Drug Class Prior Authorization Criteria Hepatitis C

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Drug Class Prior Authorization Criteria Hepatitis C Line of Business: Medicaid P & T Approval Date: Interim (pending P&T approval) Effective Date: July 1, 2018 This policy has been developed through

1 Drug Class Prior Authorization Criteria Hepatitis C Line of Business: Medicaid P & T Approval Date: Interim (pending P&T approval) Effective Date: July 1, 2018 This policy has been developed through review of medical literature, consideration of medical necessity, generally accepted medical practice standards, and approved by the IEHP Pharmacy and Therapeutics Subcommittee. Drugs Requiring Prior Authorization Review: Daklinza (daclatasvir), Epclusa (velpatasvir, sofosbuvir), Harvoni (ledipasvir, sofosbuvir), Mavyret (glecaprevir, pibrentasvir), Olysio (simeprevir), Pegasys (peginterferon alfa- 2a), Ribavirin, Sovaldi (sofosbuvir), Viekira XR (dasabuvir, ombitasivir, paritaprevir, ritonavir), Vosevi (sofosbuvir, velpatasvir, voxilaprevir), Zepatier (elbasvir, grazoprevir) Formulary Alternatives: None AASLD Approved Indications: Regimen 1a NC 1a CC Genotype (NC = Non-; CC = ) 1b CC NC CC NC CC NC CC NC 1b NC Mavyret (Glecaprevir/Pibrentasvir) Harvoni (Ledipasvir/sofosbuvir) Epclusa (Sofosbuvir/velpatasvir) Zepatier (Elbasvir/grazoprevir) Vosevi (Sofosbuvir/velpatasvir/ voxilaprevir) Viekira XR (Dasubuvir/ombitasivir/ paritaprevir/ritonavir) 5 CC 6 NC 6 CC

2 Criteria: Mavyret (glecaprevir/pibrentasvir) Covered Uses: Exclusion Criteria: Required Medical Information: Age Restrictions: Prescriber Restrictions: Coverage Duration: Other Criteria: Hepatitis C N/A Must meet the following requirement: a) Treatment criteria in Section I: Identifying treatment candidates b) Requested drug must be used in an antiviral treatment regimen and duration recommended by the AASLD (please see Section III: HCV Treatment Regimen). N/A IEHP Hepatitis Center of Excellence specialist Per AASLD Guidelines Re-treatment request with history of failing to achieve a SVR, or relapse after achieving a SVR with a prior completed treatment regimen consisting of Sovaldi or Harvoni, will be reviewed by IEHP pharmacist in accordance to the AASLD recommendations. Harvoni (ledipasvir/sofosbuvir) Covered Uses: Exclusion Criteria: Required Medical Information: Hepatitis C N/A Must meet the following requirement: a) Treatment criteria in Section I: Identifying treatment candidates b) Requested drug must be used in an antiviral treatment regimen and duration recommended by the AASLD (please see Section III: HCV Treatment Regimen). a. For genotype 1 treatment for naïve patients without cirrhosis, 8week duration is recommended for members who meet all of the following criteria: i. Non-black

3 ii. HIV-uninfected iii. HCV RNA level is <6 million IU/mL c) Failure, contraindication, clinically significant adverse effects to preferred agents: Mavyret. Requests will be reviewed by IEHP pharmacist. Age Restrictions: Prescriber Restrictions: Coverage Duration: Other Criteria: N/A IEHP Hepatitis Center of Excellence specialist Per AASLD Guidelines Re-treatment request with history of failing to achieve a SVR, or relapse after achieving a SVR with a prior completed treatment regimen consisting of Sovaldi or Harvoni, will be reviewed by IEHP pharmacist in accordance to the AASLD recommendations. Daklinza (daclatasvir), Epclusa (velpatasvir/sofosbuvir), Olysio (simeprevir), Pegasys (peginterferon alfa-2a), Sovaldi (sofosbuvir), Viekira XR (dasabuvir/ombitasivir/paritaprevir/ ritonavir), Vosevi (sofosbuvir/velpatasvir/voxilaprevir), Zepatier (elbasvir/grazoprevir) Covered Uses: Exclusion Criteria: Required Medical Information: Age Restrictions: Prescriber Restrictions: Coverage Duration: Hepatitis C N/A Must meet the following requirement: a) Treatment criteria in Section I: Identifying treatment candidates b) Requested drug must be used in an antiviral treatment regimen and duration recommended by the AASLD (please see Section III: HCV Treatment Regimen). a. For genotype 1 treatment for naïve patients without cirrhosis, 8week duration is recommended for members who meet all of the following criteria: i. Non-black ii. HIV-uninfected iii. HCV RNA level is <6 million IU/mL c) Failure, contraindication, clinically significant adverse effects to preferred agents: Mavyret. Requests will be reviewed by IEHP pharmacist. N/A IEHP Hepatitis Center of Excellence specialist Per AASLD Guidelines

