CurrentViva Health PlanPolicy IC-0338

Hemophilia Products – Coagulation Factor XIII A-subunit: Tretten® (Intravenous)

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This policy governs prior authorization, dosing, dispensing, and renewal of Tretten for routine bleeding prophylaxis in members with congenital factor XIII A-subunit deficiency.

Policy Summary

PayerViva Health Plan

PolicyHemophilia Products – Coagulation Factor XIII A-subunit: Tretten® (Intravenous)

Policy CodePolicy IC-0338

Change TypeNo material change

Effective DateN/A

Last ReviewJun 2, 2026

Next Review DateN/A

Key ActionObtain prior authorization before treatment and monthly authorization for the dispensing quantity before delivering factor product.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 monthsInitial authorization

12 monthsRenewal authorization

4,025 unitsQuantity limit

35 IU/kg monthlyRoutine dose

5 doses

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CurrentViva Health PlanPolicy IC-0338

Hemophilia Products – Coagulation Factor XIII A-subunit: Tretten® (Intravenous)

Customize your policy alerts

Sign up for vivahealthplan Policy IC-0338 alerts

Get alerted when Policy IC-0338 changes without checking for updates manually.

Monitor payer policy activity

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This policy governs prior authorization, dosing, dispensing, and renewal of Tretten for routine bleeding prophylaxis in members with congenital factor XIII A-subunit deficiency.

Policy Summary

PayerViva Health Plan

PolicyHemophilia Products – Coagulation Factor XIII A-subunit: Tretten® (Intravenous)

Policy CodePolicy IC-0338

Change TypeNo material change

Effective DateN/A

Last ReviewJun 2, 2026

Next Review DateN/A

Key ActionObtain prior authorization before treatment and monthly authorization for the dispensing quantity before delivering factor product.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 monthsInitial authorization

12 monthsRenewal authorization

4,025 unitsQuantity limit

35 IU/kg monthlyRoutine dose

5 doses

Acute-bleeding inventory

D68.2Covered diagnosis

Coverage Criteria

Initial approval criteria

Covered when all of the following are met:

Initial approval

Confirmed diagnosis: Diagnosis of congenital factor XIII A-subunit deficiency has been confirmed by blood coagulation testing.
Indication: Tretten is used for routine prophylaxis of bleeding.

Renewal criteria

Renewal requires all of the following:

Renewal

Continued eligibility: The member continues to meet the relevant indication-specific criteria identified in the initial approval criteria.
Safety: The member has no unacceptable toxicity from Tretten, including allergic or anaphylactic reactions, thromboembolic events, or development of neutralizing antibodies (inhibitors).
Dose rationale: Any dose increase is supported by an acceptable clinical rationale.
Examples include weight gain, half-life study results, or increased breakthrough bleeding when the member is fully adherent to therapy.
Inventory control: The cumulative amount of medication on hand is considered, and authorization allows up to five doses on hand for treatment of acute bleeding episodes for the duration of the authorization.up to 5 doses on hand
Clinical response: The member has demonstrated a beneficial response to therapy, with the frequency of bleeding episodes decreased from the pretreatment baseline.decreased bleeding frequency from pretreatment baseline

Coding and Quantity Parameters

Covered HCPCS CodeHCPCSCovered

J7181

Tretten

Covered Diagnosis CodesICD-10Covered

D68.2

Hereditary deficiency of other clotting factors

NDCNDC

00169-7013-xx

Tretten NDC

Dosing limit

Maximum quantity4,025 billable units

Supply periodPer 28-day supply

Unit typeHCPCS billable units

BMI threshold for half-life study

BMI thresholdBMI ≥ 30

Required actionPerform a half-life study

Study purpose

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Duration

Prior authorization is required for Tretten. Initial authorization is valid for 3 months (90 days), and renewal authorization may be granted every 12 months (365 days).

Initial authorization: 3 months (90 days)
Renewal authorization: Every 12 months (365 days)

Prior Authorization

Monthly Dispensing Authorization Required

Rendering providers must obtain authorization for the dispensing quantity each month before delivering the factor product.

Monthly dispensing authorization is required before delivery.
The submission must support the requested dispensing quantity.

Unsupported block type: documentation

Background

Tretten is an intravenous coagulation factor XIII A-subunit replacement product used for routine prophylaxis of bleeding in members with congenital factor XIII A-subunit deficiency. The policy addresses maintenance treatment rather than acute bleeding treatment; routine dosing is administered monthly to maintain a target trough factor XIII activity of at least 10%.

Definitions

Minimally treated member

DefinitionA minimally treated member has fewer than 50 exposure days to factor products

Exposure measureExposure days to factor products

Related requirementFor members previously receiving a different factor product, inhibitor testing is required

Half-life study

PurposeDetermine the appropriate Tretten dose and dosing interval

When requiredWhen the requested routine prophylaxis dose exceeds dosing limits

Additional trigger

Initial Therapy

Initial approval

Initial approval requires all of the following:

Initial therapy

Confirmed diagnosis: Congenital factor XIII A-subunit deficiency is confirmed by blood coagulation testing.
Indication: Tretten is used for routine prophylaxis of bleeding.

