilumab). Available at: http://www.ipdanalytics.com/. Effective date: 07/01/2019 Revised date: 05/22/2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Daklinza (daclatasvir) BILLING CODE Must use valid NDC code BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) Alternative preferred products include Mavyret and Sofosbuvir/velpatasvir (generic for Epclusa) QUANTITY LIMIT 28 for a 28 day supply LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Daklinza (daclatasvir) is a non-preferred product and will only be considered for coverage under the pharmacy benefit when the following criteria are met: Members must be clinically diagnosed with one of the following disease states and meet their individual criteria as stated. HEPATITIS C (without cirrhosis or with compensated cirrhosis (Child-Turcotte-Pugh Class A)) For initial authorization: 1. Member must be 18 years of age or older; AND 2. Member is treatment-nave with genotype 1 or 3 (laboratory documentation required) ; AND 3. Member will be prescribed Daklinza in combination with Sovaldi (prior authorization required); AND 4. Medication must be prescribed by a board certified hepatologist, gastroenterologist, infectious disease specialist or a nurse practitioner working with the above specialists; AND 5. Members documented viral load taken within 6 months of beginning therapy and submi tted with chart notes; 6. Member has tried and failed courses of treatment with Sofosbuvir/velpatasvir (generic for Epclusa) and Mavyret (Dates and HCV RNA values must be documented in chart notes). 7. Dosage allowed: Daklinza one tablet taken orally once daily for 12 weeks. Note: Members life expectancy must be no less than one year due to non-liver related comorbidities. Please submit fibrosis score and drug screening with prior authorization. If member meets all the requirements listed above, the medication will be approved for 12 weeks. For reauthorization or for retreatment: 1. Member must be in compliance with ALL other initial criteria and be treatment-experienced with genotype 1 or 3; AND 2. Member will be prescribed Daklinza in combination with Sovaldi (prior authorization required); AND 3. Prescriber must submit completed Supplemental Form Hepatitis Cfor KY Medicaid with reauthorization request (see Appendix A below); AND 4. Member is compliant with drug therapy regimen by paid pharmacy claims; AND5. Member has documented current monthly negative urine drug and alcohol screens for 3 consecutive months (laboratory documentation required); AND 6. If the member has a recent history (within the past 6 months) of alcohol or substance abuse, the following is required: a) Documentation that the member has completed or is participating in a recovery program, receiving alcohol or substance abuse counseling services, or seeing an addiction specialist as part of HCV treatment; AND b) Documentation that the member is not actively participating in illicit substance use or alcohol abuse with confirmatory laboratory testing (e.g., urine drug screen); AND 7. Member has evidence of liver fibrosis stage 3 or 4 confirmed by liver biopsy, or elastography only (lab chart notes required) unless one of the following (fibrosis stage F0-4 covered): a) Hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation); b) Post liver transplantation; c) Extrahepatic disease (i.e., kidney disease: proteinuria, nephrotic syndrome or membranoprolifer ative glomerulonephritis; cryoglobulinemia with end-organ manifestations (e.g., vasculitis)); d) HIV or HBV coinfection. 8. Dosage allowed: Daklinza one tablet taken orally once daily for 12 weeks. Note: Members life expectancy must be no less than one year due to non-liver related comorbidities. If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 weeks. CareSource considers Daklinza (daclatasvir) not medically necessary for the treatment of the diseases that are not listed in this document. DATE ACTION/DESCRIPTION 05/01/2019 Policy for Daklinza created. References: 1. Daklinza [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; November, 2017. 2. Hepatitis CInformation | Division of Viral Hepatitis | CDC. (2015, May 31). Retrieved from https://www.cdc.gov/hepatitis/hcv/index.htm. 3. American Association for the Study of Liver Diseases and the Infectious Diseases Society of America (AASLD) and Infectious Diseases Society of America (IDSA ). HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C; 2017. Available at: https://www.hcvguidelines.org/. 