ModifiedCentenePolicy CP.PHAR.218

Clinical Policy: Factor IX (Human, Recombinant)

Coverage and prior authorization criteria for factor IX replacement products for treatment and prophylaxis of congenital hemophilia B for Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyClinical Policy: Factor IX (Human, Recombinant)

Policy CodePolicy CP.PHAR.218

Change TypeMaterial updates — codes, durations, dosing documentation, indication/dosage form added

Effective Date05.01.16

Next Review Date

Key ActionSubmit prior authorization with documentation including current body weight (kg) and evidence meeting the listed criteria.

SourceLink

POLICY UPDATE CHANGES

Added HCPCS code J7213.

Extended initial and continued authorization durations for hemophilia prophylaxis from 6 months to 12 months for Medicaid/HIM lines of business; commercial prophylaxis durations revised to 6 months or to member's renewal date.

Clarified that documentation of body weight is required for calculation of appropriate dosage; for continued therapy member's current weight is only needed if a higher dose is requested.

Added newly approved indication for Rebinyn for routine prophylaxis and new 3,000 IU dosage form.

8products requiring PA

6 mocommercial prophylaxis duration

12 moMedicaid/HIM prophylaxis duration

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Yesweight documentation required

Coverage Criteria for Factor IX Products

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial Approval: 1. Diagnosis of congenital hemophilia B (factor IX deficiency).

Prescriber: 2. Prescribed by or in consultation with a hematologist.

Age (AlphaNine only): 3. For AlphaNine SD requests only: member age >= 17 years when specified by product labeling.

Follow product-specific age and indication notes from manufacturer labeling.

Indication: 4. Indication is for control and prevention of bleeding episodes, perioperative management, or routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

Prophylaxis product restriction: 5. Routine prophylaxis requests are limited to Alprolix, BeneFIX, Idelvion, Ixinity, Rebinyn, or Rixubis (per product labeling).

Weight documentation: 6. Documentation of the member's current body weight (in kg) is provided to support dosing calculations.

Providers must submit office chart notes, lab results or other clinical information supporting that member has met all approval criteria.

Dose limit: 7. Requested dose does not exceed the FDA‑approved maximum recommended dose for the relevant product and indication.

See product-specific maximum doses in dosing sections (e.g., AlphaNine SD, BeneFIX, Alprolix, Idelvion, Ixinity, Rebinyn).

Continued Therapy — Continued therapy covered when one of the following is met

Continued therapy covered when one of the following is met

Continued Therapy: a. Member is currently receiving the medication via the Centene benefit or has previously met initial approval criteria;

Continued Therapy: b. Member is currently receiving the medication and is enrolled in a state/product with continuity of care regulations (refer to state‑specific addendums).

Clinical response requirement: 2. Member is responding positively to therapy (clinical benefit observed).

Dose increase request: If request is for a dose increase, both: (a) documentation of the member's current body weight in kg is provided; and (b) the new dose does not exceed the FDA‑approved maximum recommended dose for the relevant indication.

Weight documentation is required only when a higher dose is requested.

Covered when indicated per product labeling

Covered when indicated per product labeling — product-specific indications and dosing for control/prevention of bleeding episodes, perioperative management, and prophylaxis

Product indications: Products are indicated for control and prevention of bleeding episodes and perioperative management; several products additionally have routine prophylaxis indications per their prescribing information (examples include BeneFIX, Idelvion, Ixinity, Rebinyn, Alprolix, Rixubis).

See product labeling for indication-specific details.

Dosing regimens — AlphaNine SD: AlphaNine SD dosing examples: minor bleeds 20–30 IU/kg IV twice, moderate 25–50 IU/kg IV twice daily, major 30–50 IU/kg IV twice daily for at least 3–5 days then maintenance; surgery 50–100 IU/kg IV twice daily before surgery then continued for 7–10 days. Maximums: bleeding episodes 100 IU/kg/day; surgery 200 IU/kg/day.

Dosing regimens — Mononine: Mononine dosing examples: minor episodes 20–30 IU/kg IV every 24 hours (maximum minor episodes 30 IU/kg/day); major trauma or surgery dosing per labeling (examples provided in product information).

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), or CP PMN.53 (Medicaid), or unless the member’s evidence of coverage document permits the use.

Specific product limitations apply: AlphaNine SD and Mononine contain low, non‑therapeutic levels of factors II, VII, and X and therefore are not indicated for treatment of factor II, VII, or X deficiencies. They are also not indicated for reversal of coumarin anticoagulant‑induced hemorrhage or for treatment of hemophilia A patients with inhibitors to factor VIII. Additionally, Mononine is not indicated in hemorrhagic states caused by hepatitis‑related hepatic factor deficiency. Separately, products including Alprolix, BeneFIX, Idelvion, Ixinity, Rebinyn, and Rixubis are not indicated for induction of immune tolerance in hemophilia B.

