CurrentMass General Brigham Health PlanPolicy N/A

Tretten (coagulation factor XIII A‑subunit [recombinant]) prior authorization

Policy governing prior authorization for Tretten under the pharmacy benefit for Mass General Brigham Health Plan commercial/exchange members; defines covered indication, continuation criteria, specialty dispensing, and authorization limits.

Policy Summary

PayerMass General Brigham Health Plan

PolicyTretten (coagulation factor XIII A‑subunit [recombinant]) prior authorization

Policy CodePolicy N/A

Change TypeBenefit designation revised to pharmacy-only

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization under the pharmacy benefit for Tretten for routine prophylaxis of congenital factor XIII A‑subunit deficiency; include documentation of current therapy for new-to-plan members treated within the past 90 days (exclude samples/assistance).

SourceLink

POLICY UPDATE CHANGES

Policy updated to indicate that it no longer applies to the medical benefit and is pharmacy benefit only, effective 01/01/2026.

Commercial/Exchangeplan applicability

Pharmacy onlybenefit designation

12 monthsapproval duration

Specialty requiredspecialty dispensing

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Coverage Criteria for Tretten

Initial Authorization

Authorization may be granted when ALL of the following are met

Initial Authorization: Requested medication is being used for prophylaxis of bleeding in members with congenital factor XIII A-subunit deficiency.

Based on Coverage Guidelines and Overview

Initial Authorization (new-to-plan): If member is new to the plan and currently receiving the medication, treatment must have been within the past 90 days (excluding samples or manufacturer's patient assistance programs).

As specified under Coverage Guidelines

Continuation of Therapy

Reauthorization will be approved when ALL of the following are met

Reauthorization: Member is experiencing benefit from therapy (e.g., reduced frequency or severity of bleeds).

Continuation of Therapy

Reauthorization duration: Reauthorization approvals are granted for up to 12 months.

Limitations

Tretten is not indicated for use in patients with congenital factor XIII B‑subunit deficiency. This exclusion reflects the product’s approved indication for A‑subunit deficiency only and the documented lack of indication for B‑subunit deficiency.

All indications other than routine prophylaxis of bleeding in congenital factor XIII A‑subunit deficiency are considered experimental/investigational and not medically necessary. Requests for use outside the approved A‑subunit prophylaxis indication may be denied on that basis.

Initial Therapy Requirements

Initial Therapy

Initial authorization requirements

Initial: Medication is prescribed for routine prophylaxis of bleeding in congenital factor XIII A-subunit deficiency.

Matches policy indication

New-to-plan members may qualify if they have been receiving Tretten within the past 90 days; exclude samples or manufacturer's patient assistance programs as evidence of treatment.

Documentation required per Coverage Guidelines

Continuation / Reauthorization Criteria

Continuation of Therapy

Reauthorization criteria and duration

Clinical benefit: Member demonstrates clinical benefit from therapy (for example, reduced frequency or severity of bleeding episodes).

Evaluate clinical response for continuation

Approval duration: Approvals for continuation of therapy will be granted for up to 12 months per authorization cycle.

See Limitations

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Tretten under the pharmacy benefit for commercial/exchange members. Authorization may be granted for members new to the plan within the past 90 days who are currently receiving treatment with the requested medication (exclude samples or manufacturer‑provided product). Tretten is designated specialty and must be filled at a contracted specialty pharmacy.

Program type: Prior Authorization (Pharmacy benefit, Commercial/Exchange members)
Specialty pharmacy fill required

Step Therapy

No step therapy requirements are specified in this policy.

Documentation Required

Site of Care / Dispensing

Billing Rule

Specialty pharmacy dispensing required

This medication has been designated as a specialty product and must be dispensed through a contracted specialty pharmacy.

Key Definitions

Routine prophylaxis — definition and related statements

DefinitionOngoing administration intended to prevent bleeding episodes in patients with congenital factor XIII A‑subunit deficiency.

Covered indicationUsed specifically for routine prophylaxis of bleeding in congenital factor XIII A‑subunit deficiency.

Non‑applicable conditionNot for use in patients with congenital factor XIII B‑subunit deficiency.

Investigational statementAll other indications besides routine prophylaxis for congenital factor XIII A‑subunit deficiency are considered experimental/investigational and not medically necessary.

Background

Tretten (coagulation factor XIII A‑subunit [recombinant]) is indicated for routine prophylaxis of bleeding in patients with congenital factor XIII A‑subunit deficiency. It is specifically not for use in congenital factor XIII B‑subunit deficiency, and any other uses beyond the A‑subunit prophylaxis indication are considered experimental/investigational and not medically necessary.

Revision History

2025-10-08operational changeLatest

Policy updated to indicate Tretten will no longer apply to the medical benefit and will be pharmacy benefit only, with the change effective 2026-01-01.

2023-12-13review

Reviewed at December P&T; formulary classification changed (switched from SGM to Custom) with an effective date of 2024-01-01.

2025-05-14review