4 Other Criteria: Re-treatment request with history of failing to achieve a SVR, or relapse after achieving a SVR with a prior completed treatment regimen consisting of Sovaldi or Harvoni, will be reviewed by IEHP pharmacist in accordance to the AASLD recommendations. Section I: Identifying Treatment Candidates a. Treatment is recommended for all patients with chronic HCV infection, except those with a short life expectancy who cannot be remediated by HCV therapy, liver transplantation, or another directed therapy. b. Patient readiness and adherence: i. Patients shall be evaluated for readiness to initiate treatment. ii. Patients selected for treatment shall be able and willing to strictly adhere to treatment protocols prescribed by their provider. iii. Caution shall be exercised with patients who have a history of treatment failure with prior HCV treatment due to non-adherence with treatment regimen and appointments. iv. Patients shall be educated regarding the potential risks and benefits of HCV therapy, as well as the potential for resistance and failed therapy if medication is not taken as prescribed. c. Age requirements: Treatment candidate must be at least the minimum age approved by the FDA for use of the medication. Section II: Other Considerations a. Quantity limits: i. Prescription of HCV therapy will be dispensed in quantities up to 28 days at a time. b. Criteria for reauthorization/continuation of therapy: i. Initial authorization criteria have been met. ii. iii. Evidence of lack of adherence may result in denial of treatment reauthorization. Missed medical appointments related to HCV may result in the denial of treatment authorization. c. Laboratory testing: i. Documentation of baseline HCV-RNA level. ii. Documentation of HCV Genotype. iii. Laboratory testing and monitoring should be consistent with current AASLD/IDSA guidelines. d. Populations unlikely to benefit from HCV Treatment: i. According to AASLD/IDSA HCV guidelines, patients with limited life expectancy for whom HCV therapy would not improve symptoms or prognosis do not require treatment. Chronic HCV is associated with a wide range of comorbid conditions. Little evidence exists to support initiation of HCV treatment in patients with limited life expectancy (less than 12 months) due to non liver-related comorbid conditions. For these patients, the benefits of HCV treatment are unlikely to be realized, and palliative care strategies should take precedence. In patients with a life expectancy less than 12 months, treatment is not recommended. e. Retreatment:

5 Retreatment will be considered where there is evidence that such retreatment will improve patient outcomes. Please refer to AASLD guidelines for recommended retreatment regimens (hcvguidelines.org). f. Criteria for coverage of investigational services (Title ): i. Investigational services are not covered except when it is clearly documented that all of the following apply. ii. Conventional therapy will not adequately treat the intended patient's condition. iii. Conventional therapy will not prevent progressive disability or premature death. iv. The provider of the proposed service has a record of safety and success with it equivalent or superior to that of other providers of the investigational service. v. The investigational service is the lowest cost item or service that meets the patient's medical needs and is less costly than all conventional alternatives. vi. The service is not being performed as a part of a research study protocol. vii. There is a reasonable expectation that the investigational service will significantly prolong the intended patient's life or will maintain or restore a range of physical and social function suited to activities of daily living. viii. All investigational services require prior authorization. Payment will not be authorized for investigational services that do not meet the above criteria or for associated inpatient care when a beneficiary needs to be in the hospital primarily because she/he is receiving such nonapproved investigational services. g. Unlabeled use of medication: Authorization for unlabeled use of drugs shall not be granted unless the requested unlabeled use represents reasonable and current prescribing practices. The determination of reasonable and current prescribing practices shall be based upon: i. Reference to current medical literature. ii. Consultation with provider organizations and academic and professional specialists. Section III: HCV Treatment Regimen (AASLD Recommendation) Treatment History and HCV Genotype Cirrhosis status Regimen Regimen Duration (GT) Bolded = Non-Formulary Preferred Hepatitis C Drug Regimen Naïve GT 1a Non- Mavyret (Glecaprevir/pibrentasvir) 300/120mg 8 weeks Non-, non-black, HIVuninfected, HCV RNA level <6 million IU/mL Non- Harvoni (Ledipasvir/sofosbuvir) 90/400mg Epclusa (sofosbuvir/velpatasvir) 400/100mg (No baseline high fold-change NS5A RAVs for 8 weeks

6 + RBV (Baseline high fold-change NS5A RAVs for Mavyret (Glecaprevir/pibrentasvir) 300/120mg Epclusa (sofosbuvir/velpatasvir) 400/100mg (No baseline high fold-change NS5A RAVs for + RBV (Baseline high fold-change NS5A RAVs for 16 weeks 16 weeks Naïve GT 1b Non- 8 weeks Non-, non-black, HIVuninfected, HCV RNA level <6 million IU/mL Non- Harvoni (ledipasvir/sofosbuvir )90/400mg 8 weeks Experienced GT 1a (failed PEG-IFN and RBV treatment) Non- 8 weeks

