Vemlidy (tenofovir alafenamide) — United Healthcare
Chronic hepatitis B infection
Preferred products
- entecavir (generic Baraclude)
- tenofovir disoproxil fumarate (generic Viread)
Initial criteria
- Diagnosis of chronic hepatitis B infection
- AND Both of the following:
- Submission of medical records documenting one of the following: Patient has a history of adverse event or intolerance to entecavir (generic Baraclude) OR Patient is not a suitable candidate for entecavir (generic Baraclude)
- AND One of the following:
- Submission of medical records documenting a history of adverse event or intolerance to tenofovir disoproxil fumarate (generic Viread)
- OR Submission of medical records documenting an estimated glomerular filtration rate below 90 mL/min
- OR Submission of medical records documenting a diagnosis of osteopenia as defined by a BMD T-score between -1 and -2.5 (BMD T-score greater than -2.5 and less than or equal to -1) based on BMD measurements from lumbar spine (at least two vertebral bodies), hip (femoral neck, total hip), or radius (one-third radius site) with evidence of progressive bone loss on serial DEXA scan
- OR Submission of medical records documenting a diagnosis of osteoporosis as defined by a BMD T-score ≤ -2.5 based on BMD measurements from lumbar spine (at least two vertebral bodies), hip (femoral neck, total hip), or radius (one-third radius site)
- OR Submission of medical records documenting a prior low-trauma or nontraumatic fracture
- OR Patient is less than 20 years of age
Reauthorization criteria
- Documentation of positive clinical response to Vemlidy therapy
- AND Patient is not a suitable candidate for entecavir (generic Baraclude) or tenofovir disoproxil fumarate (generic Viread)
Approval duration
12 months