CurrentmhnPolicy CP.PHAR.181

Hemin (Panhematin) — Coverage Criteria for Acute Hepatic Porphyrias

Policy governing medical necessity criteria, dosing limits, and authorization requirements for Panhematin (hemin) for treatment of acute hepatic porphyrias for members covered by the payer.

Policy Summary

Payermhn

PolicyHemin (Panhematin) — Coverage Criteria for Acute Hepatic Porphyrias

Policy CodePolicy CP.PHAR.181

Change TypeNo material changes

Effective DateFeb 1, 2024

Next Review DateFeb 25, 2025

Key ActionSubmit prior authorization with clinical symptoms, ≥4× urine ALA/PBG, current body weight, and dosing ≤6 mg/kg/24h.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥16minimum age for coverage

6 mg/kgmaximum dose /24h

14 daysinitial approval length

350 mgsingle-dose vial

J1640HCPCS

Coverage and Medical Necessity Criteria

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inv-01: Initial Therapy - Acute Porphyria

Covered when ALL of the following are met:

Acute Porphyria initial approval: 1) Diagnosis of acute porphyria (AIP, variegate porphyria [VP], or hereditary coproporphyria [HCP]) confirmed by BOTH: (a) presence of clinical symptoms (e.g., abdominal pain, chest/leg/back pain, peripheral neuropathy, hyponatremia, tachycardia, sweating, tremor, dysuria, incontinence, constipation, nausea, vomiting) and (b) history of at least a four-fold increase of urine 5-aminolevulinic acid (ALA) or porphobilinogen (PBG) from a random urine sample within the past year (see Appendix D); 2) Age ≥ 16 years; 3) Documentation of member's current body weight (in kg); 4) Dose does not exceed 6 mg/kg in any 24-hour period.

Approval duration: 14 days

inv-02: Continuation Therapy - Acute Porphyria

Covered when ALL of the following are met:

Acute porphyria continued therapy: 1) Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; or (b) currently receiving medication and enrolled in a state/product with continuity of care regulations; 2) Member is responding positively to therapy; 3) Documentation of member's current body weight (in kg); 4) If request is for a dose increase, the new dose does not exceed 6 mg/kg in any 24-hour period.

Approval duration: Up to 14 days

Non‑FDA approved indications not addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy or the member's evidence of coverage. See off‑label use policies CP.CPA.09 (commercial), HIM.PA.154 (Health Insurance Marketplace), and CP.PMN.53 (Medicaid) for required standards and documentation.

Coverage of Panhematin is provided only when the requested service also complies with the member's benefit terms and all applicable legal and regulatory requirements. This clinical policy is a guide to medical necessity used to inform coverage decisions; it does not guarantee payment. Coverage determinations remain subject to the terms, conditions, exclusions, and limitations of the member's coverage documents (e.g., evidence of coverage, certificate of coverage, policy or contract) and applicable state and federal rules.

Initial Therapy: Dosing and Documentation

inv-22: Initial Therapy Dosing

Initial dosing and limits:

Dosing limits: Dose 1–4 mg/kg/day IV for 3–14 days based on clinical signs (standard clinical dose 3–4 mg/kg/day); repeat dose in more severe cases no earlier than every 12 hours; do not exceed 6 mg/kg in any 24-hour period.Do not exceed 6 mg/kg/24h

Standard clinical dose 3–4 mg/kg/day

inv-23: Initial therapy documentation

Policy updates and documentation requirements:

Documentation of member's current body weight (kg) is required for dose calculation.

Requirement added during prior reviews to ensure appropriate dosing

Continuation Therapy Requirements

inv-24: Continuation Therapy

Continuation therapy requirements:

Continued therapy: 1) Member is currently receiving medication via Centene benefit or previously met initial approval criteria OR continuity of care applies per state/product; 2) Member is responding positively to therapy; 3) Documentation of member's current body weight (in kg); 4) If increasing dose, new dose must not exceed 6 mg/kg in any 24-hour period.

Approval: up to 14 days

Provider Requirements and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Panhematin (hemin) for acute porphyria. Providers must submit a prior authorization request and supply documentation demonstrating that the member meets the policy’s approval criteria for acute porphyria.

Request must include clinical indication and relevant history
Ensure submitted information supports diagnosis and criteria in policy (see Criteria section)

Note

Medical Necessity and Prior Authorization

This policy is a guide to medical necessity determinations; providers must follow the Health Plan’s medical necessity and prior authorization procedures when requesting coverage. Coverage decisions are subject to the terms, exclusions, and limitations of the member’s coverage and applicable state law.

Submit requests through the Health Plan’s designated prior authorization portal or process
Verify member eligibility and benefits prior to submission

Documentation Required

Documentation Requirement

Providers must submit documentation supporting that the member has met ALL approval criteria. Failure to submit required documentation may result in denial of the request.

Include office chart notes detailing symptoms and clinical course
Attach relevant laboratory results (e.g., urine ALA/PBG) and diagnostic testing
Provide prior treatment history and response to therapies

Documentation Required

Required Clinical Documentation

Required clinical documentation must include objective evidence of acute porphyria and items necessary for dose calculation and safety monitoring.

