CurrentCareSourcePolicy N/A

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

Defines prior authorization and medical necessity criteria, dosing limits, and recommended approvals for recombinant and plasma-derived Factor IX products (Alprolix, Idelvion, Rebinyn, BeneFIX, Ixinity, Rixubis, AlphaNine SD, Profilnine) for treatment of Hemophilia B and select other factor deficiencies.

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 ActionPrior Authorization is recommended; approve listed Factor IX products only if the specified criteria and dosing are met.

SourceLink

POLICY UPDATE CHANGES

Annual Revision on 02/19/2025 with 'No criteria changes' noted in history.

Mononine was removed previously as it is obsolete (noted in 02/28/2024 history).

8Listed Factor IX products

1Non-FDA supported uses listed

0Material criteria changes in revision

Coverage Summary

Payer: UTILIZATION MANAGEMENT MEDICAL POLICY. Policy Title: Hemophilia Factor IX Products Utilization Management Medical Policy. Effective date (review date): 02/19/2025 (annual revision noted with no criteria changes). Coverage stance: Covered with criteria (prior authorization recommended). This policy defines prior authorization and medical necessity criteria, dosing limits, and specialist prescriber requirements for recombinant extended‑half‑life, recombinant standard‑half‑life, and plasma‑derived Factor IX products.

Covered agents: Alprolix, Idelvion, Rebinyn, BeneFIX, Rixubis, Ixinity, AlphaNine SD, Profilnine. The policy also identifies a single non‑FDA supported but supported use: Profilnine for Factor II and Factor X deficiencies (approved for 1 year when criteria are met).

Dosing thresholds (high-level)

Extended agents — routine prophylaxis≤100 IU/kg, no more frequently than once weekly

Extended agents — on-demand treatment≤100 IU/kg, every ≥6 hours; duration ≤10 days

Extended agents — perioperative≤100 IU/kg, every ≥24 hours; duration ≤10 days

Standard agents — routine prophylaxis≤100 IU/kg, up to twice weekly

Standard agents — on-demand treatment≤100 IU/kg, every ≥12 hours; duration ≤10 days

Standard agents — perioperative≤100 IU/kg, every ≥8 hours; duration ≤10 days

AlphaNine/Profilnine — routine prophylaxis≤50 IU/kg, up to twice weekly

AlphaNine/Profilnine — on-demand/perioperative≤100 IU/kg, up to twice daily; duration ≤10 days

Recommended Authorization / Medical Necessity

General Prior Authorization and Prescriber Requirement

Prior Authorization is recommended; approve when ALL of the following are met:

ALL of the following

Requested agent is one of: Alprolix, Idelvion, Rebinyn, BeneFIX, Ixinity, Rixubis, AlphaNine SD, Profilnine
Agent is prescribed by or in consultation with a physician who specializes in hemophilia or the condition being treated
Requested use meets the specific FDA-approved indication dosing regimen listed for the agent (see agent-specific trees)

FDA-Approved Indication for Hemophilia B (Agents: Alprolix, Idelvion, Rebinyn, BeneFIX, Ixinity, Rixubis)

Approve ONE of the dosing regimens below for Hemophilia B when prescribed by or in consultation with a hemophilia specialist:

ANY of the following

Extended half-life agents (Alprolix, Idelvion, Rebinyn): Routine prophylaxis
- Approve up to 100 IU per kg intravenously at an interval no more frequently than once weekly≤100 IU/kg; interval ≥ once weekly
Extended half-life agents (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≤100 IU/kg; interval ≥ 6 hours; duration ≤ 10 days
Extended half-life agents (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

AlphaNine SD and Profilnine (Plasma-derived) - Hemophilia B

Approve when ALL of the following are met:

ALL of the following

Indication: Hemophilia B
Dosing options
- Routine prophylaxis: approve up to 50 IU per kg intravenously no more frequently than twice weekly≤50 IU/kg; interval ≥ twice weekly
- On-demand treatment and control 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≤100 IU/kg; interval ≥ twice daily; duration ≤ 10 days

Profilnine - Other Supported Uses (Factor II and Factor X Deficiencies)

Approve Profilnine for 1 year when prescribed by or in consultation with a hemophilia specialist and ALL dosing criteria below are met:

ALL of the following

Indication
- Factor II deficiency
- Factor X deficiency
Dosing options (use recommended Hemophilia B dosing where limited data exist)
- Routine prophylaxis: approve up to 50 IU per kg intravenously no more frequently than twice weekly≤50 IU/kg; interval ≥ twice weekly

Exclusions / Not Recommended

Coverage is not recommended when the request does not meet the Recommended Authorization Criteria

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

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required

Prior Authorization is recommended for medical benefit coverage of listed Factor IX products; approval granted only if criteria and dosing are met.

