Eplontersen (Wainua)
Policy governing medical necessity and prior authorization criteria for eplontersen (Wainua) for treatment of hereditary transthyretin-mediated amyloidosis with polyneuropathy for affected lines of business.
Added HCPCS codes C9399 and J3490 to coding implications.
Revised initial approval duration for Medicaid/HIM/ICHRA from 6 to 12 months.
Added new prefilled syringe formulation to product availability and added ICHRA line of business.
Coverage Criteria
Initial Approval Criteria
Covered when ALL of the following are met
All conditions required for initial approval.
Continuation Therapy Criteria
Covered when ALL of the following are met
All conditions required for continuation approval.
Non-FDA approved indications that are not specifically addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies. For Commercial lines of business refer to CP.CPA.09, for Health Insurance Marketplace/ICHRA refer to HIM.PA.154, and for Medicaid refer to CP.PMN.53 or the member's evidence of coverage documents.
This clinical policy is intended to provide a guide to medical necessity to assist in coverage decisions and benefit administration; it does not constitute a contract or a guarantee of payment or outcomes. Coverage remains subject to all terms, conditions, exclusions, and limitations of the member's coverage documents (for example, evidence of coverage, certificate of coverage, policy, or contract of insurance), as well as applicable state and federal requirements and Health Plan administrative policies and procedures.
Concurrent use of Wainua (eplontersen) with either Onpattro or Amvuttra is explicitly prohibited for both initial and continuation approvals. Requests for dosing that exceed the policy limit are not allowed; the maximum permitted dose is 45 mg once monthly. Documentation that concurrent therapy is not being used and that the requested dose does not exceed the stated maximum must be included with prior authorization requests.
Coding and Dosing
Provider Actions and Prior Authorization
Prior Authorization Required
Prior authorization is required for Wainua. Approval durations vary by line of business: Medicaid/HIM/ICHRA — 12 months; Commercial — 6 months or to the member's renewal date, whichever is longer. The policy serves as guidance for medical necessity determinations but does not guarantee payment.
- PA required prior to initiation
- Medicaid/HIM/ICHRA approval duration: 12 months
- Commercial approval duration: 6 months or to member renewal date, whichever is longer
Documentation Requirements
Providers must submit clinical documentation to support that the member meets all approval criteria. Required documentation includes office chart notes, relevant laboratory results, biopsy reports (if performed), and genetic testing confirming a TTR mutation when applicable.
- Office chart notes detailing diagnosis and clinical status
- Laboratory results supporting clinical criteria
- Biopsy report demonstrating amyloid deposits (Congo red staining) or medical justification if biopsy is negative or not performed
- DNA sequencing/genetic testing confirming TTR mutation
Missing Documentation Denial Risk
Requests that lack documentation confirming the presence of a TTR mutation or lack biopsy/diagnosis documentation risk denial. Negative biopsy does not necessarily exclude disease, but absence of supporting documentation may lead to denial of the request.
- Denial likely if no documentation of TTR mutation when required
- Denial risk if biopsy data or adequate clinical justification for absence of biopsy is not provided
Coverage Conditions and Denial Risk
Coverage and approval are subject to the terms, conditions, exclusions, and limitations of the member's coverage documents and applicable state and federal requirements. This policy is a guide to medical necessity and does not guarantee payment or alter contractual obligations.
- Coverage decisions are subject to evidence of coverage, certificate of coverage, policy, contract of insurance, and state/federal requirements
- Policy guides medical necessity determinations but is not a payment guarantee
Claims and Contract Documentation
Providers are responsible for accurate billing and for complying with contract requirements when submitting claims. Submission of the required supporting documentation is necessary to facilitate coverage review and payment.
- Submit complete clinical documentation with prior authorization and claims
- Provider remains responsible for billing in accordance with contractual obligations
Step Therapy / Concurrent Therapy
No step therapy sequence specified for Wainua in this policy. Concurrent use of Wainua with Onpattro or Amvuttra is not permitted and must be avoided.
- Step therapy: Not applicable — no required sequence specified
- Do not prescribe Wainua concurrently with Onpattro or Amvuttra
Prior Authorization Guidance / Policy Usage
This policy is intended to serve as a guide to medical necessity and coverage decision support. Providers should exercise professional judgment and are responsible for clinical decisions and ensuring documentation is sufficient for review.
- Policy guides medical necessity determinations
- Providers remain responsible for clinical care decisions and documentation submission
Background
Eplontersen (Wainua) is a transthyretin‑directed antisense oligonucleotide indicated for the treatment of hereditary transthyretin‑mediated amyloidosis with polyneuropathy in adults. Confirmation of the diagnosis typically requires both demonstration of amyloid deposits on tissue biopsy or a medical justification for treatment without a positive biopsy, and genetic documentation of a pathogenic TTR mutation. The approved adult dosing regimen is 45 mg subcutaneously once monthly and prior authorization is required per Health Plan procedures.
Definitions
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