CurrentUnitedHealthcarePolicy N/A

Step therapy for Ixinity (coagulation factor IX recombinant)

Defines UnitedHealthcare's step therapy requirements for coverage of Ixinity, requiring trial of preferred recombinant factor IX products or specific physician attestation; applies to members whose benefit plans implement this program.

Policy Summary

PayerUnitedHealthcare

PolicyStep therapy for Ixinity (coagulation factor IX recombinant)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateFeb 1, 2025

Next Review DateNov 20, 2024

Key ActionObtain prior authorization and document failure, contraindication, or intolerance to two preferred recombinant factor IX products or provide qualifying physician attestation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

2required failures

Ixinitytarget medication

NCstate

Coverage Criteria for Ixinity

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Primary pathway: History of failure, contraindication, or intolerance to two of the following preferred products: Benefix; Rixubis.2 products

Document trials and failures/contraindications/intolerances to preferred products.

Alternate pathway (physician attestation): Physician attestation that the patient would preferentially benefit from Ixinity based on one of the following qualifying clinical conditions: patient is at high risk for development of inhibitors (e.g., family history of inhibitors, high‑risk genetic mutation, history of initial intensive therapy), patient has undergone immune tolerance induction/therapy, or patient has developed inhibitors.N/A

Attestation must specify the qualifying condition.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Approval is granted for up to 12 months when criteria are met.

Approval duration: 12 months
State mandates, federal requirements, and member-specific benefit plan coverage may affect coverage

Step Therapy

Step Therapy Requirements

Member must try one or more preferred recombinant factor IX products before coverage of Ixinity is approved. Ixinity will be approved when the member has a history of failure, contraindication, or intolerance to two preferred products, or when a qualifying physician attestation is provided.

Preferred products include: Benefix; Rixubis
Ixinity approved only after failure, contraindication, or intolerance to two preferred recombinant factor IX products, or per physician attestation

Documentation Required

Provider must submit documentation of prior trials and outcomes or a physician attestation documenting medical necessity. Documentation should include history of trials, reasons for failure/contraindication/intolerance, and any relevant clinical information (e.g., inhibitor history, immune tolerance induction, genetic risk factors).

Required documentation: history of prior trials and failures/contraindications/intolerances to preferred products
Or: physician attestation describing clinical rationale (e.g., high inhibitor risk, prior immune tolerance induction, documented inhibitors)

Denial Risk

Failure to Meet Step Therapy Trials — Denial Risk

Coverage may be denied if the member has not tried (and failed or had a contraindication or intolerance to) two preferred recombinant factor IX products as required by the step therapy program.

Denial risk applies when step therapy trials are not met

Step Therapy Details

Step	Requirement	Notes
1	Member must trial preferred recombinant factor IX products before Ixinity will be approved	Preferred products listed: Benefix; Rixubis. Document trials and reasons for discontinuation (failure, contraindication, or intolerance).
2	Approval of Ixinity requires failure, contraindication, or intolerance to two preferred products	If two preferred products have not failed, coverage may be denied; provider must submit history of prior trials and failures/intolerances or contraindications.
3	Alternate pathway: Physician attestation	Physician attestation that the patient would preferentially benefit from Ixinity for qualifying clinical reasons (e.g., high risk for inhibitor development, family history of inhibitors, prior inhibitor development, success with a product, high‑risk genetic mutation, history of intensive therapy, or prior immune tolerance induction/therapy).
Approval duration	When criteria are met, prior authorization is approved for 12 months	State mandates and member‑specific benefit plan coverage may affect authorization and site‑of‑care rules.

Background

Step therapy programs encourage use of lower‑cost alternatives within therapeutic classes; this program applies that principle to recombinant coagulation factor IX products for patients with hemophilia B. The intent is to require trials of preferred products prior to authorizing higher‑cost or non‑preferred agents such as Ixinity.

Under this program, approval of Ixinity is granted when the member meets one of the approval pathways: documented failure, contraindication, or intolerance to two preferred recombinant factor IX products (for example, Benefix or Rixubis), or when a physician provides attestation that the patient would preferentially benefit from Ixinity because of specific clinical circumstances (for example, high risk for inhibitor development, prior inhibitor history, success with a prior product, high‑risk genetic mutation, history of intensive therapy, or immune tolerance therapy).

Prior authorization is required and, when criteria are met, approvals are issued for 12 months. Providers must submit documentation of prior trials and reasons for discontinuation, or a physician attestation specifying the qualifying clinical condition. Note that state mandates and the member’s plan-specific benefit may affect coverage and site‑of‑care rules.

Site of Care and State Rules

Note

Infusion center coverage may be affected by state mandates and member benefit

State mandates and the member's specific benefit plan may affect coverage and site-of-care rules for infusion centers; check applicable state regulations and the member's plan for any restrictions or exclusions.

State mandates and federal regulatory requirements may apply.
Member-specific benefit plan coverage may impact whether infusion center services are covered.