4. Afdhal, N. (2012). Fibroscan (Transient Elastography) for the Measurement of Liver Fibrosis. Gastroenterology & Hepatolog y, 8(9), 605-607. Effective date: 07/01/2019 Revised date: 05/01/2019 Appendix A. Supplemental Form Hepatitis Cfor KY Medicaid 1. Prescriber must answer ALL of the following questions with prior authorization submission: a) Is retreatment necessary due to treatment failure or reinfection? b) Was the member compliant (e.g., few to no missed doses) with previous Direct-Acting Antiviral (DAA) therapy? If not, why? c) Were there any additional factors that led to DAA treatment failure? If so, describe these factors and how they have been addressed or are no longer relevant. 2. Member has been evaluated for potential clinically significant drug interactions. Please see package insert for details: https://www.rxabbvie.com/pdf/mavyret_pi.pdf. 3. Provider attests that: a) Member is willing and able to comply with the requirements of the proposed retreatment plan; AND b) Any factors that may have led to noncompliance with previous treatment(s) have been addressed; AND c) Member has received education regarding risk behaviors (e.g., IV drug use) associated with HCV infection. Prescribers name: Signature: Date:
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Austedo (deutetrabenazine) BILLING CODE Must use valid NDC code BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Preferred Product) QUANTITY LIMIT up to 48 mg per day LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Austedo (deutetrabenazine) is a preferred product and will only be considered for coverage under the pharmacy benefit when the following criteria are met: Members must be clinically diagnosed with one of the following disease states and meet their individual criteria as stated. CHOREA ASSOCIATED WITH HUNTINGTONS DISEASE For initial authorization: 1. Member must be at least 18 years and older and medication is prescribed by neurologist or psychiatrist or nurse practitioner within a psychiatric or neurologic practice; AND 2. Member must have diagnosis of Huntingtons disease with chorea symptoms; AND 3. Documented consultation on risks of suicidal ideation or behavior while on Austedo is submitted with members chart notes (Austedo is contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression); AND 4. Members baseline Total Maximal Chorea Score (of the Unified Huntingtons Disease Rating Scale (UHDRS)) is s ubmitted with chart notes. 5. Dosage allowed: Starting dose of 6 mg once daily with weekly titration by 6 m g per day up to maximum dosage of 48 mg (24 mg twice daily). If member meets all the requirements listed above, the medication will be approved for 3 months. For reauthorization: 1. Member must be in compliance with all other initial criteria; AND 2. Member must have documentation of improvement of Total Maximal Chorea Scores after week 12. If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months. TARDIVE DYSKINESIA (TD) For initial authorization: 1. Member is 18 years of age and older and medication is prescribed by neurologist or psychiatrist or nurse practitioner within a psychiatric or neurologic practice ; AND 2. Member has clinical diagnosis of Tardive Dyskinesia documented in chart notes ; AND 3. Member must try and fail at least 1 other guideline recommended treatments first (e.g., clonazepam, ginkgo biloba, etc.); AND 4. Chart notes confirming that member does not have risk for suicidal or violent behavior and has stable psychiatric symptoms; AND 5. If member has a history of substance use disorder, chart notes confirming that member is in remission for at least 3 months must be provided; AND 6. Members The Abnormal Involuntary Movement Scale (AIMS) score is documented in chart notes; AND 7. Member does not have ANY of the following: a) History of hepatic impairment; b) History of renal impairment; c) Allergy, hypersensitivity, or intolerance to tetrabenazine. 8. Dosage allowed: Starting dose of 12 mg once daily with weekly titration by 6 mg per day up to maximum dosage of 48 mg (24 mg twice daily). If member meets all the requirements listed above, the medication will be approved for 6 months. For reauthorization: 1. Member must be in compliance with all other initial criteria; AND 2. Member must have documentation of improvement of AIMS score. If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months. CareSource considers Austedo ( deutetrabenazine) not medically necessary for the treatment of the diseases that are not listed in this document. DATE ACTION/DESCRIPTION 06/16/2017 New policy for Austedo created. 11/01/2017 New diagnosis of Tardive Dyskinesia was added. 