CurrentmhnPolicy CP.PHAR.218

Clinical Policy: Factor IX (Human, Recombinant)

Policy governing prior authorization and medical necessity criteria for human and recombinant factor IX products used to treat congenital hemophilia B for commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyFactor IX (Human, Recombinant) — coverage criteria for congenital hemophilia B

Policy CodePolicy CP.PHAR.218

Change TypeNo material change

Effective DateMay 1, 2016

Next Review Date

Key ActionProvider must submit documentation (office notes, labs, current body weight) demonstrating the member meets all approval criteria when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

7Factor IX products requiring prior authorization

3FDA-approved uses

12/6 moProphylaxis approval duration

≥17AlphaNine SD minimum age

J7193-J7213HCPCS codes referenced

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Coverage Criteria for Factor IX Therapies

Initial Therapy Criteria

Covered when ALL of the following are met for Initial Approval (Congenital Hemophilia B):

Initial Approval - Congenital Hemophilia B: Member has a diagnosis of congenital hemophilia B (factor IX deficiency).

Initial Approval - Prescriber: Medication is prescribed by or in consultation with a hematologist.

Initial Approval - Age requirement for AlphaNine SD: For AlphaNine SD requests only: member age is ≥ 17 years.

Initial Approval - Indication: Request is for one of the following uses: control and prevention of bleeding episodes; perioperative management; or routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

Initial Approval - Product restriction for prophylaxis: For routine prophylaxis requests, the requested product is one of: Alprolix, BeneFIX, Idelvion, Ixinity, Rebinyn, or Rixubis.

Initial Approval - Documentation: Documentation of the member's current body weight in kilograms is provided.

Initial Approval - Dose limit: Requested dose does not exceed the FDA‑approved maximum recommended dose for the relevant indication.

Product-specific dosing and indications

Covered when ALL of the following are met for Continuation/Renewal (Congenital Hemophilia B):

Continuation Therapy - Ongoing treatment or continuity of care: Member is currently receiving the medication via the Centene benefit or previously met initial approval criteria, OR member is currently receiving the medication and is enrolled in continuity of care where applicable.

Continuation Therapy - Clinical response: Member is responding positively to therapy.

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Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient supporting documentation of efficacy and safety per the applicable off‑label use policy (for example, CP.CPA.09 for commercial, HIM.PA.154 for the health insurance marketplace, or CP.PMN.53 for Medicaid) or other evidence of coverage documents.

The discontinued product Mononine has been removed from the criteria and is no longer supported by this policy. Requests for discontinued products will not be authorized.

The listed recombinant Factor IX products (Alprolix, BeneFIX, Idelvion, Ixinity, Rebinyn, and Rixubis) are not indicated for induction of immune tolerance in patients with hemophilia B; this use is not supported by the policy.

HCPCS and other billing codes included in this clinical policy are provided for informational purposes only. Inclusion of a code does not by itself establish medical necessity or guarantee coverage; providers should follow current professional coding guidance when submitting claims.

Coding and HCPCS References

Referenced HCPCS Codes (group 1)HCPCS

J7193	Factor IX (antihemophilic factor, purified, non-recombinant) 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

Referenced HCPCS Codes (group 2)HCPCS

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 i.u.

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for requests for AlphaNine SD, Alprolix, BeneFIX, Idelvion, Ixinity, Rebinyn, and Rixubis. Use the referenced HCPCS/J-codes when submitting prior authorization requests and claims. Providers must demonstrate that all clinical criteria are met (diagnosis, hematologist involvement where required, indication, dosing within FDA limits, and documentation of current body weight when applicable).

Affected HCPCS/J-codes include J7193, J7195, J7200, J7201, and J7213 (added 05.24.23).
Prior authorization templates and criteria have been revised over time — verify current PA template requirements when submitting.
Requests lacking adequate clinical documentation (office chart notes, lab results, weight in kg, prior treatment history, hematologist consultation) may be denied.

Billing Rule

Background and Scope

Factor IX products, both human and recombinant, are indicated for patients with congenital hemophilia B (inherited factor IX deficiency) for three primary uses: on‑demand control and prevention of bleeding episodes, perioperative management, and routine prophylaxis to reduce the frequency of bleeding. Product selection and dosing vary by indication and by product as detailed in the respective prescribing information.

Definitions

inv-19: Congenital Hemophilia B

DefinitionInherited factor IX deficiency (Congenital Hemophilia B, also called Christmas disease).

