CurrentUnitedHealthcarePolicy 2025 P 3079-10

Xyntha®(antihemophilic factor [recombinant]) - Step Therapy - UnitedHealthcare Commercial Plansopen_in_new

UnitedHealthcare Step Therapy program requiring trial of preferred recombinant factor VIII products before coverage of Xyntha for Hemophilia A; includes approval criteria, duration, and administrative rules for commercial plans.

Policy Summary

PayerUnitedHealthcare

PolicyXyntha®(antihemophilic factor [recombinant]) - Step Therapy - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 3079-10

Change TypeAnnual review / administrative updates

Effective DateNov 16, 2025

Next Review Date

Key ActionCoverage for Xyntha requires documentation meeting one of the program criteria (history of failure/intolerance to three preferred products or prescriber attestation of preferential benefit); authorizations issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

Program effective date set to 11/16/2025 and P&T approval dates updated through 9/2025.

Preferred agents list updated over time to add Advate and Recombinate (9/2020).

Physician attestation language was modified to 'prescriber attestation' (9/2023).

6Named preferred agents

3Preferred-agent failures required

12mAuthorization duration

Summary of Changes & Key Points

Step therapy requires trial of preferred recombinant factor VIII products before coverage of Xyntha. Rationale: all standard half‑life recombinant factor VIII products are expected to produce similar clinical results with very few product differentiators, and the program is intended to encourage lower‑cost alternatives. Program effective date: 11/16/2025. P&T approval dates range: 10/2016 - 9/2025.

Key thresholds / statistics

Number of preferred-agent failures required3

Authorization duration12 months

Named preferred agents6 (Advate; Kogenate FS; Kovaltry; Novoeight; Nuwiq; Recombinate)

Treatment duration threshold: 'current treatment less than'50 days

Initial intensive therapy high-risk duration> 5 days

Approval Criteria for Xyntha (Hemophilia A)

Authorization will be issued for 12 months. UnitedHealthcare Step Therapy program requiring trial of preferred recombinant factor VIII products before coverage of Xyntha for Hemophilia A; includes approval criteria, duration, and administrative rules for commercial plans.

Products Named in Criteria

Preferred products (named in criteria)mixed

	Advate (recombinant factor VIII)
	Kogenate FS (recombinant factor VIII)
	Kovaltry (recombinant factor VIII)
	Novoeight (recombinant factor VIII)
	Nuwiq (recombinant factor VIII)
	Recombinate (recombinant factor VIII)

Target productmixed

Xyntha (antihemophilic factor [recombinant])

What Providers Must Do

Prior Authorization

Step therapy prior authorization required

Coverage for Xyntha requires documentation meeting one of the program criteria: either (a) history of failure, contraindication, or intolerance to three listed preferred recombinant factor VIII products, or (b) prescriber attestation that the patient would preferentially benefit from Xyntha due to specified inhibitor-risk factors or history. Authorization will be issued for 12 months.

Authorization duration 12 months

Documentation Required

Documentation of prior failures/intolerances

Document the patient’s history of failure, contraindication, or intolerance to three of the named preferred products before approval will be granted.

Required number of preferred-product failures: 3

Key Definitions

Prescriber attestation: A documented statement from the prescriber that the patient would preferentially benefit from Xyntha due to specific inhibitor‑risk factors or history.

Preferred products: Advate; Kogenate FS; Kovaltry; Novoeight; Nuwiq; Recombinate.

Policy Updates & Review Timeline

11/16/2025Program effective date

Program effective date set to 11/16/2025.

10/2016 - 9/2025P&T approval dates range

P&T approval dates range: 10/2016 through 9/2025.

9/2025Annual reviewLatest

Annual review with no changes to coverage criteria. Updated references.

Policy Summary

PayerUnitedHealthcare

PolicyXyntha®(antihemophilic factor [recombinant]) - Step Therapy - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 3079-10

Change TypeAnnual review / administrative updates

Effective DateNov 16, 2025

Next Review Date

SourceLink

On This Page

Documentation Required

Prescriber attestation documentation

If requesting approval via prescriber attestation, include a documented statement from the prescriber that the patient would preferentially benefit from Xyntha because they meet one of the listed conditions (high risk for inhibitor development, has developed inhibitors, or has undergone immune tolerance induction).

Denial Risk

Automated approval / denial risk

UnitedHealthcare may approve initial or reauthorization requests based solely on prior claim/medication history, diagnosis codes (ICD-10), and/or claim logic; conversely, the absence of required supporting documentation may result in denial.

Operational note: approvals are authorized for 12 months; UnitedHealthcare may approve initial and reauthorization based on previous claim/medication history, diagnosis codes and/or claim logic, and automated approval/re‑approval processes may be used where applicable.

9/2024Annual review

Annual review with no changes to coverage criteria. Updated references.

9/2023Terminology update

Modified physician attestation language to 'prescriber attestation'. Updated references.

9/2020Preferred agents updated

Modified program updating preferred agents, adding Advate and Recombinate.

10/2019Annual review

Annual review with no changes to coverage criteria. Updated reference.

10/2018Annual review

Annual review with no change to clinical intent. Updated state mandate verbiage and references.

10/2017Program created

New step therapy program created for Xyntha.