Chronic Hepatitis C 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 her medical condition. 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 limited life expectancy due to non-liver-related conditions. This applies regardless of fibrosis stage or viral load. Harvoni is a fixed-dose combination of ledipasvir, a hepatitis C virus (HCV) NS5A inhibitor, and sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor. The drug is FDA-indicated for the treatment of chronic hepatitis C genotype 1 infection in adults.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage of Epclusa 400mg-100mg, once daily for 12 weeks and ribavirin 200 mg three times daily for three weeks. 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 limited life expectancy due to non-liver-related conditions. All patients should be treated, regardless of fibrosis stage. Per the guidelines, cirrhotic patients are high priority for treatment, and Epclusa for 12 weeks is recommended as first-line therapy for treatment naive, genotype 3 patients.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Technivie (ombitasvir-paritaprevir-ritonavir 12.5 mg/75 mg/50 mg) tablets for 12 weeks. 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 treatment naive genotype 4 patients should be treated with Technivie and ribavirin for 12 weeks. However, this is recommended as an alternate regimen rather than first-line therapy.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Epclusa with ribavirin 400 mg – 100 mg tablet for 24 weeks. 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. However, the patient has satisfied this recommendation with two treatments, including a failed treatment with Viekira Pak, an NS5A inhibitor.

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