CurrentCignaPolicy IP0355

Hemophilia - Eptacog Products - Sevenfact

Cigna coverage policy for medical necessity and authorization of Sevenfact (recombinant Factor VIIa) for treatment of bleeding episodes in adolescents and adults (≥12 years) with hemophilia A or B with inhibitors; applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyHemophilia - Eptacog Products - Sevenfact

Policy CodePolicy IP0355

Change TypeNo material changes

Effective DateMar 1, 2025

Next Review Date

Key ActionObtain prior authorization and document age (≥12 years), inhibitor status meeting criteria, and that the medication is prescribed by or in consultation with a hematologist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥12min age

≥5 BUinhibitor threshold

2,700 mcg/kg/28ddose limit

up to 12 moauth duration

J7212billing code

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Initial Therapy — Hemophilia A or B with Inhibitors

Sevenfact is considered medically necessary when ONE of the following is met:

Indication groups

Hemophilia A with Inhibitors: A. Age 12 years or older; B. ONE of: i. Positive inhibitor titer at least 5 Bethesda Units or greater; ii. History of an inhibitor with anamnestic response to increased Factor VIII replacement therapy that, according to the prescriber, precludes use of Factor VIII replacement to treat bleeding episodes; iii. History of an inhibitor with refractory hemostatic response to increased Factor VIII replacement therapy that, according to the prescriber, precludes use of Factor VIII replacement to treat bleeding episodes; C. Medication is prescribed by, or in consultation with, a hematologist
Dosing: up to 2,700 mcg/kg intravenously per 28 days
Hemophilia B with Inhibitors: A. Age 12 years or older; B. ONE of: i. Positive inhibitor titer at least 5 Bethesda Units or greater; ii. History of an inhibitor with anamnestic response to increased Factor IX replacement therapy that, according to the prescriber, precludes use of Factor IX replacement to treat bleeding episodes; iii. History of an inhibitor with refractory hemostatic response to increased Factor IX replacement therapy that, according to the prescriber, precludes use of Factor IX replacement to treat bleeding episodes; C. Medication is prescribed by, or in consultation with, a hematologist
Dosing: up to 2,700 mcg/kg intravenously per 28 days

Continuation / Reauthorization

Continuation of Sevenfact is considered medically necessary when ALL of the following are met:

Reauthorization: 1. Original medical necessity criteria for the covered diagnosis continue to be met; 2. Documentation of beneficial response to Sevenfact as determined by the prescriber

Approval duration: up to 12 months

Sevenfact (eptacog alfa) is considered experimental, investigational, or unproven for any use other than treatment of bleeding episodes in patients with hemophilia A or hemophilia B with inhibitors. Such uses are not covered under this policy.

Use of Sevenfact for indications outside the specified populations of adolescents and adults (aged ≥ 12 years) with hemophilia A or B with inhibitors is not covered. These non‑covered indications are considered experimental, investigational, or unproven and may be denied.

Provider Actions, Prior Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Coverage is limited to the policy indications for hemophilia A or B with inhibitors and to dosing limits noted in the policy. Bill with HCPCS J7212 for Sevenfact (Factor VIIa recombinant) and ensure prior authorization is obtained before therapy initiation to avoid claim denials.

Prior authorization required
Bill using HCPCS J7212 (Factor VIIa recombinant)
Coverage limited to policy indications and dosing limits
Receipt of sample product does not satisfy criteria

Note

Therapy Selection Considerations

When selecting a bypass agent, consider inhibitor type (low- vs high-responding), current inhibitor titer, bleed location, prior response to agents, and guideline-recommended indications. National and WFH guidance note no absolute preference between Sevenfact and NovoSeven RT for hemophilia with inhibitors; however, NovoSeven RT is also used in other settings (e.g., acquired hemophilia A) where Sevenfact is not. Choose therapy consistent with these factors and the member-specific clinical scenario, and ensure selection aligns with the policy criteria for coverage.

Consider inhibitor titer and response history when choosing agent
No blanket preference between Sevenfact and NovoSeven RT for hemophilia A/B with inhibitors
NovoSeven RT may be appropriate for other indications (e.g., acquired hemophilia A) not covered for Sevenfact

Documentation Required

Required Documentation

Documentation must be submitted with prior authorization requests. Include evidence that the member meets all applicable criteria for hemophilia A or B with inhibitors and that treatment is prescribed by or in consultation with a hematologist.

Age ≥ 12 years
Evidence of inhibitor: positive titer ≥ 5 Bethesda Units OR documented history of inhibitor with anamnestic response OR documented history of refractory hemostatic response to factor replacement therapy
Prescriber is a hematologist or documentation of hematology consultation
For reauthorization, documentation of beneficial clinical response is required
Dosing and frequency within policy limits (up to 2,700 mcg/kg per 28 days)

Denial Risk

Non‑Covered Uses

Uses outside of hemophilia A or B with inhibitors — including other bleeding disorders or indications not specified in this policy — are considered experimental, investigational, or unproven and may be denied.

Non-covered: indications other than hemophilia A or B with inhibitors
Experimental/investigational rationale may lead to denial

Definitions

High-responding inhibitor — definition and implications

DefinitionHigh-responding inhibitor: titer >= 5 Bethesda Units (BU)

Clinical significanceTends to persist and typically precludes effective treatment with factor VIII or IX replacement, necessitating use of bypass agents such as recombinant Factor VIIa

Policy usageSpecified as the qualifying laboratory criterion ('Positive inhibitor titer at least 5 Bethesda Units or greater') for coverage of Sevenfact in hemophilia A or B with inhibitors

Patient population noteApplies within this policy to adolescents and adults aged >= 12 years with hemophilia A or B

OpenPayer

Hemophilia - Eptacog Products - Sevenfact

Coverage Criteria for Sevenfact (eptacog)

Coding and Thresholds

Provider Actions, Prior Authorization & Documentation

Background

Definitions