Currentculinary health fundPolicy N/A

Hemophilia - Altuviiio Utilization Management Medical Policy

This policy governs prior authorization and medical benefit coverage criteria for Altuviiio (recombinant Factor VIII Fc-VWF-XTEN fusion protein) for treatment of Hemophilia A in adults and children under the Culinary Health Fund.

Policy Summary

Payerculinary health fund

PolicyHemophilia - Altuviiio Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeAnnual review — no material changes

Effective DateN/A

Next Review DateFeb 11, 2026

Key ActionSubmit prior authorization showing indication, recent inhibitor testing as required, and specialist involvement for approval up to 1 year.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearauthorization duration

50 IU/kgmax dose per administration

≥1.0 BU/mLinhibitor threshold

once weeklyprophylaxis frequency

Authorization and Medical Necessity Criteria

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Initial Therapy: Patient must meet all of i, ii, and iii

i. Indication: Altuviiio is being used in at least ONE of: (a) routine prophylaxis; (b) on-demand treatment and control of bleeding episodes; (c) perioperative management of bleeding

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ii. Inhibitor testing / prior Factor VIII exposure: Either (a) Factor VIII inhibitor testing performed within the past 30 days AND no positive test for Factor VIII inhibitors ≥ 1.0 Bethesda units/mL, OR (b) patient has not received Factor VIII therapy in the pastinhibitor negative < 1.0 BU/mL

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iii. Prescriber: Medication is prescribed by or in consultation with a hemophilia specialist

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Current or Past Altuviiio Use (FDA-Approved Indication B)

Approve for 1 year if the patient meets ALL of the following (i, ii, and iii):

Current/Past Altuviiio: Patient must meet all of i, ii, and iii

i. Indication: Altuviiio is being used in at least ONE of: (a) routine prophylaxis; (b) on-demand treatment and control of bleeding episodes; (c) perioperative management of bleeding

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ii. Inhibitor testing for current/past users: Either (a) Factor VIII inhibitor testing performed within the past 365 days AND no positive test for Factor VIII inhibitors ≥ 1.0 Bethesda units/mL, OR (b) prescriber attests that the patient does not have clinical manifestations suggesting presence of Factor VIII inhibitorsinhibitor negative < 1.0 BU/mL

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iii. Prescriber: Medication is prescribed by or in consultation with a hemophilia specialist

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Dosing Limits

Approve the following dosing regimens (A, B, and/or C):

A. Routine prophylaxis: Approve up to 50 IU per kg intravenously no more frequently than once weekly50 IU/kg, ≤ once weekly

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B. On-demand treatment: Approve up to 50 IU per kg intravenously with additional doses once every 2 to 3 days for up to 10 days per episode50 IU/kg, dosing every 2–3 days up to 10 days

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C. Perioperative management: Approve up to 50 IU per kg intravenously with additional doses once every 2 to 3 days for up to 10 days per procedure50 IU/kg, dosing every 2–3 days up to 10 days

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Coverage is not recommended for clinical situations that are not specifically listed in the Recommended Authorization Criteria. Criteria will be updated as new published data become available; requests outside the listed criteria should be considered non-covered unless and until the authorization criteria are amended to include them.

Testing Thresholds and Code-related Thresholds

Factor VIII inhibitor positive threshold

Positive inhibitor threshold≥ 1.0 Bethesda units/mL

Testing window — initial therapyFactor VIII inhibitor testing performed within the past 30 days (initial therapy requirement)

Testing window — current/past AltuviiioFactor VIII inhibitor testing performed within the past 365 days (for current or past Altuviiio users)

Prior Authorization, Documentation, and Prescriber Requirements

Prior Authorization

Prior authorization required

Prior authorization is recommended for medical benefit coverage of Altuviiio. Approval is recommended when patients meet the specified clinical criteria and dosing limits; approvals are provided for the duration noted (typically 1 year). Requests for doses outside the established dosing in this policy will be reviewed case-by-case by a clinician.

Approvals may be extended if the patient continues to meet criteria and dosing.
All approvals are provided for the duration noted in the policy.

Step Therapy

Step therapy / sequencing

No formal step therapy sequence is required by this policy. Requests for dosing outside the documented dosing regimens will be considered on a case‑by‑case basis by a clinician; prescriber must be a specialist.

Clinician review (Medical Director or Pharmacist) for requests outside established dosing.
Prescriber must be a physician who specializes in the condition being treated.

Documentation Required

Factor VIII inhibitor testing within 30 days for initial therapy

For initial therapy, Factor VIII inhibitor testing must have been performed within the past 30 days and be negative (< 1.0 BU/mL), unless the patient has never received prior Factor VIII therapy.

Initial therapy requires testing within 30 days and no positive inhibitor ≥ 1.0 Bethesda units/mL.
If the patient has not received Factor VIII therapy in the past, testing is not required for initial approval.

Documentation Required

Specialist prescribing required; state indication

Altuviiio must be prescribed by, or in consultation with, a hemophilia specialist. The prescriber should document the indication (routine prophylaxis, on‑demand treatment, or perioperative management).

Specialist involvement is required due to specialized evaluation and monitoring needs.
Indication must be stated: routine prophylaxis, on‑demand treatment, or perioperative management.

Denial Risk

Coverage not recommended outside listed criteria

Coverage is not recommended for situations not listed in the Recommended Authorization Criteria. Requests outside the specified criteria and dosing are therefore unlikely to be approved.

Criteria will be updated as new published data are available.
Coverage not recommended for circumstances not listed in the policy's Recommended Authorization Criteria.

Clinical Background

Hemophilia A is an X‑linked bleeding disorder caused by deficiency of clotting Factor VIII and primarily affects males. Disease severity is classified by residual plasma Factor VIII activity: severe (<1%), moderate (1–5%), and mild (6–49%). Clinical implications of these categories include increased spontaneous bleeding and joint hemorrhages in severe disease, with progressively lower bleeding risk in moderate and mild disease; treatment selection and intensity (prophylaxis, on‑demand therapy, or perioperative management) are guided by severity and bleeding phenotype.

Key Definitions and Product Description

Severity classification by plasma Factor VIII activity

Severe Hemophilia APlasma Factor VIII activity < 1%

Moderate Hemophilia APlasma Factor VIII activity 1–5%

Mild Hemophilia APlasma Factor VIII activity 6–49%

Altuviiio (product description)

Altuviiio descriptionRecombinant Factor VIII Fc-VWF-XTEN fusion protein (recombinant DNA‑derived Factor VIII concentrate) with prolonged (3–4 fold) half-life

IndicationsRoutine prophylaxis, on-demand treatment, and perioperative management of bleeding in Hemophilia A

PopulationIndicated for use in adults and children with Hemophilia A

Policy Summary

Payerculinary health fund

PolicyHemophilia - Altuviiio Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeAnnual review — no material changes

Effective DateN/A

Next Review DateFeb 11, 2026

Key ActionSubmit prior authorization showing indication, recent inhibitor testing as required, and specialist involvement for approval up to 1 year.

SourceLink

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