Line of Business: Medi-Cal Effective Date: August 16, 2017 Revision Date: August 16, 2017 Chronic Hepatitis C Drug Class Prior Authorization Protocol 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: Daklinza (daclatasvir), Epclusa (velpatasvir, sofosbuvir), Harvoni (ledipasvir, sofosbuvir), Olysio (simeprevir), Pegasys (peginterferon alfa-2a), Ribavirin, Sovaldi (sofosbuvir), Viekira XR (dasabuvir, ombitasivir, paritaprevir, ritonavir), Zepatier (elbasvir, grazoprevir) Policy/Criteria: A. Drug: Harvoni (ledipasvir/sofosbuvir) Diagnosis: a. Chronic Hepatitis C Specialist: a. IEHP Hepatitis Center of Excellence Specialist Criteria: a. Age 18 years of age or older; b. Confirmed diagnosis of chronic hepatitis C and genotype; c. Documented baseline quantitative HCV RNA test; d. Must meet treatment criteria in Section I: Identifying treatment candidates; e. Requested drug must be used in an antiviral treatment regimen and duration recommended by the AASLD (please see Section II: HCV Treatment Regimen)
1. For genotype 1 treatment for naïve patients without cirrhosis, 8 week duration is recommended for non-black, HIV-uninfected and whose HCV RNA level is <6 million IU/mL; Re-Authorization Criteria: a. 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 Formulary Status: Non-formulary preferred, PA applies B. Drug: Epclusa (velpatasvir/sofosbuvir) Diagnosis: a. Chronic Hepatitis C Specialist: a. IEHP Hepatitis Center of Excellence Specialist Criteria: a. Age 18 years of age or older; b. Confirmed diagnosis of chronic hepatitis C and genotype; c. Documented baseline quantitative HCV RNA test; d. Must meet treatment criteria in Section I: Identifying treatment candidates; e. Requested drug must be used in an antiviral treatment regimen and duration recommended by the AASLD (please see Section II: HCV Treatment Regimen) Re-Authorization Criteria: a. 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. Formulary Status: Non-formulary preferred, PA applies
C. Drugs: Daklinza (daclatasvir), Olysio (simeprevir), Pegasys (peginterferon alfa-2a), Sovaldi (sofosbuvir), Viekira XR (dasabuvir / ombitasivir / paritaprevir / ritonavir), Zepatier (elbasvir / grazoprevir) Diagnosis: a. Chronic Hepatitis C Specialist: a. IEHP Hepatitis Center of Excellence Specialist Criteria: i. Age 18 years of age or older; ii. Confirmed diagnosis of chronic hepatitis C and genotype; iii. Documented baseline quantitative HCV RNA test; iv. Must meet treatment criteria in Section I: Identifying treatment candidates; v. Requested drug must be used in an antiviral treatment regimen and duration recommended by the AASLD (please see Section II: HCV Treatment Regimen); vi. Failure, contraindication, clinically significant adverse effects to preferred agents: Harvoni and Epclusa. Requests will be reviewed by IEHP pharmacist Re-Authorization Criteria: a. 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. Formulary Status: Non-formulary, PA applies
Section I: Identifying Treatment Candidates A. Any of the following clinical states identify candidates for treatment: 1. Evidence of Stage 2 or greater hepatic fibrosis/cirrhosis including one of the following: Liver biopsy confirming a METAVIR score F2 or greater; OR Transient elastography (Fibroscan ) score greater than or equal to 7.5 kpa; OR FibroSure score of greater than or equal to 0.48; OR APRI score greater than 0.7 OR FIB-4 greater than 3.25. 2. Evidence of extra-hepatic manifestation of hepatitis C virus, such as type 2 or 3 essential mixed cryoglobulinemia with end-organ manifestations (e.g. vasculitis), or kidney disease (e.g. proteinuria, nephrotic syndrome or membranoproliferative glomerulonephritis). 3. Persons with hepatocellular carcinoma with a life expectancy of greater than 12 months; 4. Pre- and post-liver transplant, or other solid organ transplant; 5. HIV-1 co-infection; 6. Hepatitis B co-infection; 7. Other coexistent liver disease (e.g. nonalcoholic steatohepatitis); 8. Type 2 diabetes mellitus (insulin resistant); 9. Porphyria cutanea tarda; 10. Debilitating fatigue impacting quality of life (e.g., secondary to extra-hepatic manifestations and/or liver disease); 11. Men who have sex with men with high-risk sexual practices; 12. Active injection drug users; 13. Persons on long-term hemodialysis; 14. Women of childbearing age who wish to get pregnant; 15. HCV-infected health care workers who perform exposure-prone procedures; B. Patient Readiness and Adherence: 1. Patients shall be evaluated for readiness to initiate treatment. 2. Patients selected for treatment shall be able and willing to strictly adhere to treatment protocols prescribed by their provider. 3. Caution shall be exercised with patients who have a history of treatment failure with prior hepatitis C treatment due to non-adherence with treatment regimen and appointments. Patients shall be educated regarding potential risks and benefits of hepatitis C virus 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 18 years of age or older.
