Harvoni denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested Harvoni for treatment of his hepatitis C virus (HCV). Findings: The physician reviewer found that per the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) treatment guidelines, there is only one treatment option for this patient in whom previous sofosbuvir plus ribavirin with or without peginterferon treatment has failed, and has no cirrhosis. “Daily fixed-dose combination of ledipavir (90 mg)/sofosbuvir (400 mg) with weight-based ribavirin for 12 weeks is recommended for patients without cirrhosis” is recommended as a Class IIb, Level C rating. AASLD/IDSA states “To date, clinical experience and trial data on the retreatment of such patients are very limited.

Nature of Statutory Criteria/Case Summary: An enrollee has requested Harvoni for eight weeks for treatment of his hepatitis C virus (HCV). Findings: Two physician reviewers found that denying treatment for a chronic disease such as HCV, because the patient does not have an advanced stage disease is not supported by the peer-reviewed literature. The U.S. Food and Drug Administration’s (FDA) label on the approved uses for Harvoni does include early stage disease. Thus, the recommendation is not to deny patients treatment if they have early stage disease but to provide treatment to avoid untoward complications from advanced disease, including liver failure and extrahepatic complications from HCV. Moreover, treatment delays may decrease the benefit of sustained virologic response (SVR).

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested Harvoni and ribavirin for 24 weeks for treatment of his hepatitis C virus. Findings: The physician reviewer found that according to the most recent joint guidelines issued by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), all patients with chronic hepatitis C should be treated except those with limited life expectancy due to non–liver-related conditions. According to the guidelines, patients with cirrhosis are considered highest priority for treatment. In patients with decompensated cirrhosis and/or liver transplant candidacy or hepatocellular carcinoma, guidelines recommend treatment with Harvoni with ribavirin for 12 weeks.

Nature of Statutory Criteria/Case Summary: An enrollee has requested Harvoni for treatment of his hepatitis C virus. Findings: The physician reviewer found that per the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) treatment guidelines, there are several treatment options with similar efficacy in general that are recommended for treatment-naïve patients with HCV genotype 1a infection. The recommended regimens include: daily Harvoni for 12 weeks (Class I, Level A); and daily fixed-dose combination of Viekira Pak and weight-based ribavirin for 12 weeks (no cirrhosis) or 24 weeks (cirrhosis) (Class I, Level A). Viekira Pak and weight-based ribavirin is approved by the U.S. Food and Drug Administration (FDA) for the treatment of HCV genotype 1a infection in treatment-naïve patients.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Harvoni, then check the rights and deadlines that apply to your plan.