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Glecaprevir/Pibrentasvir Drug and Biologic Coverage Policy Effective Date ............................................ 9/1/2021 Next Review Date… ..................................... 9/1/2022 Coverage Policy Number ............................... IP0187 Glecaprevir/Pibrentasvir Table of Contents Related Coverage Resources Overview .............................................................. 1 Interferon Therapy Medical Necessity Criteria ................................... 1 Reauthorization Criteria ....................................... 4 Authorization Duration ......................................... 4 Conditions Not Covered....................................... 5 Background .......................................................... 5 References .......................................................... 7 INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations. Overview This policy supports medical necessity review for glecaprevir/pibrentasvir (Mavyret™). Medical Necessity Criteria Glecaprevir/pibrentasvir (Mavyret) is considered medically necessary when ONE of the following is met (1, 2, 3, 4, or 5): 1. Chronic Hepatitis C Virus (HCV) Genotype 1, 2, 3, 4, 5, or 6, Treatment-Naïve. Individual meets ALL of the following criteria (A, B, C, and D): A. Individual is 3 years of age or older B. Individual does not have cirrhosis OR has compensated cirrhosis (Child-Pugh A) C. Approve for 8 weeks if individual is HCV treatment-naïve (the individual has NOT previously received treatment for their chronic HCV infection) D. The medication is prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician Page 1 of 7 Coverage Policy Number: IP0187 2. Chronic Hepatitis C Virus (HCV), Genotype 1, Treatment-Experienced. Individual meets ALL of the following criteria (A, B, and C): A. Individual is 3 years of age or older B. Individual meets ONE of the following conditions (i, ii, iii, or iv): NS5A-Experienced, NS3/4-Naïve i. Approve for 16 weeks if the individual meets ALL of the following criteria (a, b, and c): a. Individual does not have cirrhosis OR has compensated cirrhosis (Child-Pugh A) b. Individual had a prior null response, prior partial response, or had relapse after prior treatment with ONE of the following NS5A-inhibitor containing products: daclatasvir (Daklinza), ledipasvir/sofosbuvir (Harvoni), or sofosbuvir/velpatasvir (Epclusa) c. Individual has NOT previously been treated with ONE of the following NS3/4A inhibitor or NS3/4A inhibitor-containing products: boceprevir (Victrelis), simeprevir (Olysio), or telaprevir (Incivek), OR ombitasvir/paritaprevir/ritonavir (Technivie), ombitasvir/paritaprevir/ritonavir, dasabuvir, co-packaged (Viekira Pak/Viekira XR), sofosbuvir/velpatasvir/voxilaprevir (Vosevi), or elbasvir/grazoprevir (Zepatier) NS3/4-Experienced, NS5A-Naïve ii. Approve for 12 weeks if the individual meets ALL of the following criteria (a, b, and c): a. Individual does not have cirrhosis OR has compensated cirrhosis (Child-Pugh A) b. Individual has NOT previously been treated with ONE of the following NS5A- inhibitor-containing products: daclatasvir (Daklinza), ledipasvir/sofosbuvir (Harvoni), or sofosbuvir/velpatasvir (Epclusa), ombitasvir/paritaprevir/ritonavir (Technivie), ombitasvir/paritaprevir/ritonavir, dasabuvir, co-packaged (Viekira Pak/Viekira XR), sofosbuvir/velpatasvir/voxilaprevir (Vosevi), or elbasvir/grazoprevir (Zepatier) c. Individual had a prior null response, prior partial response, or had relapse after prior treatment with ONE of the following NS3/4A inhibitor or NS3/4A inhibitor- containing products: boceprevir (Victrelis), simeprevir (Olysio), or telaprevir (Incivek) Pegylated Interferon/Interferon, Ribavirin, Sofosbuvir-Experienced iii. Approve for 8 weeks if the individual meets BOTH of the following (a and b): a. Individual does NOT have cirrhosis b. Individual had a prior null response, prior partial response, or had relapse after prior treatment with ONE of the following regimens: interferon ± ribavirin, pegylated interferon ± ribavirin, sofosbuvir (Sovaldi) + ribavirin, sofosbuvir (Sovaldi) + pegylated interferon + ribavirin iv. Approve for 12 weeks if the individual meets BOTH of the following (a and b): a. Individual has compensated cirrhosis (Child-Pugh A) b. Individual had a prior null response, prior partial response, or had relapse after prior treatment with ONE of the following regimens: interferon ± ribavirin, pegylated interferon ± ribavirin, sofosbuvir (Sovaldi) + ribavirin, sofosbuvir (Sovaldi) + pegylated interferon + ribavirin C. The medication is prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician 3. Chronic Hepatitis C Virus (HCV), Genotype 2, 4, 5, or 6, Treatment-Experienced. Individual meets ALL of the following criteria (A, B, and C): A. Individual is 3 years of age or older B. Individual meets ONE of the following (i or ii): i. Approve for 8 weeks if the individual meets BOTH of the following criteria (a and b): a. Individual does NOT have cirrhosis Page 2 of 7 Coverage Policy Number: IP0187 b. Individual had a prior null response, prior partial response, or had relapse after prior treatment with ONE of the following regimens: interferon ± ribavirin, pegylated interferon ± ribavirin, sofosbuvir (Sovaldi) + ribavirin, sofosbuvir (Sovaldi) + pegylated interferon + ribavirin ii. Approve for 12 weeks if the individual meets BOTH of the following criteria (a and b): a. Individual has compensated cirrhosis (Child-Pugh A) b. Individual had a prior null response, prior partial response, or had relapse after prior treatment with ONE of the following regimens: interferon ± ribavirin, pegylated interferon ± ribavirin, sofosbuvir (Sovaldi)+ ribavirin, sofosbuvir (Sovaldi) + pegylated interferon + ribavirin C. The medication is prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician 4. Chronic Hepatitis C Virus (HCV), Genotype 3, Treatment-Experienced. Individual meets ALL of the following criteria (A, B, and C): A. Individual is 3 years of age or older B. Approve for 16 weeks if individual meets BOTH of the following (i and ii): i. Individual does not have cirrhosis OR has compensated cirrhosis (Child-Pugh A) ii. Individual had a prior null response, prior partial response, or had relapse after prior treatment with ONE of the following regimens: interferon ± ribavirin, pegylated interferon ± ribavirin, sofosbuvir (Sovaldi) + ribavirin, sofosbuvir + pegylated interferon + ribavirin C. The medication is prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician 5. Hepatitis C Virus (HCV) Kidney or Liver Transplant Recipients, Genotype 1, 2, 3, 4, 5, or 6. Individual meets ALL of the following criteria (A, B, C, and D): A. Individual is 3 years of age or older B. Individual is a kidney or liver transplant recipient with hepatitis C virus (HCV) C. Individual meets ONE of the following conditions (i, ii, or iii): i. Individual has genotype 2, 4, 5, or 6 HCV - Approve for 12 weeks ii. Individual has genotype 1 HCV and meets ONE of the following criteria (a or b): a. Approve for 16 weeks if individual is genotype 1 HCV and meets BOTH of the following (1 and 2): NS5A-Experienced, NS3/4-Naïve 1) Individual had a prior null response, prior partial response, or had relapse after prior treatment with ONE of the following NS5A-inhibitor containing products: daclatasvir (Daklinza), ledipasvir/sofosbuvir (Harvoni), or sofosbuvir/velpatasvir (Epclusa) 2) Individual has NOT previously been treated with ONE of the following NS3/4A inhibitor
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