CurrentMass General Brigham Health PlanPolicy N/A

Factor VIII Concentrates

Defines prior authorization and coverage criteria for Factor VIII products (pharmacy benefit) for members with Hemophilia A, acquired Hemophilia A, von Willebrand disease, and acquired von Willebrand syndrome; applies to Mass General Brigham Health Plan commercial/exchange members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyFactor VIII Concentrates

Policy CodePolicy N/A

Change TypeRevised (benefit application, approval length, Jivi age)

Effective DateFeb 1, 2026

Next Review Date

Key ActionObtain prior authorization for Factor VIII products through the pharmacy benefit and document prior trial of a preferred product when requesting non-preferred agents or Jivi (unless member meets specified exceptions).

SourceLink

POLICY UPDATE CHANGES

Policy updated to indicate it no longer applies to the medical benefit and applies to the pharmacy benefit only.

Approval length changed to 12 months for initial approvals and reauthorizations.

Age for Jivi eligibility lowered from 12 years to 7 years to align with FDA approval.

12 monthsapproval/reauthorization duration

90 dayscontinuity new-to-plan

>=7Jivi minimum age

Multiple

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Coverage and Medical Necessity Criteria

Hemophilia A — Preferred products

Authorization may be granted when ALL of the following are met:

Eligible product: Requested product is one of the listed preferred Factor VIII products (Advate, Adynovate, Afstyla, Altuviiio, Eloctate, Esperoct, Koate, Kogenate FS, Kovaltry, Novoeight, Nuwiq, Recombinate, Xyntha, Xyntha Solofuse)

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Disease criteria: Member has mild disease (see Appendix A) and has had an insufficient response to desmopressin or a documented clinical reason for not using desmopressin (see Appendix B) OR member has moderate or severe disease (see Appendix A)

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Hemophilia A — Non-preferred products and Jivi

Authorization of non-preferred products or Jivi requires meeting product-specific criteria:

Non-preferred product requirement: Member meets Hemophilia A disease criteria (mild with desmopressin failure/intolerance OR moderate/severe) AND documentation of inadequate response or intolerance to one preferred product or clinical rationale why preferred products are not appropriate

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Jivi-specific: Jivi may be authorized if ONE of the following: (1) Member has mild disease and has had an insufficient response to desmopressin or a documented clinical reason for not using desmopressin; (2) Member has moderate or severe disease; OR (3) Member has previously received treatment for hemophilia A with a factor VIII product AND is 7 years of age or older

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Von Willebrand Disease (VWD)

Authorization may be granted for Alphanate, Humate-P, or Koate when ANY of the following are met:

Type 1/2A/2M/2N VWD: Member has type 1, 2A, 2M, or 2N von Willebrand disease and has had an insufficient response to desmopressin or a documented clinical reason for not using desmopressin (see Appendix B)

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Type 2B or 3 VWD: Member has type 2B or type 3 von Willebrand disease

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Acquired Hemophilia A

Authorization may be granted when the following are met:

Preferred agents: Requested product is one of the listed preferred factor VIII products or Jivi for treatment of acquired hemophilia A

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Non-preferred requirement: If non-preferred, member must meet indication for acquired hemophilia A AND have documentation of inadequate response or intolerance to one preferred product or clinical rationale why preferred products are not appropriate

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Acquired von Willebrand syndrome

Authorization may be granted when the following are met:

Product: Authorization of Alphanate or Humate-P may be granted for treatment of acquired von Willebrand syndrome

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Continuation of therapy (Reauthorization)

Reauthorization may be granted when ALL of the following are met:

Initial criteria met: Initial criteria have been met

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Positive response: Member is experiencing a positive response to therapy (e.g., reduced frequency or severity of bleeds)

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There are no therapies explicitly listed as excluded from coverage in this policy. However, non-preferred factor VIII agents require additional justification prior to approval: authorization of a non-preferred product requires the member meet the Hemophilia A disease criteria (mild disease with insufficient response to desmopressin or a documented clinical reason for not using desmopressin, or moderate/severe disease) and documentation of an inadequate response or intolerance to one preferred product or a clinical rationale why preferred products are not appropriate.

Providers requesting non-preferred agents should be prepared to supply clinical documentation of prior trial and failure or intolerance to a preferred factor VIII product, or a clear clinical rationale for why preferred products cannot be used, to avoid denial.

Requests for non-preferred factor VIII products may be denied if there is no documentation of inadequate response or intolerance to a preferred product or no clinical rationale explaining why preferred products are inappropriate. The policy requires that authorization of a non-preferred product be supported by the same Hemophilia A disease criteria used for preferred products plus evidence of prior inadequate response or intolerance to one preferred product or a clinical justification.

When submitting prior authorization for a non-preferred factor VIII product, include documentation of the specific preferred product trial(s), the nature of the inadequate response or intolerance, and any relevant clinical details (for example, reasons desmopressin was not used if applicable) to satisfy the policy requirements.

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required (pharmacy benefit) for Factor VIII products. Approvals are granted when coverage criteria for the specific indication are met.

Pharmacy benefit prior authorization required for Factor VIII products
Contact Pharmacy PA: 800-711-4555

Step Therapy

Step-through Requirement for Non-Preferred Agents

Step requirement for non-preferred products: prior authorization of a non-preferred Factor VIII product will only be considered when the member meets the disease criteria (mild with inadequate response to desmopressin, or moderate/severe disease) and there is documentation of an inadequate response or intolerance to one preferred product, or clear clinical rationale why preferred products are not appropriate.

Applies to non-preferred Factor VIII products (see preferred product list in Hemophilia A criteria)
Documentation must show trial and inadequate response or intolerance to one preferred product, or justification for bypassing preferred products

Clinical Definitions and Criteria

Hemophilia severity classification — Appendix A

Severe hemophiliaFactor activity < 1%; predominantly spontaneous bleeding episodes, especially into joints and muscles; also severe bleeding with trauma, injury, or surgery.

Moderate hemophiliaFactor activity 1% to 5%; occasional spontaneous bleeding episodes; severe bleeding with trauma, injury, or surgery.

Mild hemophiliaFactor activity 6% to 40%; bleeding mainly with significant injury, trauma, or surgery (not predominantly spontaneous).

Clinical reasons for not using desmopressin — Appendix B

Age limitationAge < 2 years is a clinical reason to avoid desmopressin.

PregnancyPregnancy is listed as a contraindication to desmopressin use.

Background and Clinical Context

Hemophilia A (factor VIII deficiency) is managed with factor VIII replacement for bleed control, perioperative management, and routine prophylaxis. This policy specifies coverage for a list of preferred factor VIII products (including Advate, Adynovate, Afstyla, Altuviiio, Eloctate, Esperoct, Koate, Kogenate FS, Kovaltry, Novoeight, Nuwiq, Recombinate, Xyntha, and Xyntha Solofuse) when the member meets disease criteria: either mild disease with insufficient response to desmopressin or documented clinical reasons for not using desmopressin or moderate or severe disease (see appendices for severity classification and clinical reasons not to use desmopressin).

The policy also addresses Jivi and non-preferred products: Jivi may be authorized under the Hemophilia A criteria or for members previously treated with a factor VIII product who are ≥7 years of age, and non-preferred products require documentation of inadequate response or intolerance to a preferred product or clinical rationale for why preferred agents are not appropriate.