CurrentMass General Brigham Health PlanPolicy N/A

Obizur (antihemophilic factor [recombinant], porcine sequence) — Coverage Criteria

Policy governing prior authorization, specialty pharmacy dispensing, quantity limits, and medical benefit handling for Obizur for treatment of acquired hemophilia A in affected Mass General Brigham Health Plan members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyObizur (antihemophilic factor [recombinant], porcine sequence) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document that Obizur is prescribed for acquired hemophilia A by or in consultation with a hematologist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 monthtypical approval duration

90 daystransitional auth window

20 BUmax established inhibitor titer

Coverage Criteria for Obizur

Initial Authorization

Authorization may be granted when EITHER of the following applies:

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Transitional continuation: Member is new to the plan within the past 90 days and is currently receiving treatment with the requested medication (excluding samples and manufacturer patient assistance programs)

Supports transitional approvals

New initiation criteria: Requested medication is prescribed for the treatment of acquired hemophilia A AND requested medication is prescribed by or in consultation with a hematologist

Standard initial authorization

Obizur (antihemophilic factor [recombinant], porcine sequence) is not indicated for von Willebrand disease and is contraindicated in patients with hemophilia A with inhibitors. Additionally, safety and efficacy have not been established in patients with a baseline anti-porcine factor VIII inhibitor titer of greater than 20 BU. These limitations should be considered when evaluating requests for therapy; requests that fall into these categories are not supported by the policy and may be denied.

Provider Requirements and Operational Rules

Prior Authorization

Prior Authorization Required

Prior authorization required. Transitional authorizations may be granted for members new to the plan within the past 90 days who are currently receiving therapy (excludes samples and manufacturer patient assistance programs).

Transitional approval: members new to plan within past 90 days currently receiving therapy
Contact specialty pharmacy for prior auth: Phone: 877-519-1908; Fax: 855-540-3693

Step Therapy

No step therapy sequencing beyond specialty designation and prior authorization requirements.

Documentation Required

Required Prescriber and Indication Documentation

Provider must document the indication and prescriber specialty. The request must state that Obizur is prescribed for acquired hemophilia A and that the prescriber is a hematologist or the therapy was prescribed/managed in consultation with a hematologist.

Indication required: Acquired hemophilia A
Prescriber required: hematologist or documented hematology consultation

Denial Risk

Indication- and Contraindication-Based Denial Risk

Requests will be denied for uses not indicated or that meet contraindications. Specifically, requests for von Willebrand disease, hemophilia A with inhibitors, patients with baseline anti-porcine factor VIII inhibitor titer >20 BU, and any other indication considered experimental/investigational are not medically necessary.

Not indicated: von Willebrand disease
Contraindicated: hemophilia A with inhibitors
Safety/efficacy not established: baseline anti-porcine factor VIII inhibitor titer > 20 BU
All other indications: experimental/investigational — not medically necessary

Definitions

Acquired hemophilia A

DefinitionAn autoimmune bleeding disorder in adults caused by autoantibodies directed against factor VIII

Indication relationObizur is indicated for on‑demand treatment and control of bleeding episodes in adults with acquired hemophilia A

Not indicated/contraindicated noteObizur is not indicated for von Willebrand disease and is contraindicated in congenital hemophilia A with inhibitors

Anti-porcine factor VIII inhibitor titer (BU)

MeasureAnti-porcine factor VIII inhibitor titer measured in Bethesda Units (BU)

Threshold relevanceSafety and efficacy of Obizur have not been established when baseline titer is > 20 BU

Clinical useTiter used to assess presence/level of inhibitors against porcine‑sequence factor VIII prior to therapy

Background

Obizur is a recombinant porcine‑sequence factor VIII product indicated for on‑demand treatment and control of bleeding episodes in adults with acquired hemophilia A. Key clinical limitations include that it is not indicated for von Willebrand disease, is contraindicated in congenital hemophilia A with inhibitors, and that its safety and efficacy have not been established when the baseline anti‑porcine FVIII inhibitor titer exceeds 20 BU.

Revision History

2025-06-01policy_effective_dateLatest

Policy effective date for Obizur (antihemophilic factor [recombinant], porcine sequence).

2025-05-14policy_review

Policy reviewed at May P&T; no clinical criteria changes and updated effective date noted for 06/01/2025.

2024-01-01policy_administrative_change

Policy transitioned from SGM to Custom, effective 01/01/2024 per December 2023 P&T review.

2023-12-13policy_review

Reviewed at December P&T; documentation of switch to Custom with subsequent effective date changes noted.