PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Zepatier (grazoprevir/elbasvir) 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 Zepatier (grazoprevir/elbasvir) 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 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 or 4 (laboratory documentation required); AND 4. Member has been tested for NS5A resistance-associated polymorphisms if Genotype is 1a; AND 5. Medication must be prescribed by a board certified hepatologist, gastroenterologist, infectious disease specialist or a nurse practitioner working with the above specialists; AND 6. Members documented viral load taken within 6 months of beginning therapy and submitted with chart notes; AND 7. Member does not have moderate to severe hepatic impairment (Child-Turcotte-Pugh Band C); AND 8. 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). 9. Dosage allowed: One tablet once daily for 12 weeks OR one tablet once daily with ribavirin for 16 weeks if member has NS5A resistance-associated polymorphisms. 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 12-16 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 without cirrhosis or with compensated cirrhosis (Child-Turcotte-Pugh Class A); AND2. 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; AND 4. 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 spec ialist 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 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 weeks OR one tablet once daily with ribavirin for 16 weeks if member has NS5A resistance-associated polymorphisms. 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 12-16 weeks, see Appendix A below. CareSource considers Zepatier (grazoprevir/elbasvir) 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 Zepatier created. 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 Medication status changed to non-preferred. Substance abuse program information is no longer required. Trial of preferred agent is required. Reauthorization criteria were removed. 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. Reauthorization 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. References: 1. Zepatier [package insert]. Merck Sharp & Dohme Corp: Whitehouse Station, NJ; February, 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 Treati ng Hepatitis C; 2017. Available at: https://www.hcvguidelines.org/. 4. 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 and Population Treatment Duration Genotype 1a: Treatment-nave or PegIFN/RBV experienced1 without baseline NS5A polymorphisms2 Zepatier 12 weeks Genotype 1a: Treatment-nave or PegIFN /RBV experienced1 with baseline NS5A polymorphisms2 Zepatier + ribavirin 16 weeks Genotype 1b: Treatment-nave or PegIFN/RBV experienced1 Zepatier 12 weeks Genotype 1a or 1b: PegIFN/RBV/PI-experienced3 Zepatier + ribavirin 12 weeks Genotype 4: Treatment-nave Zepatier 12 weeks Genotype 4: PegIFN/RBV-experienced1 Zepatier + ribavirin 16 weeks 1Peginterferon alfa + ribavirin. 2Polymorphisms at amino acid positions 28, 30, 31, or 93. 3Peginterferon alfa + ribavirin + HCV NS3/4A protease inhibitor. Appendix 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: https://www.merck.com/product/usa/pi_circulars/z/zepatier/zepatier_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 Xeomin (incobotulinumtoxinA) BILLING CODE J0588 BENEFIT TYPE Medical SITE OF SERVICE ALLOWED Office COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) QUANTITY LIMIT up to 600 Units per treatment LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Xeomin (incobotulinumtoxinA) 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. BLEPHAROSPASM For initial authorization: 1. Member is 18 years of age or older with diagnosis of blepharospasm, as indicated by one or more of the following: a) Benign essential blepharospasm; b) Blephar ospasm associated with dystonia; c) Blepharospasm associated with facial nerve (cranial nerve VI I) disorders such as Bell palsy; AND 2. Member does not have neuromuscular disease (e.g., myasthenia gravis). 3. Dosage allowed: The total initial dose of Xeomin in both eyes should not exceed 70 Units (35 Units/eye). The maximum dose per eye: 10-50 Units. 