Centene Panhematin Coverage Update: Prior Auth

Coverage Criteria for Panhematin (hemin)

Acute Porphyria (initial)

Covered when ALL of the following are met

Acute Porphyria criteria: 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/limb/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; 2. Age ≥ 16 years; 3. Documentation of member's current body weight (kg); 4. Dose does not exceed 6 mg/kg in any 24-hour period.

Approval duration: 14 days

Prevention of Porphyria Attacks (off-label)

Covered when ALL of the following are met (off-label)

Prevention of porphyria attacks: 1. Diagnosis of acute porphyria (AIP, VP, or HCP) confirmed by history of at least a four-fold increase of urine ALA or PBG from a random urine sample within the past year; 2. Age ≥ 16 years; 3. Member has experienced ≥4 porphyria attacks per year defined as episodes requiring hospitalization, an urgent healthcare visit, or IV Panhematin; 4. Panhematin is not prescribed concurrently with Givlaari; 5. Documentation of member's current body weight (kg); 6. Dose is within the FDA maximum for any FDA‑approved indication or is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).

Approval duration: Medicaid/HIM 12 months; Commercial 6 months or to renewal date

Continuation Therapy

Criteria for continuation of therapy

Continuation for acute attacks: 1. Member currently receiving medication via Centene benefit or previously met initial approval criteria OR continuity of care applies; 2. Member is responding positively to therapy; 3. Documentation of member's current body weight (kg); 4. Member has not received more than 14 days of treatment with Hemin; 5. If request is for a dose increase, new dose does not exceed 6 mg/kg in any 24-hour period.

Approval duration: Up to 14 days

Continuation for prophylaxis: 1. Member currently receiving medication via Centene benefit or previously met initial approval criteria OR continuity of care applies; 2. Member is responding positively to therapy; 3. Documentation of member's current body weight (kg); 4. If request is for a dose increase, new dose is within FDA maximum for any FDA‑approved indication or is supported by practice guidelines/peer‑reviewed literature (prescriber must submit supporting evidence).

Approval duration: Medicaid/HIM 12 months; Commercial 6 months or to renewal date

Dosing and continuation criteria

Covered when ALL of the following dosing-related conditions are met

Dosing and duration: IV dosing 1–4 mg/kg/day (standard clinical practice 3–4 mg/kg/day) for 3–14 days based on clinical signs.duration: 3-14 days

Maximum 6 mg/kg per 24 hours

Repeat dosing interval: Repeat dose in more severe cases no earlier than every 12 hours.>=12 hours between repeat doses

Do not exceed 6 mg/kg in any 24-hour period

Continued therapy limitation: For acute porphyria continued therapy, member should not have received more than 14 days of treatment.<=14 days for acute treatment continuation

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation of efficacy and safety per the applicable off‑label use policy (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or there is other evidence of coverage supporting the use.

There are no explicit clinical exclusions listed in this policy. Clinical eligibility and coverage decisions should be made using the stated approval criteria and required documentation.

Uses that lack sufficient documentation of efficacy and safety as required by the applicable off‑label use policy are considered not authorized. Providers must supply the evidence and clinical data specified by off‑label policy references when requesting coverage for non‑FDA indications.

Coding information provided in this policy is for reference only and does not guarantee coverage. Inclusion or omission of codes is informational; lack of required clinical documentation (for example, diagnostic labs or weight for dosing calculations) may render a request unapprovable or affect reimbursement.

Initial Therapy Criteria

Prior Authorization

Prior Authorization / Documentation Callouts

Prior authorization is required for Panhematin (hemin). Provider must submit documentation supporting the diagnosis, weight (kg) for dose calculation, laboratory confirmation, and dosing rationale. Incomplete documentation may result in denial. Non-covered indications include uses not consistent with the FDA-approved indication or policy criteria.

Prior authorization required
Documentation of current body weight in kg is required for dose calculation
Required documentation: clinical symptoms consistent with acute porphyria; laboratory evidence of ≥4-fold increase in urine ALA or PBG within the past year; dosing plan not to exceed 6 mg/kg in any 24-hour period; treatment duration and clinical rationale
Documentation insufficiency / Non-covered indications: uses outside the FDA-approved indication (e.g., to repair neuronal damage or for unconfirmed diagnoses) may be denied
Step therapy: carbohydrate loading (e.g., ~400 g glucose/day for 1–2 days) should be considered prior to hemin per FDA labeling; documentation of attempted carbohydrate therapy or reason it was not attempted should be provided when applicable

Initial Therapy Criteria

Covered when ALL of the following are met:

Continuation and Renewal Criteria

Continuation

Continuation/renewal requirements for members already receiving therapy

Continuation: Member must be currently receiving medication via Centene benefit or have previously met initial approval, be responding positively to therapy, provide documentation of current body weight (kg), and meet dosing constraints (member has not received >14 days of Hemin; dose increases must not exceed 6 mg/kg/24h).

