CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tretten (Coagulation Factor XIII A‑subunit) coverage

Defines medical benefit coverage, dosing, authorization, and dispensing requirements for Tretten (recombinant coagulation factor XIII A‑subunit) for members of Neighborhood Health Plan of Rhode Island (Medicaid, Commercial; Medicare guidance noted). Applies to providers requesting authorization and dispensing the medication.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTretten (Coagulation Factor XIII A‑subunit) coverage

Policy CodePolicy N/A

Change TypeNo material change

Effective DateOct 1, 2019

Next Review DateN/A

Key ActionSubmit authorization requests including diagnosis confirmation by blood coagulation testing, original prescription details, requested amount and vial sizes, patient clinical history and product inventory to obtain coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J7181J-code

D68.2ICD-10

35 IU/kgDose

4,025Max units /28d

Up to 5On-hand doses allowed

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Coverage Criteria for Tretten

Initial coverage criteria

Coverage is provided when ALL of the following are met:

Entry criteria: Diagnosis of congenital factor XIII A-subunit deficiency confirmed by blood coagulation testing; AND Used for routine prophylaxis of bleeding; AND Dose consistent with recommended 35 IU/kg once monthly to achieve trough FXIII activity >= 10% using a validated assay; AND Dosing limits (maximum 4,025 billable units per 28 days) observed unless dose increase is supported by a half-life study or other clinical justification.35 IU/kg once monthly; target trough >= 10%

Medicare members who received Tretten within the past 365 days are not subject to step therapy requirements.

Renewal criteria

Renewal coverage requires ALL of the following:

Renewal criteria: Patient continues to meet initial coverage criteria; AND Absence of unacceptable toxicity (examples: anaphylaxis/allergic reaction, thromboembolic events, development of neutralizing antibodies/inhibitors); AND Any increases in dose are supported by acceptable clinical rationale (e.g., weight gain, half-life study results, increased breakthrough bleeding despite adherence); AND Cumulative on-hand medication assessed and limited to up to 5 doses on-hand for treatment of acute bleeding; AND For routine prophylaxis, renewals approved for a 12-month authorization period with demonstrated beneficial response (decreased bleeding frequency from baseline).Up to 5 doses on-hand; 12-month authorization for routine prophylaxis

Dose increases require documentation of clinical justification.

Hemophilia Management Program requirements

Hemophilia Management Program conditions (required in specified scenarios):

Hemophilia program requirements: Perform a half-life study when the requested dose exceeds dosing limits or when the member has a BMI >= 30 to determine appropriate dose and dosing interval; AND For minimally treated patients (<50 exposure days) previously on a different factor product, perform inhibitor testing at baseline and then at each comprehensive care visit (yearly for mild/moderate, semi-annually for severe).<50 exposure days for 'minimally treated'; BMI >= 30 triggers half-life study

Dispensing and dosing controls (monthly dispensing authorization, limits on vial dispensing, and limits on on-hand doses) apply as part of the Hemophilia Management Program.

This policy is limited to use of Tretten for members with a confirmed diagnosis of congenital Factor XIII A‑subunit deficiency. Coverage requires documentation that the diagnosis was confirmed by blood coagulation testing and that therapy is being used for routine prophylaxis of bleeding. The document does not list other explicit non‑covered indications; instead, it restricts coverage to this specific hereditary deficiency and the routine prophylaxis indication described above.

Use of Tretten for indications other than routine prophylaxis in confirmed congenital FXIII A‑subunit deficiency — or use without documentation of diagnosis, appropriate dosing, and monitoring — does not meet the coverage criteria and therefore will not be approved. For requests outside routine prophylaxis, provide clinical rationale and supporting documentation (diagnostic testing, dosing justification, and monitoring plans). Monthly dispensing authorizations must include prescription details, requested quantity, available vial sizes, patient product inventory, and relevant clinical history as specified by the Hemophilia Management Program.

Coding and Billing

Covered HCPCS & NDCHCPCS | NDCCovered

J7181	Tretten, Coagulation Factor XIII A-Subunit (recombinant), 1 IU
00169-7013-xx	Tretten NDC (package insert listed NDC)

Covered Diagnosis CodesICD-10Covered

D68.2

Hereditary deficiency of other clotting factors

Target trough FXIII activity

Target trough FXIII activityTarget trough FXIII activity >= 10% (measured by a validated assay)

Clinical goalAchieve trough FXIII activity at or above 10% to reduce bleeding risk during monthly prophylaxis

Assay requirementUse a validated FXIII activity assay to document trough level

Maximum billable units

Maximum billable units (medical benefit)4,025 billable units per 28 day supply

Implication for dosingDosing plans must not exceed 4,025 units per 28 days unless supported by documented half-life study or BMI-based justification

Provider Actions, Authorization & Documentation

Prior Authorization

Authorization period & Medicare exception

Initial authorizations are provided for 3 months unless otherwise specified. The cumulative amount of medication the member has on-hand will be taken into account when issuing authorizations; up to 5 on-hand doses for treatment of acute bleeding episodes will be permitted at the time of the authorization request. Initial and renewal authorization periods may vary by specific covered indication. For Medicare members, prior step therapy requirements do not apply if the member has received the medication within the past 365 days.

Initial authorization period: 3 months (unless otherwise specified)
On-hand doses allowed at authorization: up to 5 doses for acute bleeding
Medicare exception: Members who received medication within prior 365 days are exempt from Step Therapy

Documentation Required

Required documentation for dispensing authorization

Rendering providers in the Hemophilia Management Program must request monthly authorization for dispensing quantity prior to delivering factor product. Prescriptions cannot be auto-filled and require an expressed need from the patient, caregiver, or prescriber. Documentation submitted with each monthly authorization request must include the original prescription, requested amount to be dispensed, available vial sizes, and patient clinical history (including current product inventory and bleed history). The cumulative on-hand medication will be considered and patients should not have more than 5 extra doses on-hand for treatment of acute bleeding episodes. Factor dose dispensed should not exceed +1% of the prescribed dose and a maximum of three vials may be dispensed per dose; if exact dosing within the threshold is not possible, dispense the lowest possible dose above +1% without increasing the prescribed dose to meet assay management requirements.

Background

Tretten is recombinant coagulation Factor XIII A‑subunit indicated for routine prophylaxis of bleeding in patients with congenital Factor XIII A‑subunit deficiency. The recommended prophylaxis dosing is 35 IU/kg once monthly with the goal of achieving a target trough FXIII activity of >= 10% as measured by a validated assay. Coverage considerations include confirmation of diagnosis by blood coagulation testing and adherence to the dosing and dispensing controls outlined in this policy.

Definitions

Congenital Factor XIII A‑subunit deficiency

DefinitionCongenital Factor XIII A‑subunit deficiency is a hereditary deficiency of the FXIII A‑subunit confirmed by blood coagulation testing

Clinical consequenceLeads to a bleeding diathesis due to impaired fibrin cross-linking and unstable clots

Therapeutic approachReplacement with recombinant FXIII A‑subunit (Tretten) given as routine monthly prophylaxis to prevent bleeding

Typical prophylaxis dose35 IU/kg once monthly to achieve target trough >=10%