CurrentCareSourcePolicy N/A

Sevenfact (recombinant Factor VIIa) — Coverage Criteria for Hemophilia A & B with Inhibitors

Defines prior authorization, coverage criteria, dosing limits, and clinician requirements for Sevenfact for treatment of bleeding episodes in adolescents and adults with hemophilia A or B with inhibitors. Affects prescribers, reviewers, and payers processing medical-benefit requests for Sevenfact.

Policy Summary

PayerCareSource

PolicySevenfact (recombinant Factor VIIa) — Coverage Criteria for Hemophilia A & B with Inhibitors

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateDec 4, 2024

Key ActionObtain prior authorization and document patient meets criteria (age ≥12, inhibitor titer ≥5 BU or qualifying clinical history) and prescriber specialty.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥12minimum patient age for approval

5 BUinhibitor titer threshold (BU)

2,700 mcg/kgmax dosing per 28 days

1 yrauthorization duration

Not indicatedlimitation of use

Policy Summary

PayerCareSource

PolicySevenfact (recombinant Factor VIIa) — Coverage Criteria for Hemophilia A & B with Inhibitors

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateDec 4, 2024

Key ActionObtain prior authorization and document patient meets criteria (age ≥12, inhibitor titer ≥5 BU or qualifying clinical history) and prescriber specialty.

SourceLink

On This Page

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inv-01: Hemophilia A with inhibitors

Approve for 1 year if the patient meets ALL of the following (A, and B or C as specified):

Hemophilia A with inhibitors — main criteria: A) Patient is ≥ 12 years of age; AND B) EITHER i) patient has a positive inhibitor titer ≥ 5 Bethesda Units (BU) OR ii) patient has a history of anamnestic response to Factor VIII replacement therapy that, according to the prescriber, precludes use of Factor VIII replacement to treat bleeding episodes OR iii) patient has a history of refractory response to increased Factor VIII dosing that, according to the prescriber, precludes use of Factor VIII replacement to treat bleeding episodes; AND C) Medication is prescribed by or in consultation with a hemophilia specialist.

Approve up to 2,700 mcg/kg IV per 28 days

inv-02: Hemophilia B with inhibitors

Approve for 1 year if the patient meets ALL of the following (A, and B or C as specified):

Hemophilia B with inhibitors — main criteria: A) Patient is ≥ 12 years of age; AND B) EITHER i) patient has a positive inhibitor titer ≥ 5 Bethesda Units (BU) OR ii) patient has a history of anamnestic response to Factor IX replacement therapy that, according to the prescriber, precludes use of Factor IX replacement to treat bleeding episodes OR iii) patient has a history of refractory response to increased Factor IX dosing that, according to the prescriber, precludes use of Factor IX replacement to treat bleeding episodes; AND C) Medication is prescribed by or in consultation with a hemophilia specialist.

Approve up to 2,700 mcg/kg IV per 28 days

Sevenfact is not indicated for the treatment of patients with congenital Factor VII deficiency. This limitation of use is stated in the product overview and means requests for Sevenfact to treat congenital Factor VII deficiency do not meet the policy’s recommended indications.

Coverage is not recommended for any circumstances that are not listed in the policy’s Recommended Authorization Criteria. The policy will be updated as new published data become available; until then, indications outside the stated criteria should be considered non-recommended for approval.

Use of Sevenfact for indications outside those specified in this policy is not recommended and is considered not approvable under the stated criteria. Requests for non‑listed uses should be denied or routed for case‑by‑case review only if new evidence emerges that supports medical necessity.

Prior Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Recommended. Approval is recommended for up to 1 year when criteria are met. Because of the specialized skills required for evaluation, diagnosis, monitoring of adverse events and long-term efficacy, Sevenfact must be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., a hemophilia specialist). Requests for doses outside the dosing documented in this policy will be considered case-by-case by a clinician (Medical Director or Pharmacist).

Approvals provided for the duration noted (up to 1 year when criteria are met).
Dose requests outside the policy dosing considered case-by-case.

Documentation Required

Required Clinical Documentation and Prescriber Specialty

Approval requires documentation that the patient meets the specific clinical criteria for the FDA‑approved indications listed below. Required documentation includes evidence of age, inhibitor titer or documented clinical history (anamnestic response or refractory response), and that the prescriber is a hemophilia specialist or is consulting with one.

Documentation of patient age (≥ 12 years).
Laboratory or clinical documentation of inhibitor titer ≥ 5 Bethesda Units OR documentation of a clinical history of an anamnestic response to factor replacement therapy OR documentation of refractory response to increased factor dosing that precludes use of factor replacement.
Prescriber specialty: medication must be prescribed by or in consultation with a hemophilia specialist (document specialty or consultation).
Clinical dosing documentation consistent with policy (e.g., up to 2,700 mcg/kg IV per 28 days); any deviations must be justified.

Documentation Required

Requirement to Document Failure or Contraindication of Factor Replacement

A positive inhibitor titer ≥ 5 Bethesda Units or a documented history of an anamnestic response to factor replacement (or refractory response to increased factor dosing) must be recorded in the medical record to support approval. If factor replacement is contraindicated or not feasible due to these findings, include the prescriber’s statement explaining why factor replacement cannot be used.

Record inhibitor titer value and date of test.
If relying on clinical history (anamnestic or refractory response), include prescriber narrative explaining how this precludes use of factor replacement.
If prescriber is consulting a hemophilia specialist, include documentation of the consultation (note, date, and specialist name).

Denial Risk

Coverage Exclusion for Non‑Listed Indications

Requests for indications not listed in the Recommended Authorization Criteria are not recommended for approval.

If requesting an unlisted indication, include supporting clinical evidence; requests will be reviewed but are generally not recommended for approval.

OpenPayer

Sevenfact (recombinant Factor VIIa) — Coverage Criteria for Hemophilia A & B with Inhibitors

Recommended Authorization Criteria

Billing and Coding Information

Prior Authorization and Documentation Requirements

Clinical Background

Key Definitions