Wainua (eplontersen) prior authorization for hATTR polyneuropathy
Defines prior authorization, specialty pharmacy, and coverage criteria for Wainua (eplontersen) for treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults for Mass General Brigham Health Plan commercial/exchange members.
Clarified that member must be experiencing clinical signs and symptoms of polyneuropathy and provided examples of acceptable clinical measures.
Updated reauthorization criteria to include examples of positive clinical response to therapy.
Included Attruby as an example of a TTR stabilizer that should not be co-prescribed with Wainua.
Coverage Criteria for Wainua (eplontersen)
Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met
Exact AND logic required for all numbered items
Continuation Therapy — Reauthorization / Continuation of Therapy criteria and examples of clinical response
Reauthorization / Continuation of Therapy
Both documentation of response and adherence to limits are required
Use of Wainua (eplontersen) in combination with other therapies that target transthyretin is prohibited. Specifically, the requested medication must not be used concomitantly with a TTR silencer (for example, Amvuttra) or a TTR stabilizer (examples include diflunisal, Attruby, Vyndamax, and Vyndaqel).
Clinical Measures and Scores
Provider Requirements and Actions
Prior Authorization and Specialty Pharmacy
Prior authorization is required for this medication. The drug is designated specialty and must be dispensed through a contracted specialty pharmacy.
- Program Type: Prior Authorization
- Benefit: Pharmacy Benefit
- Specialty dispensing required — must be filled at contracted specialty pharmacy
Step Therapy
No step therapy requirements are specified for this medication.
Required Documentation
Submit documentation to support medical necessity, including diagnosis and genetic confirmation of hATTR-related polyneuropathy, patient age, clinical severity measures, prescriber specialty, and treatment plan.
- Diagnosis: polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR polyneuropathy)
- Genetic evidence: documentation of a pathogenic or likely pathogenic transthyretin (TTR) mutation (e.g., V30M)
- Age: patient is ≥ 18 years old
- Clinical signs/scores: one of - Polyneuropathy disability (PND) score ≤ IIIb; Stage 1 or 2 familial amyloidotic polyneuropathy (FAP)/Coutinho stage; Neuropathy Impairment Scale score ≥ 10 and ≤ 130
- Prescriber: prescribed by or in consultation with a neurologist
- Treatment intent: statement that requested medication will not be used concurrently with a TTR silencer (e.g., Amvuttra) or a TTR stabilizer (e.g., diflunisal, Attruby, Vyndamax, Vyndaqel)
- Recent therapy note: if member is new to the plan within 90 days and currently receiving treatment, supply information about prior authorization and how medication was obtained (exclude samples or manufacturer assistance programs)
Triggers for Denial
Authorizations may be denied if required criteria or documentation are not met.
- Diagnosis not consistent with hATTR polyneuropathy
- No documentation of a pathogenic/likely pathogenic TTR mutation
- Patient age < 18 years
- Clinical severity does not meet specified thresholds (PND score, FAP/Coutinho stage, or Neuropathy Impairment Scale not in required range)
- Prescriber is not a neurologist and no neurology consultation provided
- Requested therapy intended to be used in combination with a TTR silencer or TTR stabilizer
- Missing or incomplete documentation for members new to the plan (e.g., therapy obtained via samples or manufacturer assistance without supporting records)
Definitions and Clinical Signs
Background on Condition and Therapy
Hereditary transthyretin-mediated amyloidosis (hATTR) is a genetic disorder that can produce progressive polyneuropathy. Wainua (eplontersen) is a transthyretin-directed antisense oligonucleotide indicated for treatment of the polyneuropathy of hATTR in adults. Coverage for Wainua requires documentation of hATTR polyneuropathy with a confirmed transthyretin (TTR) mutation, evidence of clinical signs or symptoms of polyneuropathy per policy-defined measures, and neurologist involvement in prescribing or consultation.
Policy Revision History
Effective date of updated policy incorporating clarifications to initial criteria and expanded reauthorization examples.
Reviewed at April P&T; updated initial criteria to provide an example of a TTR mutation, clarified requirement for clinical signs and symptoms of polyneuropathy, required neurologist prescribing/consultation, and listed Attruby as a TTR stabilizer not to be co-prescribed; reauthorization criteria updated to include examples of positive clinical response to therapy.
Reviewed for September P&T with an effective date of 2024-11-01 for that review cycle.
Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.