CurrentCareSourcePolicy N/A

Givlaari (givosiran) Policy

Medical-benefit pharmacy policy defining prior-authorization criteria for Givlaari (givosiran) for adults with acute hepatic porphyria (AHP), including initial and reauthorization requirements, dosing/quantity limit, exclusions, and prescriber specialty requirements. Applies to Arkansas PASSE medical benefit.

Policy Summary

PayerCareSource

PolicyGivlaari (givosiran) Policy

Policy CodePolicy N/A

Change TypeCriteria updates & guideline alignment

Effective DateJul 1, 2024

Next Review Date

Key ActionObtain prior authorization and submit documentation demonstrating initial or reauthorization criteria are met, including lab confirmation of elevated urinary ALA or PBG.

SourceLink

POLICY UPDATE CHANGES

Added diagnostic confirmation via biochemical testing and trigger avoidance criterion.

Changed recurrent attack definition from clinical trial definition to guideline definition and allowed patients already receiving prophylactic hemin to qualify without meeting recurrent attack definition.

Added new reference (AGA 2023).

New policy created.

4AHP subtypes listed

>=18Minimum age (years)

2.5 mg/kgDose (monthly)

6 moInitial approval duration

12 moReauth duration

Coverage Summary

Coverage stance: covered_with_criteria. Scope: Medical-benefit pharmacy policy defining prior-authorization criteria for Givlaari (givosiran) for adults with acute hepatic porphyria (AHP). Effective date: 2024-07-01; Last review: 2024-01-26. Givlaari (givosiran) is approved for the treatment of adults with AHP and is covered under this policy when the prior authorization criteria (including age, diagnostic confirmation, recurrent-attack criteria or current prophylactic hemin use, prescriber specialty, exclusions, and dosing limits) are met.

Initial Authorization — Acute Hepatic Porphyria (AHP)

Initial Authorization - Acute Hepatic Porphyria (AHP)

Covered when ALL of the following are met:

ALL of the following

Member is at least 18 years of age
Member has a documented diagnosis of Acute Hepatic Porphyria with one of the following types: acute intermittent porphyria (AIP), hereditary coproporphyria (HCP), variegate porphyria (VP), or aminolevulinic acid dehydratase deficiency porphyria (ADP)

Policy Summary

PayerCareSource

PolicyGivlaari (givosiran) Policy

Policy CodePolicy N/A

Change TypeCriteria updates & guideline alignment

Effective DateJul 1, 2024

Next Review Date

Key ActionObtain prior authorization and submit documentation demonstrating initial or reauthorization criteria are met, including lab confirmation of elevated urinary ALA or PBG.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Prescriber specialty is gastroenterologist or hepatologist

policy history indicates addition of neurology and hematology to accepted prescriber specialties (12/20/2022)

Diagnosis must be confirmed by labs showing an elevated level of urinary ALA or PBG (elevated within the past year)Elevated urinary ALA or PBG within past year

document text notes a numeric typographic error; policy requires biochemical confirmation (added 12/20/2022)

ONE of

At least 4 porphyria attacks in the past year requiring hospitalization, urgent care visit, or intravenous hemin administration at home>= 4 attacks in past year
Recurrent attacks definition per guideline
Member is currently receiving off-label hemin treatment for attack prophylaxis
Patients already receiving prophylactic hemin may qualify without meeting recurrent attack definition (01/26/2024)

Chart notes include documentation of active recurrent porphyria attacks (as above)

Member has been assessed for possible attack triggers (e.g., certain drugs, smoking, alcohol, or low carbohydrate diets) and counseled to avoid these potential causative factors

Added trigger avoidance criterion (12/20/2022)

Exclusions

Member does NOT have prior or anticipated liver transplant
liver transplant exclusion added (12/20/2022)
Member does NOT have active HIV, hepatitis B, or hepatitis C infection

Member will not be receiving concomitant prophylactic treatment with IV hemin (Panhematin). Note: Hemin for treatment of acute attacks is permitted

Concomitant prophylactic IV hemin prohibited; acute-use hemin permitted

Prior Authorization

Obtain prior authorization

Submit a prior authorization request to the medical benefit reviewer with documentation demonstrating that the patient meets all initial or reauthorization criteria for Givlaari (givosiran).

Include prescriber specialty (gastroenterologist or hepatologist; neurology and hematology were added to accepted specialties per policy history).
Note: Givlaari is a medical benefit and prior authorization is required.

Reauthorization (Continuation) Criteria

For approval of additional therapy, ALL of the following must be met:

ALL of the following

Chart notes document reduced number of porphyria attacks requiring hospitalization, urgent care, or Panhematin use
Reauthorization requirement
ANY of the following
- Chart notes document reduced severity of attack symptoms such as pain and decreased opioid use
Member is not using Panhematin for attack prophylaxis (Panhematin allowed for acute use only)

Documentation Required

Document attack history or prophylactic hemin use

Provide documentation of the patient’s porphyria attack history for initial approval and, for reauthorization, include chart notes documenting reduced attacks or improvement in symptom severity (for example, less pain or decreased opioid use).