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 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 6 months. CERVICAL DYSTONIA (SPASMODIC TORTICOLLIS) For initial authorization: 1. Member has a pain or abnormal head position with documented turning of the head (torticollis), lateral tilt of the neck (laterocollis), flexion of the head (anterocollis), or extension of the head ( retrocollis) causing adverse effect on daily functioning; AND 2. Member has tried and failed one oral medication such as trihexyphenidyl (Artane), clonazepam (Klonopin), or baclofen; AND 3. Member does not have any of the following: a) Fixed contractures causing decreased neck range of motion; b) Neuromuscular disease (e.g., myasthenia gravis); c) Prior surgical treatment. 4. Dosage allowed: 300 Units . 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 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 6 months. CHRONIC SIALORRHEA For initial authorization: 1. Member is 18 years of age or older; AND 2. Member has chronic sialorrhea resulting from Parkinsons disease, atypical parkinsonism, stroke, or traumatic brain injury, that was present for at least three months (chart notes required) ; AND 3. Member does not have any of the following: a) A history of aspiration pneumonia, amyotrophic lateral sclerosis, salivary gland or duct malformation, and gastroesophageal reflux disease; b) Bleeding disorders or is currently on anticoagulants; c) Pregnancy. 4. Dosage allowed: The recommended total dose is 100 Units per treatment session consisting of 30 Units per parotid gland and 20 Units per submandibular gland. If member meets all the requirements listed above, the medication will be approved for 16 weeks. For reauthorization: 1. Member must be in compliance with all other initial criteria; AND 2. 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. SPASTICITY (Upper Limb Only) For initial authorization: 1. Member has confirmed diagnosis of post-stro ke spasticity of the upper limb (at least six months post-stroke); AND 2. Chart notes submitted with documentation of abnormal muscle tone that is interfering with functional ability (or that is expected to affect joint contracture in future growth); AND 3. Medication is being requested to improve function or allow additional therapeutic modality to be employed. 4. Dosage allowed: Vary 5-100 Units given in divided doses among affected muscles. 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. 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 Xeomin (incobotulinumtoxinA) 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: Glabellar Lines (considered cosmetic) Tension headache, cervicogenic headache Myofascial pain syndrome Tremors such as benign essential tremor, chronic motor tic disorder and tics associated with Tourette Syndrome Parkinson's disease DATE ACTION/DESCRIPTION 08/06/2018 New policy for Xeomin created. Age requirement removed for diagnoses of Cervical Dystonia and Upper Limb Spasticity. Criterion no infection at proposed injection site removed from Cervical Dystonia diagnosis; pain and abnormal head position requirements clarified and medications trial added. For Upper Limb Spasticity Ashworth scale requirement removed, post-stroke requirement and chart notes requirement of abnormal muscle tone documentation added. 04/05/2019 New indication of Chronic Sialorrhea added. Dose allowance increased for diagnosis of Cervical Dystonia. Trial of Botox removed form diagnosis of Blepharospasm. References: 1. Xeomin [package insert].Greensboro, NC: Merz Pharmaceuticals, LLC; August 2011. 2. Brashear A, Lew MF, Dykstra DD, et al, Safety and Efficacy of NeuroBloc (Botulinum Toxin Type B) in Type A-Responsive Cervical Dystonia, Neurology, 1999, 53(7):1439-46. 3. Clinical Use of Botulinum Toxin, Arch Neurol, 1991, 48(12):1294-8. 4. Benecke R, Jost WH, Kanovsky P, et al, A New Botuli num Toxin Type A Free of Complexing Proteins for Treatment of Dystonia, Neurology, 2005, 64(11):1949-51. 5. Borodic GE and Pearce LB, New Concepts in Botulinum Toxin Therapy, Drug Saf, 1994, 11(3):145-52. Jankovic Jand BrinMF, Therapeutic Uses of Botulinum Toxin, NEngl JMed,1991, 324(17):1186-94. 6. Naumann Mand Jankovic J, “Safety of Botulinum Toxin Type A: A Systematic Review and Meta-Analysis,” Curr Med Res Opin, 2004, 20(7):981-90. 7. Russman, BS, Tilton, A, Gormley ME. Jr. Cerebral palsy; a rational approach to a treatment protocol, and the role of botulinum toxin in treatment, Muscle Nerve Suppl 1997; 6:S181. 8. Fishman LM, Anderson C, Rosner B. Botox and physical therapy in the treatment of Piriformis syndrome Am JPhys Med Rehabil. 2002 Dec;81(12):936-42. 9. Assessment: botulinum neurotoxin for the treatment of movement disorders (an evidence-based review). Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. http://www.guideline.gov/content.aspx?id=12947(M arch11, 2011). 10. Assessment: botulinum neurotoxin for the treatment of spasticity (an evidence-based review). Report of the Therapeutics and Technology Assessment Subcommittee of the American Academyof Neurology. http://www.guideline.gov/content.aspx?id= 12942(March112011). 11. Simpson DM, et al. Assessment: Botulinum neurotoxin for the treatment of movement disorders (an evidence-based review). Report of the Therapeutics and Technology Subcommittee of the American Academy of Neurology. Neurology. 2008;70(19) :1699-706. 12. Neumann M, et al. Assessment: Botulinum neurotoxin in the treatment of autonomic disorders and pain. Report of the Therapeutics and Technology Subcommittee of the American Academy of Neurology. Neurology. 2008; 70:1707-14. 13. Keam SJ, Muir VJ, Deek s ED. Botulinum toxin A (Dysport): in dystonias and focal spasticity. Drugs 2011;71(8):1043-58. 14. Ondo WG, Hunter C, Moore W. A double-blind placebo-controlled trial of botulinum toxin Bfor sialorrhea in Parkinsons disease. Neurology. 2004;62(1):37-40. 15. Simpson DM, et al. Practice guideline update summary: botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurolog y. 2016 May 10;86(19):1818-26. 16. Teasell R, et al. Evidence to practice: botulinum toxin in the treatment of spasticity post stroke. Top Stroke Rehabil. 2012 Mar-Apr;19(2):115-21. 17. Chen R, et al. Botulinum toxin for Post-stroke Limb Spasticity. Ischemic Str oke Therapeutics. 2016; 203-207. 18. Cameron MH, et al. Botulinum toxin for symptomatic therapy in multiple sclerosis. Curr Neurol Neurosci Rep. 2014 Aug;14(8):463. Effective date: 07/01/2019 Revised date: 05/14/2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Vosevi (sofosbuvir/velpatasvir/voxilaprevir) 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 Vosevi (sofosbuvir/velpatasvir/voxilaprevir) 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, for reauthorization or for retreatment: 1. Member must be treatment-experienced, 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 have previously been treated with an HCV regimen containing an NS5A inhibitor1; OR 4. Member has genotype 1a or 3 (laboratory documentation required) and have previously been treated2 with an HCV regimen containing sofosbuvir without an NS5A inhibitor; AND 5. Medication must be prescribed by a board certified hepatologist, gastroenterologist, infectious disease specialist or a nurse practitioner working with the above specialists; 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: 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. 1NS5A inhibitor experience included daclatasvir, elbasvir, ledipasvir, ombitasvir, or velpatasvir. 2Prior treatment experience included sofosbuvir with or without any of the following: peginterferon alfa/ribavirin, ribavirin, HCV NS3/4A protease inhibitor (boceprevir, simeprevir, or telaprevir). 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 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; AND 4. 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 spec ialist 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 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 weeks. If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 weeks. CareSource considers Vosevi (sofosbuvir/velpatasvir/voxilaprevir) not medically necessary for the treatment of the diseases that are not listed in this document.DATE ACTION/DESCRIPTION 05/01/2019 New policy for Vosevi created. References: 1. Vosevi [package Insert]. Foster City, CA: Gilead Sciences, Inc.; 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 & Hepatology, 8(9 ), 605-607. Effective date: 07/01/2019 Revised date: 05/01/2019Appendix 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 addr essed; 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 Ultomiris (ravulizumab-cwvz) BILLING CODE J3590 BENEFIT TYPE Medical SITE OF SERVICE ALLOWED Home/Office/Outpatient COVERAGE REQUIREMENTS Prior Authorization Required (Preferred Product) QUANTITY LIMIT see Dosage allowed below LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Ultomiris (ravulizumab-cwvz) is a 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. PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) For initial authorization: 1. Member with diagnosis of PNH as confirmed by flow cytometry (PNH type III red cells or GPI-AP-deficient polymorphonuclear cells (PMNs)); AND 2. Medication is prescribed by a hematologist or nephrologist; AND 3. Member has received vaccination against Neisseria meningitidis (i.e., Menactra, Menveo, MenHibrix); AND 4. Member has LDH levels > 1.5 times the upper limit of normal documented in chart notes; AND 5. Member has one or more of the following documented in chart notes: a) History of at least 1 blood transfusion within the past 24 months due to anemia or anemia related symptoms or personal beliefs precluding transfusion; b) Presence of organ damage due to chronic hemolysis. 6. Dosage allowed: Administered as an IV infusion. Body weight
