CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tretten (factor XIII A-subunit) intravenous therapy — Coverage Criteria

Covers clinical and administrative criteria for authorization, dosing, dispensing, and renewal of Tretten (intravenous) for members of Neighborhood Health Plan of Rhode Island across Medicaid, Commercial, and Medicare-Medicaid Plan (MMP) lines when provided via the medical benefit.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTretten (factor XIII A-subunit) intravenous therapy — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateOct 1, 2019

Next Review DateN/A

Key ActionSubmit authorization requests with original prescription details, requested amount and vial sizes, patient clinical history including product inventory and bleed history, and documentation confirming diagnosis by blood coagulation testing for congenital factor XIII A-subunit deficiency.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

D68.2covered diagnosis code (ICD-10)

J7181HCPCS J-code

35 IU/kgrecommended prophylaxis dose

3 monthsinitial auth period

Up to 5

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allowed on-hand doses

Coverage Criteria for Tretten (factor XIII A‑subunit)

Initial coverage (routine prophylaxis)

Covered when ALL of the following are met

Diagnosis and indication: Diagnosis of congenital factor XIII A-subunit deficiency confirmed by blood coagulation testing AND used for routine prophylaxis of bleeding.

FDA-approved indication; confirmation by blood coagulation testing required

Dose and administration: Dose = 35 IU/kg administered once monthly to achieve a target trough FXIII activity ≥ 10% using a validated assay.35 IU/kg monthly; target trough >= 10%

Per dosing/administration section and FDA labeling

Authorization limits: Initial authorization period per policy (typically 3 months) with consideration of cumulative on-hand medication; up to 5 on-hand doses allowed for treatment of acute bleeding episodes during the authorization period.Up to 5 on-hand doses

Authorization limits and on-hand dosing for acute bleeding

Renewal criteria

Renewal covered when ALL of the following are met

Continue criteria: Patient continues to meet the initial coverage criteria for congenital factor XIII A-subunit deficiency and routine prophylaxis.

Continuation of initial criteria required

Safety and toxicity: Absence of unacceptable toxicity (examples: allergic/anaphylactic reactions, thromboembolic events, development of neutralizing antibodies).

Unacceptable toxicity grounds for denial

Dose changes: Any increases in dose must be supported by acceptable clinical rationale (e.g., weight gain, half-life study results, increased breakthrough bleeding despite adherence).

Dose increases require justification

Demonstrated benefit:

Hemophilia management program conditions

Hemophilia management program requirements (conditions where additional testing is required)

Half-life study indications: Perform a half-life study if the requested routine prophylaxis dose exceeds dosing limits or for members with BMI ≥ 30 to determine appropriate dose and dosing interval.Dose exceeds dosing limits OR BMI >= 30

Hemophilia Management Program requirement

Inhibitor testing for minimally treated patients: For minimally treated patients (<50 exposure days to factor products) previously receiving a different factor product, perform inhibitor testing at baseline and then at every comprehensive care visit (yearly for mild/moderate; semi-annually for severe).<50 exposure days

Inhibitor testing schedule per Hemophilia Management Program

Policy limits and the coverage criteria in this document apply specifically to congenital factor XIII A-subunit deficiency. Coverage is tied to a confirmed diagnosis by blood coagulation testing and use for routine prophylaxis of bleeding; indications outside of congenital factor XIII A-subunit deficiency are not included as covered indications in this policy.

Use of Tretten for diagnoses other than congenital factor XIII A-subunit deficiency (ICD-10 D68.2) is not supported by this policy as a covered indication. The policy’s covered diagnosis list identifies D68.2 (hereditary deficiency of other clotting factors) as the relevant covered diagnosis.

