Drug and Biologic Coverage Policy Effective Date ............................................ 9/1/2021 Next Review Date… ..................................... 9/1/2022 Coverage Policy Number ............................... IP0186 Ledipasvir/Sofosbuvir Table of Contents Related Coverage Resources Overview .............................................................. 1 Authorized Generics Medical Necessity Criteria ................................... 1 Interferon Therapy Reauthorization Criteria ....................................... 4 Omnibus Codes Authorization Duration ......................................... 4 Conditions Not Covered....................................... 5 Background .......................................................... 6 References .......................................................... 8 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 the following products: • Harvoni® (ledipasvir/sofosbuvir tablets and oral pellets) • ledipasvir/sofosbuvir tablets (authorized generics to Harvoni 90 mg/400 mg tablets only) Medical Necessity Criteria Ledipasvir/sofosbuvir (Harvoni) is considered medically necessary when ONE of the following is met (1, 2, 3, 4, 5 or 6): 1. Chronic Hepatitis C Virus (HCV) Genotype 1, Adult. Individual meets ALL of the following criteria (A, B, and C): A. Individual is 18 years of age or older B. Individual meets ONE of the following (i, ii, or iii): i. Approve for 8 weeks if the individual meets ALL of the following criteria (a, b, c, d, and e) Page 1 of 8 Coverage Policy Number: IP0186 a. Individual is treatment-naïve b. Individual does NOT have cirrhosis c. Individual does NOT have human immunodeficiency virus (HIV) d. Individual is NOT awaiting liver transplantation e. Baseline hepatitis C virus (HCV) RNA is < 6 million IU/mL ii. Approve for 12 weeks if the individual meets ONE of the following criteria (a, b, c, or d): a. Treatment-naïve and ONE of the following (1, 2, 3, or 4): 1) Individual with or without HIV, with compensated cirrhosis (Child-Pugh A), regardless of baseline HCV RNA 2) Individual with or without HIV, without cirrhosis and has a baseline HCV RNA ≥ 6 million IU/mL 3) Individual awaiting transplant with compensated cirrhosis (Child-Pugh A), regardless of baseline HCV RNA 4) Individual awaiting transplant without cirrhosis and has a baseline HCV RNA ≥ 6 million IU/mL b. Treatment-experienced* individual and does NOT have cirrhosis c. Treatment-experienced* individual with compensated cirrhosis (Child-Pugh A) and meets BOTH of the following (1 and 2): 1) Individual is ribavirin eligible 2) The medication will be prescribed in combination with ribavirin d. Treatment-naïve or treatment-experienced* individual with decompensated cirrhosis (Child-Pugh B or C) and meets BOTH of the following (1 and 2): 1) Individual is ribavirin eligible 2) The medication will be prescribed in combination with ribavirin iii. Approve for 24 weeks if the individual meets ONE of the following criteria (a or b): a. Treatment-experienced* individual with compensated cirrhosis (Child-Pugh A) and is ribavirin ineligible, according to the prescriber b. Treatment-naïve or treatment-experienced* individual with decompensated cirrhosis (Child-Pugh B or C) and is ribavirin ineligible, according to the prescriber C. The medication is prescribed by, or in consultation with, a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician *Note: Treatment-experienced individuals are those who have failed treatment with either peginterferon alfa + ribavirin or a hepatitis C virus protease inhibitor [for example, boceprevir (Victrelis), simeprevir (Olysio), or telaprevir (Incivek/Incivo)] + peginterferon + ribavirin. 2. Chronic Hepatitis C Virus (HCV) Genotype 1, Pediatric. Individual meets ALL of the following criteria (A, B, and C): A. Individual is 3 to 17 years of age B. Individual meets ONE of the following criteria (i or ii) i. Approve for 12 weeks if the individual meets ONE of the following criteria (a or b): a. Treatment-naïve individual without cirrhosis or with compensated cirrhosis (Child-Pugh A) b. Treatment-experienced* individual without cirrhosis ii. Approve for 24 weeks if the individual is treatment-experienced* and has compensated cirrhosis (Child-Pugh A) C. The medication is prescribed by, or in consultation with, a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician *Note: Treatment-experienced individuals are those who have failed treatment with either peginterferon alfa + ribavirin or a hepatitis C virus protease inhibitor [for example, boceprevir (Victrelis), simeprevir (Olysio), or telaprevir (Incivek/Incivo)] + peginterferon + ribavirin. 3. Chronic Hepatitis C Virus (HCV) Genotype 4, 5, or 6. Individual meets the following criteria: Page 2 of 8 Coverage Policy Number: IP0186 A. Approve for 12 weeks if the individual meets BOTH of the following (i and ii): i. Individual is 3 years of age or older ii. The medication is prescribed by, or in consultation with, a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician 4. Recurrent Hepatitis C Virus (HCV) Post-Liver Transplantation, Genotypes 1 or 4. Individual meets ALL of the following criteria (A, B, and C): A. Individual is 3 years of age or older B. Individual has recurrent hepatitis C virus (HCV) after a liver transplantation and ONE of the following (i or ii): i. Approve for 12 weeks if the individual meets ONE of the following (a or b): a. Treatment-naïve or treatment-experienced* individual without cirrhosis or with compensated cirrhosis (Child-Pugh A) b. Treatment-naïve individual with decompensated cirrhosis (Child-Pugh B or C) and the medication will be prescribed in combination with ribavirin ii. Approve for 24 weeks if the individual meets the following: a. Treatment-experienced* individual with decompensated cirrhosis (Child-Pugh B or C) and the medication will be prescribed in combination with ribavirin C. The medication is prescribed by, or in consultation with, one of the following prescribers who is affiliated with a transplant center: a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician *Note: Treatment-experienced individuals are those who have failed treatment with either peginterferon alfa + ribavirin or a hepatitis C virus protease inhibitor [for example, boceprevir (Victrelis), simeprevir (Olysio), or telaprevir (Incivek/Incivo)] + peginterferon + ribavirin. 5. Recurrent Hepatitis C Virus (HCV) Post-Liver Transplantation, Genotypes 5 or 6. Individual meets ALL of the following criteria (A, B, and C): A. Individual is 18 years of age or older B. Individual has recurrent hepatitis C virus (HCV) after a liver transplantation and ONE of the following (i or ii): i. Approve for 12 weeks if the individual meets ONE of the following (a or b): a. Treatment-naïve or treatment-experienced* individual without cirrhosis or with compensated cirrhosis (Child-Pugh A) b. Treatment-naïve individual with decompensated cirrhosis (Child-Pugh B or C) and the medication will be prescribed in combination with ribavirin ii. Approve for 24 weeks if the individual meets the following: a. Treatment-experienced* individual with decompensated cirrhosis (Child-Pugh B or C) and the medication will be prescribed in combination with ribavirin C. The medication is prescribed by, or in consultation with, one of the following prescribers who is affiliated with a transplant center: a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician *Note: Treatment-experienced individuals are those who have failed treatment