Pharmacy Prior Authorization Criteria

Hepcludex (bulevirtide-gmod)

Indications for Prior Authorization

Hepcludex (bulevirtide-gmod)

• For diagnosis of Chronic Hepatitis Delta (CHD)
  Indicated for the treatment of chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis.

  This indication is approved under accelerated approval based on a decrease in HDV RNA and alanine aminotransferase (ALT) normalization. An improvement in disease-related clinical outcomes has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Criteria

Hepcludex

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of chronic hepatitis delta virus (HDV) infection
AND
• Submission of medical records (e.g., chart notes, lab results) documenting detectable HDV RNA within the 6 months before initiating therapy [2]
AND
• Patient has active liver disease (e.g., ALT above the upper limit of normal [ULN], evidence of hepatic fibrosis by noninvasive testing [e.g., transient elastography]) [2]
AND
• Patient is without decompensated liver disease (e.g., Child-Pugh Class B or C)
AND
• Prescriber attests that the patient has been counseled on the importance of adherence to therapy with risk of disease reactivation and need for ongoing monitoring if discontinued
AND
• Prescribed by or in consultation with one of the following:
• Hepatologist
• Gastroenterologist
• Infectious disease specialist

Hepcludex

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy (e.g., ALT normalization, improvement in or stabilization of fibrosis, undetectable HDV RNA level)
AND
• Prescriber attests that the patient has been counseled on the importance of adherence to therapy with risk of disease reactivation and need for ongoing monitoring if discontinued

P & T Revisions

2026-07-16, 2026-07-16, 2026-07-16

References

1. Hepcludex Prescribing Information. Gilead Sciences, Inc. Foster City, CA. May 2026.
2. Wedemeyer H, Aleman S, Brunetto MR, et al. A Phase 3, Randomized Trial of Bulevirtide in Chronic Hepatitis D. N Engl J Med. 2023;389(1):22-32.

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Revision History

• 2026-07-16: New program
• 2026-07-16: New program
• 2026-07-16: New program

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