Coding, Quantity Limits, and Diagnosis Codes

Covered HCPCSHCPCSCovered

J7181

Tretten, HCPCS J-code

NDCNDC

00169-7013-xx

Tretten NDC (manufacturer Novo Nordisk)

Covered Diagnosis CodesICD-10Covered

D68.2

Hereditary deficiency of other clotting factors

Quantity limit (Pharmacy benefit) — Tretten 2,000-3,125 IU vial

Drug and vial sizesTretten, 2,000–3,125 IU vial

Quantity limit (pharmacy benefit)2 vials per 28-day supply

Applicable benefitPharmacy benefit (quantity limit applies to outpatient pharmacy dispensing)

Max units (Medical benefit)

Max billable units4,025 billable units per 28-day supply

Unit definition1 billable unit = 1 IU (per coding section)

Provider Requirements, Authorization, and Documentation

Prior Authorization

Prior Authorization Period

Unless otherwise specified, initial authorization is provided for 3 months (may vary by indication). The cumulative amount of medication the patient has on-hand will be taken into account for authorizations. Up to 5 on‑hand doses for treatment of acute bleeding episodes will be permitted at the time of the authorization request.

Initial authorization period: 3 months (may vary by indication)
On‑hand supply considered when authorizing; up to 5 extra doses allowed

Step Therapy

Step Therapy Exception for MMP

Step therapy requirements do not apply to members enrolled in the Hemophilia Management Program (MMP) who have received Tretten within the past 365 days.

Applies to MMP members with documented receipt of Tretten within 365 days

Background and Clinical Context

Tretten is indicated for routine prophylaxis of bleeding in patients with congenital factor XIII A-subunit deficiency. The policy requires diagnosis confirmation by blood coagulation testing. Clinical trial evidence summarized in the policy demonstrated a substantially reduced annual bleeding rate compared with historical rates; common adverse events reported include extremity pain, increased D-dimer, and headache. The recommended prophylaxis dosing in the policy is 35 IU/kg once monthly to achieve a trough factor XIII activity of at least 10%.

Definitions

Hereditary deficiency of factor XIII A-subunit confirmed by blood coagulation testing

DefinitionCongenital (hereditary) deficiency of factor XIII A-subunit confirmed by blood coagulation testing

Confirmation methodDiagnosis must be confirmed by blood coagulation testing (validated assay)

Indication contextUsed as the covered indication for routine prophylaxis of bleeding in patients with FXIII A-subunit deficiency

Supporting evidenceTretten is indicated for routine prophylaxis in congenital factor XIII A-subunit deficiency per clinical trial data

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTretten (factor XIII A-subunit) intravenous therapy — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateOct 1, 2019

Next Review DateN/A

SourceLink

On This Page

For routine prophylaxis renewals, patient has demonstrated beneficial response (decreased frequency of bleeding episodes from pre-treatment baseline).

Renewals for routine prophylaxis approved for 12 months if benefit shown

On-hand medication consideration: Authorization will account for cumulative on-hand medication; allowance for up to 5 on-hand doses for acute bleeding during the authorization period.Up to 5 on-hand doses

Cumulative on-hand amounts considered at renewal

Applicable benefitMedical benefit (applies to billed units for administration/infusion)

Documentation Required

Required Documentation for Authorization

Authorization requests and monthly dispensing authorization submissions must include the original prescription information, requested amount to be dispensed, vial sizes available from the manufacturer, patient clinical history (including product inventory and bleed history), and supporting test results as applicable.

Include original prescription, requested amount, vial sizes, patient clinical history, product inventory, and bleed history
Provide relevant supporting laboratory or test results (e.g., coagulation testing) when applicable

Denial Risk

Denial Triggers

Requests that fail to document diagnosis confirmation by blood coagulation testing for congenital factor XIII A‑subunit deficiency, lack required dispensing/authorization documentation, or do not account for on‑hand supply (including allowance of up to 5 on‑hand doses) may be denied.

Denial triggers: no coagulation test confirmation for congenital factor XIII A‑subunit deficiency
Denial triggers: missing prescription details, vial sizes, patient history, or supporting test results
Denial triggers: failure to consider cumulative on‑hand medication supply