CurrentCommunity-CarePolicy N/A

Givlaari (givosiran) Medical Benefit Medication Utilization Policy

Defines medical necessity criteria, authorization periods, and coding for givosiran (Givlaari) for treatment of acute hepatic porphyria for covered members and the provider requirements to obtain approval.

Policy Summary

PayerCommunity-Care

PolicyGivlaari (givosiran) Medical Benefit Medication Utilization Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization with documentation including provider specialty, confirmed acute hepatic porphyria subtype, history of ≥2 documented attacks in the last 6 months, recent elevated urinary/plasma PBG, and patient weight.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥2documented attacks required (6 mo)

6 moinitial auth period

1 yrcontinuation auth

J0223HCPCS

Dec 2022last reviewed

Coverage Criteria for Givlaari (givosiran)

Initial Therapy

Covered when ALL of the following are met

Initial Approval - Acute hepatic porphyria: (i) Prescribed by, or in consultation with, a hepatologist, gastroenterologist, or a provider who specializes in the treatment of porphyria; (ii) Diagnosis of one of the following acute hepatic porphyria subtypes: acute intermittent porphyria, delta-aminolevulinic acid dehydratase porphyria, hereditary coproporphyria, or variegate porphyria; (iii) History of ≥ 2 documented porphyria attacks requiring hospitalization, urgent care visits, or IV hemin administration within the last 6 months; (iv) Documentation of elevated urinary or plasma porphobilinogen (PBG) levels within the past year with reference range provided.see text

A patient weight is required for approval

Continuation Therapy

Covered when ALL of the following are met

Continuation Approval - Acute hepatic porphyria: (i) Diagnosis of acute hepatic porphyria; (ii) Documentation of demonstrated clinical benefit with givosiran (Givlaari) therapy (e.g., decrease in the number of porphyria attacks that require hospitalization, urgent healthcare visits, or IV hemin administration).

Policy Summary

PayerCommunity-Care

PolicyGivlaari (givosiran) Medical Benefit Medication Utilization Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Continuation authorized for 1 year if criteria met

Covered when ALL of the following are met: (i) prescribed by, or in consultation with, a hepatologist, gastroenterologist, or porphyria specialist; (ii) diagnosis of one of the specified acute hepatic porphyria subtypes (acute intermittent porphyria, delta-aminolevulinic acid dehydratase porphyria, hereditary coproporphyria, or variegate porphyria); (iii) history of ≥ 2 documented porphyria attacks requiring hospitalization, urgent care visits, or IV hemin administration within the last 6 months; and (iv) documentation of elevated urinary or plasma porphobilinogen (PBG) within the past year with the reference range provided. A patient weight is required for approval.

Prior authorization is required and must include the documentation elements above. For continuation of therapy, documentation must show an ongoing diagnosis of acute hepatic porphyria and demonstrated clinical benefit from givosiran (for example, a decrease in attacks requiring hospitalization, urgent healthcare visits, or IV hemin). Initial authorization, if approved, is for 6 months; continuation authorization, if approved, is for 1 year.

Coding and Attack Thresholds

Applicable HCPCS CodesHCPCSCovered

J0223

Injection, givosiran, 0.5 mg

Documented attacks

Documented porphyria attacks threshold>= 2 documented porphyria attacks requiring hospitalization, urgent care visits, or IV hemin administration within the last 6 months

Time window for attacksWithin the last 6 months

Types of encounters countedHospitalization, urgent care visits, or IV hemin administration

Provider Requirements and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Givlaari (givosiran) for the treatment of acute hepatic porphyria. Requests must include the clinical documentation listed below to be considered for approval.

Submit prior authorization before initiating therapy.
Include clinical notes, relevant lab results, and specialist consultation documentation.

Note

Important Provider Action

Providers must ensure requests are submitted by, or in consultation with, an appropriate specialist experienced in porphyria management.

Acceptable prescribers: hepatologist, gastroenterologist, or provider who specializes in treatment of porphyria.
If submitted in consultation, include name and specialty of consulting provider and consult note.

Documentation Required

Required Documentation

Required documentation to support medical necessity for initial approval:

Prescribing provider specialty (hepatology, gastroenterology, or porphyria specialist).
Confirmed acute hepatic porphyria subtype (acute intermittent porphyria, ALA dehydratase porphyria, hereditary coproporphyria, or variegate porphyria).
History of ≥ 2 documented porphyria attacks requiring hospitalization, urgent care visits, or IV hemin administration within the last 6 months.
Recent weight (required for dosing/approval).
Laboratory evidence of elevated urinary or plasma porphobilinogen (PBG) within the past year with reference range provided.
For continuation requests: documentation of clinical benefit from givosiran (for example, decrease in number of porphyria attacks requiring hospitalization, urgent care, or IV hemin).

Denial Risk

Denial Triggers / Documentation Deficiencies

Requests lacking the required specialty involvement, missing subtype confirmation, absent attack history, missing recent weight, or without documented elevated PBG (with reference range) are at high risk for denial.

Missing specialist prescriber or consult note may result in denial.
No documentation of ≥ 2 attacks in the prior 6 months will not meet initial approval criteria.
Absence of laboratory evidence of elevated PBG within the past year will risk denial.
No recent weight documented will prevent approval.

Definitions

Porphyria attack

DefinitionAn episode meeting criteria for a porphyria attack includes events that require hospitalization, urgent care visits, or IV hemin administration

Associated conditionOccurs in patients with acute hepatic porphyria subtypes (e.g., acute intermittent porphyria, delta-ALA dehydratase porphyria, hereditary coproporphyria, variegate porphyria)

Objective evidenceMay be supported by elevated urinary or plasma porphobilinogen (PBG) within the past year with reference range provided

Background

Acute hepatic porphyrias are a group of inherited metabolic disorders characterized by episodic neurovisceral attacks. Givosiran (Givlaari) is indicated to reduce the frequency of porphyria attacks in patients with acute hepatic porphyria and is considered under this policy when the specified diagnostic, attack history, and laboratory criteria are met.