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UTILIZATION MANAGEMENT MEDICAL POLICY Hemophilia Factor IX Products Utilization Management Medical Policy Extended Half-Life_Recombinant Products

Policy Summary

PayerCareSource

PolicyUTILIZATION MANAGEMENT MEDICAL POLICY Hemophilia Factor IX Products Utilization Management Medical Policy Extended Half-Life_Recombinant Products

Policy CodePolicy N/A

Change TypeAnnual revision; no criteria changes

Effective DateFeb 19, 2025

Next Review Date

Key ActionSubmit prior authorization requests for any listed Factor IX product and include documentation of hemophilia specialist involvement; approvals are typically granted for 1 year and must follow product-specific dosing limits.

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POLICY UPDATE CHANGES

Annual Revision, Review Date = 02/19/2025 with summary: No criteria changes.

Mononine was removed from the policy as it is obsolete (02/28/2024).

8Listed Factor IX products

1 yearTypical approval duration

No criteria changesLatest revision impact

Coverage Summary

Defines prior authorization recommendation, coverage criteria, dosing limits, indications, and prescribing requirements for Factor IX products (Alprolix, Idelvion, Rebinyn, BeneFIX, Ixinity, Rixubis, AlphaNine SD, Profilnine) for treatment of hemophilia B and select other factor deficiencies under the medical benefit. Prior authorization is recommended and the agent must be prescribed by or in consultation with a hemophilia specialist; approvals are generally for 1 year.

Specifies product-specific dosing thresholds and frequency limits for routine prophylaxis, on-demand treatment, and perioperative management (e.g., extended half-life recombinants up to 100 IU/kg no more frequently than once weekly for routine prophylaxis; standard half-life recombinants up to 100 IU/kg no more frequently than twice weekly for routine prophylaxis; plasma-derived products up to 50 IU/kg no more frequently than twice weekly for routine prophylaxis).

Includes Profilnine off-label use for Factor II and Factor X deficiencies with limited supporting evidence; Profilnine may be approved for these other factor deficiencies when prescribed by or in consultation with a hemophilia specialist (approved for 1 year with dosing aligned to hemophilia B recommendations).

Status: CURRENT; history notes annual review with no material criteria changes and prior administrative removal of an obsolete product (Mononine).

Key thresholds / Quick facts

Approval duration1 year

Alprolix/Idelvion/Rebinyn routine prophylaxis<= once weekly; dose <= 100 IU/kg

Alprolix/Idelvion/Rebinyn on-demand>= 6 hours between doses; up to 10 days; dose <= 100 IU/kg

Alprolix/Idelvion/Rebinyn perioperative>= 24 hours between doses; up to 10 days; dose <= 100 IU/kg

BeneFIX/Ixinity/Rixubis routine prophylaxis<= twice weekly; dose <= 100 IU/kg

BeneFIX/Ixinity/Rixubis on-demand>= 12 hours between doses; up to 10 days; dose <= 100 IU/kg

BeneFIX/Ixinity/Rixubis perioperative>= 8 hours between doses; up to 10 days; dose <= 100 IU/kg

AlphaNine SD/Profilnine routine prophylaxis<= twice weekly; dose <= 50 IU/kg

AlphaNine SD/Profilnine on-demand/perioperative<= twice daily; up to 10 days; dose <= 100 IU/kg

Medical-Necessity Criteria

General Prior Authorization and Prescriber Requirement

Prior Authorization is recommended and agent must be prescribed by or in consultation with a hemophilia specialist.

ALL of the following

Prior Authorization is required for medical benefit coverage of Alprolix, Idelvion, Rebinyn, BeneFIX, Ixinity, Rixubis, AlphaNine SD, and Profilnine.
Agent must be prescribed by or in consultation with a physician who specializes in the condition being treated (hemophilia specialist).

FDA-Approved Indication: Hemophilia B

Approve the requested agent for 1 year if prescribed by/with a hemophilia specialist; approve ONE of the following dosing regimens as applicable to the product.