Continuation and Renewal

Continuation and renewal

Renewal may be authorized when all of the following are met:

Continuation therapy

Continued eligibility: The member continues to meet the indication-specific criteria identified in the initial approval criteria.
Safety: The member has no unacceptable toxicity from Tretten, including allergic or anaphylactic reactions, thromboembolic events, or development of neutralizing antibodies (inhibitors).
Dose rationale: Any dose increase is supported by an acceptable clinical rationale.
Examples include weight gain, half-life study results, or increased breakthrough bleeding when the member is fully adherent to therapy.

Quantity Limits

Quantity limit

ProductTretten

Maximum quantity4,025 billable units

Supply periodPer 28-day supply

Policy Summary

PayerViva Health Plan

PolicyHemophilia Products – Coagulation Factor XIII A-subunit: Tretten® (Intravenous)

Policy CodePolicy IC-0338

Change TypeNo material change

Effective DateN/A

Last ReviewJun 2, 2026

Next Review DateN/A

Key ActionObtain prior authorization before treatment and monthly authorization for the dispensing quantity before delivering factor product.

SourceLink

On This Page

Determine the appropriate Tretten dose and dosing interval

Minimal treatment exposure threshold

Exposure thresholdFewer than 50 exposure days to factor products

Policy termMinimally treated member

Additional applicabilityApplies to members previously receiving a different factor product

Maximum vials per dose

Maximum vials3 vials

Applies toEach dose

Dispensing ruleNo more than three vials may be dispensed per dose

Dispensed dose threshold

Dose limitNot more than 1% above the prescribed dose

Applies toFactor dose dispensed

Dose adjustment ruleThe prescribed dose should not be increased to meet assay management requirements

Maximum acute-bleeding inventory

Maximum inventoryUp to 5 doses on hand

PurposeTreatment of acute bleeding episodes

Inventory basisCumulative medication on hand is considered at authorization and dispensing

Documentation Required

Half-Life Study Required

A half-life study is required when routine prophylaxis dosing exceeds the limits in Part II or when the member has a BMI of 30 or greater. The study must determine the appropriate dose and dosing interval.

Perform when the requested routine prophylaxis dose exceeds applicable dosing limits.
Perform for members with BMI ≥ 30.
Document the appropriate dose and dosing interval based on the study.

Documentation Required

Inhibitor Testing

For minimally treated members with fewer than 50 exposure days to factor products who previously received a different factor product, inhibitor testing is required.

Baseline inhibitor testing is required.
Repeat testing at every comprehensive care visit: yearly for mild or moderate members and semi-annually for severe members.

Billing Rule

Monthly Dispensing Submission

Before each monthly dispensing, the rendering provider must submit authorization information for the quantity to be delivered.

Original prescription information
Requested amount to be dispensed
Vial sizes available to order from the manufacturer
Member clinical history, including current product inventory and bleed history

Documentation Required

Renewal Documentation Required

Renewal requires continued fulfillment of the indication-specific criteria, no unacceptable drug toxicity, and documentation supporting any dose increase. On-hand medication must also be considered, with authorization allowing up to five acute-bleeding doses for the duration of the authorization.

Confirm continued eligibility under the applicable indication criteria.
Review for unacceptable toxicity.
Provide an acceptable clinical rationale for any dose change.
Account for cumulative medication inventory and allow no more than five acute-bleeding doses on hand.

Denial Risk

Indication Not Met

Authorization may be denied when congenital factor XIII A-subunit deficiency has not been confirmed by blood coagulation testing or when Tretten is not being used for routine prophylaxis of bleeding.

Congenital factor XIII A-subunit deficiency must be confirmed.
Routine prophylaxis of bleeding must be established.

Denial Risk

Unacceptable Toxicity

Renewal may be denied for unacceptable toxicity, including allergic or anaphylactic reactions, thromboembolic events, or development of neutralizing antibodies (inhibitors).

Allergic or anaphylactic reactions, including anaphylaxis, wheezing, rash, urticaria, chest tightness, or hypotension
Thromboembolic events, including thromboembolism or pulmonary embolism
Development of neutralizing antibodies (inhibitors)

Denial Risk

Unsupported Dose Increase

Any dose increase must be supported by an acceptable clinical rationale. Without adequate support, the renewal request may be denied.

Examples include weight gain, half-life study results, or increased breakthrough bleeding despite full adherence to therapy.
Do not increase the dose solely to meet assay management requirements.

Denial Risk

No Demonstrated Benefit

Continued authorization requires a demonstrated beneficial response to therapy, shown by a decrease in bleeding frequency from the pretreatment baseline.

Document decreased bleeding frequency compared with the pre-treatment baseline.

Billing Rule

Expressed Dispensing Need Required

A prescription cannot be filled without an expressed need from the member, caregiver, or prescribing practitioner. Autofilling is prohibited.

Obtain an expressed dispensing need before filling.
Do not autofill prescriptions.

Billing Rule

Excess Inventory Controls

Rendering providers must consider the member’s cumulative medication inventory when dispensing. Members should not have more than five extra doses on hand for treatment of acute bleeding episodes.

Apply cumulative inventory controls to each dispensing decision.
Limit extra on-hand inventory to 5 doses for acute bleeding episodes.
Dispensing requires an expressed need; inventory must be reviewed before delivery.

For members with a BMI ≥ 30

Inventory control: The cumulative amount of medication on hand is considered, and authorization allows up to five doses on hand for treatment of acute bleeding episodes for the duration of the authorization.up to 5 doses on hand

Clinical response: The member has demonstrated a beneficial response to therapy, with the frequency of bleeding episodes decreased from the pretreatment baseline.decreased bleeding frequency from pretreatment baseline