Continued therapy limits

Rules for continued treatment after initial administration

Duration cap: Member should not receive more than 14 days of treatment for acute porphyria continued therapy.<=14 days

Criterion added in 1Q 2026 review

Provider Actions, Documentation, and Prior Authorization

Prior Authorization

Prior authorization — show diagnostic criteria and eligibility

Prior authorization is required. The request must demonstrate the member meets diagnostic criteria (clinical symptoms consistent with acute porphyria and a history of at least a four‑fold increase in urine ALA or PBG within the past year), age ≥16 years, documentation of current body weight, and dosing within limits (not exceeding 6 mg/kg in any 24‑hour period).

Clinical symptoms examples: abdominal pain, neuropathy, hyponatremia, tachycardia, sweating, tremor, dysuria, incontinence, constipation, nausea, vomiting.
Laboratory confirmation: ≥4× upper limit of normal for urine ALA or PBG (random sample) within past year.
Age requirement: ≥16 years.

Prior Authorization

Reference HCPCS J1640 and include clinical documentation

Prior authorization requests must reference HCPCS code J1640 (Injection, hemin, 1 mg) and include supporting clinical documentation (diagnosis, weight, indication, and relevant labs).

Include J1640 on authorization submission.
Attach clinical documentation: diagnosis, current body weight, and urine ALA/PBG results.

Coding and Billing

HCPCS Codes referencedHCPCS

J1640

Injection, hemin, 1 mg

inv-10: Diagnostic urinary marker elevation — >= 4x upper limit of normal for urine ALA or PBG (random sample)

Diagnostic threshold>= 4x upper limit of normal for urine ALA or PBG (random urine sample)

Sample typeRandom urine sample

Supporting noteVariations in lab reference ranges and reporting may differ; 4x ULN on random sample is appropriate evaluative tool (Appendix D)

inv-11: Maximum daily dose — 6 mg/kg in any 24-hour period

Maximum daily dose6 mg/kg in any 24-hour period

Clinical dosing cap relevanceDose constraint applied to initial and continued therapy; requests must not exceed this limit

Step Therapy Considerations

Step	Requirement / Description
1	Consider carbohydrate loading (e.g., 400 g glucose/day for 1–2 days) prior to administering Panhematin as initial therapy.

Step	Requirement / Description
1	No explicit step therapy sequence is specified in the policy; the 1Q 2026 update added an off‑label prevention indication but did not define preceding step requirements.

Quantity Limits and Vial Information

inv-31: Panhematin (hemin for injection) — Dose per clinical dosing guidance

ProductPanhematin (hemin for injection)

Dosing guidanceDose per clinical dosing guidance: mg/kg-based IV dosing for acute attacks (standard practice 3–4 mg/kg/day; 1–4 mg/kg/day recommended)

Administration routeIV (intravenous)

inv-32: Panhematin (hemin) — Dose based on mg/kg; vial size 350 mg single-dose

Vial strengthSingle-dose lyophilized powder vial: 350 mg

Dose basisDosing based on mg/kg (calculate using current body weight)

Dose preparation

Site of Care / Administration

Note

IV administration permitted in infusion settings; site of care not restricted

Panhematin is administered intravenously per the dosing regimen; the policy does not restrict a specific site of care and allows administration in infusion settings as appropriate.

IV dosing 1–4 mg/kg/day (standard 3–4 mg/kg/day) for 3–14 days per clinical signs.
Site of care is not specifically restricted in the policy.

Note

IV administration—typical infusion settings implied, not mandated

IV administration is required per dosing regimen; typical infusion center settings are implied but the policy does not mandate a specific infusion location.

Dosing and administration are intravenous and based on mg/kg dosing guidance.
Setting (infusion center) is typical but not prescriptively required by the policy.

Background

Hemin (Panhematin) is indicated for the amelioration of recurrent attacks of acute intermittent porphyria (AIP). Per product dosing guidance, IV administration is typically 1 to 4 mg/kg/day (with common clinical practice at 3–4 mg/kg/day) for 3 to 14 days based on clinical signs, and doses must not exceed 6 mg/kg in any 24‑hour period.

Definitions and Terms

inv-21: acute intermittent porphyria — AIP

AcronymAIP = acute intermittent porphyria

Related termsAlso listed: VP = variegate porphyria; HCP = hereditary coproporphyria

ContextAIP is the primary acute hepatic porphyria indication addressed in this policy

inv-22: 5-aminolevulinic acid — ALA

AbbreviationALA = 5-aminolevulinic acid

RoleUrinary ALA elevation (>=4x ULN) used with clinical symptoms to confirm acute porphyria diagnosis

Testing note

Revision History and Policy Updates

2025-11-06material_changeLatest

Added off-label indication for prevention of porphyria attacks and added continued therapy criterion ensuring members have not received more than 14 days of treatment.

2024-02-09clarification

Corrected example symptom wording from 'hypernatremia' to 'hyponatremia' during the 1Q 2024 annual review.

2022-01-01administrative

OpenPayer

Clinical Policy: Hemin (Panhematin)

Coverage Criteria for Panhematin (hemin)

Initial Therapy Criteria

Continuation and Renewal Criteria

Provider Actions, Documentation, and Prior Authorization

Coding and Billing

Step Therapy Considerations

Quantity Limits and Vial Information

Site of Care / Administration

Background

Definitions and Terms

Revision History and Policy Updates