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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