CurrentCignaPolicy IP0623

Factor IX Products

Cigna policy governing prior authorization, coverage criteria, dosing, and coding for recombinant and plasma-derived Factor IX products used to treat hemophilia B (and selected other factor deficiencies) for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyFactor IX Products

Policy CodePolicy IP0623

Change TypeDosing addednew stand‑alone policy

Effective DateMay 1, 2026

Next Review Date

Key ActionSubmit prior authorization with specialist documentation and dosing that matches an approved regimen to obtain up to 1 year approval.

SourceLink

POLICY UPDATE CHANGES

Added dosing to the policy for all products.

New stand-alone policy created; criteria previously housed in Clotting Factors and Antithrombin class policy.

Mononine was removed as it is obsolete.

Annual revisions with no criteria changes recorded on 05/15/2025 and 05/01/2026.

8Products listed

1 yearStandard approval

100 IU/kgCommon per-dose max

J7193-J7213HCPCS J-codes listed

Coverage Criteria for Factor IX Products

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FDA-Approved Indications and Dosing

Covered when ALL of the following are met for the specified agents:

General prior auth and prescriber requirement: Prior authorization required; agent prescribed by or in consultation with a hemophilia specialist

Approvals provided for the duration noted (typically 1 year).

Covered indications for Alprolix, Idelvion, Rebinyn, BeneFIX, Ixinity, Rixubis

Dosing group A (Alprolix, Idelvion, Rebinyn): i. Routine prophylaxis: approve up to 100 IU/kg IV no more frequently than once weekly; AND/OR ii. On-demand treatment: approve up to 100 IU/kg IV no more frequently than every 6 hours for up to 10 days per episode; AND/OR iii. Perioperative management: approve up to 100 IU/kg IV no more frequently than every 24 hours for up to 10 days per procedure.
Any of i-iii (A) can be approved.
Dosing group B (BeneFIX, Ixinity, Rixubis): i. Routine prophylaxis: approve up to 100 IU/kg IV no more frequently than twice weekly; AND/OR ii. On-demand treatment: approve up to 100 IU/kg IV no more frequently than every 12 hours for up to 10 days; AND/OR iii. Perioperative management: approve up to 100 IU/kg IV no more frequently than every 8 hours for up to 10 days; AND/OR iv. Immune tolerance therapy: approve up to 200 IU/kg IV no more frequently than once daily.
Any of i-iv (B) can be approved.

Covered indications for AlphaNine SD and Profilnine

Dosing for plasma-derived products: A) Routine prophylaxis: approve up to 50 IU/kg IV no more frequently than twice weekly; AND/OR B) On-demand and perioperative management: approve up to 100 IU/kg IV no more frequently than twice daily for up to 10 days; AND/OR C) Immune tolerance therapy: approve up to 200 IU/kg IV once daily.
Any of A-C can be approved.

Other Uses with Supportive Evidence

Covered when ALL of the following are met for Profilnine:

Other supported uses: Factor II deficiency or Factor X deficiency when prescribed by or in consultation with a hemophilia specialist

Approve for 1 year; limited dosing available — recommended dosing for hemophilia B is cited when applicable: A) Routine prophylaxis: up to 50 IU/kg IV no more frequently than twice weekly; AND/OR B) On-demand and perioperative management: up to 100 IU/kg IV no more frequently than twice daily for up to 10 days.

Use of Alprolix, Idelvion, Rebinyn, BeneFIX, Ixinity, Rixubis, AlphaNine, or Profilnine for any indication not expressly listed in this policy is considered not medically necessary and will not be covered.

Any other uses not specified in the policy statements are considered not medically necessary. The coverage criteria in this policy will be updated as new published data become available.

Coding and Dose Limits

Considered medically necessary HCPCS J-codesHCPCSCovered

J7193	Factor IX (antihemophilic factor, purified, nonrecombinant), per IU
J7194	Factor IX, complex, per IU
J7195	Injection, Factor IX (antihemophilic factor, recombinant), per IU, not otherwise specified
J7200	Injection, Factor, IX, (antihemophilic factor, recombinant), Rixubis, per IU
J7201	Injection, Factor IX, fc fusion protein (recombinant), Alprolix, 1 IU
J7202	Injection, Factor IX, albumin fusion protein, (recombinant), Idelvion, 1 IU
J7203	Injection Factor IX, (antihemophilic factor, recombinant), glycoPEGylated, (Rebinyn), 1 iu
J7213	Injection, coagulation factor IX (recombinant), Ixinity, 1 IU

Dose limits referenced

Common per-dose maximum for many agentsUp to 100 IU/kg per dose for routine prophylaxis, on-demand treatment, and perioperative management (varies by product and indication).

Plasma-derived prophylaxis limitUp to 50 IU/kg per dose for routine prophylaxis with plasma-derived products (no more frequently than twice weekly).

Immune tolerance induction (I.T.I.) limitUp to 200 IU/kg per dose for immune tolerance therapy, typically no more frequently than once daily.

Frequency considerations for extended half-life productsAlprolix, Idelvion, Rebinyn: routine prophylaxis up to 100 IU/kg no more frequently than once weekly; on‑demand/perioperative regimens reference 100 IU/kg with specified maximum dosing intervals.

Frequency considerations for standard half-life productsBeneFIX, Ixinity, Rixubis: routine prophylaxis up to 100 IU/kg no more frequently than twice weekly; on‑demand and perioperative regimens reference 100 IU/kg with specified maximum dosing intervals.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization is required for benefit coverage of listed Factor IX products (Alprolix, Idelvion, Rebinyn, BeneFIX, Ixinity, Rixubis, AlphaNine, Profilnine). Approvals may be granted for up to 1 year when the agent is prescribed by or in consultation with a hematology/hemophilia specialist. Requests for doses outside the established dosing in this policy will be reviewed case-by-case by a clinician (Medical Director or Pharmacist).

Prior authorization required for Alprolix, Idelvion, Rebinyn, BeneFIX, Ixinity, Rixubis, AlphaNine, and Profilnine.
Approvals up to 1 year when prescribed by or in consultation with a hemophilia specialist.
Requests for doses outside policy dosing considered case-by-case by clinician.

Note

Specialist Prescribing Requirement

Because of the specialized skills required for evaluation, diagnosis, and monitoring of patients treated with recombinant Factor IX products, the agent must be prescribed by or in consultation with a physician who specializes in the condition being treated (for example, a hematology/hemophilia specialist).

Billing Rule

Coding and Claim Submission Requirements

Claims submitted without covered diagnosis and/or procedure codes referenced in the applicable Coverage Policy may be denied. Providers must use the most appropriate codes as of the date of submission. Reimbursement will only be provided if the requested service is submitted in accordance with the relevant criteria outlined in this policy, including covered diagnosis and/or procedure code(s).

Claims submitted for services not accompanied by covered code(s) under this policy will be denied as not covered.
Use the most appropriate diagnosis/procedure codes effective on the submission date.

OpenPayer

Factor IX Products

Coverage Criteria for Factor IX Products

Coding and Dose Limits

Provider Requirements and Prior Authorization

Background

Key Definitions