Hepatitis C Virus Genotype 3a: when insurers say no, reviewers often say yes

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested Sovaldi and ribavirin for six months for treatment of her chronic hepatitis C virus genotype 3a. Findings: Three physician reviewers found that as 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.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Epclusa 400-100 mg tablets for 12 weeks for treatment of the enrollee’s chronic hepatitis C virus (HCV) genotype 3a. 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 in all cases, regardless of fibrosis stage. Per the guidelines, Epclusa for 12 weeks is recommended as a first-line regimen for non-cirrhotic treatment naïve genotype 3 patients. This is based on the ASTRAL-3 trial for Epclusa, which showed a high cure rate of 98%.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested Sovaldi for treatment of the enrollee’s chronic hepatitis C virus genotype 3a. 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. The recommendations apply regardless of fibrosis stage. The guidelines do not recommend Sovaldi with ribavirin any longer for genotype 3. This is based on the significantly higher effectiveness of two other regimens (Nelson, et al; Foster, et al).

A female enrollee requested an eight-week course of Harvoni 90/400 mg for medical treatment of her hepatitis C virus, genotype 3a. Findings: Three physician reviewers found thatreview of the submitted documentation fails to establish the medical necessity of the requested medication. Harvoni is not indicated for the treatment of HCV, genotype 3. According to the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) recommendations for treatment of HCV, the combination of sofosbuvir and weight-based ribavirin for 24 weeks is the preferred treatment regimen for patients with genotype 3 infection. For these reasons, the requested medication is not medically necessary for treatment of the patient’s medical condition.

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 3a was denied, the published record says the denial is worth fighting.