CurrentMass General Brigham Health PlanPolicy N/A

RiaSTAP (fibrinogen concentrate [human])

Defines prior authorization, coverage criteria, limits, and specialty pharmacy requirement for RiaSTAP (fibrinogen concentrate [human]) under the pharmacy benefit for Mass General Brigham Health Plan (MassHealth UPPL) effective 2024-01-01.

Policy Summary

PayerMass General Brigham Health Plan

PolicyRiaSTAP (fibrinogen concentrate [human])

Policy CodePolicy N/A

Change TypeFormulary classification change (SGM → Custom)

Effective DateJan 1, 2024

Next Review Date

Key ActionPrior authorization is required for RiaSTAP; authorization may be granted per the listed coverage criteria and durations.

SourceLink

POLICY UPDATE CHANGES

Reviewed at Dec P&T, switched from SGM to Custom effective 1/1/2024.

3Covered Indications

1Not Indicated

12 moMax initial approval (prophylaxis)

1 moMax initial approval (acute/periop)

Coverage Summary

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Policy status: Covered with criteria. This policy covers RiaSTAP (fibrinogen concentrate [human]) for the FDA-approved indication: treatment of acute bleeding episodes in congenital fibrinogen deficiency (including afibrinogenemia and hypofibrinogenemia). The policy also limits coverage to listed compendial uses — prophylaxis to reduce frequency of bleeding episodes in afibrinogenemia and perioperative management of bleeding in afibrinogenemia — and deems all other indications experimental/investigational and not medically necessary. Effective and payer metadata: Mass General Brigham Health Plan; MassHealth UPPL effective 2024-01-01 (administrative formulary change reviewed 12/13/2023).

Initial Authorization - FDA Indication and Compendial Uses

Authorization may be granted when ALL of the following are met or when member is currently receiving treatment:

Covered indications (ANY of the following)

Treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia (FDA-approved indication)
Perioperative management of bleeding in members with a diagnosis of afibrinogenemia (compendial use)
Prophylaxis to reduce the frequency of bleeding episodes in afibrinogenemia (compendial use) — requires justification from medical records
Members new to the plan who are currently receiving treatment with the requested medication (may be authorized), excluding when product was obtained as samples or via manufacturer's patient assistance programs

Initial Therapy Criteria

Initial Authorization - FDA Indication and Compendial Uses (Quick Reference)

Quick reference to covered indications (see Coverage Summary criteria for full details):

Covered indications (ANY of the following)

Treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia (FDA-approved)
Perioperative management of bleeding in members with a diagnosis of afibrinogenemia (compendial)
Prophylaxis to reduce the frequency of bleeding episodes in afibrinogenemia (compendial) — requires justification from medical records
New members currently receiving treatment may be authorized (excluding samples or manufacturer assistance program supplies)

Prior authorization is required for RiaSTAP. Initial authorization durations vary by indication: prophylaxis in afibrinogenemia — initial approval up to 12 months; treatment of acute bleeding episodes and perioperative management — initial approval up to 1 month. These durations reflect the policy's initial-approval rules and limits.

Continuation Therapy Criteria

Reauthorization / Continuation Criteria

Authorization for continuation may be granted only if member meets initial criteria and demonstrates benefit when applicable:

ALL of the following

All members requesting continuation of therapy must meet all initial authorization criteria
Prophylaxis-specific
- For prophylaxis to reduce the frequency of bleeding episodes in afibrinogenemia: authorization of 12 months may be granted when the member is experiencing benefit from therapy (e.g., reduced frequency of bleeding episodes)

Authorization Durations / Limits

Max initial approval (prophylaxis)12 months

Max initial approval (acute/perioperative)1 month

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is required for RiaSTAP. Authorization may be granted per the policy's coverage criteria and durations. For prior authorization submission, use the specialty medication contact channels for specialty products and the non-specialty contact channels for non-specialty products as listed.

Specialty medication phone: 877-519-1908; fax: 855-540-3693
Non-specialty medication phone: 800-711-4555; fax: 844-403-1029

Documentation Required

Documentation for prophylaxis

For prophylaxis to reduce the frequency of bleeding episodes in afibrinogenemia, medical records must justify the use and document clinical benefit (for example, a reduced frequency of bleeding episodes) to support initial authorization and reauthorization.

Medical records must show rationale for prophylaxis in afibrinogenemia
Documentation of benefit (e.g., fewer bleeding episodes) is required for reauthorization

Billing Rule

Specialty pharmacy requirement

RiaSTAP is designated a specialty medication and must be dispensed through a contracted specialty pharmacy under the plan's pharmacy benefit.

Medication is specialty-designated and subject to specialty pharmacy dispensing requirements

Prior Authorization

New member current treatment exception

Members new to the plan who are currently receiving RiaSTAP may be authorized to continue therapy; this exception does not apply when the product was obtained as samples or through the manufacturer's patient assistance programs.

New-member continuation allowed when actively receiving treatment
Excludes products obtained as samples or via manufacturer patient assistance programs

Clinical Evidence

Key evidence and references cited in the policy include the product labeling and professional guidance: RiaSTAP [package insert], CSL Behring LLC; June 2021, and MASAC recommendations concerning products licensed for the treatment of hemophilia and other bleeding disorders (revised March 2022). The policy notes that compendial uses such as perioperative management and prophylaxis in afibrinogenemia are referenced in the label/guidance.

Background & Definitions

Background: RiaSTAP is FDA-approved for the treatment of acute bleeding episodes in congenital fibrinogen deficiency (including afibrinogenemia and hypofibrinogenemia). Compendial uses included in the policy are prophylaxis to reduce bleeding frequency in afibrinogenemia and perioperative management of bleeding in afibrinogenemia. The policy restricts coverage to these indications and considers all other uses experimental/investigational and not medically necessary.

Definitions

AfibrinogenemiaCongenital absence of fibrinogen leading to bleeding episodes (covered condition for RiaSTAP use).

HypofibrinogenemiaCongenital low fibrinogen levels leading to bleeding episodes (covered for acute treatment).