CurrentUnitedHealthcarePolicy 2025 P 2326-2

Wainua (eplontersen) prior authorization / medical necessity

Defines UnitedHealthcare prior authorization and medical necessity criteria for initial and reauthorization coverage of Wainua (eplontersen) for treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR) in adults, including prescriber requirements, diagnostic and clinical severity thresholds, contraindicated combinations, authorization duration, and program notes.

Policy Summary

PayerUnitedHealthcare

PolicyWainua (eplontersen) prior authorization / medical necessity

Policy CodePolicy 2025 P 2326-2

Change TypeRevised - combination therapy exclusion updated

Effective DateMay 1, 2025

Next Review Date

Key ActionPrior authorization/medical necessity required; submit documentation of pathogenic TTR mutation and baseline disease severity, ensure neurologist involvement, and confirm no concurrent oligonucleotide or transthyretin stabilizer therapy.

SourceLink

POLICY UPDATE CHANGES

Added Attruby to Vyndaqel/Vyndamax and relabeled as transthyretin stabilizer agents not to be used in combination.

12Authorization Duration

3Baseline severity options

1Prescriber requirement (neurologist)

Coverage Summary

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This policy covers Wainua (eplontersen) with prior authorization/medical necessity for treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR) in adults. Prescriber requirement: must be prescribed by or in consultation with a neurologist. Diagnostic requirements: documented diagnosis of hATTR with polyneuropathy and documentation of a pathogenic TTR mutation (e.g., V30M). Severity requirements: baseline disease severity must meet one of the following thresholds — PND score ≤ IIIb, FAP Stage 1 or 2, or NIS score ≥ 10 and ≤ 130. Combination therapy exclusions: not to be used in combination with specified oligonucleotide agents (e.g., Onpattro/patisiran, Amvuttra/vutrisiran, Tegsedi/inotersen) or transthyretin stabilizers (e.g., Vyndaqel/Vyndamax/tafamidis, Attruby/acoramidis). Authorization duration: 12 months.

Key thresholds and quick facts

Authorization duration12 months

Prescriber requirementPrescribed by or in consultation with a neurologist

PND thresholdBaseline polyneuropathy disability (PND) score ≤ IIIb

FAP Stage thresholdBaseline FAP Stage 1 or 2

NIS thresholdBaseline neuropathy impairment (NIS) score ≥ 10 and ≤ 130

Initial Therapy Criteria

Initial Authorization

Wainua will be approved based on all of the following criteria:

ALL of the following

Both of the following
- Diagnosis of hATTR amyloidosis with polyneuropathy
- Documentation that the patient has a pathogenic TTR mutation (e.g., V30M)
Prescribed by or in consultation with a neurologist
Documentation of one of the following
- Patient has a baseline polyneuropathy disability (PND) score ≤ IIIbPND score ≤ IIIb
- Patient has a baseline FAP Stage 1 or 2FAP Stage 1 or 2
- Patient has a baseline neuropathy impairment (NIS) score ≥ 10 and ≤ 130NIS score between 10 and 130 inclusive
Patient has not had a liver transplant
Presence of clinical signs and symptoms of the disease (e.g., peripheral sensorimotor polyneuropathy, autonomic neuropathy, motor disability, etc.)
Not receiving Wainua in combination with either of the following
- Not receiving oligonucleotide agents (e.g., Onpattro [patisiran], Amvuttra [vutrisiran], Tegsedi [inotersen])
- Not receiving a transthyretin stabilizer (e.g., Vyndaqel/Vyndamax [tafamidis], Attruby [acoramidis])

Continuation / Reauthorization Criteria

Reauthorization

Wainua will be approved for reauthorization when BOTH of the following are met:

ALL of the following

Documentation that the patient has experienced a positive clinical response to Wainua therapy (e.g., improved neurologic impairment, motor function, quality of life, slowing of disease progression, etc.)
Clinical measures should be documented in chart / prior auth submission
Not receiving Wainua in combination with either of the following
- Not receiving oligonucleotide agents (e.g., Onpattro [patisiran], Amvuttra [vutrisiran], Tegsedi [inotersen])
- Not receiving a transthyretin stabilizer (e.g., Vyndaqel/Vyndamax [tafamidis], Attruby [acoramidis])

Authorization will be issued for 12 months.

Provider Actions & Requirements

Prior Authorization

Prior authorization required for Wainua

Prior authorization / medical necessity is required for Wainua (eplontersen). Initial approval requires documentation of: diagnosis of hATTR amyloidosis with polyneuropathy; a pathogenic TTR mutation (e.g., V30M); prescriber is a neurologist or in consultation with one; baseline disease severity meeting one of the specified thresholds (PND ≤ IIIb, FAP Stage 1 or 2, or NIS score between 10 and 130); no prior liver transplant; presence of clinical signs/symptoms of disease; and not receiving Wainua in combination with disallowed agents.

Documentation Required

Documentation of mutation and baseline severity required

Submit documentation of the pathogenic TTR mutation (example: V30M) and the patient’s baseline disease severity — e.g., PND score, FAP stage, or NIS score — with the prior authorization request.

Documentation Required

Reauthorization clinical response documentation

For reauthorization, provide documentation that the patient has experienced a positive clinical response to Wainua (examples include improved neurologic impairment, improved motor function, improved quality of life, or slowing of disease progression).

Billing Rule

Authorization duration

Authorizations for Wainua are issued for 12 months.

Denial Risk

Combination therapy exclusion

Claims may be denied if Wainua is used in combination with the listed oligonucleotide agents or transthyretin stabilizers.

Onpattro (patisiran)
Amvuttra (vutrisiran)
Tegsedi (inotersen)
Vyndaqel/Vyndamax (tafamidis)
Attruby (acoramidis)

Applicable Codes

ICD-10 diagnosis codes (examples referenced)ICD-10

No codes listed

Example referenced drug classes (combination contraindications)mixedNot Covered

Onpattro	patisiran (oligonucleotide agent) — example of agent not to be combined
Amvuttra	vutrisiran (oligonucleotide agent) — example of agent not to be combined
Tegsedi	inotersen (oligonucleotide agent) — example of agent not to be combined
Vyndaqel/Vyndamax	tafamidis (transthyretin stabilizer) — example of agent not to be combined
Attruby	acoramidis (transthyretin stabilizer) — example of agent not to be combined

Background

Wainua (eplontersen) is a transthyretin-directed antisense oligonucleotide indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR) in adults. This policy documents that prior authorization/medical necessity is required under UnitedHealthcare Pharmacy Clinical Pharmacy Programs (Program 2025 P 2326-2).

Definitions: hATTR — hereditary transthyretin-mediated amyloidosis; PND — polyneuropathy disability score; FAP Stage — familial amyloid polyneuropathy stage; NIS — Neuropathy Impairment Score.

Revision History

2/2024P&T approval

P&T approval for Prior Authorization/Medical Necessity program (new program) noted 2/2024.

2/2025P&T approvalLatest

P&T approval noted 2/2025; material change: Updated combination therapy exclusion examples by adding Attruby to Vyndaqel/Vyndamax and relabeling as transthyretin stabilizer agents not to be used in combination; updated reference.