D. Populations Unlikely to Benefit from Hepatitis C Virus Treatment: According to AASLD/IDSA hepatitis C virus Guidelines, patients with limited life expectancy for whom hepatitis C virus therapy would not improve symptoms or prognosis do not require treatment. Chronic hepatitis C is associated with a wide range of comorbid conditions. Little evidence exists to support initiation of hepatitis C virus treatment in patients with limited life expectancy (less than 12 months) due to non liver-related comorbid conditions. For these patients, the benefits of hepatitis C virus 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. Section II: HCV Treatment Regimen (AASLD Recommendation) Treatment History and HCV Genotype (GT) Naïve GT 1a Non-, non-black, HIVuninfected, HCV RNA level <6 million IU/mL Regimen Bolded = Non-Formulary Preferred Hepatitis C Drug Regimen Regimen Duration 8 weeks Non- Sofosbuvir + velpatasvir 400/100mg Non- Non- + RBV (Baseline high fold-change NS5A RAVs for elbasvir are detected) (No baseline high fold-change NS5A 150/100/25mg daily + dasabuvir 250mg bid + RBV Sofosbuvir + simeprevir 400/150mg Daclatasvir/sofosbuvir 60/400mg
Sofosbuvir + velpatasvir 400/100mg (No baseline high fold-change NS5A (compensated ) + RBV (Baseline high fold-change NS5A RAVs for elbasvir are detected) 150/100/25mg daily + dasabuvir 250mg bid + RBV Sofosbuvir + simeprevir 400/150mg ± RBV (Member must be screened and is negative for the NS3Q80K polymorphism) Naïve GT 1b Non-, non-black, HIVuninfected, HCV RNA level <6 million IU/mL Non- 8 weeks Non- Sofosbuvir/velpatasvir 400/100 mg 150/100/25mg + dasabuvir 250mg bid Sofosbuvir + simeprevir 400/150mg Daclatasvir/sofosbuvir 60/400mg Sofosbuvir/velpatasvir 400/100 mg
150/100/25mg daily + dasabuvir 250mg bid Experienced GT 1a (failed PEG- IFN and RBV treatment) (compensated ) Non- Sofosbuvir + simeprevir 400/150mg ± RBV Sofosbuvir/velpatasvir 400/100 mg + RBV (Baseline high fold-change NS5A RAVs for elbasvir are detected) (No baseline high fold-change NS5A 150/100/25mg daily + dasabuvir 250mg bid + RBV Sofosbuvir + simeprevir 400/150mg Daclatasvir/sofosbuvir 60/400mg + RBV Sofosbuvir/velpatasvir 400/100 mg (No baseline high fold-change NS5A + RBV (Baseline high fold-change NS5A RAVs for elbasvir are detected)
(compensated ) 150/100/25mg daily + dasabuvir 250mg bid + RBV Sofosbuvir/simeprevir 400/150mg ± RBV (Member must be screened and is negative for the NS3Q80K polymorphism) Experienced GT 1b (failed PEG-IFN and RBV treatment) Non- Sofosbuvir/velpastavir 400/100mg 150/100/25mg daily + dasabuvir 250mg bid Sofosbuvir/simeprevir 400/150mg Daclatasvir/sofosbuvir 60/400mg + RBV Sofosbuvir/velpastavir 400/100mg (compensated ) 150/100/25mg daily + dasabuvir 250mg bid Sofosbuvir/simeprevir 400/150mg ± RBV Experienced GT Non- + RBV
