CurrentUnitedHealthcarePolicy N/A

Esperoct (antihemophilic factor [recombinant], glycopegylated-exei) step therapy

Step therapy program that requires trial of preferred recombinant factor VIII products before coverage of Esperoct for members with Hemophilia A; affects prescribers and pharmacy/medical benefit prior authorization processes.

Policy Summary

PayerUnitedHealthcare

PolicyEsperoct step therapy (Hemophilia A)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJun 1, 2025

Next Review DateMar 1, 2025

Key ActionObtain prior authorization documenting failure of three preferred recombinant FVIII products or a prescriber attestation of preferential benefit for Esperoct.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

Fail 3step requirement

3+P&T reviews

NCapplicable state

Coverage Criteria — Esperoct (Hemophilia A)

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Failure of preferred products: History of failure, contraindication, or intolerance to three of the following preferred products: Advate; Kogenate FS; Novoeight; Kovaltry; Nuwiq; Recombinate3 products

As listed in policy

Prescriber attestation of preferential benefit: Prescriber attestation that the patient would preferentially benefit from Esperoct based on one of: high risk for development of inhibitors (family history of inhibitors, high‑risk genetic mutation, or history of initial intensive therapy >5 days), prior immune tolerance induction/therapy, or patient has developed inhibitorsN/A

Physician attestation required

Provider Actions & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Esperoct. Approvals will be issued for up to 12 months when all prior authorization criteria are met.

Approval duration: 12 months

Step Therapy

Step Therapy Requirements

Step therapy: Member must have a history of failure, contraindication, or intolerance to three preferred recombinant antihemophilic factor VIII products prior to approval of Esperoct. The preferred products include Advate, Kogenate FS, NovoEight, Kovaltry, Nuwiq, and Recombinate. If the step therapy requirement is met with documented failure/intolerance to three listed preferred products, Esperoct may be approved.

Preferred products: Advate; Kogenate FS; NovoEight; Kovaltry; Nuwiq; Recombinate
Requirement: Failure, contraindication, or intolerance to three preferred products

Documentation Required

Required Supporting Documentation

Required supporting documentation: Documentation must include clinical records demonstrating failure, contraindication, or intolerance to three of the listed preferred recombinant factor VIII products OR a prescriber attestation meeting the specified exceptions. The prescriber attestation must state the medical rationale that the patient would preferentially benefit from Esperoct and include one or more of the following: high risk for inhibitor development (for example family history of inhibitors, known high‑risk genetic mutation, history of intensive therapy), prior immune tolerance induction/therapy, or documented development of inhibitors.

Acceptable documentation: clinical notes, infusion records, laboratory results, or prior authorization history showing failure/intolerance/contraindication to three preferred products
Or: Prescriber attestation describing one or more exception reasons (high inhibitor risk, prior immune tolerance induction, existing inhibitors)

Denial Risk

Failure to Meet Requirements May Lead to Denial

Failure to meet step therapy or attestation requirements may result in denial of the request. Lack of adequate documentation to support failure/intolerance/contraindication to three preferred products or an incomplete prescriber attestation will trigger a denial or request for additional information.

Incomplete or missing documentation may lead to denial
Clinical justification must be specific and contemporaneous

Initial Therapy Criteria

Initial Therapy — Esperoct

Initial coverage rules

Step failure pathway: Approval when there is history of failure, contraindication, or intolerance to three preferred recombinant FVIII products as listed (Advate; Kogenate FS; Novoeight; Kovaltry; Nuwiq; Recombinate)3 products

Preferred products enumerated in policy

Attestation pathway: Approval when prescriber attests patient would preferentially benefit from Esperoct due to high inhibitor risk, prior immune tolerance induction/therapy, or developed inhibitorsN/A

Prescriber attestation required

Step Therapy Requirements and Table

Step	Requirement	Notes / Documentation	Coverage Status
1
Or — Prescriber attestation that the patient would preferentially benefit from Esperoct based on one of: high risk for inhibitor development (family history of inhibitors, high‑risk genetic mutation, history of intensive initial therapy >5 days), prior immune tolerance induction/therapy, or patient has developed inhibitors
Prescriber attestation must specify the qualifying clinical reason(s); prior authorization required. Approval issued for 12 months when criteria met.
Covered with criteria

Definitions and Risk Factors

Patient characteristics that increase inhibitor development risk

Family history of inhibitorsFamily history of inhibitors increases risk for inhibitor development

High‑risk genetic mutationPresence of a high‑risk genetic mutation associated with inhibitor formation

History of intensive initial therapy (>5 days)History of initial intensive therapy longer than 5 days (e.g., multiple consecutive days of factor exposure) increases inhibitor risk

Prior immune tolerance induction/therapyHistory of prior immune tolerance induction or immune tolerance therapy is a marker of elevated inhibitor risk or prior inhibitor management

Prior development of inhibitorsPatient has previously developed inhibitors to factor VIII

Background

Hemophilia A is managed with replacement recombinant factor VIII products to prevent and control bleeding. Step therapy programs are used to encourage use of lower-cost preferred recombinant FVIII alternatives prior to coverage of higher-cost agents.

Esperoct (antihemophilic factor [recombinant], glycopegylated-exei) is reserved under this step therapy approach. Coverage for Esperoct will be considered when one of the following is met: a documented history of failure, contraindication, or intolerance to three listed preferred recombinant FVIII products, or a prescriber attestation that the patient would preferentially benefit from Esperoct based on specified clinical factors (for example, high risk for development of inhibitors, prior immune tolerance induction/therapy, or presence of inhibitors).

When criteria are met and prior authorization is approved, authorization will be issued for 12 months. Providers should include documentation supporting the applicable pathway (treatment history or prescriber attestation) and confirm any state or plan-specific requirements that may apply.