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    v1.0.28
    OpenPayerPolicy UpdatesViva HealthViva Health Wainua (eplontersen) Coverage | OpenPa…
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    CurrentViva HealthPolicy IC-0858

    Wainua (eplontersen) — Coverage and Prior Authorization

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    Defines Viva Health's coverage, prior authorization, dosing, and renewal criteria for Wainua (eplontersen) subcutaneous therapy for treatment of hATTR polyneuropathy for applicable members.

    Policy Summary
    PayerViva Health
    PolicyWainua (eplontersen) — Coverage and Prior Authorization
    Policy CodePolicy IC-0858
    Change TypeAdministrative review — no material coverage changes
    Effective DateJun 2, 2026
    Last ReviewJun 2, 2026
    Next Review DateJun 2, 2026
    Key ActionObtain prior authorization: initial approval valid for 6 months (180 days); renewals may be authorized every 12 months (365 days).
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    45 mgapproved dose per administration
    180 daysinitial prior authorization length
    365 daysrenewal prior authorization length
    NDC 00310-9420-xxlisted product NDC

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    C9399, J3490
    billing codes listed

    Coverage Criteria for Wainua (eplontersen)

    Initial and Renewal Coverage Criteria

    Covered when ALL of the following universal and indication‑specific criteria are met. Initial authorizations are valid for 6 months (180 days); renewals may be provided every 12 months (365 days) when renewal criteria are met.

    ALL of the following

    • ALL of the following

      • ALL of the following

        • Member is at least 18 years of age

          See initial authorization length

      • ALL of the following

        • Member is receiving supplementation with vitamin A at the recommended daily allowance

      • ALL of the following

        • Must not be used in combination with other transthyretin (TTR) reducing or stabilizing agents (e.g., tafamidis, patisiran, acoramidis, inotersen, vutrisiran)

    • ALL of the following

      • ALL of the following

        • Definitive diagnosis of hATTR amyloidosis documented in a proband with suggestive findings (including imaging or histopathology) and a heterozygous pathogenic or likely pathogenic TTR variant identified by molecular genetic testing

      • ALL of the following

        • ONE of: Subjective member symptoms suggestive of neuropathy
        • ONE of: Abnormal nerve conduction studies consistent with polyneuropathy
        • ONE of: Abnormal neurological examination suggestive of neuropathy

      • ALL of the following

    • ALL of the following

      • ALL of the following

        • Administer 45 mg subcutaneously once monthly via prefilled syringe

          Maximum dose frequency: 45 mg every 28 days

      • ALL of the following

        • Use appropriate code: Use HCPCS C9399 (hospital outpatient) or J3490 as appropriate

    • ALL of the following

      • ALL of the following

        • Initial prior authorization valid for 6 months (180 days)

      • ALL of the following

        • Renewal prior authorization may be provided every 12 months (365 days)

    Initial Therapy Requirements and Dosing

    Initial Therapy Criteria

    Initial therapy is covered when ALL of the following are satisfied.

    ALL of the following

    • ALL of the following

      • Member is at least 18 years of age

    • ALL of the following

      • Member is receiving vitamin A supplementation at the recommended daily allowance

    • ALL of the following

      • Not used concurrently with other TTR‑reducing or stabilizing agents (e.g., tafamidis, patisiran, acoramidis, inotersen, vutrisiran)

    Continuation / Renewal Therapy Requirements

    Continuation/Renewal Therapy Criteria

    Renewal/continuation of prior authorization for Wainua (eplontersen) is granted only when ALL of the following are satisfied.

    ALL of the following

    • ALL of the following

      • Member continues to meet universal clinical criteria specified for initiation of therapy (including age ≥18 years and documented definitive diagnosis of hATTR with supportive findings)

        See initial therapy criteria for required diagnostic testing, exclusion of other causes, and baseline assessments.

      • Member continues vitamin A supplementation at the recommended daily allowance
      • Member is not receiving concomitant transthyretin (TTR)–reducing or TTR–stabilizing agents

    • ALL of the following

    Billing and Coding

    HCPCS CodesHCPCS
    C9399Unclassified drugs or biologicals (hospital outpatient use ONLY)
    J3490Unclassified drugs
    NDCNDCCovered
    00310-9420-xxWainua 45 mg/0.8 mL single-dose prefilled syringe NDC
    Maximum dose frequency
    Approved dose45 mg per administration
    Maximum frequencyEvery 28 days (once monthly)
    Route and presentationSubcutaneous administration via prefilled syringe

    Prior Authorization, Eligibility, and Provider Requirements

    Prior Authorization

    Prior authorization required; specify durations, age, and eligibility conditions

    Prior authorization is required. Initial authorization is valid for 6 months (180 days); renewals may be provided every 12 months (365 days). Member must be at least 18 years old, be receiving vitamin A supplementation at the recommended daily allowance, not be receiving concomitant TTR‑reducing or ‑stabilizing agents, and meet the indication‑specific diagnostic and clinical criteria for hATTR polyneuropathy.