1a/1b (failed Sofosbuvir and RBV with or without PEG- IFN) Experienced GT 1a/1b (failed NS3 Protease Inhibitor {telaprevir, boceprevir or simeprevir} treatment + PEG- IFN/RBV) Non- + RBV Sofosbuvir/velpatasvir 400/100 mg + RBV (GT1a: Baseline high fold-change NS5A + RBV (No baseline high fold-change NS5A Daclatasvir/sofosbuvir 60/400mg + RBV Sofosbuvir/velpastavir 400/100mg + RBV (No baseline high fold-change NS5A + RBV (GT1a: Baseline high fold-change NS5A Experienced GT 1a/1b (failed simeprevir + sofosbuvir ) or (failed HCV NS5A inhibitor) Non- Deferral of treatment is recommended, pending availability of data Testing for resistance-associated variants that confer decreased susceptibility to NS3 protease inhibitor and to NS5A inhibitors is recommended Please refer to AASLD guideline -- May consider nucleotide-based triple or quadruple DAA regimens + RBV (unless RBV is contraindicated) Nucleotide-based dual DAA therapy + RBV (unless RBV is contraindicated) -- 12-24 weeks
Naïve GT2 Non- Sofosbuvir/velpatasvir 400/100mg (non-) Daclatasvir/sofosbuvir 60/400mg Experienced GT2 (failed PEG- IFN/RBV) Sofosbuvir/velpatasvir 400/100mg Cirrhosis (compensated ) Daclatasvir/sofosbuvir 60/400mg 16-24 weeks Non- Sofosbuvir/velpastavir 400/100mg (non-) Daclatasvir/sofosbuvir 60/400mg Sofosbuvir/velpastavir 400/100mg Experienced GT2 (failed sofosbuvir + RBV) (compensated ) Regardless of status Daclatasvir/sofosbuvir 60/400mg 16 24 weeks Sofosbuvir/velpastavir 400/100mg + RBV Naïve GT3 Non- Sofosbuvir/velpatasvir 400/100mg Sofosbuvir/velpatasvir 400/100mg Experienced GT3 (failed IFN+RBV) Non- Sofosbuvir/velpatasvir 400/100mg Sofosbuvir/velpatasvir 400/100mg + RBV Daclatasvir/sofosbuvir 60/400mg + RBV Experienced GT3 (failed sofosbuvir + RBV) Regardless of status Daclatasvir/sofosbuvir 60/400mg + RBV Sofosbuvir/velpatasvir 400/100mg+RBV Naïve GT4 Regardless of status
Sofosbuvir/velpastavir 400/100mg Experienced GT4 (failed PEG- IFN+RBV) Non- 150/100/25mg + RBV Sofosbuvir/velpastavir 400/100mg 150/100/25mg + RBV + RBV (prior on-treatment virologic failure failure to suppress or breakthrough + RBV Sofosbuvir/velpastavir 400/100mg Naïve GT 5 or 6 (compensated ) Regardless of status 150/100/25mg + RBV + RBV (prior on-treatment virologic failure failure to suppress or breakthrough Sofosbuvir/velpatasvir 400/100mg Experienced GT5 or GT 6 (failed PEG-IFN + RBV) Regardless of status Sofosbuvir/velpatasvir 400/100mg Clinical Justification: Please refer to the American Association for the Study of Liver Diseases (AASLD) HCV Clinical Practice Guideline.
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36. California Department of Health Care Services Treatment Policy for the Management of Chronic Hepatitis C. 37. Gilead Sciences. Epclusa [package insert]. 2016. Foster City, CA, Gilead Sicences, Inc. Change Control Date Change 08/16/2017 Added Harvoni as NF Preferred to the Medi-Cal Formulary (at parity with Epclusa)