7 (No baseline high fold-change NS5A RAVs for + RBV (Baseline high fold-change NS5A RAVs for (No baseline high fold-change NS5A RAVs for + RBV (Baseline high fold-change NS5A RAVs for 16 weeks 16 weeks Experienced GT 1b (failed PEG-IFN and RBV treatment) Non- 8 weeks Experienced GT 1a/1b (failed NS3 Protease Inhibitor {telaprevir, boceprevir or simeprevir} + PEG-IFN + RBV) Non- Experienced GT 1a/1b (failed non-ns5a inhibitor, sofosbuvir containing regimen) Non- and Vosevi (sofosbuvir/velpatasvir/voxilaprevir) 400/100/100mg (for genotype 1a)

8 Experienced GT 1a/1b (failed NS5A inhibitor DAA) Non- and (for genotype 1b) Vosevi (sofosbuvir/velpatasvir/voxilaprevir) 400/100/100mg Naïve GT2 Non- 8 weeks Cirrhosis Experienced GT2 (failed PEG-IFN and RBV) Non- 8 weeks Experienced GT2 (failed sofosbuvir + RBV) Non- and Naïve GT3 Non- 8 weeks Experienced GT3 (failed PEG-IFN and RBV) Non- + sofosbuvir 400mg Experienced GT3 (failed DAA experienced, including NS5A inhibitors) Non- and Vosevi (sofosbuvir/velpatasvir/voxilaprevir) 400/100/100mg Vosevi (sofosbuvir/velpatasvir/voxilaprevir) 400/100/100mg + RBV (for prior NS5S inhibitor failure and cirrhosis)

9 Naïve GT4 Non- 8 weeks Experienced GT4 (failed PEG-IFN and RBV) Non- 8 weeks Experienced GT4 (failed DAA experienced, including NS5A inhibitors) Non- and Vosevi (sofosbuvir/velpatasvir/voxilaprevir) 400/100/100mg Naïve GT 5 or 6 Non- 8 weeks

10 Experienced GT5 or GT 6 (failed PEG-IFN and RBV) Non- 8 weeks Experienced GT4 (DAA experienced, including NS5A inhibitors) Non- and Vosevi (sofosbuvir/velpatasvir/voxilaprevir) 400/100/100mg Clinical Justification: Please refer to the American Association for the Study of Liver Diseases (AASLD) HCV Clinical Practice Guideline. References: 1. American Association for the Study of Liver Diseases. Available from: 2. European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of hepatitis C virus infection. J Hepatol. 2011;55(2): Epub 2011 Mar Poordad F. Big Changes Are Coming in Hepatitis C Curr Gastroenterol Rep 2011;13(1): Hofmann WP, Zeuzem S. A new standard of care for the treatment of chronic HCV infection. Nat Rev Gastroenterol Hepatol 2011;8(5): Pawlotsky JM. The Results of Phase III Clinical Trials with Telaprevir and Boceprevir Presented at the Liver Meeting 2010: A New Standard of Care for Hepatitis C Virus Genotype 1 Infection, But with Issues Still Pending. Gastroenterology. 2011;140(3): Victrelis [package insert]. Whitehouse Statin, NJ: Merck & Co., Inc; 2011, Prescribing Information. 7. Poordad F, McCone J, Bacon B et al. Boceprevir for untreated chronic HCV genotype 1 infection. NEJM 2011;364: Bacon B, Gordon S, Lawitz E et al. Boceprevir for previously treated chronic HCV genotype 1 infection. NEJM 2011;364: Jensen DM. A new era of hepatitis C therapy begins. N Engl J Med. 2011;364(13): INCIVEK (telaprevir) Prescribing Information. 11. Jacobson I, McHutchison J, Dusheiko G, et al. Telaprevir for Previously Untreated Chronic Hepatitis C Virus Infection. N Engl J Med. 2011;364: Zeuzem S, Andreone P, Pol S, et al. Telaprevir for Retreatment of HCV Infection. N Engl J Med. 2011;364: Jacobson, Ira. SVR results of a once-daily regimen of simeprevir (SMV, TMC435) plus sofosbuvir (SOF, GS-7977) with or without ribavirin in and non- HCV genotype 1 treatment-naïve and prior null responder patients: The COSMOS study. AASLD 2013 Nov. 14. OLYSIO [package insert]. Titusville, NJ: Janssen Therapeutics, Division of Janssen Products, LP; Sovaldi [package insert]. Foster City, CA: Gilead Sciences Inc.;2013.

