CurrentMass General Brigham Health PlanPolicy N/A

RiaSTAP (fibrinogen concentrate) coverage

Defines prior authorization, coverage indications, limitations, and specialty pharmacy requirements for RiaSTAP (human fibrinogen concentrate) for Commercial/Exchange members of Mass General Brigham Health Plan.

Policy Summary

PayerMass General Brigham Health Plan

PolicyRiaSTAP (fibrinogen concentrate) coverage

Policy CodePolicy N/A

Change TypeBenefit transfer to pharmacy

Effective DateJan 1, 2026

Next Review Date

Key ActionSubmit prior authorization under the pharmacy benefit with documentation of indication and benefit for prophylaxis when applicable.

SourceLink

POLICY UPDATE CHANGES

Policy updated to reflect that RiaSTAP no longer applies to the medical benefit and is under the pharmacy benefit only.

Prior AuthorizationProgram Type

PharmacyBenefit

Specialty PharmacySpecialty limitations

1 monthInitial approval duration

12 monthsProphylaxis duration

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Coverage Criteria for RiaSTAP (fibrinogen concentrate)

Initial Authorization Criteria

Authorization may be granted when one of the following criteria is met:

Criteria list: Treatment of acute bleeding episodes in members with a diagnosis of congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

Supports FDA-approved indication.

Criteria list: Perioperative management of bleeding in members with a diagnosis of afibrinogenemia.

Compendial use.

Criteria list: Prophylaxis to reduce the frequency of bleeding episodes in members with afibrinogenemia (medical record justification required).

Compendial use; justification required.

Continuation Therapy

Continuation of therapy rules

Prophylaxis continuation: Authorization of 12 months may be granted for continued prophylaxis in members with afibrinogenemia when the member is experiencing benefit from therapy (e.g., reduced frequency of bleeding episodes).

Benefit must be documented.

Other indications continuation: All members (including new members) requesting continuation for indications other than prophylaxis must meet all initial authorization criteria.

Includes new members.

Approval Duration Limits

Approval durations

Approval durations: Initial approvals for treatment of acute bleeding episodes and perioperative management will be granted for 1 month; initial approvals and reauthorizations for prophylaxis will be granted for 12 months.

Duration-based limitation.

Use of RiaSTAP for dysfibrinogenemia and for any indications beyond those specified as FDA-approved or listed as compendial uses is considered experimental/investigational and not medically necessary.

All indications other than the FDA-approved indication (treatment of acute bleeding episodes in congenital fibrinogen deficiency) and the two compendial uses — perioperative management of bleeding in afibrinogenemia and prophylaxis to reduce the frequency of bleeding episodes in afibrinogenemia — are not covered and considered investigational/not medically necessary.

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior authorization required

Prior authorization is required for RiaSTAP under the pharmacy benefit for Commercial/Exchange members; authorization may be granted when the member meets the FDA indication or specified compendial uses.

Benefit moved to Pharmacy Benefit; specialty pharmacy required.

Step Therapy

Step therapy

No step therapy requirement is specified for RiaSTAP.

Documentation Required

Required documentation

Key Definitions

Congenital fibrinogen deficiency — definitions

DefinitionCongenital fibrinogen deficiency: inherited conditions characterized by low or absent functional fibrinogen leading to bleeding; includes afibrinogenemia and hypofibrinogenemia.

AfibrinogenemiaComplete absence of functional fibrinogen; associated with bleeding and is included in the FDA indication for RiaSTAP.

HypofibrinogenemiaReduced levels of functional fibrinogen resulting in bleeding diathesis; included in the FDA indication for RiaSTAP.

DysfibrinogenemiaDisorder of qualitatively abnormal fibrinogen; RiaSTAP is not indicated for dysfibrinogenemia.

Clinical significanceThese inherited fibrinogen deficiencies can cause acute bleeding episodes; RiaSTAP is indicated for treatment of acute bleeding in affected pediatric and adult patients.

Background

RiaSTAP is a human fibrinogen concentrate indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency (including afibrinogenemia and hypofibrinogenemia). It is not indicated for dysfibrinogenemia; compendial uses include perioperative management and prophylaxis in afibrinogenemia.