CurrentUnitedHealthcarePolicy CS2O25D0087K

Givlaari (givosiran) for acute hepatic porphyria — coverage criteria

Defines UnitedHealthcare coverage criteria for use of Givlaari (givosiran) to treat adults with acute hepatic porphyria, including initial and continuation authorization requirements and applicable billing codes; affects providers prescribing Givlaari to members in applicable states.

Policy Summary

PayerUnitedHealthcare

PolicyGivlaari (givosiran) for acute hepatic porphyria — coverage criteria

Policy CodePolicy CS2O25D0087K

Change TypeClinical evidence updatedapplication guidance added

Effective DateApr 1, 2025

Next Review Date

Key ActionPrior authorization required; initial authorization limited to no more than 12 months and dosing must follow FDA‑approved labeling.

SourceLink

POLICY UPDATE CHANGES

Updated Clinical Evidence and References sections to reflect the most current information.

Application Kansas Added instruction to refer to the state's Medicaid clinical policy.

≥2Min attacks (6 mo)

12 moMax auth period

2.5 mg/kgFDA dosing

J0223HCPCS

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Initial Therapy

Covered when ALL of the following are met:

Initial Therapy - all required: 1) Diagnosis of an acute hepatic porphyria (AHP) (acute intermittent porphyria, hereditary coproporphyria, variegate porphyria, or ALA dehydratase deficient porphyria);

From Initial Therapy section.

Initial Therapy - active disease: 2) Patient has active disease defined as at least 2 documented porphyria attacks within the past 6 months (per clinical trial definition).>= 2 attacks in prior 6 months

From Initial Therapy and Definitions.

Initial Therapy - hemin documentation and concomitant therapy: 3) If the patient is currently receiving prophylactic hemin: provider attestation that baseline hemin administration requirements and the rate/number of porphyria attacks have been documented, and a plan to discontinue prophylactic hemin once Givlaari is started; and patient will not receive concomitant prophylactic hemin while on Givlaari.

From Initial Therapy and Concomitant therapy restriction.

Initial Therapy - transplant exclusion: 4) Patient has not had a liver transplant.

Patients with prior liver transplant are excluded.

Initial Therapy - prescriber: 5) Prescribed by, or in consultation with, a hematologist or specialist with expertise in diagnosis and management of AHPs.

From Initial Therapy prescriber requirement.

Initial Therapy - dosing and authorization period: 6) Givlaari dosing is in accordance with FDA‑approved labeling; and 7) Initial authorization will be for no more than 12 months.

From Dosing and Prior authorization sections.

Continuation Therapy

Reauthorization covered when ALL of the following are met:

Continuation Therapy - prior treatment: 1) Patient has previously received Givlaari for treatment of AHP.

From Continuation Therapy.

Continuation Therapy - clinical response: 2) Documentation that the patient has experienced a positive clinical response while on Givlaari.

Required documentation for reauthorization.

Continuation Therapy - transplant exclusion: 3) Patient has not had a liver transplant.

Patients with prior liver transplant are excluded.

Continuation Therapy - prescriber: 4) Prescribed by, or in consultation with, a hematologist or specialist with expertise in diagnosis and management of AHPs.

Patients who have undergone a liver transplant are explicitly excluded from coverage under both the initial therapy and continuation (reauthorization) criteria for Givlaari. The policy requires that the patient has not had a liver transplant as a condition for approval at initiation and again for reauthorization, and presence of a transplant is a listed trigger for likely denial.

Coverage for Givlaari is limited to patients who meet the documented diagnosis of an acute hepatic porphyria and the policy's definition of active disease. For initial therapy the patient must have a diagnosis of AHP (acute intermittent porphyria, hereditary coproporphyria, variegate porphyria, or ALA dehydratase deficient porphyria) and at least 2 documented porphyria attacks within the past 6 months. Use is not supported when these diagnostic or attack‑frequency requirements are not met.

Concomitant prophylactic hemin is not permitted while on Givlaari. If the patient is currently receiving prophylactic hemin, the provider must attest that baseline hemin administration requirements and the patient’s attack rate/number have been documented and provide a plan to discontinue prophylactic hemin once Givlaari is started. Continued use of hemin without this documentation or plan is a basis for denial.

