CurrentUnitedHealthcarePolicy 2025D0087H

Givlaari (givosiran) — Clinical Coverage Criteria for Acute Hepatic Porphyria

Clinical coverage criteria for use of Givlaari (givosiran) to treat acute hepatic porphyrias (AHP) under UnitedHealthcare medical benefit drug policies; applies to providers prescribing and administrating the drug for covered members.

Policy Summary

PayerUnitedHealthcare

PolicyGivlaari (givosiran) — Clinical Coverage Criteria for Acute Hepatic Porphyria

Policy CodePolicy 2025D0087H

Change TypeNo material changes

Effective DateApr 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization with documented AHP diagnosis and either ≥2 porphyria attacks in the past 6 months or current prophylactic hemin use; initial authorization ≤12 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

70%reduction in porphyria attacks (ENVISION)

1.9 vs 6.5mean attack rate (Givlaari vs placebo)

≤12 moinitial auth max

≤12 moreauthorization max

Coverage Criteria for Givlaari (givosiran)

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Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Diagnosis of an acute hepatic porphyria (AHP) (acute intermittent porphyria, hereditary coproporphyria, variegate porphyria, ALA dehydratase deficient porphyria)

Attack history or hemin use: One of: patient has active disease with ≥2 documented porphyria attacks within the past 6 months; OR patient is currently receiving prophylactic hemin to prevent attacks>=2 attacks in past 6 months

ENVISION trial-aligned definition

Documentation and exclusions: Provider attestation that baseline hemin administration requirements and the baseline rate and/or number of porphyria attacks are documented; patient has not had a liver transplant; patient will not receive concomitant prophylactic hemin while on Givlaari; prescribed by or in consultation with a hematologist or AHP specialist; dosing per FDA-approved labeling; initial authorization <= 12 months

Continuation Therapy — Reauthorization covered when ALL of the following are met

Reauthorization covered when ALL of the following are met

Prior therapy: Patient has previously received Givlaari for the treatment of AHP

Response: Documentation that the patient has experienced a positive clinical response while on Givlaari

Exclusions and prescribing: Patient has not had a liver transplant; patient will not receive concomitant prophylactic hemin while on Givlaari; prescribed by or in consultation with a hematologist or AHP specialist; dosing per FDA-approved labeling; reauthorization <= 12 months

Patients who have undergone a liver transplant are excluded from coverage for Givlaari; documentation must confirm the member has not had a liver transplant prior to initiating or continuing therapy.

Concomitant prophylactic hemin while receiving Givlaari is not allowed. Providers must attest that the patient will not receive concomitant prophylactic hemin treatment while on Givlaari as a condition of both initial authorization and reauthorization.

Provider Authorization, Documentation, and Denial Rules

Prior Authorization

Prior Authorization Required

Prior Authorization Required. Prior authorization is required for initiation of Givlaari (givosiran) for the treatment of acute hepatic porphyria (AHP). Initial approvals are limited to a maximum duration of 12 months.

Initial authorization duration: up to 12 months
Prescriber requirement: Prescribed by or in consultation with a hematologist or AHP specialist
Dosing: Must follow FDA-approved labeling

Prior Authorization

Reauthorization / Continuation Therapy

Reauthorization (continuation) requires documentation of prior receipt of Givlaari and evidence of clinical benefit while on therapy. Reauthorizations are limited to a maximum of 12 months.

Reauthorization duration: up to 12 months
Must document positive clinical response on Givlaari
Prescriber requirement: Prescribed by or in consultation with a hematologist or AHP specialist
Dosing: Must follow FDA-approved labeling

Documentation Required

Documentation Required at Initiation

Provider attestation and baseline documentation are required at initiation. The provider must confirm prior hemin use and baseline attack frequency before starting Givlaari.

Attestation that baseline hemin administration requirements and rate/number of porphyria attacks prior to givosiran initiation have been documented
If patient was receiving prophylactic hemin prior to initiation, that use must be documented

Denial Risk

Contraindications / Denial Risks

Contraindications / Denial Risks: Patients with a prior liver transplant, or those who will receive concomitant prophylactic hemin while on Givlaari, are not eligible. Requests that do not include required baseline documentation or lack specialist prescribing/consultation may be denied.

Denial risks include: history of liver transplant
Denial risks include: planned concomitant prophylactic hemin while on Givlaari
Incomplete requests lacking provider attestation of baseline hemin/attack documentation or lacking specialist involvement may be denied

Background on Acute Hepatic Porphyrias

Acute hepatic porphyrias (AHP) are a group of inherited metabolic disorders that cause recurrent neurovisceral attacks often requiring urgent care, hospitalization, or intravenous hemin. Givlaari (givosiran) is an RNA‑interference therapy indicated for AHP and demonstrated clinical benefit in pivotal trials.

Coverage for Givlaari requires a confirmed diagnosis of an AHP and supporting documentation of disease activity or prior treatment. For initial therapy, the policy requires documentation of baseline hemin administration needs and the rate or number of porphyria attacks; for continuation, documentation must show prior Givlaari use with a positive clinical response. Prescribing must be by—or in consultation with—a hematologist or specialist experienced in AHP management, dosing must follow the FDA label, and authorizations are limited to no more than 12 months for both initial and reauthorization periods.

Definitions

Porphyria attack (ENVISION trial definition)

DefinitionPorphyria attack defined per the Phase 3 ENVISION trial as an event requiring hospitalization, an urgent healthcare visit, or intravenous hemin administration at home.

Trial inclusion thresholdENVISION required ≥2 porphyria attacks meeting the above definition in the 6 months prior to study entry.

Efficacy endpoint aligned to definitionENVISION measured efficacy by the rate of porphyria attacks that required hospitalization, urgent healthcare visit, or IV hemin administration at home.

Observed treatment effectGivlaari reduced mean attack rate to 1.9 vs 6.5 with placebo (70% reduction) during the 6‑month double‑blind period, using the ENVISION attack definition.

Hemin use metricMean days of hemin use in ENVISION were 4.7 days with Givlaari vs 12.8 days with placebo, where hemin use was for attacks defined as above.