Hepatitis C Genotype 1 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 Harvoni 90-400 mg, one tablet daily for 12 weeks for the treatment of her hepatitis C. Findings: The physician reviewer found that according to the most recent joint guidelines issued by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America, 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. This patient should be considered treatment-naive, as she was previously treated with interferon rather than PEG-interferon with ribavirin. The guidelines recommend that non-cirrhotic, treatment-naive, genotype 1 patients should be treated with Harvoni for 12 weeks.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Harvoni 90-400mg medication, one tablet daily, 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 and the Infectious Diseases Society of America (AASLD/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 1 patients should be treated with Harvoni for 12 weeks. These recommendations are based on multiple randomized clinical trials, and the medication is U.S.

Where the denial was upheld

The patient is a 57-year-old man with hepatitis C genotype 1 and cirrhosis. He has failed treatment with interferon and ribavirin due to side effects including bone marrow and psychiatric effects. He has a long list of complicating diagnoses including hypertension and cholelithiasis. The patient’s provider has recommended the patient begin treatment with ribavirin monotherapy. The Health Plan has denied authorization and coverage for the requested therapy on the basis it is not medically necessary for treatment of the patient’s medical condition.The issue of treatment failure and the benefit of ongoing therapy with interferon or ribavirin as a method to suppress inflammation has been addressed in the published guidelines of the American Association for the Study of Liver Disease.

Nature of Statutory Criteria/Case Summary: An enrollee has requested Harvoni for eight weeks for treatment of her hepatitis C. Findings: Two physician reviewers found that the proposed treatment is medically necessary and is considered the standard of care for the treatment of the patients with hepatitis C, genotype 1 infection. The current medical evidence supports the requested medication in this clinical setting. The requested treatment regimen is expected to potentially prevent further damage of the liver and disease progression. It is advantageous to initiate treatment for patients with early stage disease. All told, the requested Harvoni for eight weeks is medically indicated for the treatment of this patient. Final Result: Two reviewers determined that the requested medication is medically necessary for treatment of the patient’s medical condition.

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 hepatitis c genotype 1, then check the rights and deadlines that apply to your plan.