CurrentUnitedHealthcarePolicy N/A

Vemlidy® (tenofovir alafenamide) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plans

Defines UnitedHealthcare Commercial Plans prior authorization and medical necessity criteria for Vemlidy (tenofovir alafenamide), including initial authorization, reauthorization, clinical documentation requirements, exclusions/plan-specific notes, and program effective date history.

Policy Summary

PayerUnitedHealthcare

PolicyVemlidy® (tenofovir alafenamide) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plans

Policy CodePolicy N/A

Change TypeNo material change (annual review)

Effective DateAug 1, 2025

Next Review Date

Key ActionProviders must submit medical records documenting history of adverse event or intolerance to entecavir and/or tenofovir disoproxil fumarate when relying on intolerance criteria.

SourceLink

POLICY UPDATE CHANGES

New program established 8/2022.

Updated language for prior use of entecavir and generic Viread (11/2022).

Annual review with no changes to clinical coverage criteria (11/2023).

Added Nevada footnote (2/2024).

Updated background with expanded pediatric indication (5/2024).

Annual review with no changes (5/2025).

12 monthsAuthorization duration on approval

6+ yrsPediatric age indication referenced

eGFR <90

Coverage Summary

This policy defines UnitedHealthcare Commercial Plans prior authorization and medical necessity criteria for Vemlidy (tenofovir alafenamide), effective 8/1/2025. Coverage stance: Covered with criteria. Vemlidy is indicated for chronic hepatitis B in adults and pediatric patients 6 years of age and older and weighing at least 25 kg with compensated liver disease. Note that plan- or state-specific rules may affect application of these criteria: plans sitused in Nevada are not subject to clinical criteria (only step therapy may be required), some plans may exclude Vemlidy or brand Viread, and supply limits may apply.

Thresholds and Authorization Duration

eGFR thresholdEstimated glomerular filtration rate below 90 mL/min (eGFR < 90 mL/min)

BMD T-score — osteopeniaDefined as BMD T-score greater than -2.5 and less than or equal to -1 (‑2.5 < T‑score ≤ ‑1) based on lumbar spine, hip, or one‑third radius measurements; provider must submit patient‑specific T‑scores and evidence of progressive bone loss on serial DEXA for osteopenia

BMD T-score — osteoporosisDefined as BMD T‑score ≤ -2.5 based on lumbar spine, hip, or one‑third radius measurements; provider must submit patient‑specific T‑score

Pediatric age/weightIndication: patients 6 years of age and older weighing at least 25 kg; policy allows approval consideration for patients <20 years of age as a criterion

Authorization duration on approvalAuthorization will be issued for 12 months

Initial Therapy Criteria

Initial Authorization

Vemlidy will be approved based on all of the following criteria:

AND

Diagnosis of chronic hepatitis B infection
AND
- ONE of (regarding entecavir)
  - Submission of medical records documenting a history of adverse event or intolerance to entecavir (generic Baraclude)
  - Patient is not a suitable candidate for entecavir (generic Baraclude)
- ONE of (regarding tenofovir disoproxil fumarate or renal/bone risk)

Continuation / Reauthorization Criteria

Reauthorization

Vemlidy will be approved based on all of the following criteria:

AND

Documentation of positive clinical response to Vemlidy therapy
Patient is not a suitable candidate for entecavir (generic Baraclude) or tenofovir disoproxil fumarate (generic Viread)

Provider Actions & Documentation Requirements

Prior Authorization

Submit medical records for prior adverse event/intolerance

Providers must submit medical records documenting history of adverse event or intolerance to entecavir and/or tenofovir disoproxil fumarate when relying on intolerance criteria.

Documentation Required

Provide BMD T-scores and DEXA evidence

When claiming osteopenia or osteoporosis, providers must submit patient-specific BMD T-scores from specified sites and evidence of progressive bone loss on serial DEXA if claiming osteopenia.

Required measurement sites: lumbar spine (at least two vertebral bodies), hip (femoral neck, total hip), or radius (one-third radius site)
Progressive bone loss on serial DEXA required when claiming osteopenia

Applicable Codes

ICD-10 Diagnosis Codes referencedICD-10

No codes listed

Notes about excluded brandsmixed

No codes listed

Clinical Evidence & References

P&T approval dates include 8/2022, 11/2022, 11/2023, 2/2024, 5/2024, and 5/2025. References: Vemlidy PI (Mar 2024); Baraclude PI (Nov 2019); Viread PI (Apr 2019).

Background

Vemlidy (tenofovir alafenamide) is indicated for treatment of chronic hepatitis B in adults and pediatric patients aged 6 years and older and weighing at least 25 kg with compensated liver disease. Comparator HBV therapies noted for prior-use considerations include entecavir (generic Baraclude), indicated for adults and children ≥2 years, and tenofovir disoproxil fumarate (generic Viread), indicated for adults and pediatric patients ≥2 years and weighing at least 10 kg; the policy requires documentation of prior adverse event/intolerance to or unsuitability for these agents when used as criteria for Vemlidy approval.

Osteopenia: BMD T-score greater than -2.5 and less than or equal to -1 based on specified measurement sites (lumbar spine, hip, or radius).

Osteoporosis: BMD T-score ≤ -2.5 based on specified measurement sites (lumbar spine, hip, or radius).

Revision History

8/2022program_initiation

Program initiated as Prior Authorization/Medical Necessity for Vemlidy (new program established).

11/2022policy_revision

Clarified prior use requirements by updating language for prior use of entecavir and generic Viread.

11/2023annual_review

Annual review with no changes to clinical coverage criteria; background and references updated.

Submission of medical records documenting a history of adverse event or intolerance to tenofovir disoproxil fumarate (generic Viread)
Submission of medical records documenting an estimated glomerular filtration rate below 90 mL/mineGFR < 90 mL/min
Submission of medical records documenting a diagnosis of osteopenia as defined by a BMD T-score greater than -2.5 and less than or equal to -1 based on BMD measurements from lumbar spine (≥2 vertebral bodies), hip (femoral neck, total hip), or radius (one-third radius site)BMD T-score: -2.5 < T-score ≤ -1
Provider must submit patient specific BMD T-scores with evidence of progressive bone loss on serial DEXA scan
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 (≥2 vertebral bodies), hip (femoral neck, total hip), or radius (one-third radius site)BMD T-score ≤ -2.5
Provider must submit patient specific BMD T-score
Submission of medical records documenting a prior low-trauma or nontraumatic fracture
Patient is less than 20 years of age