Mavyret denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Mavyret 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. The guidelines recommend that all patients should be treated, regardless of fibrosis stage. As ultrasound elastography showed a lack of cirrhosis, thus this patient should be treated as a non-cirrhotic patient. The guidelines recommend that non-cirrhotic treatment naive genotype 1a patients should be treated with Mavyret.

Nature of Statutory Criteria/Case Summary: The patient is a 33-year-old male who was diagnosed with chronic hepatitis C. Laboratory results dated 10/20/18 revealed the patient’s viral load was 1,450,000 IU/mL. On 2/28/19, the provider noted the patient was diagnosed with hepatitis C, genotype 3 infection in October 2018, and he has never been treated for hepatitis C. On 2/28/19, serum fibrosis testing was consistent with F0, lack of fibrosis. The patient has requested authorization and coverage for Mavyret for eight weeks. The Health Plan denied the requested and reported the requested medication is not medically necessary for the treatment of this patient. At issue in this case is whether Mavyret for eight weeks is medically necessary for the treatment of the patient’s medical condition.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: A male enrollee has requested authorization and coverage for Mavyret 100-40 mg tablets for four weeks. 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 all patients should be treated, regardless of fibrosis stage. The guidelines recommend that non-cirrhotic treatment-naïve genotype 3 patients should be treated with Mavyret for eight weeks. These recommendations apply regardless of fibrosis stage. A trial showed a 95% cure rate with eight weeks of treatment.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage of Mavyret for 12 weeks. Findings: The physician reviewer found that according to the 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 all patients should be treated, regardless of fibrosis stage. The guidelines recommend that non-cirrhotic, treatment naive, genotype 1a patients should be treated with Mavyret for eight weeks. These recommendations are based on multiple randomized clinical trials. Additionally, the medication is 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 Mavyret, then check the rights and deadlines that apply to your plan.