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

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested Harvoni for treatment of the enrollee’s medical condition. 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. The guidelines recommend that non-cirrhotic treatment-naïve genotype 1a patients should be treated with Harvoni for 12 weeks. These recommendations are based on multiple randomized clinical trials, and the medication is U.S.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Mavyret for eight weeks. The Health Plan has denied this request indicating that the requested medication regimen is not medically necessary for treatment of the enrollee’s hepatitis C. The submitted documentation supports the requested medication regimen in this clinical setting. According to recent guidelines, 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. Per the guidelines, non-cirrhotic, treatment-naive, genotype 1a patients should be treated with Mavyret for eight weeks. These recommendations are based on multiple randomized clinical trials, and the medication is U.S.

Where the denial was upheld

This patient is a 52-year-old man who has hepatitis C genotype 1A. He was once treated in 1997 with regular IFN and apparently did not respond. It appears that he had a six-month course of therapy at that time. More recently, the patient was treated with Pegasys and ribavirin for 48 weeks and his last primary clearance rate was apparently undetectable. Another six months of therapy has been requested by his provider. The Health Plan has denied this request on the basis it is not medically necessary for treatment of the patient’s condition.Review of the submitted records reveals that continuation of Pegasys and ribavirin therapy is not medically indicated for treatment of this patient’s hepatitis C virus. It is not the community standard to treat genotype 1 patients for 18 months with increased dosage of ribavirin. The requested therapy is not likely to be of benefit.

A 63-year-old male enrollee has requested authorization a 12-week course of Sovaldi 400mg and Olysio 150mgfor treatment of his hepatitis C. Findings: The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested medication combination in this patient’s case. This patient has been diagnosed with hepatitis C, genotype 1a. On the date incdicated, ultrasound of the abdomen showed normal liver morphology. In this patient’s case, there is no demonstration either through liver biopsy, liver fibrosis panel or elastography that the patient has significant fibrosis. There is a lack of support for the requested medication combination in this clinical setting. The advantage of treatment in patients with minimal to no fibrosis has not been established.

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