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Sovaldi (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 Sovaldi (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 if member is 18 years of age and older must 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) ; AND 2. Member is treatment-nave with genotype 2 or 3 (laboratory documentation required); AND 3. Medication must be used in combination with ribavirin; 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; AND 6. Member does not have moderate to severe hepatic impairment (Child-Turcotte-Pugh Band C). 7. Dosage allowed: Sovaldi (one tablet once daily ) + ribavirin for 12 weeks for genotype 2; Sovaldi (one tablet once daily ) + ribavirin for 24 weeks for g enotype 3. 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 w ill be approved for 12-24 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); AND3. Member is compliant with drug therapy regimen by paid pharmacy claims; AND 4. 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 syndrome or membranoproliferative glomerulonephritis; c ryoglobulinemia with end-organ manifestations (e.g., vasculitis)); d) HIV or HBV coinfection. 7. Dosage allowed: Sovaldi (one tablet once daily) + ribavirin for 12 weeks for genotype 2; Sovaldi (one tablet once daily) + ribavirin for 24 weeks for genotype 3. Note: Members life expectancy must be no less than one year due to non-liver related comorbidities. If member meets all the reauthorization requirements listed above, the medication will be approved for 12-24 weeks, see Appendix A below. CareSource considers Sovaldi (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 Sovaldi 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 cons ecutive 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. Reauthorization 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. Sovaldi [ package Insert]. Foster City, CA: Gilead Sciences, Inc.; November, 201 7. 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 & Hepatology, 8(9), 605-607. Effective date: 07 /01/2019 Revised date: 05/01/2019 Appendix. Treatment Duration Genotype Pediatric Patient Population 12 Years of Age and Older or Weighing at Least 35 kg Regimen and Duration Genotype 2 Treatment-nave and treatment-experienced without cirrhosis or with compensated cirrhosis (Child-Pugh A) Sovaldi + ribavirin 12 weeks Genotype 3 Treatment-nave and treatment-experienced without cirrhosis or with compensated cirrhosis (Child-Pugh A) Sovaldi + ribavirin 24 weeks Appendix 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: https://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/sovaldi/sovaldi_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 Relistor (methylnaltrexone) 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 stool softeners, bulk forming laxatives, osmotic laxatives, stimulant laxatives, lubricant laxatives QUANTITY LIMIT 90 tablets per 30 days, or 30 pre-filled syringes per 30 days (15 syringes or single-dose vials in cancer/advanced illness) LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Relistor (methylnaltrexone) 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. OPIOID-INDUCED CONSTIPATION (OIC) For initial authorization: 1. Member is 18 years old or older , with diagnosis of OIC; AND 2. One of the following: a) Member has been receiving opioids for non-cancer pain for longer than 4 weeks, and does not require frequent (e.g., weekly) opioid dosage escalation; b) Member has diagnosis of an advanced illness or active cancer ; AND 3. Medication must be prescribed by or in consultation with a gastroenterologist, oncologist, palliative care or pain management specialist; AND 4. One of the following: a) Member is un able to swallow oral medications , a nd has a documented 4-day trial and failure of ALL of the following: i) Suppository