11 16. Department of Veterans Affairs National Hepatitis C Resource Center Program and the Office of Public Health. Chronic Hepatitis C Virus (HCV) Infection: Treatment Considerations. March 27, Available from: Afdhal N, Zeuzem S, Kwo P, et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014a;370(20): Kowdley KV, Gordon SC, Reddy KR, et al. Ledipasvir and sofosbuvir for 8 or for chronic HCV without cirrhosis. N Engl J Med. 2014;370(20): Feld JJ, Kowdley KV, Coakley E, et al. Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med. 2014;370(17): Ferenci P, Bernstein D, Lalezari J, et al. ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV. N Engl J Med. 2014;370(21): Poordad F, Hezode C, Trinh R, et al. ABT-450/r-Ombitasvir and Dasabuvir with Ribavirin for Hepatitis C with Cirrhosis. N Engl J Med. 2014;[Epub ahead of print] 22. Lawitz E, Poordad FF, Pang PS, et al. Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomised, phase 2 trial. Lancet. 2014a;383(9916): Lawitz E, Sulkowski MS, Ghalib R, et al. Simeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naive patients: the COSMOS randomised study. Lancet. 2014b;384(9956): Zeuzem S, Jacobson IM, Baykal T, et al. Retreatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med. 2014;370(17): Andreone P, Colombo MG, Enejosa JV, et al. ABT-450, ritonavir, ombitasvir, and dasabuvir achieves 97% and 100% sustained virologic response with or without ribavirin in treatment-experienced patients with HCV genotype 1b infection. Gastroenterology. 2014;147(2): Janssen Therapeutics. Simeprevir [package insert] Titusville, NJ, Janssen Therapeutics. 27. Lawitz E, Mangia A, Wyles D, et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med May 16;368(20): Jacobson IM, Gordon SC, Kowdley KV, et al. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N Engl J Med May 16;368(20): Zeuzem S, Dusheiko GM, Salupere R. Sofosbuvir + ribavirin for 12 or 24 weeks for patients with HCV genotype 2 or 3: the VALENCE trial. In: Program and abstracts of the 64th Annual Meeting of the American Association for the Study of Liver Diseases; November 1-5, 2013; Washington, DC. Abstract Lawitz E, Poordad F, Brainard DM, et al. Sofosbuvir in combination with pegifn and ribavirin for provides high SVR rates in HCV-infected genotype 2 or 3 treatment experienced patients with and without compensated cirrhosis: results from the LONESTAR-2 study. In: Program and abstracts of the 64th Annual Meeting of the American Association for the Study of Liver Diseases; November 1-5, 2013; Washington, DC. Abstract LB Sulkowski MS, Rodriguez-Torres M, Lalezari JP, et al. All-oral therapy with sofosbuvir plus ribavirin for the treatment of HCV genotype 1, 2, and 3 infection in patients co-infected with HIV (PHOTON-1). In: Program and abstracts of the 64th Annual Meeting of the American Association for the Study of Liver Diseases; November 1-5, 2013; Washington, DC. Abstract American Association for the Study of Liver Diseases. Recommendation for Testing, Managing and Treating Hepatitis C. Available at: Assessed July, 12, California Department of Health Care Services Utilization and Treatment Policy for Simeprevir and Sofosbuvir in the Management of Hepatitis C.

12 34. California Department of Health Care Services Treatment Policy for the Management of Chronic Hepatitis C. 35. Gilead Sciences. Epclusa [package insert] Foster City, CA, Gilead Sciences, Inc. 36. Gilead Sciences: Vosevi [package insert] Foster City, CA, Gilead Sciences, Inc. 37. AbbVie: Mavyret [package insert] North Chicago, IL, AbbVie Inc. Change Control Date Change RPH 7/3/18 Updated PA Criteria based on new DHCS Management Policies: IK Added Sections I and II based on identifying treatment candidates and Other considerations, respectively. Removed previous criteria identifying candidates through required clinical states. New DHCS policy states all patients with chronic HCV are recommended to receive HCV treatment. Age limit is no longer limited to 18 years and above. Treatment candidates are now restricted to the minimum age approved by the FDA for use of the medication. Other considerations now includes: Quantity limits, Criteria for reauthorization, Lab testing, Retreatment, Criteria for coverage of investigational services, and Unlabeled use of medication. Populations unlikely to benefit from Hep C treatment remained from the previous version. 06/29/2018 Changed Format IK

Drug Class Prior Authorization Criteria Hepatitis C

Drug Class Prior Authorization Criteria Hepatitis C Line of Business: Medicaid P & T Approval Date: Interim Criteria Pending P&T Approval Effective Date: August 16, 2018 This drug class prior authorization