Documentation Required

Specialist prescriber or consultation required

Agent must be prescribed by or in consultation with a physician who specializes in hemophilia or the condition being treated.

Billing Rule

Approval duration and dose exceptions

Approvals are provided for the duration noted (typically 1 year for non‑FDA uses like Profilnine in Factor II/X deficiency); requests for doses outside established dosing may require review by Medical Director or Pharmacist.

Typical approval duration: 1 year for non‑FDA uses (e.g., Profilnine for Factor II/X)

Background and Guidelines

Scope: This policy covers recombinant extended‑half‑life Factor IX products (Alprolix, Idelvion, Rebinyn), recombinant standard‑half‑life Factor IX products (BeneFIX, Ixinity, Rixubis), and plasma‑derived Factor IX products (AlphaNine SD, Profilnine) for management of patients with hemophilia B and selected other factor deficiencies where supported (see Profilnine for Factor II/X).

Incidence and clinical features: Hemophilia B is an X‑linked recessive bleeding disorder caused by factor IX gene mutations occurring in about 1 in 30,000 male births and affecting roughly ~5,000 people in the US. Severity is classified by factor IX activity level: <1% = severe, 1%–5% = moderate, and >5%–40% = mild. Severe disease is associated with spontaneous bleeding (eg, hemarthrosis, intracerebral hemorrhage) and risk of joint disease and disability.

Inhibitor risk and treatment implications: Development of inhibitors to factor concentrates is less frequent than in hemophilia A but can occur in up to ~5% of patients; higher doses and specialized management may be required if inhibitors develop.

Guideline support: The policy references contemporary guideline sources including the National Bleeding Disorders Foundation / MASAC recommendations and the International Society on Thrombosis and Haemostasis (ISTH) clinical practice guideline (both cited 2024) as supporting documents for the role and use of Factor IX products.

Guideline referencesMASAC (2024) and ISTH guideline (2024)

Definitions

Routine prophylaxis: Scheduled infusions to prevent bleeding; dosing frequency and maximum IU/kg are specified per agent class (examples: extended‑half‑life agents up to 100 IU/kg no more frequently than once weekly; standard agents up to 100 IU/kg no more frequently than twice weekly; plasma‑derived agents up to 50 IU/kg no more frequently than twice weekly).

On‑demand treatment: Intermittent dosing to control acute bleeding episodes; dosing frequency, IU/kg, and duration limits are specified (examples: extended agents up to 100 IU/kg no more frequently than every 6 hours for up to 10 days; standard agents up to 100 IU/kg no more frequently than every 12 hours for up to 10 days; plasma‑derived agents up to 100 IU/kg no more frequently than twice daily for up to 10 days).

Perioperative management: Dosing around surgical procedures with specified frequency and duration limits (examples: extended agents up to 100 IU/kg no more frequently than every 24 hours for up to 10 days; standard agents up to 100 IU/kg no more frequently than every 8 hours for up to 10 days; plasma‑derived agents follow Hemophilia B dosing recommendations where data are limited, e.g., up to 100 IU/kg no more frequently than twice daily for up to 10 days).

OpenPayer

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

Coverage Summary

Recommended Authorization / Medical Necessity

Product Coding (by coverage status)

Provider Actions & Authorization Requirements

Background and Guidelines

Definitions

Revision History

Alprolix	Coagulation Factor IX (recombinant) Fc fusion protein intravenous infusion
Idelvion	Coagulation Factor IX (recombinant) albumin fusion protein intravenous infusion
Rebinyn	Coagulation Factor IX (recombinant) glycoPEGylated intravenous infusion
BeneFIX	Coagulation Factor IX (recombinant) intravenous infusion
Rixubis	Coagulation Factor IX (recombinant) intravenous infusion
Ixinity	Coagulation Factor IX (recombinant) intravenous infusion
AlphaNine SD	Factor IX Complex (plasma-derived) intravenous infusion
Profilnine	Plasma-derived Factor IX intravenous infusion (also used for Factor II and X deficiencies)