For continuation (reauthorization), coverage requires prior receipt of Givlaari and documentation of a positive clinical response while on therapy; reauthorization likewise requires the patient has not had a liver transplant, is managed by or in consultation with an appropriate specialist, will not receive concomitant prophylactic hemin, and that dosing follows the FDA‑approved labeling. Reauthorizations are limited to no more than 12 months.

Provider Requirements and Actions

Prior Authorization

Prior Authorization and Authorization Period

Prior Authorization Required: Prior authorization is required for Givlaari (givosiran). Initial authorizations will be approved for up to 12 months and dosing must follow FDA‑approved labeling.

Initial authorization duration: up to 12 months
Dosing: per FDA‑approved labeling

Note

Concomitant Therapy Restriction

Concomitant prophylactic hemin is prohibited while the patient is receiving Givlaari. If the patient is currently receiving prophylactic hemin, the provider must document baseline hemin administration requirements (rate/number) and confirm the plan to discontinue prophylactic hemin when initiating Givlaari.

No concomitant prophylactic hemin during Givlaari therapy
If on prophylactic hemin at baseline: document baseline hemin dose/frequency and attack rate; provide attestation of plan to stop prophylactic hemin when Givlaari is started

Documentation Required

Required Documentation

Required documentation must be submitted with the authorization request: provider attestation of baseline hemin administration and attack frequency, documentation of diagnosis and attack history, and records showing prescribing clinician specialty and prior Givlaari use when applicable.

Provider attestation of baseline hemin use (if applicable) and plan to discontinue prophylactic hemin
Documentation of AHP diagnosis (eg, AIP, HCP, VP, ALAD deficiency)
Record of ≥2 porphyria attacks in the prior 6 months for initial therapy requests
For continuation: documentation of positive clinical response to Givlaari and prior receipt of Givlaari
Documentation that patient has not had a liver transplant
Prescriber is a hematologist or specialist experienced in AHP management

Denial Risk

Triggers for Potential Denial

Triggers for potential denial include requests that do not meet initial or continuation criteria: no documentation of an AHP diagnosis, insufficient attack frequency for initial therapy (fewer than 2 attacks in the past 6 months), lack of baseline hemin documentation when patient is on prophylactic hemin, use of concomitant prophylactic hemin while on Givlaari, prior liver transplant, prescribing clinician without appropriate specialty or consult, or dosing not consistent with FDA labeling.

No documented diagnosis of acute hepatic porphyria (AHP)
Fewer than 2 documented porphyria attacks in the prior 6 months for initial requests
Missing provider attestation of baseline hemin use when applicable
Request includes concomitant prophylactic hemin with Givlaari
Patient has had a liver transplant
Prescriber is not a hematologist or AHP‑experienced specialist and no consult is provided
Dosing inconsistent with FDA‑approved labeling

Background on Acute Hepatic Porphyria

Acute hepatic porphyrias (AHPs) are a group of rare inherited hepatic enzyme disorders that cause recurrent neurovisceral attacks characterized by severe abdominal pain, neuropsychiatric symptoms, and other systemic manifestations. Givlaari (givosiran) is an RNA‑interference therapeutic that reduces hepatic ALAS1 mRNA, lowering ALA and PBG levels implicated in attacks.

In this policy context, active disease is operationalized as the clinical trial definition used in ENVISION and the policy: at least 2 documented porphyria attacks within the past 6 months that required hospitalization, an urgent healthcare visit, or intravenous hemin administration. The ENVISION trial demonstrated a meaningful reduction in attacks with givosiran, which underpins the coverage framework requiring both a documented diagnosis of AHP and a minimum attack frequency for initiation.

E80.0	Hereditary erythropoietic porphyria.
E80.1	Porphyria cutanea tarda.
E80.20	Unspecified porphyria.
E80.21	Acute intermittent (hepatic) porphyria.
E80.29	Other porphyria.

OpenPayer

Givlaari (givosiran) for acute hepatic porphyria — coverage criteria

Coverage Criteria for Givlaari (givosiran)

Billing and Diagnosis Codes

Provider Requirements and Actions

Definitions and Qualifying Disease Activity

Background on Acute Hepatic Porphyria