CurrentColorado Rocky Mountain Health PlansPolicy CS2026D0087L

Givlaari (givosiran) — Medical Benefit Drug Coverage Criteria

Defines medical benefit drug coverage criteria for givosiran (Givlaari) for members with acute hepatic porphyria and describes authorization, continuation, coding, and clinical background. Applies to the payer's commercial medical benefit plans except where state-specific exceptions are noted.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyGivlaari (givosiran) — Medical Benefit Drug Coverage Criteria

Policy CodePolicy CS2026D0087L

Change TypeNo material changes

Effective DateApr 1, 2026

Next Review Date

Key ActionObtain prior authorization with documentation of AHP diagnosis, evidence of active disease (≥2 documented porphyria attacks in prior 6 months or current prophylactic hemin use), provider attestation of baseline hemin/attack frequency, and dosing per FDA labeling (2.5 mg/kg monthly).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2.5FDA dosing (mg/kg)

>=2/6moActive disease threshold

12Auth duration (months)

J0223HCPCS

Coverage Criteria for Givlaari (givosiran)

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Initial Therapy

Covered when ALL of the following are met:

Initial Therapy - All criteria: Diagnosis of an acute hepatic porphyria (AHP) (eg, acute intermittent porphyria, hereditary coproporphyria, variegate porphyria, ALA dehydratase–deficient porphyria); AND one of the following: (1) patient has active disease defined as ≥2 documented porphyria attacks in the past 6 months, OR (2) patient is currently receiving prophylactic hemin; AND provider attestation that baseline hemin administration requirements (prophylactic or treatment) and the rate/number of porphyria attacks prior to initiation of givosiran have been documented; AND patient has not had a liver transplant; AND patient will not receive concomitant prophylactic hemin while on givosiran; AND prescribed by, or in consultation with, a hematologist or specialist with expertise in AHP; AND givosiran dosing is in accordance with FDA labeling (2.5 mg/kg subcutaneously once monthly); AND initial authorization will be for no more than 12 months.

Represents initial authorization requirements from policy.

Continuation Therapy

Covered for continuation when ALL of the following are met:

Continuation Therapy - All criteria: Patient has previously received givosiran for the treatment of AHP; AND documentation that the patient has experienced a positive clinical response while on givosiran; AND patient has not had a liver transplant; AND patient will not receive concomitant prophylactic hemin while on givosiran; AND prescribed by, or in consultation with, a hematologist or specialist with expertise in AHP; AND givosiran dosing is in accordance with FDA labeling (2.5 mg/kg subcutaneously once monthly); AND reauthorization will be for no more than 12 months.

Represents reauthorization requirements from policy.

Patients with a history of liver transplantation are excluded from coverage for givosiran. The policy explicitly requires that the patient has not had a liver transplant as a condition for both initial authorization and continuation/reauthorization of therapy (initial and reauthorization approvals are limited to ≤12 months).

For operational processing, verify documentation in the medical record or prior procedure history confirming absence of liver transplant. Requests that show evidence of prior liver transplantation should be denied consistent with this exclusion.

Concomitant use of givosiran with prophylactic hemin is not permitted. The policy requires an explicit attestation that the patient will not receive concomitant prophylactic hemin treatment while on Givlaari for both initial authorization and continuation.

Operational note: prior authorization must include a provider attestation confirming no concurrent prophylactic hemin will be administered during givosiran therapy. Requests that document ongoing prophylactic hemin use at the time of initiation, or intent to continue prophylactic hemin concurrently, should be denied per policy.

Coding — HCPCS and Diagnosis Codes

Applicable HCPCS CodesHCPCS

J0223

Injection, givosiran, 0.5 mg.

Diagnosis (ICD-10) Codes referencedICD-10

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

inv-07: Attack frequency threshold — initial coverage

Minimum attack frequency for initial coverageAt least 2 documented porphyria attacks in the prior 6 months

Alternative to attack requirementCurrent receipt of prophylactic hemin counts in lieu of ≥2 attacks

Attack definition used in trialAttack requiring hospitalization, urgent healthcare visit, or IV hemin administration at home

Provider Actions — Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for initiation and continuation of Givlaari (givosiran). Requests must include documentation of the diagnosis of an acute hepatic porphyria (AHP) and objective evidence of disease activity or current prophylactic hemin use, as described below. Initial authorizations will be for no more than 12 months; reauthorization for continuation therapy will be for no more than 12 months.

Affected product: Givlaari (givosiran) — dosing per FDA labeling (2.5 mg/kg subcutaneously monthly)
Initial and continuation requests require PA prior to drug dispensing

Documentation Required

Required Documentation

Providers must submit baseline and ongoing clinical documentation to support medical necessity. This includes confirmation of AHP diagnosis, documentation of attack frequency or evidence of prophylactic hemin use, and provider attestation of baseline hemin administration (if applicable). Also include specialists’ consultation notes when prescribed by a non-hematologist.

Diagnosis: specify type of AHP (eg, acute intermittent porphyria, hereditary coproporphyria, variegate porphyria, ALA dehydratase deficient porphyria)
Attack history: at least 2 documented porphyria attacks in the prior 6 months for initial therapy, or documentation of recurrent attacks per prescriber rationale
Hemin documentation: provider attestation of baseline hemin administration requirements (prophylactic or treatment), including frequency/rate and timing relative to givosiran initiation
Specialist involvement: prescribing clinician is a hematologist or specialist with AHP expertise, or documentation of hematology consultation
Dosing: chart or prescription showing Givlaari dosing consistent with FDA labeling

Denial Risk

Denial Triggers — High Risk for Incomplete Requests

Denial is likely when supporting documentation is absent or insufficient. Common denial triggers include missing or unclear diagnosis, inadequate evidence of active disease or prior therapies, failure to provide provider attestation regarding baseline hemin administration, concomitant prophylactic hemin use while on givosiran, or prior liver transplant.

Missing diagnosis of AHP or unspecified AHP subtype
No documentation of ≥2 porphyria attacks in the past 6 months (when required) or lack of documentation supporting current prophylactic hemin use
No provider attestation of baseline hemin administration (frequency/requirements) prior to givosiran initiation
Evidence of liver transplant in the medical record
Documentation that patient will receive concomitant prophylactic hemin while on Givlaari

Clinical Background

Acute hepatic porphyrias (AHPs) are a group of ultra-rare, inherited disorders of hepatic heme biosynthesis that cause episodic neurovisceral attacks (severe abdominal pain, neurologic symptoms) and can lead to long-term complications. Givosiran (Givlaari) is an RNA interference therapy that targets hepatic ALAS1 mRNA to reduce production of neurotoxic intermediates and thereby decrease attack frequency.

In this policy context, givosiran is indicated for patients with AHP who meet clinical criteria demonstrating active disease and who have no history of liver transplant and will not receive concurrent prophylactic hemin. Authorization (initial or reauthorization) is limited to no more than 12 months and dosing must follow FDA labeling.