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

Where the denial was overturned

Nature of Statutory Criteria/ Case Summary: The enrollee is requesting authorization and coverage for the medication, Harvoni 90-400mg, for 12 weeks. The enrollee was diagnosed 15 years prior with chronic hepatitis C virus (HCV); genotype 1a and is treatment naïve. He also has a history of throat cancer and chronic myeloid leukemia. Laboratory results show a hepatitis viral load of 2,040,000 IU/mL. An ultrasound performed revealed a medial liver elastography of 4.6 kPa, corresponding to a METAVIR score of F0-1. Anti-viral resistance testing was done. This enrollee is Caucasian with a non-cirrhotic, chronic Hepatitis C genotype 1a infection. He is not subject to a short life expectancy that cannot be remediated with HCV treatment. According to current clinical guidelines and literature, Ledipasvir/Sofosbuvir (Harvoni) is a highly effective and safe treatment option for this enrollee.

Nature of Statutory Criteria/Case Summary: An enrollee has requested Viekira Pak for treatment of his hepatitis C virus (HCV). Findings: The physician reviewer found that per the joint guidelines issued by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), the recommended regimen for treatment-naïve patients with HCV genotype 1a infection includes daily fixed-dose combination of paritaprevir/ritonavir/ombitasvir plus twice-daily dosed dasabuvir and weight-based ribavirin for 12 weeks as a Class I, Level A rating. Paritaprevir/ritonavir/ombitasvir plus dasabuvir and weight-based ribavirin was approved by the U.S. Food and Drug Administration (FDA) for the treatment of HCV genotype 1a infection in treatment-naïve patients based on registration trials.

Where the denial was upheld

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.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Vosevi 400-100 mg 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 applies regardless of fibrosis stage. The guidelines recommend that cirrhotic or non-cirrhotic genotype 1a patients who have failed an NS5A inhibitor should be treated with regimens including Vosevi and Mavyret.

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 infection, genotype 1a was denied, the published record says the denial is worth fighting.