Product-specific dosing and frequency

Alprolix, Idelvion, Rebinyn — Routine prophylaxis: Approve up to 100 IU per kg intravenously at an interval no more frequently than once weekly.Dose <= 100 IU/kg; frequency <= once weekly
Alprolix, Idelvion, Rebinyn — On-demand treatment and control of bleeding episodes: Approve up to 100 IU per kg intravenously no more frequently than once every 6 hours for up to 10 days per episode.Dose <= 100 IU/kg; >=6 hours between doses; duration <= 10 days
Alprolix, Idelvion, Rebinyn — Perioperative management: Approve up to 100 IU per kg intravenously no more frequently than once every 24 hours for up to 10 days per procedure.Dose <= 100 IU/kg; >=24 hours between doses; duration <= 10 days
BeneFIX, Ixinity, Rixubis — Routine prophylaxis: Approve up to 100 IU per kg intravenously no more frequently than twice weekly.Dose <= 100 IU/kg; frequency <= twice weekly
BeneFIX, Ixinity, Rixubis — On-demand treatment and control of bleeding episodes: Approve up to 100 IU per kg intravenously no more frequently than once every 12 hours for up to 10 days per episode.Dose <= 100 IU/kg; >=12 hours between doses; duration <= 10 days
BeneFIX, Ixinity, Rixubis — Perioperative management: Approve up to 100 IU per kg intravenously no more frequently than once every 8 hours for up to 10 days per procedure.Dose <= 100 IU/kg; >=8 hours between doses; duration <= 10 days
AlphaNine SD and Profilnine — Routine prophylaxis: Approve up to 50 IU per kg intravenously no more frequently than twice weekly.Dose <= 50 IU/kg; frequency <= twice weekly
AlphaNine SD and Profilnine — On-demand treatment of bleeding episodes and perioperative management: Approve up to 100 IU per kg intravenously no more frequently than twice daily for up to 10 days.Dose <= 100 IU/kg; frequency <= twice daily; duration <= 10 days

Other Supported Indications (Profilnine only)

Profilnine may be approved for other factor deficiencies with supportive evidence when prescribed by/with a hemophilia specialist; approve for 1 year.

ANY of the following

Factor II deficiency (Profilnine): Approve Profilnine for 1 year when prescribed by or in consultation with a hemophilia specialist. Dosing: Routine prophylaxis — up to 50 IU per kg IV no more frequently than twice weekly; On-demand and perioperative — up to 100 IU per kg IV no more frequently than twice daily for up to 10 days.Prophylaxis dose <=50 IU/kg twice weekly; On-demand/periop dose <=100 IU/kg twice daily; duration <=10 days
Factor X deficiency (Profilnine): Approve Profilnine for 1 year when prescribed by or in consultation with a hemophilia specialist. Limited dosing available; recommended dosing per hemophilia B guidance: Routine prophylaxis up to 50 IU per kg IV no more frequently than twice weekly; On-demand/perioperative up to 100 IU per kg IV no more frequently than twice daily for up to 10 days.Prophylaxis dose <=50 IU/kg twice weekly; On-demand/periop dose <=100 IU/kg twice daily; duration <=10 days

Conditions Not Recommended for Approval

Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria.

Coverage is not recommended for indications or circumstances other than those explicitly listed in the Recommended Authorization Criteria.

Criteria will be updated as new published data are available.

Provider Actions

Prior Authorization

Prior Authorization required

Submit a prior authorization request for any listed Factor IX product (Alprolix, Idelvion, Rebinyn, BeneFIX, Ixinity, Rixubis, AlphaNine SD, Profilnine). Approval is recommended when the patient meets the stated clinical criteria and product-specific dosing regimens. Approvals are granted for a duration of 1 year.

Documentation Required

Specialist involvement required

The agent must be prescribed by, or in consultation with, a physician who specializes in the condition being treated (a hemophilia specialist). Documentation of specialist involvement should be provided with the authorization request.