All coverage determinations under this policy are subject to the specific terms, conditions, exclusions, and limitations contained in the member’s coverage documents and to applicable state and federal requirements. When state Medicaid provisions conflict with this clinical policy, the state Medicaid provisions take precedence.

Coverage is governed by the member’s evidence of coverage, certificate of coverage, policy or contract of insurance and by applicable Health Plan administrative policies and procedures. The Health Plan retains the right to change, amend, or withdraw this clinical policy at any time; the policy does not constitute a contract or guarantee of payment.

Use of Factor IX products for non‑FDA approved indications without the required off‑label documentation or evidence described above is considered not medically necessary per the referenced off‑label use policies.

This clinical policy provides guidance to assist in medical necessity determinations and the administration of benefits but does not guarantee coverage. Providers must exercise clinical judgment and ensure requests comply with plan documents and any applicable legal or regulatory requirements.

Coding and Dosing Information

Products requiring prior authorizationmixed

AlphaNine SD	Factor IX, human (plasma-derived)
Mononine	Factor IX, human (plasma-derived)
Alprolix	Factor IX, recombinant
BeneFIX	Factor IX, recombinant
Idelvion	Factor IX, recombinant (albumin-fused)
Ixinity	Factor IX, recombinant
Rebinyn	Factor IX, recombinant
Rixubis	Factor IX, recombinant

Maximum dosing thresholds

AlphaNine SD maximum dose (bleeding episodes)100 IU/kg/day

AlphaNine SD maximum dose (surgery)200 IU/kg/day

Mononine maximum dose (minor episodes)30 IU/kg/day

Alprolix maximum dose (bleeding episodes)100 IU/kg/dose

Alprolix maximum dose (surgery)100 IU/kg/dose

Dose thresholds (per product)

AlphaNine SD dosing examples

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Determined by Plan Documents

Prior authorization is determined by the member's plan documents and the Health Plan may set the effective date for this clinical policy. Clinical policy criteria are used to assist coverage decisions but do not replace the terms, conditions, exclusions, and limitations of the member's evidence of coverage or contract.

Coverage decisions subject to evidence of coverage, certificate of coverage, policy, contract of insurance, and applicable state/federal requirements
Health Plan-level administrative policies and procedures may affect prior authorization requirements
Clinical policy effective date is as determined by the Health Plan

Documentation Required

Documentation Required for Prior Authorization

Providers must submit documentation supporting that the member meets all approval criteria. Incomplete documentation may result in delayed review or denial.

Background

Factor IX replacement products are indicated for on‑demand treatment of bleeding episodes, perioperative management, and for routine prophylaxis to reduce the frequency of bleeding in patients with congenital hemophilia B. Individual products have product‑specific labeled indications and dosing regimens (including prophylaxis schedules) that must be followed when seeking coverage; routine prophylaxis is an indicated use for several recombinant products per their prescribing information.

Definitions and Terms

Hemophilia B — definition

TermHemophilia B (congenital factor IX deficiency, 'Christmas disease')

Primary clinical useTreated with factor IX replacement products for control and prevention of bleeding episodes

Also treated forPerioperative management of bleeding

Routine prophylaxis — examples

DefinitionRoutine prophylaxis: regularly scheduled Factor IX dosing to reduce frequency of bleeding episodes (examples include weekly or twice-weekly regimens depending on product)

BeneFIX example100 IU/kg once weekly for prophylaxis

Policy Summary

PayerCentene

PolicyClinical Policy: Factor IX (Human, Recombinant)

Policy CodePolicy CP.PHAR.218

Change TypeMaterial updates — codes, durations, dosing documentation, indication/dosage form added

Effective Date05.01.16

Next Review Date

Key ActionSubmit prior authorization with documentation including current body weight (kg) and evidence meeting the listed criteria.

SourceLink

On This Page

Dosing regimens — Alprolix: Alprolix: indicated for control/prevention of bleeding episodes and perioperative management; maximum for bleeding episodes 100 IU/kg/dose and for surgery 100 IU/kg/dose per labeling. Dosing varies by bleed severity with possible repeat doses as clinically indicated.

Dosing regimens — BeneFIX: BeneFIX: minor 20–30 IU/kg IV every 12–24 hours, moderate 25–50 IU/kg every 12–24 hours, major 50–100 IU/kg; surgery 50–100 IU/kg IV every 12–24 hours. Routine prophylaxis example: 100 IU/kg once weekly. Maximum dose examples up to 200 IU/kg/day per labeling.

Dosing regimens — Idelvion: Idelvion: indicated for control/prevention and perioperative management; dosing for minor/moderate bleeds 30–60 IU/kg IV every 48–72 hours; major bleeds 60–100 IU/kg IV every 48–72 hours until hemostasis; maintenance dosing typically weekly per labeling.

