Hepatitis B denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested Entecavir for treatment of his medical condition. Findings: The physician reviewer found that Entecavir is medically necessary in this case, irrespective of the patient’s hepatitis B e antigen (HBeAg) status or current viral load. The goal of therapy is long term viral suppression. The American Association for the Study of Liver Disease guidelines for treatment of hepatitis B state that “for HBeAg-negative patients, relapse is frequent even when HBV DNA has been suppressed to undetectable levels…for more than a year; thus, the endpoint for stopping treatment is unclear”. If an HBeAg-positive patient is converted to negative for e antigen, it is unclear that entecavir therapy could be stopped.

Nature of Statutory Criteria/Case Summary: The patient has been diagnosed with hepatitis B. The provider noted that the patient’s hepatitis B was undetectable while being treated with Viread. She had been treated with Viread since 2017, and she has had a successful pregnancy while taking Viread. The provider noted that the patient’s hepatitis B was well-controlled on Viread. The patient was noted to be planning a pregnancy. The patient has requested authorization and coverage for the brand name medication Viread. The Health Plan has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient. At issue in this case is whether the brand name medication Viread is medically necessary for the treatment of the patient’s medical condition.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Baraclude for treatment of the enrollee’s hepatitis B. Findings: The physician reviewer found that This patient is currently on brand-name Baraclude (entecavir). Per American Association for the Study of Liver Disease guidelines for treatment of hepatitis B, Baraclude (entecavir) is a recommended medication. Entecavir-mediated viral suppression is a first-line therapy recommended by the guidelines, and has been shown to decrease the risk of decompensation and hepatocellular carcinoma. However, the brand formulation is not recommended over the generic formulation. Additionally, generic medications must demonstrate bioequivalence, with the exact same active ingredient, to be approved for use.

Nature of Statutory Criteria/Case Summary: The patient has requested reimbursement and prospective authorization and coverage for entecavir tablets. In this case, prophylaxis of hepatitis B is warranted, as the patient will be on chemotherapy, resulting in a risk of reactivation of hepatitis B. Guidelines for the treatment of hepatitis B from the American Association for the Study of Liver Disease (AASLD) recommend entecavir and Vemlidy as compared with alternatives for the treatment of chronic hepatitis B. There is a lack of documentation in the records provided that the patient has a contraindication to treatment with Vemlidy. Overall, as the formulary alternative Vemlidy is recommended by AASLD guidelines for the treatment of hepatitis B, the requested entecavir was not indicated for this patient.

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 b, then check the rights and deadlines that apply to your plan.