of glycerin or bisacodyl ; ii) Enema of sodium phosphate, glycerin, mineral oil, or docusate; iii) Enema of bisacodyl ; OR b) Member is able to swallow oral medication, and has a documented 4-day trial and failure of ALL of the following: i) A bulk forming laxative (e.g., psyllium, methylcellulose) ; ii) An osmotic agent (e.g., polyethylene glycol, lactulose); iii) A stimulant laxative (e.g., bisacody l, sennosides); iv) A stool softener (e.g., docusate); v) A lubricant laxative (e.g., mineral oil) ; vi) Amitiza (lubiprostone) ( requires prior authorization); vii) Symproic (naldemedine) ( requires prior authorization); viii) Movantik (naloxegol) (requires prior authorization); AND 5. Member does NOT have a known or suspected mechanical gastrointestinal obstruction. 6. Dosage allowed: For OIC in non-cancer pain: oral tablet 450 mg once daily in the morning or subcutaneous injection 12 mg once daily. For OIC in advanced illness or cancer : up to 12 mg every other day as needed subcutaneously. Note: Relistor oral tablet is not indicated for OIC in advanced illness . If member meets all the requirements listed above, the medication will be approved for 3 months. For reauthorization: 1. Member meets all initial authorization criteria; AND 2. Member has not experienced severe or persistent diarrhea during treatment; AND 3. Chart notes have been provided that show the member has shown improvement of signs and symptoms of constipation. If member meets all the reauthorization requirements above, the medication will be approved for an additional 6 months. CareSource considers Relistor (methylnaltrexone) 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 Relistor created. References: 1. ClinicalTrials. gov. Identifier NCT01186770. A study of oral methylnaltrexone (MNTX) for the treatment of opioid-induced constipation in subjects with chronic, non-malignant pain. Available: clinicaltrials.gov/ct2/show/NCT01186770. 2. ClinicalTrials.gov. Identifier NCT 01004393. Methylnaltrexone for opioid-induced constipation in cancer patients. Available: clinicaltrials.gov/ct2/show/NCT01004393. 3. ClinicalTrials.gov. Identifier NCT 00672477. Study evaluating subcutaneous methylnaltrexone for treatment of opioid-induced constipation in patients with advanced i llness. Avail able: clinicaltrials.gov/ct2/show/NCT 00672477. 4. Crockett SD, et al . American gastroenterological association institute guideline on the medical management of opioid-induced constipation. Gastroenterology. 2019 Jan 1;156(1):218-26. 5. Nee J, et al. Efficacy of treatments for opioid-Induced constipation: systematic review and meta-analysis. Clinical Gastroenterology and Hepatology. 2018 Oct 1;16(10):1569-84. 6. Relistor [prescribing information]. Bridgewater, NJ: Salix Pharmaceuticals Inc. 2018 Mar. Effective date: 07/01/2019 Revised date: 05/20/2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Ravicti (glycerol phenylbuytyrate) 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 product includes Buphenyl QUANTITY LIMIT 11.2 mL/m2/day LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Ravicti (glycerol phenylbuytyrate) 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. UREA CYCLE DISORDERS (UCDs) For initial authorization: 1. Medication must be prescr ibed by, or in consultation with a metabolic or genetic specialist; AND 2. Member has documented history of hyperammonemia associated with diagnosis of a UCD as one of the following : a) Carbamoyl phosphate synthetase 1 deficiency (CPS1 D); b) Orthinine transcarbamylase deficiency (OTCD) ; c) Argininosuccinate synthetase deficiency (ASSD/classic citrullinemia/type 1 citrullinemia) ; d) Argininosuccinate lyase deficiency (ASLD/ argininosuccinic aciduria) ; e) Arginase deficiency ( ARG1D/argininemia); AND 3. Member must currently be treated with, and adherent to dietary protein restriction, and when appropriate, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements) as documented in chart notes , or evi dent in pharmacy claims history ( Note: Arginine supplementation should be used in all UCDs except ARG1D, citrulline supplementation should be used in OTCD and CPSID ); AND 4. Dietary treatment has been insufficient to maintain plasma ammonia levels below the upper limit of normal (ULN), 35 mol/L , despite treatment adherence; AND 5. Member tried and failed treatment with Buphenyl except one of the following: a) Not tolerated Buphenyl due to severe adverse effects ; b) Has c ontraindication to Buphenyl (e.g., hypersensitivity, pregnancy, breastfeeding) ; c) Failed to maintain ammonia levels below ULN (35 mol/L) despite optimized dosing (13 g/m2/day, max: 20 g/day) and treatment adherence; d) Treatment w as complicated by a clinical state where there is sodium retention and edema (e.g., congestive heart failure, severe renal insufficiency) ; AND 6. Member does not have ANY of the following: a) N-acetylglutamate synthase (NAGS) deficiency ; b) Concomitant use of drugs known to increase ammonia levels (e.g., valproate, haloperidol , systemic corticosteroids); AND 7. Ravicti is NOT being used to treat acute hyperammonemia. 