Clinical Policy: Eplontersen (Wainua)
Coverage policy governing medical necessity and prior authorization criteria for Wainua (eplontersen) for treatment of adults with hereditary transthyretin-mediated amyloidosis with polyneuropathy for Health Net lines of business (Commercial, HIM, Medicaid).
HCPCS codes C9399 and J3490 were added to the coding section.
Criteria updated per FDA labeling for an FDA-approved drug; initial criteria aligned with labeling.
Criterion excluding members who previously received Onpattro or Amvuttra was removed in a 2Q 2025 annual review.
Coverage Criteria
Initial Therapy
Covered when ALL of the following are met for initial approval:
Approval duration: Medicaid/HIM 6 months; Commercial 6 months or to renewal date.
Continuation Therapy
Continued therapy — member must meet ONE of the following and additional requirements:
In addition, member must be responding positively to therapy (improvement in measures of polyneuropathy such as motor strength, sensation, reflexes; quality of life; motor function; walking ability; or nutritional status). Wainua must not be prescribed concurrently with Onpattro or Amvuttra; member must not have had a liver transplant. If request is for a dose increase, new dose must not exceed 45 mg once monthly. Continued approval duration: Medicaid/HIM 12 months; Commercial 6 months or to renewal date.
Other Indications
Other diagnoses/indications and exclusions
Non‑FDA approved indications that are not addressed in this policy are excluded unless sufficient documentation per off‑label use policies is provided; use for non‑FDA approved indications without sufficient supporting documentation is considered not authorized.
Requests for uses that are non–FDA approved and are not specifically addressed in this policy are excluded from coverage unless the provider supplies sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies (for example, CP.CPA.09 for commercial, HIM.PA.154 for marketplace, or CP.PMN.53 for Medicaid).
The presence of a procedure or billing code in this policy is for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage; providers must follow the plan’s coverage criteria and current coding guidance when submitting claims.
Use of eplontersen (Wainua) for non–FDA approved indications without adequate supporting documentation per the off‑label use policies referenced in this policy is considered not authorized and may be denied.
Coding
Provider Actions & Billing
Prior Authorization Required
Prior Authorization Required: Prior authorization is required. Provider must submit documentation supporting the diagnosis and that the member meets all approval criteria.
Required Documentation
Documentation Required: Providers must submit office chart notes, laboratory results, genetic test confirming TTR mutation, biopsy reports or documentation justifying treatment without a positive biopsy, consultation notes if prescribed by non-neurologist, and any other clinical information supporting that the member meets the policy criteria.
- Include genetic test results confirming TTR mutation
- Include biopsy report or clinical justification for lack of biopsy
- Include neurologist consultation or prescription by/with neurologist
Concurrent Therapy Restriction
Concurrent Therapy Restriction: Wainua (eplontersen) must not be prescribed concurrently with Onpattro or Amvuttra per this policy.
- Concurrent prescribing with Onpattro or Amvuttra is prohibited
Non‑FDA Indications
Non‑FDA/Off‑Label Requests: Requests for indications not addressed in this policy (non‑FDA approved) may be denied without sufficient documentation per applicable off‑label use policies.
- Off‑label requests require sufficient documentation of efficacy and safety per payer off‑label policies
Initial Therapy
Initial Therapy
Covered when ALL of the following are met for initial approval:
Approval duration: Medicaid/HIM 6 months; Commercial 6 months or to renewal date.
Continuation Therapy
Continuation Therapy
Continued therapy — member must meet ONE of the following and additional requirements:
In addition, member must be responding positively to therapy (improvement in measures of polyneuropathy such as motor strength, sensation, reflexes; quality of life; motor function; walking ability; or nutritional status). Wainua must not be prescribed concurrently with Onpattro or Amvuttra; member must not have had a liver transplant. If request is for a dose increase, new dose must not exceed 45 mg once monthly. Continued approval duration: Medicaid/HIM 12 months; Commercial 6 months or to renewal date.
Step Therapy / Therapeutic Sequencing
| Step | Requirement / Restriction | Notes |
|---|---|---|
| 1 | Wainua (eplontersen) must not be prescribed concurrently with other transthyretin (TTR)-targeted agents (Onpattro or Amvuttra). | This concurrent therapy restriction is included in the initial and continuation approval criteria. |
| Prior exclusion for prior receipt of Onpattro or Amvuttra | A prior criterion excluding members who previously received Onpattro or Amvuttra was removed per the 2Q 2025 annual review. | Revision history documents removal of the prior-receipt exclusion (2Q 2025). |
Quantity Limits
Background
Eplontersen (Wainua) is a transthyretin (TTR)‑directed antisense oligonucleotide indicated for treatment of polyneuropathy of hereditary TTR‑mediated amyloidosis in adults. The dosing regimen described in this policy is 45 mg subcutaneously once monthly (single‑dose autoinjector 45 mg/0.8 mL). HCPCS codes C9399 and J3490 are referenced in the coding section for informational purposes.
Definitions
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