Dosing regimens — Ixinity: Ixinity dosing examples: minor 30–60 IU/kg IV every 24 hours, moderate 40–60 IU/kg every 24 hours, major 60–100 IU/kg every 12–24 hours. Routine prophylaxis regimens include twice‑weekly dosing (examples: 35–75 or 40–70 IU/kg twice weekly) with product-specific maximums (e.g., bleeding episode maximum ~127 IU/kg/dose; weekly maximums up to 150 IU/kg/week noted in labeling).

Dosing regimens — Rebinyn: Rebinyn (glycopegylated): on‑demand treatment dosing 40 IU/kg for minor/moderate bleeds and 80 IU/kg for major bleeds; maximum dose 80 IU/kg/dose. Perioperative dosing examples: 40 IU/kg pre‑op for minor surgery, 80 IU/kg pre‑op for major surgery; repeat 40 IU/kg doses at 1–3 day intervals as clinically needed with possible extension to once weekly maintenance after the first week.

Operational note: Each product includes specific numeric dosing regimens for minor, moderate, and major bleeds, as well as surgical dosing and specified maximum doses; providers must follow the FDA‑approved product labeling for exact dosing and maximums.

See chunks 18, 20, 22, and 24 for product-specific numeric dosing and maximums.

Minor: 20-30 IU/kg IV twice; Moderate: 25-50 IU/kg IV twice daily; Major: 30-50 IU/kg IV twice daily; Surgery: 50-100 IU/kg IV twice daily

BeneFIX dosing and maximumsMinor: 20-30 IU/kg IV every 12-24 hrs; Major/surgery: 50-100 IU/kg IV every 12-24 hrs; Routine prophylaxis: 100 IU/kg once weekly; Maximum: 200 IU/kg/day

Idelvion dosing examplesMinor/moderate: 30-60 IU/kg IV every 48-72 hrs; Major: 60-100 IU/kg IV every 48-72 hrs; Maintenance dosing: weekly

Ixinity dosing and maximumsMinor: 30-60 IU/kg IV every 24 hrs; Major: 60-100 IU/kg IV every 12-24 hrs; Routine prophylaxis: twice weekly regimens (varies by age); Maximum bleeding dose: 127 IU/kg/dose; Maximum weekly: 150 IU/kg/week

Rebinyn dosing and maximumsMinor/moderate: 40 IU/kg; Major: 80 IU/kg; Perioperative: pre-op 40 IU/kg (minor) or 80 IU/kg (major); Maximum dose: 80 IU/kg/dose

Acceptable documentation includes office chart notes, laboratory results, and other relevant clinical information
If requesting a dose increase, submit the member's current body weight in kilograms
For continued therapy, current weight is required only if a higher dose is being requested

Denial Risk

Denial Risk and Coverage Limitations

Requests may be denied if the requested use is for a non‑FDA approved indication that lacks sufficient off‑label documentation, or if required documentation (including weight for dose calculations) is not provided. Coverage is governed by the terms of the member's coverage documents.

Non‑FDA indications not addressed in this policy require off‑label policy documentation (CP.CPA.09, HIM.PA.154, CP PMN.53) or evidence of coverage support
Lack of required documentation (e.g., body weight for dose calculation) may lead to denial
Coverage decisions remain subject to contract terms, exclusions, and limitations

Note

Formulary / Non‑Formulary Handling

Formulary or PDL status may direct providers to non‑formulary, no‑coverage, or alternative policies for the applicable line of business. Check formulary status and follow the referenced policies when the requested product is non‑formulary or not covered.

For non‑formulary drugs or those not on the PDL, refer to commercial and marketplace non‑formulary policies (CP.CPA.190 for commercial, HIM.PA.103 for marketplace, CP PMN.16 for Medicaid)
For drugs on the formulary/PDL, the no‑coverage criteria policy may apply (CP PMN.255 for Medicaid)
When requested use is off‑label, refer to off‑label use policies for the relevant line of business

Documentation Required

Provider Responsibilities and Administrative Requirements

Providers must follow Health Plan administrative policies when submitting requests and documentation; adherence to plan procedures and timely submission help ensure appropriate processing of prior authorization requests.

Submit complete clinical documentation with the authorization request to avoid delays
Ensure documentation aligns with the member's evidence of coverage and applicable plan requirements

Maintenance dose given weekly

Ixinity exampleTwice-weekly regimens (age-dependent dosing; e.g., 40-70 IU/kg IV twice weekly)

'Health Plan' definition

Health Plan definitionA health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or an affiliate

Policy roleThis clinical policy is used to assist in making coverage decisions and administering benefits but does not constitute a contract or guarantee of payment

Contract precedenceCoverage decisions are subject to the member's coverage documents and applicable state/federal requirements; Medicaid provisions take precedence when in conflict