8. Dosage allowed: 4.5 to 11.2 mL/m2/day (5 to 12.4 g/m2/day). If member meets all the requirements listed above, the medication will be approved for 12 months. For reauthorization: 1. Member meets all initial authorization requirements ; AND 2. Chart notes have been provided that show the member has shown improvement of signs and symptoms of disease (e.g., normalized plasma ammonia levels) . If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months. CareSource considers Ravicti (glycerol phenylbuytyrate) 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: Byler disease (progressive familial intrahepatic cholestas is 1 (PFIC-1)) Cirrhosis, hepatic encephalopathy Cystic fibrosis Medium-chain acyl-CoA dehydrogenase (MCAD) deficiency DATE ACTION/DESCRIPTION 05/20/2019 New policy for Ravicti created. References: 1. Ravicti [package insert]. Lake Forest, IL: Horizon Therapeutics; 2018 Dec. 2. Buphenyl (sodium phenylbutyrate) [prescribing information]. Deerfield, IL: Horizon Pharma; June 2015. 3. ClinicalTrials.gov. Identifier: NCT00992459. Efficacy and Safety of HPN-100 for the Tr eatment of Adults With Urea Cycle Disorders . Available: clinicaltrials.gov/ct2/show/NCT00992459. 4. ClinicalTrials.gov. Identifier: NCT01347073. Study of the Safety, Pharmacokinetics and Efficacy of HPN-100, in Pediatric Subjects With Urea Cycle Disorders (UCDs). Available: clinicaltrials.gov/ct2/show/NCT01347073. 5. ClinicalTrials.gov. Identifier: NCT 00999167. A Study of Safety and Efficacy of HPN-100 in Subjects With Cirrhosis and Episodic Hepatic Encephalopathy (HALT-HE). Available: c linicaltrials.gov/ct2/show/NCT00999167. 6. ClinicalTrials.gov. Identifier: NCT01881984. Use of Ravicti in Patients With MCAD Deficiency With the 985A>G (K304E) Mutation. Available: clinicaltrials.gov/ct2/show/NCT01881984. 7. Hberle J, et al . Suggested Guidelines for the Diagnosis and Management of Urea Cycle Disorders. Orphanet Journal of Rare Diseases. 2012 Dec;7(1):32. Available: ncbi.nlm.nih.gov/pmc/articles/PMC3488504. 8. National Organization for Rare Diseases. rarediseases.org/physician-guide/urea-cycle-disorders . 9. NIH Rare Diseases Clinical Research Network: Urea Cycle Disorders Consortium. Urea Cycle Treatment Guidelines. Available: rarediseasesnetwork.org/cms/ucdc/healt hcare-professionals/treatment-g uidelines . 10. Ah Mew N, et al. Urea cycle disorders overview. In: Adam MP, et al., eds. GeneReviews [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2019. 2003 Apr 29 [updated 2017 Jun 22]. Effective date: 07/01/2019 Revised date: 05/20/2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Mavyret (glecaprevir and pibrentasvir) 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 Epclusa QUANTITY LIMIT 84 tabs per 28 days LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Mavyret (glecaprevir and pibrentasvir) 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: 1. Member must be 18 years of age or older; AND 2. Member is treatment-nave with genotype 1, 2, 3, 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 any of the following: a) Moderate to severe hepatic impairment (Child-Turcotte-Pugh Band C); b) Currently on atazanavir and rifampin. 6. Dosage allowed: Three tablets (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg) taken orally once daily with food. 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 8 weeks for treatment-nave members with no cirrhosis or for 12 weeks for treatment-nave members with compensated cirrhosis, 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 one of the following: a) genotype 1, who previously have been treated with a regimen containing an HCV NS5A inhibitor1 or an NS3/4A protease inhibitor2, but not both; OR b) genotype 1, 2, 3, 4, 5 or 6 with regimens containing interferon, pegylated interferon, ribavirin, and/or sofosbuvir, but no prior treatment experience with an HCV NS3/4A protease inhibitor2 or NS5A inhibitor1; 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; AND 4. 