Diagnosis: Infectious disease /Hepatitis
Treatment: Pharmacy prescription drugs
The insurer denied Vemlidy 25MG OR TABS
The denial is upheld in whole

The patient with chronic hepatitis B virus (HBV) infection which has resulted in cirrhosis, portal hypertension, and esophageal varices.

Tenofovir alafenamide (TAF) (trade name -Vemlidy) has recently been FDA-approved for chronic HBV infection. TAF is a drug modified from an existing FDA-approved drug for chronic HBV infection, tenofovir disoproxil fumarate (TDF). TAF is more stable in the plasma and can provide similar efficacy with lower circulating drug concentration in patients with HBV infection. TDF has been linked to kidney and bone toxicity in some patients. In phase 3 registration trials, TAF was not inferior to TDF in antiviral efficacy for both HBeAg-positive and HBeAg-negative patients, while associated with less reduction in the estimated glomerular filtration rate and bone mineral density. Current HBV treatment guidelines and existing data supports the use of TAF as one of the first-line antiviral agents for patients with chronic HBV infection without hepatic decompensation. However, more real-world data with long-term observation are needed to better define the role of TAF compared to other oral anti-HBV regimens. Additional studies are also needed to evaluate the efficacy and safety of TAF in special populations such as those with impaired hepatic function, existing impaired renal and/or bone function, and in pregnant women.

Based on the materials provided and the current medical literature, TAF (Vemlidy) is an appropriate agent for this patient but alternative agents, including TDF, could also be appropriate and efficacious. There are multiple FDA-approved agents to treat chronic HBV infection but there is no current data which would suggest TAF (Vemelidy) is more efficacious than other FDA-approved agents. It is not medically necessary for TAF Vemelidy to be the preferred agent for this patient.