Vemlidy 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 Vemlidy tablets for treatment of the enrollee's chronic hepatitis B virus (HBV). The Health Plan has denied this request indicating that the requested medication is not medically necessary for treatment of the patient’s chronic hepatitis B virus (HBV). Findings: The physician reviewer found that the requested medication is medically necessary for treatment of the patient’s medical condition. Therefore, the Health Plan’s denial should be overturned. The submitted documentation supports the medical necessity of the requested medication. Guidelines for the treatment of hepatitis B from the American Association for the Study of Liver Disease (AASLD) recommend entecavir and tenofovir compared with alternatives for the treatment of chronic hepatitis B.

Findings: The physician reviewer found that for Vemlidy tablets. Current medical guidelines for the treatment of hepatitis B recommend entecavir and tenofovir for the treatment of chronic hepatitis B when compared with other treatment alternatives. Notably, the Vemlidy formulation of tenofovir (tenofovir alafenamide) is effective for hepatitis B and associated with a lower incidence of side effects, such as osteopenia and renal disease, when compared to the Viread formulation of tenofovir (tenofovir disoproxil fumarate). In this case, the patient is an Asian female with a history of chronic hepatitis B. One study found that Asian females have a higher risk of osteoporosis, and the records indicate that this patient already has low bone density. As such, treatment of the patient with Vemlidy is more appropriate than treatment with Viread.

Where the denial was upheld

The patient is requesting authorization and coverage for Vemlidy 25 mg tablets.Findings: Guidelines recommend entecavir and tenofovir for the treatment of chronic hepatitis B. In comparison with tenofovir disoproxil fumarate (Viread), the Vemlidy formulation of tenofovir is effective for hepatitis B, but is associated with fewer incidence of side effects such as osteopenia and renal disease. However, the other guidelines also support the safety and efficacy of entecavir for the treatment of hepatitis B, and entecavir is not associated with these adverse effects. This patient does not have a documented contraindication to entecavir.

Findings: The physician reviewer found that a patient has requested authorization and coverage for Vemlidy. The patient has chronic hepatitis B and was initially treated with tenofovir, which remains a first‑line therapy. The medical record does not document clinical factors that would justify switching from tenofovir fumarate to Vemlidy. Therefore, the requested Vemlidy is not medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested medication is not medically necessary for the treatment of the patient's medical condition. Therefore, the Health Plan's denial should be upheld.Credentials/Qualifications: The reviewer is board-certified in internal medicine with subspecialty certifications in gastroenterology and transplant hepatology, and is actively practicing.

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