Hepatitis C Virus Infection 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 Viekira Pak or Harvoni for treatment of his hepatitis C virus (HCV). Findings: Two physician reviewers found that according to the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) recommendations for testing, managing, and treating hepatitis C, patients with chronic active hepatitis C are eligible for treatment and should be treated with FDA approved antiviral therapy regardless of fibrosis score. Moreover, “Successful hepatitis C treatment results in sustained virologic response (SVR), which is tantamount to virologic cure, and as such, is expected to benefit nearly all chronically infected persons.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested Daklinza to be used in conjunction with Sovaldi for 12 weeks for treatment of his hepatitis C virus (HCV). Findings: The physician reviewer found that according to the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) “Successful hepatitis C treatment results in sustained virologic response (SVR), which is tantamount to virologic cure, and as such, is expected to benefit nearly all chronically infected persons.” Guidelines further state that “The goal of treatment of HCV-infected persons is to reduce all-cause mortality and liver-related health adverse consequences, including end-stage liver disease and hepatocellular carcinoma, by the achievement of virologic cure as evidenced by a sustained virologic response.” In this case, the patient has F2 fibrosis,…

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Epclusa for 12 weeks for treatment of the enrollee’s chronic hepatitis C virus (HCV) genotype 1a. 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. This recommendation applies to all patients, regardless of fibrosis stage. The guidelines recommend that treatment naïve genotype 1a patients should be treated with regimens including Zepatier with ribavirin for 16 weeks when NS5A resistance is found, Harvoni for 12 weeks, or Epclusa for 12 weeks.

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 hepatitis c virus infection, then check the rights and deadlines that apply to your plan.