Panhematin (IV hemin) is not permitted for prophylaxis; Panhematin use is allowed for acute attacks only and prophylactic Panhematin disqualifies approval.

Quantity, Approval Duration, and Not Medically Necessary

ALL of the following

Dose/Quantity limit: Dosage allowed/Quantity limit: 2.5 mg/kg subcutaneous injection once monthly2.5 mg/kg once monthly
Initial duration: Initial approval duration: 6 months if initial criteria met6 months
Reauthorization duration: Reauthorization approval duration: 12 months if reauthorization criteria met12 months
Not medically necessary: Givlaari (givosiran) is considered not medically necessary for indications not listed in this document; refer to Off-Label policy for other uses

Billing Rule

Dosing and quantity limit adherence

Prescribe and administer Givlaari per the policy dosing and quantity limits and adhere to the stated approval durations.

Dose: 2.5 mg/kg subcutaneous injection once monthly.
Initial approval duration: 6 months; Reauthorization duration: 12 months.

Exclusions / Denial Risk

Exclusion Criteria

Member does NOT have prior or anticipated liver transplant
liver transplant exclusion added 12/20/2022
Member does NOT have active HIV, hepatitis B, or hepatitis C infection
Member will not be receiving concomitant prophylactic IV hemin (Panhematin)
Hem in for acute attacks is permitted

Denial Risk

Exclusion criteria risk

Claims may be denied if the patient meets any exclusion criteria specified in the policy.

Prior or anticipated liver transplant
Active HIV infection, hepatitis B, or hepatitis C
Concomitant prophylactic IV hemin (Panhematin)

Provider Actions & Documentation Requirements

Documentation Required

Provide diagnostic biochemical confirmation

Include laboratory confirmation of AHP by submitting urinary ALA or PBG results obtained within the past year to confirm the diagnosis.

Policy threshold: elevated urinary ALA or PBG within the past year (policy text lists “24 times the upper limit of normal” but policy history indicates diagnostic confirmation criterion was added and the BRIEF notes this appears to be a typographic error; intended threshold is ≥2× ULN).

Documentation Required

Assess and document trigger counseling

Document that the patient has been assessed for potential porphyria attack triggers and that counseling was provided to avoid those triggers.

Assess and document counseling regarding certain drugs, smoking, alcohol, and low‑carbohydrate diets as potential triggers.

Prior Authorization

Prior authorization submission

When submitting prior authorization requests, include documentation supporting both initial and reauthorization criteria.

Recommended documents: relevant labs (urinary ALA/PBG), chart notes documenting attack frequency or reduction, notes on prophylactic hemin use if applicable, and prescriber specialty information.

Applicable Codes & Benefit

Benefit Type / Prior Authorizationmixed

Medical benefit	Givlaari (givosiran) classified as Medical benefit under Arkansas PASSE
Prior Authorization Required	Policy requires prior authorization

Clinical Evidence

In the pivotal phase 3 ENVISION trial, patients treated with givosiran experienced an average of 70% fewer porphyria attacks than placebo. Historically, intravenous hemin (Panhematin) has been the mainstay for treating acute attacks and has been used off-label for attack prevention/prophylaxis.

Background

Givlaari (givosiran) is an ALAS1-directed small interfering RNA (siRNA) that causes degradation of ALAS1 mRNA in hepatocytes to lower ALAS1 and reduce accumulation of the neurotoxic intermediates aminolevulinic acid (ALA) and porphobilinogen (PBG). It is FDA-approved for adults with acute hepatic porphyria (AHP). Historically, intravenous hemin (Panhematin) has been used as the mainstay treatment for acute attacks and has also been used off-label for prophylaxis in patients with recurrent attacks.

Key Thresholds for Givlaari (givosiran)

Age>= 18 years

Diagnostic biochemical confirmationElevated urinary ALA or PBG within the past year (document notes '24 times the upper limit of normal' — typographic error; intended elevated ALA/PBG)

Recurrent attacks>= 4 attacks in the past year requiring hospitalization, urgent care, or IV hemin at home (or current prophylactic hemin)

Dose2.5 mg/kg subcutaneous once monthly

Definitions

Recurrent attacks: at least 4 attacks in the past year requiring hospitalization, urgent care, or intravenous hemin administration at home, or current prophylactic hemin use.

Diagnostic confirmation: elevated urinary ALA or PBG within the past year (documented biochemical confirmation).

Revision History

04/23/2020initial_policy

Initial policy created (New policy for Givlaari).

12/20/2022material_change

Material updates: transferred to new template, updated J code and references, added diagnostic confirmation via biochemical testing (urinary ALA/PBG criterion), added trigger avoidance criterion, and expanded accepted prescriber specialties to include neurology and hematology.

01/26/2024material_changeLatest

Material guideline-based change: updated recurrent attack definition from the clinical trial definition to the guideline definition (AGA 2023) and allowed patients already receiving prophylactic hemin to qualify without meeting the recurrent attack definition; AGA 2023 reference added.

01/26/2024non-material_changeLatest

Non-material update: added new reference (AGA 2023).