ModifiedHealth NetPolicy CP.PHAR.222

Factor XIII A-Subunit, Recombinant (Tretten)

Policy governing medical necessity and prior authorization criteria for Tretten (recombinant factor XIII A-subunit) for routine prophylaxis in congenital factor XIII A-subunit deficiency for Health Net lines of business.

Policy Summary

PayerHealth Net

PolicyFactor XIII A-Subunit, Recombinant (Tretten)

Policy CodePolicy CP.PHAR.222

Change TypeRevised and clarified approval durationscriteria clarifications

Effective Date05.01.16

Next Review Date

Key ActionSubmit prior authorization with documentation (chart notes, labs, or bleed history/factor XIII activity) demonstrating the member meets all clinical criteria for routine prophylaxis.

SourceLink

POLICY UPDATE CHANGES

For Commercial line of business, initial and continued approval durations revised to '6 months or to the member's renewal date, whichever is longer;' for Medicaid and HIM lines of business, continued approval duration revised from 6 months to 12 months.

Clarified requirement for coverage of factor XIIIa for routine prophylaxis: requirement for factor XIII activity level or documentation of bleed history applies only to requests for new starts to routine prophylactic therapy.

Removed 'life-threatening' from 'life-threatening or serious bleed' criterion to avoid potential misinterpretation.

Updated sites of serious bleeds per World Federation of Hemophilia guideline in Appendix D.

6 moApproval duration (Commercial)

12 moApproval duration (Medicaid/HIM)

≥10%

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Target trough activity

35 IU/kgDose (monthly)

Coverage Criteria for Tretten (Factor XIII A-Subunit, Recombinant)

inv-01: Initial Therapy

Covered when ALL of the following are met:

Congenital Factor XIII A-Subunit Deficiency - initial: 1. Diagnosis of congenital factor XIII A-subunit deficiency; 2. Prescribed by or in consultation with a hematologist; 3. Request is for routine prophylaxis to prevent or reduce the frequency of bleeding episodes; 4. For routine prophylaxis requests, member meets ONE of: a) Member has previously used factor XIIIa for routine prophylaxis; b) Member has severe hemophilia (factor level < 1%); c) Member has experienced at least one serious spontaneous bleed (see Appendix D).

Appendix D defines serious bleeding and spontaneous bleed.

inv-02: Continuation Therapy

Covered for continuation when ALL of the following are met:

Congenital Factor XIII A-Subunit Deficiency - continued: 1. Member meets ONE of: a) Currently receiving medication via Centene benefit or previously met initial approval criteria; b) Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy.

Refer to state-specific addendums for continuity of care details.

Requests for Tretten for members with congenital factor XIII B-subunit deficiency are not authorized and are excluded from coverage.

Coding listed in this policy is provided for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage; coverage and reimbursement remain subject to the member’s plan terms, applicable exclusions, and limitations. Providers should reference current professional coding guidance before submitting claims.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the request includes sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy (see CP.CPA.09 for commercial, HIM.PA.154 for marketplace, CP.PMN.53 for Medicaid) or other evidence of coverage documentation.

Coding, Dosing Targets, and Approval Durations

HCPCS CodesHCPCS

J7181

Injection, factor XIII A-subunit, (recombinant), per IU

HCPCS CodesHCPCS

J7181

Injection, factor XIII A-subunit, (recombinant), per IU

inv-08: Target trough Factor XIII activity — clinical target value

Target trough Factor XIII activity≥ 10%

PurposeTrough level target to guide routine prophylaxis dosing (35 IU/kg IV once monthly)

Dose adjustment guidanceConsider dose adjustment if adequate coverage is not achieved with 35 IU/kg

inv-09: Approval duration (Commercial) — 6 months or to the member's renewal date, whichever is longer

Approval duration (Commercial)6 months or to the member's renewal date, whichever is longer

Applies toCommercial line of business (initial and continued approvals)

Provider Actions, Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization for Tretten

Prior authorization is required for Tretten. Tretten is authorized only for routine prophylaxis of congenital factor XIII A‑subunit deficiency when the member meets the policy’s clinical criteria (including diagnosis, hematology involvement, and prophylaxis indication). Requests for Tretten for congenital factor XIII B‑subunit deficiency will be denied.

