Currentculinary health fundPolicy N/A

Panhematin (hemin) Utilization Management — Coverage Criteria

Defines prior authorization and coverage criteria for Panhematin (hemin intravenous infusion) for acute intermittent porphyria and other acute hepatic porphyrias for members of Culinary Health Fund.

Policy Summary

Payerculinary health fund

PolicyPanhematin (hemin) Utilization Management — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateOct 8, 2025

Key ActionObtain prior authorization and document diagnostic confirmation (elevated urinary ALA or PBG and clinical features) with specialist involvement for approvals up to 1 year.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥16minimum age for coverage

≤6 mg/kgmaximum daily dosing limit

1 yearauthorization period

Requires specialistspecialist required

Monitor ironmonitoring

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FDA-Approved Indication — Acute Intermittent Porphyria

Approve for 1 year if the patient meets ALL of the following (A, B, C, and D):

A-D

A) Patient is >= 16 years of age.age >=16
ALL of the following
- i. Patient demonstrated clinical features associated with acute intermittent porphyria (examples include neurovisceral symptoms, blistering lesions, hepatic involvement, peripheral neuropathy, abdominal pain, constipation, muscle weakness, and extremity pain).
- ONE of
  - a) Elevated urinary aminolevulinic acid (ALA) greater than the upper limit of normal.
  - b) Elevated urinary porphobilinogen (PBG) greater than the upper limit of normal.
C) Acute intermittent porphyria is related to the menstrual cycle.
D) Medication is prescribed by or in consultation with a gastroenterologist, hepatologist, or a physician who specializes in acute intermittent porphyria.

Other Uses with Supportive Evidence — Acute Hepatic Porphyria

Approve for 1 year if the patient meets ALL of the following (A, B, and C):

A-C

A) Patient is >= 16 years of age.age >=16
ALL of the following
- i. Patient demonstrated clinical features associated with acute hepatic porphyria (examples include neurovisceral symptoms, blistering lesions, hepatic involvement, peripheral neuropathy, abdominal pain, constipation, muscle weakness, and extremity pain).
- ONE of
  - a) Elevated urinary aminolevulinic acid (ALA) greater than the upper limit of normal.

Coverage of Panhematin (hemin) is not recommended for circumstances that are not listed in the Recommended Authorization Criteria. Requests for use outside the specified indications and clinical criteria should be denied; the Recommended Authorization Criteria define the allowed uses, required diagnostic confirmation, prescriber specialty involvement, and dosing limits.

Prescriber Requirements and Documentation

Prior Authorization

Prior Authorization Recommended

Prior Authorization is recommended for Panhematin. Approvals are generally for up to 1 year and require that patients meet the listed clinical criteria and dosing. Because of the specialized skills required for evaluation and monitoring, Panhematin must be prescribed by or in consultation with a gastroenterologist, hepatologist, or a clinician who specializes in acute hepatic or intermittent porphyria. Requests for doses outside the established dosing will be reviewed case-by-case by a clinician (Medical Director or Pharmacist).

Approvals: up to 1 year
Prescriber: gastroenterologist, hepatologist, or porphyria specialist
Dosing exceptions reviewed case-by-case

Note

Prior Carbohydrate Therapy Context

Carbohydrate loading (glucose tablets or dextrose solutions) has been used in the early stages of an acute porphyria attack, but there are no clear data demonstrating benefit. Panhematin (hemin) is indicated when carbohydrate therapy is known or suspected to be inadequate; guidelines recommend hemin therapy for treatment of acute attacks and for prevention in patients with recurrent attacks (e.g., ≥ four attacks per year) with reassessment of ongoing prophylaxis every 6–12 months. Repeated long-term hemin treatment can lead to iron overload and hepatic injury; consider monitoring and specialist management.

Carbohydrate loading: used but not established effective
Panhematin indicated when carbohydrate therapy inadequate
Prophylaxis consideration for ≥ 4 attacks/year; reassess every 6–12 months
Monitor for iron overload and hepatic damage with long-term hemin

Documentation Required

Required Diagnostic and Prescriber Documentation

Diagnostic confirmation by biochemical testing (elevated urinary ALA or PBG) plus compatible clinical features is required. The medication must be prescribed by or in consultation with a gastroenterologist, hepatologist, or a clinician who specializes in the specific porphyria. Include documentation of age (≥16 years), test results confirming elevated ALA or PBG, clinical features consistent with acute hepatic or intermittent porphyria, relation to menstrual cycle when applicable, and planned dosing (up to 6 mg/kg IV once daily, no more frequently than every 14 days per 30 days).

Diagnostic tests: elevated urinary ALA or PBG documented
Clinical features: neurovisceral symptoms, abdominal pain, neuropathy, hepatic involvement, blistering lesions, etc.
Age: ≥ 16 years
Prescriber specialty documented
Planned dosing documented: up to 6 mg/kg IV once daily; frequency limits

Denial Risk

Not Recommended Indications

Requests for Panhematin for indications not listed in the Recommended Authorization Criteria are not recommended for approval. Criteria will be updated as new published data become available.

Denial risk for non‑listed indications

Key Definitions

Acute Hepatic Porphyria (AHP) — definition and subtypes

DefinitionAcute hepatic porphyrias (AHPs) are porphyrias with enzyme deficiency in the liver characterized by acute neurovisceral symptoms with or without cutaneous manifestations.

Included subtypesAcute intermittent porphyria (AIP), variegate porphyria (VP), 5-aminolevulinic acid dehydratase deficiency porphyria (ALAD), hereditary coproporphyria (HCP).

Typical clinical featuresIntermittent symptoms such as abdominal pain, constipation, muscle weakness, peripheral neuropathic pain, autonomic signs (rapid pulse, hypertension), insomnia, and emotional complications; VP and HCP often have photosensitivity.

Panhematin — description and typical indication

Agent descriptionPanhematin (hemin) is an intravenous hemin preparation derived from processed red blood cells used to treat acute intermittent porphyria attacks.

Indication contextIndicated to ameliorate recurrent attacks of acute intermittent porphyria (AIP) temporally related to the menstrual cycle when carbohydrate therapy is known or suspected to be inadequate.

Safety noteSafety and effectiveness in patients <16 years of age have not been established.

Clinical Background

Porphyrias are inherited or acquired metabolic disorders of heme biosynthesis that lead to accumulation of porphyrins or porphyrin precursors. The acute hepatic porphyrias (AHPs) are a subgroup with hepatic enzyme defects (including acute intermittent porphyria, variegate porphyria, hereditary coproporphyria, and ALAD deficiency) that present with intermittent neurovisceral symptoms such as severe abdominal pain, neuropathy, and autonomic dysfunction; some AHPs may also have cutaneous manifestations.

Management of acute attacks focuses on supportive care and therapies that suppress hepatic heme precursor production. Intravenous hemin (Panhematin) is indicated to ameliorate attacks of acute intermittent porphyria and is used in AHPs when carbohydrate therapy is inadequate or expected to be inadequate. Repeated hemin exposure may require monitoring (for example, iron stores), and prescribing should be by or in consultation with a gastroenterologist, hepatologist, or clinician experienced in AHP.

OpenPayer

Panhematin (hemin) Utilization Management — Coverage Criteria

Coverage and Authorization Criteria

Dosing and Coding Limits

Prescriber Requirements and Documentation

Key Definitions

Clinical Background