CurrentColorado Rocky Mountain Health PlansPolicy 2025 P 2109-11

Xyntha® (antihemophilic factor [recombinant]) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plansopen_in_new

Defines UnitedHealthcare commercial plan prior authorization and medical necessity criteria for initiation and reauthorization of Xyntha for treatment of Hemophilia A (congenital Factor VIII deficiency) in adults and children, including required documentation, trial/failure or hypersensitivity to alternative recombinant factor products, high-risk/inhibitor considerations, and authorization durations.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyXyntha® (antihemophilic factor [recombinant]) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 2109-11

Change TypeAnnual review; non-material revisions

Effective DateNov 16, 2025

Next Review Date

Key ActionSubmit prior authorization with documentation of hemophilia A plus either trials/failure of three listed recombinant products, hypersensitivity to three listed products, or prescriber attestation supporting preferential benefit; approvals issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

Annual review with no changes to coverage criteria reported for 9/2025.

Revised outline of coverage criteria in 9/2024 without change to clinical intent.

Modified physician attestation to prescriber attestation in 9/2023.

Added Advate and Recombinate as preferred/alternative agents in 9/2020.

Program originally created 10/2016 and implemented 11/16/2025 effective date.

3Paths to initial approval

12 moAuthorization duration (initial & reauthorization)

Coverage Summary

This policy defines UnitedHealthcare commercial plan prior authorization and medical necessity criteria for initiation and reauthorization of Xyntha (antihemophilic factor [recombinant]) for treatment of Hemophilia A (congenital Factor VIII deficiency) in adults and children. Coverage stance: covered_with_criteria. Authorization duration for both initial approvals and reauthorizations is 12 months. Effective date: 11/16/2025; last review: 9/2025.

Quick facts / thresholds

Trial requirementtrial of three listed recombinant factor products

Hypersensitivity requirementhistory of hypersensitivity to three listed recombinant factor products

Current treatment days thresholdless than 50 days

Paths to initial approval3

Authorization duration12 months

Referenced alternative recombinant products6

Initial Authorization (Medically Necessary)

Xyntha will be approved based on both of the following criteria:

ALL of the following

Diagnosis of hemophilia A
One of the following
- Submission of documentation showing failure to meet clinical goals (e.g., continuation of spontaneous bleeds, inability to achieve appropriate trough level) after a trial of three of the following recombinant factor products: Advate; Kogenate FS; Kovaltry; NovoEight; Nuwiq; Recombinatetrial of three agents
  Must document trials of three agents from the listed products
- Submission of documentation showing history of hypersensitivity to three of the following recombinant factor products: Advate; Kogenate FS; Kovaltry; NovoEight; Nuwiq; Recombinate

Reauthorization (Continued Therapy)

Xyntha will be approved for reauthorization when the following is met: (Authorization of therapy will be issued for 12 months.)

ALL of the following

Documentation of positive clinical response to Xyntha therapy
Authorization of therapy will be issued for 12 months.

Limitations / Exclusions

Xyntha is not indicated for von Willebrand's disease. Indications other than Hemophilia A (congenital Factor VIII deficiency) are not addressed by this policy and therefore are not covered under the program's Hemophilia A prior authorization/medical necessity criteria.

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization requirement

PA required and approvals issued only when criteria met; initial and reauthorization approvals issued for 12 months.

Documentation Required

Documentation of prior trials or hypersensitivity

Submit documentation showing trials and failure to meet clinical goals with three specified recombinant factor products (Advate; Kogenate FS; Kovaltry; NovoEight; Nuwiq; Recombinate), or documentation of hypersensitivity to three of these recombinant products, or provide prescriber attestation describing high-risk status, inhibitor development, or immune tolerance therapy.

Document trials and failure with three of: Advate; Kogenate FS; Kovaltry; NovoEight; Nuwiq; Recombinate
OR document hypersensitivity to three of the above products

Applicable Codes

Referenced alternative recombinant factor products (for trial/failure or hypersensitivity criteria)mixed

	Advate (recombinant factor VIII product) - listed as alternative product
	Kogenate FS (recombinant factor VIII product) - listed as alternative product
	Kovaltry (recombinant factor VIII product) - listed as alternative product
	NovoEight (recombinant factor VIII product) - listed as alternative product
	Nuwiq (recombinant factor VIII product) - listed as alternative product
	Recombinate (recombinant factor VIII product) - listed as alternative product

Indication codes referenced in program logicICD-10

Hemophilia A (congenital Factor VIII deficiency) - diagnosis required

Clinical Evidence & References

Evidence sources referenced include the Xyntha package insert (Wyeth Pharmaceuticals, July 2022) and MASAC guidance (MASAC Document #290, Oct 2, 2024; MASAC Document #243, Jun 28, 2016). These sources inform clinical intent and background; however, the policy criteria described are administrative prior authorization/medical necessity requirements used by UnitedHealthcare.

Definitions (operational)

High risk for inhibitorsExamples include family history of inhibitors with success on product, current treatment <50 days, high risk genetic mutation, or history of initial intensive therapy >5 days.

Positive clinical responseDocumentation showing clinical improvement on Xyntha therapy (not further specified in policy).

Background

Xyntha is indicated in adults and children with hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management, and routine prophylaxis to reduce bleeding frequency. It is not indicated for the treatment of von Willebrand's disease. This policy establishes prior authorization and medical necessity criteria for UnitedHealthcare commercial plans for initiation and reauthorization of Xyntha, including required documentation of diagnosis, trials/failure or hypersensitivity to specified alternative recombinant factor products (e.g., Advate, Kogenate FS, Kovaltry, NovoEight, Nuwiq, Recombinate), and provisions for prescriber attestation for patients at high risk for inhibitors, with inhibitors, or undergoing immune tolerance therapy. The program history notes addition of preferred/alternative agents (Advate and Recombinate) and multiple annual reviews since program creation.

Revision History

10/2016 / implemented 11/16/2025program_creation

Program originally created 10/2016 and implemented 11/16/2025 effective date.

9/2020added

Added Advate and Recombinate as preferred/alternative agents; updated background to include routine prophylaxis indication.

9/2023revised

Modified physician attestation to prescriber attestation (terminology change only; no clinical coverage change).