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 liv er 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 tra nsplantation; 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: Three tablets (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg) taken orally once daily with food. Note: Members life expectancy must be no less than one year due to non-liver related comorbidities. 1 NS5A inhibitor regimens includes ledipasvir and sofosbuvir or daclatasvir with pegylated interferon and ribavirin. 2 NS3/4A protease inhibitor regimens includes simeprevir and sofosbuvir, or simeprevir, boceprevir, or telaprevir with pegylated interferon and ribavirin. If member meets all the requirements listed above, the medication will be approved for 8-16 weeks, see Appendix A below. CareSource considers Mavyret (glecaprevir and pibrentasvir) not medically necessary for the treatment of the diseases that are not listed in this document. DATE ACTION/DESCRIPTION 11/22/2017 New policy for Mavyret created. 12/07/2017 Criterion of life expectancy 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. Reauthorization criteria added for treatment-experienced members. New Appendix added (Supplemental Form Hepatitis Cfor KY Medicaid). 05/01/2019 Coverage was adjusted for age; drug covered for members of 12 years of age and older. References: 1. Mavyret [Package insert]. North Chicago, IL: AbbVie Inc.; August 2017. 2. 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/. 3. Hepatitis CInformation | Division of Viral Hepatitis | CDC. (2015, May 31). Retrieved from https://www.cdc.gov/hepatitis/hcv/index.htm. 4. 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: 05/01/2019Appendix A. Treatment Duration for Mavyret for Treatment-Experienced Members Treatment Duration HCV Genotype Member Previously Treated with a Regimen Containing: No Cirrhosis Compensated Cirrhosis (Child-Pugh A) 1 An NS5A inhibitor1 without prior treatment with an NS3/4A protease inhibitor 16 weeks 16 weeks An NS3/4A PI2 without prior treatment with an NS5A inhibitor 12 weeks 12 weeks 1, 2, 4, 5 or 6 Prior treatment experience with regimens containing interferon, pegylated interferon, ribavirin, and/or sofosbuvir, but no prior treatment experience with an HCV NS3/4A PI or NS5A inhibitor 8 weeks 12 weeks 3 Prior treatment experience with regimens containing interferon, pegylated interferon, ribavirin, and/or sofosbuvir, but no prior treatment experience with an HCV NS3/4A PI or NS5A inhibitor 16 weeks 16 weeks 1 NS5A inhibitor r egimens included ledipasvir and sofosbuvir or daclatasvir with pegylated interferon and ribavirin. 2 NS3/4A protease inhibitor regimens included sim eprevir and sofosbuvir, or simeprevir, boceprevir, or telaprevir with pegylated interferon and ribavirin. Appendix 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: 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 Kalydeco (ivacaftor) BILLING CODE Must use valid NDC code BENEFIT TYPE Pharmacy SITE OF SERVICE ALLOWED Home COVERAGE REQUIREMENTS Prior Authorization Required (Preferred Product) QUANTITY LIMIT 150 mg tablets-60 per 30 days 50 mg & 75 mg granules-56 per 30 days LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Kalydeco (ivacaftor) 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. CYSTIC FIBROSIS For initial authorization: 1. Member must be 6 months of age or older; AND 2. Medication must be prescribed by a pulmonologist or an infectious disease specialist; AND 3. Member has had genetic testing documented in chart notes with one of the following mutations in the CFTR gene: 2789+5G A, 3272-26A G, 3849+10kbC T, 711+3AG, A1067T, A455E, D110E, D110H, D1152H, D1270N, D579G, E193K, E56K, E831X, F1052V, F1074L, G1069R, G1244E, G1349D, G178R, G551D, G551S, K1060T, L206W, P67L, R1070Q, R1070W, R117C, R117H, R347H, R352Q, R74W, S1251N, S1255P, S549N, S549R, S945L, or S977F. 4. Dosage allowed: Up to 150 mg every 12 hours. See package insert for details on dosing. 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. Members adherence to medication is confirmed by claims history. If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months. CareSource considers Kalydeco (ivacaftor) not medically necessary for the treatment of the diseases that are not listed in this document. DATE ACTION/DESCRIPTION 06/12/2017 New policy for Kalydeco created. 