Clinical notes documenting acute porphyria symptoms (e.g., abdominal pain, peripheral neuropathy, hyponatremia, tachycardia, sweating, tremor, urinary symptoms, nausea/vomiting)
Laboratory confirmation: history of ≥4-fold increase in urine 5‑aminolevulinic acid (ALA) or porphobilinogen (PBG) from a random urine sample within the past year (see Appendix D)
Documentation of prior carbohydrate therapy and response, if applicable
Medication administration records or prior authorization history if previously treated

Documentation Required

Weight Documentation Required for Dosing

Document the member’s current body weight (in kilograms) for dose calculation. Hemin dosing is weight-based and approval requires weight documentation; doses must not exceed 6 mg/kg in any 24‑hour period.

Provide most recent weight in kg in the chart notes or intake documentation
If dosing change requested, include recalculated dose showing ≤6 mg/kg/24 hours

Note

Consider Carbohydrate Trial Before Panhematin

Before administering Panhematin, consider a trial of carbohydrate loading (for example, ~400 g glucose/day for 1–2 days) when clinically appropriate, as attacks may respond to carbohydrate therapy.

Document attempts and response to carbohydrate therapy (type, dose, duration) when applicable
If carbohydrate therapy is not appropriate or was inadequate, include rationale in submission

Coding and Diagnostic Thresholds

HCPCS CodesHCPCSCovered

J1640

Injection, hemin, 1 mg

inv-06: Diagnostic lab threshold — ALA or PBG >4x upper limit of normal in random urine sample

Diagnostic thresholdConcentration of ALA or PBG in a random urine sample greater than four times the upper limit of normal

Sample typeRandom urine sample

RationaleFourfold increase used to establish diagnosis of acute hepatic porphyria (AHP) per Appendix D (Wang 2019)

Laboratory variabilityReference ranges and reporting (with/without creatinine correction) may differ across U.S. laboratories

Use in prior authorizationRequired as part of documentation to confirm acute porphyria for coverage

Key Terms and Abbreviations

inv-16: ALA — 5-aminolevulinic acid

TermALA

Definition5-aminolevulinic acid

AppendixListed in Appendix A: Abbreviation/Acronym Key

inv-17: PBG — porphobilinogen

TermPBG

Definitionporphobilinogen

AppendixListed in Appendix A: Abbreviation/Acronym Key

inv-18: AIP — acute intermittent porphyria

TermAIP

Definitionacute intermittent porphyria

ContextIncluded among porphyrias that may qualify for Panhematin therapy

inv-19: VP — variegate porphyria

TermVP

Definitionvariegate porphyria

ContextListed in Appendix A: Abbreviation/Acronym Key and referenced in diagnostic criteria

inv-20: HCP — hereditary coproporphyria

TermHCP

Definitionhereditary coproporphyria

ContextListed in Appendix A: Abbreviation/Acronym Key and referenced in diagnostic criteria

inv-21: ALA/PBG testing — Appendix D ALA and PBG Laboratory Testing referenced

ReferenceAppendix D: ALA and PBG Laboratory Testing referenced for diagnostic lab requirements

PurposeProvides the diagnostic laboratory threshold used to establish AHP (see Appendix D)

Policy updateRequired labs for diagnosis revised to align with Givlaari; Appendix D added in 1Q 2023 review

Background and Indication

Panhematin (hemin for injection) is indicated for the amelioration of recurrent attacks of acute intermittent porphyria (AIP)1–4 mg/kg/day IV for 3–14 days (standard 3–4 mg/kg/day), with repeat dosing in severe cases not sooner than every 12 hours and a hard maximum of 6 mg/kg in any 24‑hour period. Documentation of the member’s current body weight is required for dose calculation, and IV administration with appropriate clinical monitoring (typically in a hospital outpatient setting) is necessary.

Step Therapy Considerations

Step	Requirement
1	Consider an appropriate period of carbohydrate loading (e.g., 400 g glucose/day for 1–2 days) before administering Panhematin when carbohydrate therapy is known or suspected to be inadequate.
Note	Carbohydrate therapy should be attempted prior to Panhematin to help avoid progression of porphyria attacks; Panhematin is intended to prevent progression to irreversible neuronal damage but does not repair existing neuronal injury.

Quantity and Vial Information

inv-26: Panhematin (hemin) — single-dose vial 350 mg

ProductPanhematin (hemin) single-dose lyophilized powder vial: 350 mg

FormulationLyophilized powder for reconstitution

Quantity limit contextListed as single-dose vial size under product availability/quantity limits

Administration Setting

Billing Rule

Hospital outpatient IV administration and monitoring

Panhematin is administered intravenously in the hospital outpatient setting; clinical dosing and monitoring are required per the policy dosing and administration guidance.

IV dosing: typical 1–4 mg/kg/day IV for 3–14 days (standard practice 3–4 mg/kg/day); do not exceed 6 mg/kg per 24 hours
Repeat dosing in severe cases no earlier than every 12 hours

Policy Summary

Payermhn

PolicyHemin (Panhematin) — Coverage Criteria for Acute Hepatic Porphyrias

Policy CodePolicy CP.PHAR.181

Change TypeNo material changes

Effective DateFeb 1, 2024

Next Review DateFeb 25, 2025

Key ActionSubmit prior authorization with clinical symptoms, ≥4× urine ALA/PBG, current body weight, and dosing ≤6 mg/kg/24h.

SourceLink

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