CurrentUnitedHealthcarePolicy N/A

Esperoct (antihemophilic factor, recombinant, glycopegylated) prior authorization

Defines UnitedHealthcare Pharmacy prior authorization and medical necessity criteria for Esperoct (recombinant FVIII glycopegylated) for treatment of people with hemophilia A, including initial and reauthorization requirements and program administration.

Policy Summary

PayerUnitedHealthcare

PolicyEsperoct prior authorization (recombinant FVIII, glycopegylated)

Policy CodePolicy N/A

Change TypeTechnical update — no material clinical changes

Effective DateJun 1, 2025

Next Review DateMar 1, 2025

Key ActionObtain prior authorization and submit documentation of diagnosis plus either trials of three alternate recombinant FVIII products, hypersensitivity to three alternates, or pediatric/PK evidence supporting exception.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

trial of 3 productsrequired prior trial

<12pediatric consideration

may supportPK testing

P&T approvedP&T history

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Coverage Criteria for Esperoct

inv-01: Initial Therapy

Covered when ALL of the following are met:

Initial Approval Core: Diagnosis of hemophilia A

Pathway A: Prior product trials: Submission of documentation showing failure to meet clinical goals after a trial of three of the following recombinant factor products: Advate; Kogenate FS; Kovaltry; NovoEight; Nuwiq; Recombinate.3 products failed/tried

Failure to meet clinical goals may include continued spontaneous bleeds or inability to achieve appropriate trough level.

Pathway B: Hypersensitivity history: Submission of documentation showing history of hypersensitivity to three of the listed recombinant factor products (Advate; Kogenate FS; Kovaltry; NovoEight; Nuwiq; Recombinate).3 products

Pediatric/PK exception: Either: patient is not to receive routine infusions more frequently than 2 times per week; OR both: patient is less than 12 years of age AND pharmacokinetic (PK) testing results suggest that more frequent than 2 times per week dosing is required.

Authorization of therapy will be issued for 12 months upon approval.

inv-02: Reauthorization

Reauthorization approved when BOTH of the following are met:

Clinical response: Documentation of positive clinical response to Esperoct therapy.

Authorization issued for 12 months.

Prescriber attestation/benefit: Prescriber attestation that the patient would preferentially benefit from Esperoct based on one of the following: high risk for inhibitor development (e.g., family history or high‑risk genetic mutation), history of prior inhibitors, or prior/ongoing immune tolerance induction; AND one of the following infusion frequency or pediatric/PK conditions is met: patient is not to receive routine infusions more frequently than 2 times per week; OR both patient <12 years of age AND PK testing indicates need for >2 times/week dosing.

Esperoct is not indicated for the treatment of von Willebrand disease. Requests for Esperoct for von Willebrand disease are excluded from coverage under this policy unless coverage is mandated by applicable state or federal law or the member’s specific benefit plan.

Esperoct is typically excluded from coverage. Coverage may only be provided when the policy’s specific clinical criteria are met, or when coverage is required by a state or federal mandate or by the member’s benefit plan. Coverage reviews and other utilization management programs may apply.

Initial Therapy

inv-14: Initial Therapy

Initial authorization — detailed criteria (all conditions must be met):

Diagnosis of hemophilia A.

Alternate product failure (step therapy): Failure to meet clinical goals after trial of three listed recombinant FVIII products: Advate; Kogenate FS; Kovaltry; NovoEight; Nuwiq; Recombinate.3 products

Failure to meet clinical goals may include continued spontaneous bleeds or inability to achieve appropriate trough level.

Hypersensitivity to alternates: History of hypersensitivity to three listed recombinant FVIII products (Advate; Kogenate FS; Kovaltry; NovoEight; Nuwiq; Recombinate).3 products

Continuation / Reauthorization Criteria

inv-15: Continuation/Reauthorization

Reauthorization/continuation — approval requires all of the following:

Reauthorization core: Documentation of positive clinical response to Esperoct therapy.

Authorization issued for 12 months upon approval.

Prescriber attestation that the patient would preferentially benefit based on high inhibitor risk, prior inhibitors, or prior immune tolerance induction; AND meet one of the infusion frequency or pediatric/PK conditions: patient is not to receive routine infusions more frequently than 2 times per week; OR both patient <12 years of age and PK testing indicates need for >2 times/week dosing.

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial approval for Esperoct will be granted only when all required diagnostic and trial criteria are met; authorization is for up to 12 months. State mandates, federal requirements, and the member's benefit plan may further restrict coverage.

Prior authorization required for Esperoct
Initial approvals valid for 12 months
Coverage may be impacted by state/federal mandates and plan benefits

Documentation Required

Submit Documentation of Diagnosis

Submit documentation confirming the diagnosis of hemophilia A. Include relevant medical records, laboratory results, and clinical notes that support the diagnosis.

Documentation of hemophilia A diagnosis (e.g., medical history, factor VIII activity levels, genetic testing if available)

Coding and Billing Guidance

Referenced coding/claims processesmixed

No codes listed

inv-06: Routine infusion frequency — dosing threshold

Routine infusion frequency limitPatients are not to receive routine infusions more frequently than 2 times per week.

PK testing exception referencePharmacokinetic (PK) testing results that suggest more frequent than 2 times per week dosing may be used to justify dosing >2 times/week.

Authorization duration when approvedAuthorization of therapy will be issued for 12 months.

Required step-therapy trials
Documented trials and clinical failure (e.g., continued spontaneous bleeds, inability to achieve appropriate trough level) of three of the following recombinant factor VIII products: Advate; Kogenate FS; Kovaltry; NovoEight; Nuwiq; Recombinate.

Definitions

inv-12: Esperoct — antihemophilic factor (recombinant), glycopegylated definition

Drug description (Esperoct)Antihemophilic factor (recombinant), glycopegylated — a recombinant coagulation Factor VIII concentrate indicated for on‑demand treatment, perioperative management, and routine prophylaxis in adults and children with hemophilia A.

Not indicated forEsperoct is not indicated for the treatment of von Willebrand disease.

Role of PK testing in dosingPharmacokinetic (PK) testing results that suggest more frequent than 2 times per week dosing may support authorization for dosing >2 times/week.

inv-13: PK testing — role in dosing frequency decisions

What PK testing isPharmacokinetic (PK) testing evaluates individual drug disposition to inform dosing frequency and trough levels for Factor VIII replacement therapy.

How PK influences authorization

Background

Esperoct (antihemophilic factor, recombinant, glycopegylated) is a recombinant Factor VIII concentrate indicated in adults and children with hemophilia A for on‑demand treatment of bleeding episodes, perioperative management, and routine prophylaxis to reduce bleeding frequency. Pharmacokinetic testing may be used to inform dosing frequency decisions. Authorization of therapy is typically issued for 12 months, and coverage may be affected by state mandates, federal requirements, or the member’s specific benefit plan.