Prior authorization required for Tretten for routine prophylaxis of congenital factor XIII A‑subunit deficiency.
Requests for Tretten for congenital factor XIII B‑subunit deficiency are not authorized and will be denied.

Prior Authorization

Prior Authorization and Approval Durations

Approval durations vary by line of business. For Commercial members initial and continued approvals are for 6 months or to the member’s renewal date, whichever is longer. For Medicaid and HIM lines of business, initial and continued approval durations are 12 months.

Commercial: initial and continued approval = 6 months or to member renewal date, whichever is longer.

Background

Factor XIII A‑subunit deficiency is a congenital bleeding disorder. Recombinant factor XIII A‑subunit (Tretten) is FDA‑approved for routine prophylaxis to prevent bleeding in patients with congenital factor XIII A‑subunit deficiency and is covered by prior authorization when the clinical criteria in this policy are met. Prior authorization is required for Tretten and approval is limited to the indications and durations specified under the policy criteria.

Definitions and Acronyms

inv-21: Serious bleeding episode — list of included anatomic sites and examples.

IntracranialIncludes bleeds within the cranial vault (intracranial hemorrhage)

Neck/throatBleeding in neck or throat structures that may compromise airway or require intervention

GastrointestinalBleeding anywhere in the GI tract (e.g., upper or lower GI bleeding)

Joints (hemarthrosis)Bleeding into a joint space (hemarthrosis)

Deep compartment musclesMuscle bleeds especially in deep compartments such as the iliopsoas, calf, or forearm

Mucous membranesBleeding from mucous membranes of the mouth, nose, or genitourinary tract

Policy Revision History

10.17.25approval_duration_revisionLatest

1Q2026 annual review revised initial Medicaid/HIM approval duration from 6 months to 12 months (no other significant clinical changes).

Policy Summary

PayerHealth Net

PolicyFactor XIII A-Subunit, Recombinant (Tretten)

Policy CodePolicy CP.PHAR.222

Change TypeRevised and clarified approval durationscriteria clarifications

Effective Date05.01.16

Next Review Date

Key ActionSubmit prior authorization with documentation (chart notes, labs, or bleed history/factor XIII activity) demonstrating the member meets all clinical criteria for routine prophylaxis.

SourceLink

On This Page

Reference review noteRevised to this wording in 1Q 2025 annual review

inv-10: Continued approval duration (Medicaid/HIM) — 12 months

Continued approval duration (Medicaid/HIM)12 months

Change noteContinued approval duration for Medicaid and HIM revised from 6 months to 12 months (noted in 1Q 2025/1Q 2026 reviews)

Applies toMedicaid and HIM lines of business (continued approvals)

Medicaid and HIM: initial and continued approval = 12 months.

Documentation Required

Prophylaxis and Documentation Requirements

For new starts of routine prophylactic therapy, documentation must include either factor XIII activity level or documentation of bleed history (for example, details of spontaneous or serious bleeds as defined in the policy Appendix D). For all requests, provider must submit supporting documentation such as office chart notes, laboratory results, and any other clinical information demonstrating the member meets the approval criteria.

New starts of routine prophylaxis: submit factor XIII activity level OR documentation of bleed history (per Appendix D).
All requests: include office chart notes, lab results, and other clinical evidence supporting criteria are met.

Step Therapy

There are no formal step‑therapy agents required; approval is based on meeting the policy’s listed clinical criteria (for example prior prophylaxis use, severe deficiency, or documented serious spontaneous bleed) rather than a step‑therapy sequence.

No step therapy specified; decision based on meeting clinical criteria (see policy A.4.a–c).

inv-22: Spontaneous bleed — definition of spontaneous bleed.

DefinitionA bleeding episode that occurs without apparent cause and is not the result of trauma.

Context of useUsed to determine eligibility for routine prophylaxis when history of at least one spontaneous bleed is required

Reference locationDefined in Appendix D: General Information

inv-23: MASAC — definition/acronym expansion.

MASACMedical and Scientific Advisory Council of the National Bleeding Disorders Foundation (formerly National Hemophilia Foundation)

RoleProvides treatment guidelines and position documents referenced by the policy

Source link noteMASAC documents available via the National Bleeding Disorders Foundation website (per policy references)