Hepatitis C Virus Genotype 1a denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: The enrollee has requested authorization and coverage for Zepatier 50/100 for 12 weeks for treatment of the enrollee’s chronic hepatitis C virus (HCV) genotype 1a. Findings: The physician reviewer found that 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 or Zepatier for 12 weeks when NS5A resistance is not found.

Nature of Statutory Criteria/Case Summary: An enrollee has requested a 12 week course of Sovaldi and Olysio for treatment of his hepatitis C virus genotype 1a. Three physician reviewers found that per the American Association for the Study of Liver Diseases (AASLD) and Infectious Disease Society of America (IDSA) guidelines, all patients with chronic active hepatitis C are eligible for treatment and should be treated with U.S. Food and Drug Administration (FDA) approved antiviral therapy regardless of fibrosis score. 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. Overall, the data supports treatment in all hepatitis C virus infected persons, except those with limited life expectancy due to non-liver-related comorbid conditions.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested Sovaldi and ribavirin for treatment of the enrollee’s chronic hepatitis C virus genotype 1a and 2b. 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 treatment guideline applies regardless of fibrosis stage or viral load. Per guidelines, when multiple genotypes are present, therapy should be chosen to maximize efficacy against each genotype. In this case, the patient was already treated with Sovaldi and Ribapak, as Sovaldi is a component of the Harvoni that was provided.

Nature of Statutory Criteria/Case Summary: An enrollee has requested Harvoni for treatment of her hepatitis C virus 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. The AASLD and IDSA guidelines noted that all patients should be treated, regardless of fibrosis stage and treatment-naïve genotype 1a patients should be treated with Harvoni or with Viekira Pak with ribavirin for 12 weeks. These guideline recommendations are based on multiple randomized clinical trials, and the medications are U.S.

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 genotype 1a, then check the rights and deadlines that apply to your plan.