CurrentHealthPartnersPolicy N/A

Gene therapy for hemophilia B — attestation and follow-up requirements

This document is an attestation form accompanying a request for one-time gene therapy for members with hemophilia B and describes prescriber and patient commitments for post‑administration monitoring and reporting to the health plan.

Policy Summary

PayerHealthPartners

PolicyGene therapy for hemophilia B — attestation and follow-up requirements

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a signed prescriber and patient attestation form listing the requested administration date and provide required follow-up documentation to the plan quarterly for up to 3.5 years.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

$3,500,000approximate one-time drug cost disclosed to patient

3.5 yearsmaximum duration of required follow-up reporting to plan

quarterlymaximum frequency of required documentation submissions

14 daystimeframe patient must report hospitalizations or rescue therapy

Attestation and Follow-up Requirements

Attestation and follow-up requirements

Coverage-related attestation and post-treatment obligations required when requesting gene therapy for hemophilia B:

Prescriber obligations: Prescriber must (a) provide ongoing assessment of the patient for treatment efficacy including evaluation of factor IX expression, breakthrough bleeding episodes, factor IX product utilization, and inhibitor development; and (b) provide documentation to the health plan, not more frequently than quarterly and not to exceed 3.5 years post-administration, including the same evaluation elements while the patient is under the prescriber’s care.quarterly; up to 3.5 years

Prescriber must list requested administration date and sign the attestation form.

Patient obligations: Patient must acknowledge understanding of gene therapy treatment, the approximate drug cost (~$3,500,000), receive counseling, be willing to attend follow-up appointments, refrain from activities risking treatment failure, inform provider within ~14 days if hospitalized or requiring rescue therapy, and participate in plan outreach.14 days reporting timeframe

Policy Summary

PayerHealthPartners

PolicyGene therapy for hemophilia B — attestation and follow-up requirements

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a signed prescriber and patient attestation form listing the requested administration date and provide required follow-up documentation to the plan quarterly for up to 3.5 years.

SourceLink

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Provider Requirements and Actions

Prior Authorization

Attestation form required

Attestation form required — A signed prescriber and patient attestation form is required with the gene therapy administration request. The prescriber must commit to providing ongoing assessment and the specific documentation described below.

Gene Therapy for Hemophilia B Attestation Form must be completed and signed by the prescriber and patient.
Requested administration date must be specified on the form.

Documentation Required

Required prescriber documentation and reporting

Required prescriber documentation and reporting — The prescriber must provide ongoing assessment and submit documentation to the health plan as specified. Documentation may include evaluation of factor IX expression, breakthrough bleeding episodes, factor IX product utilization, and inhibitor development. Reports must not be submitted more frequently than quarterly and must not exceed 3.5 years post-administration.

Ongoing assessment items: evaluation of factor IX expression; breakthrough bleeding episodes; factor IX product utilization; inhibitor development.
Reporting frequency: no more frequently than quarterly.
Reporting duration: not to exceed 3.5 years post-administration while the patient is under the care of the prescriber.

Step Therapy

Step therapy

Step therapy — No step therapy requirements are stated on the attestation form.

Denial Risk

Failure to submit required follow-up

Failure to submit required follow-up — If the prescriber fails to provide the required ongoing assessment and documentation (including evaluation of factor IX expression, breakthrough bleeding, factor IX product utilization, and inhibitor development), this may affect continued coverage or post-administration review by the health plan.

Consequences may include denial of requests for additional related services or review actions by the plan if follow-up documentation is not provided as required.

Clinical Background

Hemophilia B is a congenital deficiency of factor IX historically managed with replacement factor IX products. Emerging gene therapy options are intended as a one-time administration to provide durable factor IX expression and reduce bleeding and replacement-product needs. The attestation form documents both prescriber and patient commitments tied to a gene therapy administration request and clarifies expectations for monitoring and reporting after treatment [[chunk 1]][[chunk 2]][[chunk 0]].

Prescribers are required to perform ongoing assessments of treatment efficacy, specifically including evaluation of factor IX expression, monitoring for breakthrough bleeding episodes, tracking factor IX product utilization, and surveillance for inhibitor development. The prescriber must submit documentation to the health plan at most quarterly and not to exceed 3.5 years post-administration, and must list the requested administration date and sign the attestation form [[chunk 1]].

Patients must acknowledge understanding of the therapy, counseling received, willingness to attend follow-up visits, commitment to avoid behaviors that could jeopardize treatment, and agree to notify their provider in a timely manner (for example, within 14 days) if hospitalized or requiring rescue therapy after treatment. The form also documents that the approximate one-time drug cost is ~$3,500,000 and requests patient contact information and signature [[chunk 2]].

Documentation Elements and Definitions

Required documentation elements for post‑administration follow‑up

Evaluation of factor IX expressionPrescriber must assess factor IX expression as part of ongoing post‑administration monitoring.

Breakthrough bleeding episodesPrescriber must document occurrence and details of breakthrough bleeding episodes during follow‑up.

Factor IX product utilizationPrescriber must record use of factor IX replacement or other factor IX products after gene therapy administration.

Inhibitor developmentPrescriber must monitor for and document development of inhibitors to factor IX.

Documentation frequency and durationProvide documentation to the health plan no more frequently than quarterly and not to exceed 3.5 years post‑administration (includes the evaluations listed above).