02/08/2018 Criterion requirement of clinical diagnoses of Tardive Dyskinesia for at least 3 months was removed. Length of initial authorization increased to 3 months. Criterion on guidelines recommended treatment was revised. Substance use disorder remission length requirement changed. New providers specialty was added for both diagnosis. 05/06/2019 The guideline recommended treatment criterion changed from two to one medication to try as a trial. References: 1. Austedo [package insert]. North Wales, PA; Teva Pharmaceuticals, Inc. August, 2017. 2. Huntington Study group. Effect of deutetrabenazine on chorea among patients with huntington disease: a randomized clinical trial. JAMA. 2016; 316(1):40-50. doi: 10.1001/jama.2016.8655. 3. Claassen DO, Carroll B, De Boer LM, et al. Indirect tolerability comparison of deutetrabenazine and tetrabenazine for huntington disease. JClin Mov Dis 2017(4):3. doi: 10.1186/s40734-017-0051-5. 4. ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). 2017. Identifier NCT 02291861, Addressing Involuntary Movements in Tardive Dyskinesia (AIM-TD) ; 2017 [cited 2017 Nov 1]. Available from: https://clinicaltrials.gov/ct2/show/NCT02291861?term=deutetrabenazine&recrs=e&rank=5. 5. ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). 2017. Identifier NCT02195700, Aim to Reduce Movements in Tardive Dyskinesia (ARM-TD); 2017 [cited 2017 Nov 1]. Available from: https://clinicaltrials.gov/ct2/show/NCT02195700?term=deutetrabenazine&recrs=e&rank=2. Effective date: 07/01/2019 Revised date: 05/06/2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Dalfampridine (generic for Ampyra) BILLING CODE Must use valid NDC code BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Preferred Product) QUANTITY LIMIT 60 tabs for 30 days LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Dalfampridine (generic for Ampyra) is a preferred product and will only be considered for coverage under the pharmacy benefit when the following criteria are met: Members must be clinically diagnosed with one of the following disease states and meet their individual criteria as stated. SYMPTOM MANAGEMENT: WALKING (GAIT) DIFFICULTIES For initial authorization: If request is for brand name Ampyra, please follow policy Medical Necessity for DAW on CareSource webpage. 1. Member must be age 18 or older; AND 2. Medication must be prescribed by, or in consultation with, or under the guidance of a neurologist; AND 3. Member has been on a disease modifying agent (Avonex (interferon beta-1a), Betaseron (interferon beta-1b), Copaxone (glatiramer acetate), Extavia (interferon beta-1b), Glatopa (glatiramer actate), Plegridy (peginterferon beta-1a), Rebif (interferon beta-1a), Aubagio (teriflunomide), Gilenya (fingolimod), Tecfidera (dimethyl fumarate), Lemtrada (alemtuzumab), Novantrone (mitoxantrone), Tysabri (natalizumab) , Ocrevus (ocrelizumab) , Mayzent (simponimod) or Mavenclad (cladribine) ) for at least the last 90 days; AND 4. Member is ambulatory and has documented baseline of the timed 25 foot walk (T25FW) between 8 and 45 seconds. 5. Dosage allowed: 10 mg every 12 hours. If member meets all the requirements listed above, the medication will be approved for 6 months. For reauthorization: 1. Member must be in compliance with all other initial criteria; AND 2. Documentation of members increase in walking speed submitted with chart notes. If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months. CareSource considers Dalfampridine (generic for Ampyra) not medically necessary for the treatment of the following disease states based on a lack of robust clinical controlled trials showing superior efficacy compared to currently available treatments: Acute spinal cord injury Disorder of neuromuscular transmis sion DATE ACTION/DESCRIPTION 07/18/2017 New policy for Ampyra created. Not covered diagnosis added. 05/16/2019 Policy modified to Dalfampridine (generic for Ampyra). Mayzent and Mavenclad added to the list of disease modifying agents; Zinbryta was removed due to market recall. References: 1. Ampyra [package insert]. Ardsley, NY: Acorda Therapeutics, Inc.; October , 2016. 2. Ampyra. Micromedex Solutions. Truven Health Analytics, Inc. Ann Arbor, MI. Available at: http://www.micromedexsolutions.com. Accessed March 16, 2017. 3. Goodman AD, Brown TR, Edwards KR, Krupp LB, Schapiro RT, Cohen R, Marinucci LN, Blight AR; MSF204 Investigators. A phase 3 trial of extended r elease oral dalfampridine in multiple sclerosis. Ann Neurol. 2010 Oct; 68(4):494-502. 4. Goodin DS, Frohman EM, Garmany GP Jr, et al. Disease modifying therapies in multiple sclerosis: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines. Neurology. 2002 Jan;58(2):169-78. Effective date: 07/01/2019 Revised date: 05/16/2019
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