Clinical featuresCauses a bleeding tendency requiring on‑demand treatment, perioperative management, or routine prophylaxis with factor IX products.

Indicated populationAdults and children with hemophilia B (congenital factor IX deficiency) — products listed include AlphaNine SD, Alprolix, BeneFIX, Idelvion, Ixinity, Rebinyn, and Rixubis.

Limitations of useSome products (e.g., AlphaNine SD) contain low non‑therapeutic levels of other clotting factors and are not indicated for reversal of coumarin anticoagulant hemorrhage; recombinant products are not indicated for induction of immune tolerance in hemophilia B.

inv-20: Routine prophylaxis

Definition

Policy Summary

Payermhn

PolicyFactor IX (Human, Recombinant) — coverage criteria for congenital hemophilia B

Policy CodePolicy CP.PHAR.218

Change TypeNo material change

Effective DateMay 1, 2016

Next Review Date

Key ActionProvider must submit documentation (office notes, labs, current body weight) demonstrating the member meets all approval criteria when requesting prior authorization.

SourceLink

On This Page

Coding Inclusion Does Not Guarantee Coverage

Codes referenced in this policy are provided for informational purposes only. Inclusion of a code in this document does not guarantee coverage. Providers should follow current professional coding guidance and the payer's billing rules when submitting claims.

Inclusion/exclusion of HCPCS or J-codes here does not ensure reimbursement.
Verify the most up-to-date coding guidance prior to claims submission.

Documentation Required

Clinical Documentation and PA Template Clarifications

Providers must submit clinical documentation supporting that the member meets all approval criteria. Prior template updates and clarifications (including changes to authorization durations and indications) should be reviewed and the most recent PA template used.

Acceptable documentation: office chart notes, hematology consultation notes, laboratory results (factor IX activity when applicable), documentation of bleed history for new prophylaxis starts if required, and current body weight in kg when relevant.
Note: Continued therapy requests only require current weight if a higher dose is being requested.
Review recent template changes (e.g., additions of HCPCS J7213, changes to prophylaxis duration) when preparing PA submissions.

Note

Formulary / Off-Label Referral

If a drug's label has recently changed or the requested use is not specifically listed in policy, refer to formulary/non-formulary and off-label use policies for the applicable line of business to determine coverage and PA requirements.

For formulary drugs, consult the line-of-business no coverage criteria policies (e.g., CP.CPA.190 for commercial, HIM.PA.33 for HIM, CP.PMN.255 for Medicaid).
For non-formulary drugs, consult the non-formulary policies (e.g., CP.CPA.190 commercial, HIM.PA.103 HIM, CP.PMN.16 Medicaid).
For off-label uses not listed in the policy, consult off-label use policies (e.g., CP.CPA.09 commercial, HIM.PA.154 HIM, CP.PMN.53 Medicaid).

Denial Risk

Insufficient Clinical Documentation May Lead to Denial

Insufficient clinical documentation that the member meets all approval criteria (diagnosis, hematologist involvement, indication, dosing limits, required labs, and weight) may result in denial of the prior authorization request.

Ensure documentation shows diagnosis of congenital hemophilia B when applicable and that the prescriber is a hematologist or consulted one.
For routine prophylaxis new starts, include any required activity levels or bleed history per the current policy language.
When requesting dose increases, include current body weight in kg.

Routine prophylaxis = ongoing, repeated dosing schedules intended to reduce the frequency of bleeding episodes in patients with hemophilia B.

Typical schedules — weeklyExamples: 100 IU/kg once weekly (BeneFIX); Rebinyn 40 IU/kg once weekly; Idelvion maintenance options: 25–40 IU/kg IV every 7 days (≥12 y) with possible extension to every 14 days.

Typical schedules — twice weeklyIxinity: ≥12 y — 40–70 IU/kg IV twice weekly; Rixubis: ≥12 y — 40–60 IU/kg IV twice weekly (product PI/age‑based regimens).

Typical schedules — every 10 or 14 daysExtended interval options: 50 IU/dL/kg IV once weekly or 100 IU/dL/kg IV once every 10 days (noting some products allow q14d regimens after stabilization, e.g., Idelvion 50–75 IU/kg IV every 14 days once well‑controlled).

Maximum dose considerationsRefer to product PI for maximum dose per indication (examples: BeneFIX max 200 IU/dL/kg/day; Rebinyn max 80 IU/kg/dose; Idelvion maintenance max 55 IU/kg/week).