    • Initial authorization length: 6 months (180 days)
    • Renewal authorization length: every 12 months (365 days)
    • Age requirement: member is at least 18 years of age
    • Member receiving vitamin A supplementation at recommended daily allowance
    • Not used in combination with other TTR reducing or stabilizing agents

    Definitions

    Definition — hATTR polyneuropathy
    TermPolyneuropathy due to Hereditary Transthyretin-Mediated (hATTR) Amyloidosis
    Diagnostic requirementsDefinitive diagnosis documented in a proband with suggestive findings (imaging or histopathology) plus a heterozygous pathogenic or likely pathogenic TTR variant on molecular genetic testing
    Clinical evidence for polyneuropathyAt least two of: subjective neuropathic symptoms; abnormal nerve conduction studies; abnormal neurological exam
    Exclusions and baselinePeripheral neuropathy attributed to hATTR with other causes excluded; baseline strength documented (e.g., MRC); no prior orthotopic liver transplant

    Quantity Limits and Dosage

    eplontersen (Wainua) — single-dose amount
    Single-dose amount45 mg per single-dose prefilled syringe
    Administration scheduleAdminister subcutaneously once monthly
    Prefilled syringe volume45 mg/0.8 mL single-dose prefilled syringe (NDC referenced elsewhere)

    Site-of-Care and Billing Context

    Billing Rule

    Use HCPCS C9399 for hospital outpatient; J3490 for other unclassified drug billing

    When billing for Wainua in the hospital outpatient setting use HCPCS C9399 (Unclassified drugs or biologicals — hospital outpatient use ONLY); J3490 is listed as the unclassified drugs code for other scenarios.

    • Hospital outpatient billing: HCPCS C9399 (Unclassified drugs or biologicals — hospital outpatient use ONLY)
    • Other settings or claims: consider J3490 (Unclassified drugs) as appropriate
    Policy Summary
    PayerViva Health
    PolicyWainua (eplontersen) — Coverage and Prior Authorization
    Policy CodePolicy IC-0858
    Change TypeAdministrative review — no material coverage changes
    Effective DateJun 2, 2026
    Last ReviewJun 2, 2026
    Next Review DateJun 2, 2026
    Key ActionObtain prior authorization: initial approval valid for 6 months (180 days); renewals may be authorized every 12 months (365 days).
    SourceLink
    On This Page
    Coverage Criteria for Wainua (eplontersen)Initial Therapy Requirements and DosingContinuation / Renewal Therapy RequirementsBilling and CodingPrior Authorization, Eligibility, and Provider RequirementsDefinitionsQuantity Limits and DosageSite-of-Care and Billing Context
    • Peripheral neuropathy attributed to hATTR and other causes of neuropathy have been excluded

  1. ALL of the following

    • Baseline strength/weakness documented using an objective clinical measuring tool (e.g., MRC muscle strength)

  2. ALL of the following

    • Member has not received an orthotopic liver transplant (OLT)

  3. ALL of the following

    • Definitive diagnosis of hATTR amyloidosis documented in a proband with supportive findings (imaging or histopathology) and a heterozygous pathogenic or likely pathogenic TTR variant on molecular genetic testing

  4. ALL of the following

    • At least TWO of the following

      • Subjective neuropathic symptoms suggestive of neuropathy
      • Abnormal nerve conduction studies consistent with polyneuropathy
      • Abnormal neurological examination suggestive of neuropathy

  5. ALL of the following

    • Baseline strength/weakness documented using an objective clinical measuring tool (e.g., MRC muscle strength)

  6. ALL of the following

    • Member has not been the recipient of an orthotopic liver transplant (OLT)

  7. ALL of the following

    • Administer 45 mg by prefilled syringe subcutaneously once monthly45 mg every 28 days

  8. ALL of the following

    • ONE of: Use HCPCS C9399 (hospital outpatient) or J3490 as appropriate for billing
    • No evidence of unacceptable adverse effects attributable to therapy (examples include ocular symptoms related to vitamin A deficiency such as night blindness or dry eyes)

  9. ALL of the following

    • ONE of: Evidence of stabilization or improvement in neuropathy signs or symptoms compared to baseline
    • ONE of: Stabilization or improvement in Medical Research Council (MRC) muscle strength compared to baseline

  10. ALL of the following

    • Prior authorization required for initiation and continuation of therapy
    • Initial prior authorization period: up to 6 months (180 days)
    • Renewal prior authorization period: may be provided every 12 months (365 days)
    • Dosing and quantity limits must be maintained: 45 mg subcutaneously once every 28 days (45 mg per dose)
    • Appropriate billing/coding should be used (HCPCS C9399 for hospital outpatient when applicable; J3490 as appropriate) and NDC 00310-9420-xx identifies Wainua 45 mg prefilled syringe

    11. ALL of the following

    • Objective documentation demonstrating continued clinical benefit or stability (e.g., narrative of signs/symptoms change, repeat neurologic exam, MRC muscle strength scores)
    • Documentation that no orthotopic liver transplant has been performed since baseline if relevant

    ALL of the following

    • If unacceptable toxicity is identified, consider discontinuation and document reason for stopping therapy
    • Ensure ongoing vitamin A supplementation and monitor for vitamin A deficiency signs that may mimic or contribute to ocular toxicity
    Prior Authorization

    Renewal requires continued eligibility, no unacceptable toxicity, and clinical stabilization or improvement

    Renewals may be granted only if the member continues to meet the universal and indication‑specific criteria, there is no unacceptable toxicity (examples include ocular symptoms related to vitamin A deficiency such as night blindness or dry eyes), and the disease is stable or improved compared with baseline as evidenced by stabilization or improvement in neuropathy signs/symptoms or MRC muscle strength.

    • Member must continue to meet the universal and other indication‑specific relevant criteria identified in Initial Therapy Criteria (see section III).
    • Document absence of unacceptable toxicity; examples include ocular symptoms related to vitamin A deficiency (e.g., night blindness, dry eyes).
    • Provide clinical evidence of stabilization or improvement versus pre‑treatment baseline: signs/symptoms of neuropathy and/or MRC muscle strength.