Hepatitis C Virus Genotype 1b: when insurers say no, reviewers often say yes

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested Harvoni for 12 weeks for treatment of her chronic hepatitis C virus genotype 1b. Findings: The physician reviewer found that according to 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 life expectancy less than 12 months due to non-liver-related conditions. This applies regardless of fibrosis stage or viral load. In treatment naïve genotype 1 patients, therapy is recommended with Harvoni for 12 weeks. These guideline recommendations are based on multiple randomized clinical trials, and the medication is U.S. Food and Drug Administration (FDA) approved for all patients with chronic hepatitis C genotype 1 regardless of fibrosis stage.

Nature of Statutory Criteria/Case Summary: An enrollee has requested a 12 week course of Harvoni for treatment of his chronic hepatitis C virus genotype 1b. Two physician reviewers found that as per the American Association for the Study of Liver Diseases (AASLD) Infectious Diseases 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 patients.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested Zepatier for treatment of the enrollee’s chronic hepatitis C virus genotype 1b. The Health Plan has denied Zepatier on the basis that Zepatier is not medically necessary without documentation of failure of or contraindication to formulary alternatives including Harvoni and Sovaldi. 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 guidelines recommend that treatment-naïve genotype 1b patients should be treated with regimens including Harvoni for 12 weeks or Zepatier for 12 weeks.

Nature of Statutory Criteria/Case Summary: An enrollee has requested Harvoni for eight weeks for treatment of his chronic hepatitis C virus genotype 1b. Findings: Two physician reviewers found that as per the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases 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 is expected to benefit nearly all chronically infected patients.

These outcomes come from California’s external review program — an independent physician panel whose decision binds the insurer. Every state has an equivalent, and internal appeals succeed even more often. If your care for hepatitis c virus genotype 1b was denied, the published record says the denial is worth fighting.