Billing Rule

Dosing limits enforce authorization

Authorizations are aligned to product-specific dosing limits (IU/kg), dosing frequency, and maximum duration per episode or procedure. Requests for doses or frequencies outside these established limits require additional review (for example, by a Medical Director or Pharmacist).

Alprolix/Idelvion/Rebinyn routine prophylaxis: up to 100 IU/kg, no more frequently than once weekly
Alprolix/Idelvion/Rebinyn on-demand: up to 100 IU/kg, no more frequently than every 6 hours, up to 10 days
Alprolix/Idelvion/Rebinyn perioperative: up to 100 IU/kg, no more frequently than every 24 hours, up to 10 days
BeneFIX/Ixinity/Rixubis routine prophylaxis: up to 100 IU/kg, no more frequently than twice weekly
BeneFIX/Ixinity/Rixubis on-demand: up to 100 IU/kg, no more frequently than every 12 hours, up to 10 days
BeneFIX/Ixinity/Rixubis perioperative: up to 100 IU/kg, no more frequently than every 8 hours, up to 10 days
AlphaNine SD/Profilnine routine prophylaxis: up to 50 IU/kg, no more frequently than twice weekly
AlphaNine SD/Profilnine on-demand/perioperative: up to 100 IU/kg, no more frequently than twice daily, up to 10 days

Background, Evidence, and Definitions

Policy covers extended half-life recombinant Factor IX products (Alprolix, Idelvion, Rebinyn), standard half-life recombinant Factor IX products (BeneFIX, Ixinity, Rixubis), and plasma-derived Factor IX products (AlphaNine SD, Profilnine).

Both routine prophylactic and on-demand (acute bleeding) dosing strategies are included, as well as perioperative management; the policy specifies product-specific IU/kg dosing limits and maximum dosing frequencies and durations for each use case.

Profilnine is noted for additional off-label uses in Factor II and Factor X deficiencies with limited available data; approval for these indications is allowed when prescribed by or in consultation with a hemophilia specialist and is limited to 1 year with dosing aligned to the hemophilia B regimens (routine prophylaxis up to 50 IU/kg twice weekly; on-demand/perioperative up to 100 IU/kg up to twice daily for up to 10 days).

Evidence sources include guideline recommendations from the National Bleeding Disorders Foundation MASAC (2024) and the International Society on Thrombosis and Haemostasis (ISTH, 2024).

Product prescribing information cited: Alprolix (2023), Idelvion (2023), Rebinyn (2022), BeneFIX (2022), Rixubis (2023), Ixinity (2024), AlphaNine SD (2022), Profilnine (2022).

Term	Definition
Routine prophylaxis
Scheduled factor replacement infusions to prevent bleeding, dosing and frequency as specified per product (e.g., up to 100 IU/kg no more frequently than once weekly for some agents; up to 50 IU/kg no more frequently than twice weekly for plasma-derived products).
On-demand treatment
Factor replacement given to control acute bleeding episodes, with dosing limits and maximum duration per episode as specified per product (e.g., up to 100 IU/kg no more frequently than every 6–12 hours for up to 10 days depending on product).

OpenPayer

UTILIZATION MANAGEMENT MEDICAL POLICY Hemophilia Factor IX Products Utilization Management Medical Policy Extended Half-Life_Recombinant Products

Coverage Summary

Medical-Necessity Criteria

Coding

Provider Actions

Background, Evidence, and Definitions

Revision History

Alprolix	Coagulation Factor IX (recombinant) Fc fusion protein, extended half-life
Idelvion	Coagulation Factor IX (recombinant) albumin fusion protein, extended half-life
Rebinyn	Coagulation Factor IX (recombinant) glycoPEGylated, extended half-life
BeneFIX	Coagulation Factor IX (recombinant), standard half-life
Ixinity	Coagulation Factor IX (recombinant), standard half-life
Rixubis	Coagulation Factor IX (recombinant), standard half-life
AlphaNine SD	Factor IX Complex (plasma-derived), standard half-life
Profilnine	Factor IX Complex (plasma-derived), used also for Factor II and X deficiencies