CurrentCignaPolicy N/A

Amyloidosis - Wainua Prior Authorization Policy

This Cigna prior authorization policy governs coverage criteria and authorization requirements for Wainua (eplontersen) for treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR) in adults for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyAmyloidosis - Wainua Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateN/A

Next Review DateDec 4, 2024

Key ActionObtain prior authorization with documentation that the patient is ≥18 years, has a pathogenic TTR variant confirmed by genetic testing, has symptomatic polyneuropathy, has no history of liver transplantation, and the medication is prescribed by or in consultation with a relevant specialist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearapproval duration

≥18min age

genetic test requiredTTR confirmation

no liver transplantno liver transplant

no combinationno combo therapy

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Coverage Criteria for Wainua (eplontersen)

Initial therapy - FDA-approved indication

Covered when ALL of the following are met for the FDA-approved indication (approve for 1 year):

FDA-Approved Indication: hATTR polyneuropathy: Patient is ≥18 years of age; AND patient has a transthyretin (TTR) pathogenic variant confirmed by genetic testing; AND patient has symptomatic polyneuropathy (examples include reduced motor strength/coordination and impaired sensation such as pain, temperature, vibration, or touch; assessments may include history and clinical exam, electromyography, or nerve conduction studies); AND patient does not have a history of liver transplantation; AND medication is prescribed by or in consultation with a neurologist, geneticist, or physician who specializes in the treatment of amyloidosis.

Approve for 1 year.

Requests for Wainua used concurrently with other transthyretin (TTR)–directed therapies are considered experimental/investigational and may be denied. The policy specifies that Wainua should not be administered in combination with other medications indicated for hATTR polyneuropathy or transthyretin-mediated amyloidosis‑cardiomyopathy (for example, vutrisiran, acoramidis, patisiran, inotersen, or tafamidis products). Combination therapy is generally not recommended because there are no controlled clinical trial data demonstrating additive efficacy.

Provider Requirements and Authorization Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approvals are provided for 1 year. Because of the specialized skills required for evaluation, diagnosis, and monitoring, Wainua must be prescribed by or in consultation with a neurologist, geneticist, or other physician who specializes in the treatment of amyloidosis.

Approval duration: 1 year
Prescriber requirement: neurologist, geneticist, or amyloidosis specialist

Step Therapy

Step therapy is not a fixed drug-sequence requirement in this policy, but specialist involvement and meeting all listed clinical criteria are required before approval. There is no specified prior trial of an alternative TTR-directed therapy documented as a prerequisite in the policy text.

No specific medication step sequence required
Specialist involvement required for authorization

Background on Wainua (eplontersen)

Wainua (eplontersen) is a transthyretin‑directed antisense oligonucleotide indicated for the treatment of polyneuropathy of hereditary transthyretin‑mediated amyloidosis (hATTR) in adults. hATTR is caused by pathogenic variants in the TTR gene that lead to multisystem dysfunction; neurologic manifestations include sensorimotor and autonomic polyneuropathy and small‑fiber neuropathy. For coverage under this policy, patients must be ≥18 years of age, have a confirmed TTR pathogenic variant by genetic testing, have symptomatic polyneuropathy documented by clinical exam or neurophysiologic testing, have no history of liver transplantation, and the medication must be prescribed by or in consultation with a neurologist, geneticist, or an amyloidosis specialist. Approvals are provided for 1 year when all criteria are met.

Definitions and Key Terms

inv-08: Polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR) — disease definition and clinical context

DefinitionA progressive disease caused by pathogenic variants in the transthyretin (TTR) gene leading to multisystem organ dysfunction; neurologic manifestations include sensorimotor polyneuropathy, autonomic neuropathy, small-fiber polyneuropathy, and carpal tunnel syndrome.

Clinical examples of symptomatic polyneuropathyReduced motor strength or coordination; impaired sensation (pain, temperature, vibration, touch).

Diagnostic assessmentsHistory and clinical exam, electromyography, or nerve conduction studies can be used to document symptomatic polyneuropathy.

Age and transplantation considerationsPolicy applies to adults (≥18 years); Wainua has not been studied in patients with prior liver transplantation and history of liver transplant is an exclusion criterion.

Indication contextWainua (eplontersen) is indicated for treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR) in adults.

Policy Summary

PayerCigna

PolicyAmyloidosis - Wainua Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateN/A

Next Review DateDec 4, 2024

SourceLink

On This Page

Documentation Required

Required Clinical Documentation

Prior authorization requests must include documentation of the patient’s age and confirmation of a pathogenic transthyretin (TTR) variant by genetic testing, evidence of symptomatic polyneuropathy, absence of prior liver transplantation, and prescriber specialty or consult note.

Age: ≥18 years
Pathogenic TTR variant confirmed by genetic testing
Documentation of symptomatic polyneuropathy (e.g., history/clinical exam, EMG, or nerve conduction studies)
No history of liver transplantation
Prescribed by or in consultation with a neurologist, geneticist, or amyloidosis specialist

Denial Risk

Concurrent Therapy — Denial Risk

Requests for concurrent use of Wainua with other medications indicated for hereditary transthyretin-mediated amyloidosis (for example, vutrisiran, patisiran, inotersen, tafamidis products, or acoramidis) are considered experimental/unproven and are not supported; such requests may be denied.

Concurrent use with Amvuttra (vutrisiran), Onpattro (patisiran), Tegsedi (inotersen), tafamidis products, Attruby (acoramidis), or similar TTR therapies is not recommended and may be denied
Combination therapy lacks controlled trial data supporting additive efficacy

inv-09: Pathogenic variant — definition as used in the policy (genetic test confirmation)

Policy definition'Pathogenic variant' denotes a disease-causing change in the transthyretin (TTR) gene confirmed by genetic testing; policy language was revised from 'mutation' to 'pathogenic variant'.

Evidence required for coverageCoverage requires confirmation of a transthyretin (TTR) pathogenic variant by genetic testing as part of the FDA‑approved indication criteria.

Testing implicationGenetic test documentation must be provided with prior authorization to verify the pathogenic TTR variant.