10/05/2018 New CFTD gene mutations added. Age coverage expanded (approved for 12 months old members and older). 05/16/2019 Age coverage expanded (approved for 6 months old members and older). References: 1. Kalydeco [package insert]. Boston, MA: Vertex Pharmaceuticals Inc; April, 2019 . 2. Kalydeco. Micromedex Solutions. Truven Health Analytics, Inc. Ann Arbor, MI. Available at: http://www.micromedexsolutions.com. Accessed March 6, 2017. 3. National Guideline Clearinghouse (NGC). Guideline summary: Cystic fibrosis pulmonary guidelines. Chronic medications for maintenance of lung he alth. In: National Guideline Clearinghouse (NGC) [Web site]. Rockville (MD): Agency for Healthcare Research and Quality (AHRQ); 2013 Apr 01. Available: https://www.atsjournals.org/doi/full/10.1164/rccm.201207-1160OE. Accessed November 27 , 2018. Effective date: 07/01/2019 Revised date: 05/16/2019
PHARMACY POLICY STATEMENT Kentucky Medicaid DRUG NAME Ingrezza (valbenazine) 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 60 caps per 30 days LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Ingrezza (valbenazine) 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. TARDIVE DYSKINESIA (TD) For initial authorization: 1. Member i s 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 moderate to severe neuroleptic-induced TD as determined by clinical observation and documented in chart notes; AND 3. Member must try and fail at least 1 other guideline recommended treatments (e.g., clonazepam, ginkgo biloba, etc.); AND 4. Chart notes confirming that m ember 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 neuroleptic malignant syndrome; b) History of long QT syndrome or cardiac arrhythmia; c) Allergy, hypersensitivity, or intolerance to tetrabenazine. 8. Dosage allowed: 40 mg once daily. After one week, increase the dose to the recommended dose of 80 mg once daily . If member meets all the requirements listed above, the medication will be approved for 3 months. For reauthorization: 1. Documentation that the member s TD symptoms have improved due to Ingrezza use as evidenced by AIMS score showing reduction of score from baseline. If member meets all the reauthorization requirements above, the medication will be approved for an additional 12 months. CareSource considers Ingrezza (valbenazine) 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: Treatment of Huntington disease, Chorea Huntington s disease Treatment of Tourette syndrome DATE ACTION/DESCRIPTION 08/29/2017 New policy for Ingrezza created. 12/14/2017 Criterion revised in collaboration with Indiana Medicaid DUR Board. Criterion requirement of clinical diagnoses of Schizophrenia or Schizoaffective Disorder, or Mood Disorder for at least 3 months was removed. Length of initial authorization increased to 3 months. Criterion on guidelines recommended treatment was revised. 12/28/2017 Criterion on negative drug test revised. Substance use disorder remission length requirement changed. 02/08/2018 New providers specialty was added: nurse practitioner within a psychiatric or neurologic practice. 05/06/2019 The guideline recommended treatment criterion changed from two to one medication to try as a trial. Criterion on negative urine drug test or positive drug test result due to current prescriptions was removed. References: 1. Ingrezza [package insert]. San Diego, CA; Neurocrine Biosciences, Inc.: April, 2017. 2. Kang N-R, Kim M-D. Tardive Dyskinesia: Treatment with Aripiprazole. Clinical Psychopharmacology and Neuroscience. 2011;9(1):1-8. doi:10.9758/cpn.2011.9.1.1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3568649/. 3. ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). 2017 Jun 9 – . Identifier NCT02274558, A Phase 3 Study of NBI-98854 for the Treatment of Tardive Dyskinesia (KINECT 3); 2017 Jun 9 [cited 2017 Jul 31]. Available from: https://clinicaltrials.gov/ct2/show/NCT02736955?cond=ingrezza&rank=1. 4. American Academy of Neurology. Summary of Evidence-based Guideline for PATIENTS and their FAMILIES. Treating and managing tardive syndromes. https://www.aan.com/Guidelines/Home/GetGuidelineContent/614. 5. Hauser RA , Factor SA, Marder SR , Knesevich MA , et al. KINECT 3: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Valbenazine for Tardive Dyskinesia. American Journal of Psychiatry 2017 174:5, 476-484. Effective date: 07/0 1/2019 Revised date: 05/06/2019
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