Pharmacy Prior Authorization Criteria

Givlaari (givosiran) - PA, NF

Indications for Prior Authorization

Givlaari (givosiran)

• For diagnosis of Acute Hepatic Porphyria
  Indicated for the treatment of adults with acute hepatic porphyria (AHP).

Criteria

Givlaari

Prior Authorization, Non-Formulary (Initial Authorization)

Length of Approval: 6 Month(s)

• Diagnosis of acute hepatic porphyria (i.e., acute intermittent porphyria, hereditary coproporphyria, variegate porphyria, ALA dehydrase deficient porphyria)
AND
• Patient has active disease with at least two documented porphyria attacks within the past 6 months
AND
• Provider attestation documenting elevated urinary or plasma levels of one of the following within the past 12 months:
• Porphobilinogen (PBG)
• Delta-aminolevulinic acid (ALA)
AND
• Patient has not had a liver transplant
AND
• Prescribed by or in consultation with one of the following:
• Gastroenterologist
• Hepatologist
• Hematologist
• Neurologist
• A specialist with expertise in the diagnosis and management of acute hepatic porphyria

Givlaari

Prior Authorization, Non-Formulary (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response while on therapy as demonstrated by both of the following:
• Reduction in hemin administration requirements
• Reduction in the rate or number of porphyria attacks
AND
• Patient has not had a liver transplant
AND
• Prescribed by or in consultation with one of the following:
• Gastroenterologist
• Hepatologist
• Hematologist
• Neurologist
• A specialist with expertise in the diagnosis and management of acute hepatic porphyria

P & T Revisions

2026-01-07, 2025-01-15, 2024-01-19, 2023-01-04, 2021-12-10, 2020-12-29, 2020-04-21, 2020-02-13, 2019-12-31

References

1. Givlaari Prescribing Information. Alnylam Pharmaceuticals, Inc. Cambridge, MA. September 2025.

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Revision History

• 2026-01-07: 2026 annual review: Updated prescriber requirement. Added drug-specific NF to existing PA criteria buckets. Updated GL name to list guideline types. Background updates.
• 2025-01-15: 2025 annual review: no criteria changes. Background updates.
• 2024-01-19: 2024 annual review - Updated reauth language to replace "documentation of" with "patient demonstrates" with no change to clinical intent.
• 2023-01-04: Annual review - no changes.
• 2021-12-10: Annual review - updated references.
• 2020-12-29: Annual review - no changes.
• 2020-04-21: Updated GPI to 85080025202020 due to GPI replication.
• 2020-02-13: Modified criterion to allow for approval in patients awaiting liver transplantation.
• 2019-12-31: New PA for Givlaari.

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