CurrentColorado Rocky Mountain Health PlansPolicy 2026 P 1434-3

Wainua™ (eplontersen) - Prior Authorization/Notification - UnitedHealthcare Commercial Plans

Defines prior authorization and reauthorization clinical criteria for Wainua (eplontersen) for treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR) in adults, duration of authorizations, and combination-therapy exclusions. Applies to UnitedHealthcare Commercial Plans within Colorado Rocky Mountain Health Plans program.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyWainua™ (eplontersen) - Prior Authorization/Notification - UnitedHealthcare Commercial Plans

Policy CodePolicy 2026 P 1434-3

Change TypeAdded exclusion (Attruby); annual review

Effective DateMay 1, 2026

Next Review Date

Key ActionPrior authorization/notification is required for Wainua; initial and reauthorization approvals are issued for 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

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

Annual review in 2/2026 with no changes to coverage criteria.

1Covered Indication

12mAuthorization Duration

3Excluded oligonucleotide agents (examples)

Excluded transthyretin stabilizers (examples)

Coverage Summary

Defines prior authorization and reauthorization clinical criteria for Wainua (eplontersen) for treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR) in adults and combination-therapy exclusions. Applies to UnitedHealthcare Commercial Plans within the Colorado Rocky Mountain Health Plans program. Coverage stance: covered_with_criteria. Authorization duration: 12 months.

Initial Authorization

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

ALL of the following

Diagnosis of hATTR amyloidosis with polyneuropathy
Patient has a pathogenic TTR mutation (e.g., V30M)
NOT receiving Wainua in combination with ANY of the following
- Oligonucleotide agents (e.g., Onpattro (patisiran), Amvuttra (vutrisiran), Tegsedi (inotersen))
  Cannot be used in combination
- Transthyretin stabilizer agents (e.g., Vyndaqel/Vyndamax (tafamadis), Attruby (acoramidis))
  Cannot be used in combination

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Reauthorization / Continuation Therapy

Reauthorization

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

ALL of the following

Documentation of positive clinical response to Wainua therapy
NOT receiving Wainua in combination with ANY of the following
- Oligonucleotide agents (e.g., Onpattro (patisiran), Amvuttra (vutrisiran), Tegsedi (inotersen))
  Cannot be used in combination
- Transthyretin stabilizer agents (e.g., Vyndaqel/Vyndamax (tafamadis), Attruby (acoramidis))
  Cannot be used in combination

Combination Therapy Exclusions (Examples)

Referenced example drugs (combination exclusions)mixedNot Covered

	Onpattro (patisiran) - oligonucleotide agent (example)
	Amvuttra (vutrisiran) - oligonucleotide agent (example)
	Tegsedi (inotersen) - oligonucleotide agent (example)
	Vyndaqel/Vyndamax (tafamadis) - transthyretin stabilizer (example)
	Attruby (acoramidis) - transthyretin stabilizer (example)

The policy lists example agents that cannot be used in combination with Wainua. Examples include oligonucleotide agents such as Onpattro (patisiran), Amvuttra (vutrisiran), and Tegsedi (inotersen), and transthyretin stabilizers such as Vyndaqel/Vyndamax (tafamadis) and Attruby (acoramidis).

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization/notification is required for Wainua; initial and reauthorization approvals are issued for 12 months when criteria are met.

Prior authorization/notification is required for Wainua.
Initial and reauthorization approvals are issued for 12 months when criteria are met.

Documentation Required

Document pathogenic TTR mutation

For initial authorization, document diagnosis of hATTR with polyneuropathy and presence of a pathogenic TTR mutation (e.g., V30M). This documentation is required for initial authorization.

Clinical Evidence & References

Wainua [package insert], AstraZeneca Pharmaceuticals LP; September 2024.

Wainua is a transthyretin-directed antisense oligonucleotide indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR) in adults.

P&T approval dates

P&T approvals2/2024; 2/2025; 2/2026

Definitions

hATTR = Hereditary transthyretin-mediated amyloidosis

Revision History

2/2024P&T approval

P&T approval recorded for Wainua (eplontersen).

2/2025material change

Material change (2/2025): Added Attruby to Vyndaqel/Vyndamax as transthyretin stabilizer agents not to be used in combination.

2/2026annual reviewLatest

Annual review in 2/2026 with no changes to coverage criteria.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyWainua™ (eplontersen) - Prior Authorization/Notification - UnitedHealthcare Commercial Plans

Policy CodePolicy 2026 P 1434-3

Change TypeAdded exclusion (Attruby); annual review

Effective DateMay 1, 2026

Next Review Date

Key ActionPrior authorization/notification is required for Wainua; initial and reauthorization approvals are issued for 12 months when criteria are met.

SourceLink

On This Page

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Documentation Required

Document clinical response for reauthorization

For reauthorization, submit documentation of positive clinical response to Wainua therapy. This documentation is required for reauthorization.

Billing Rule

Automated approvals and supply limits may apply

UnitedHealthcare may approve initial and reauthorization based solely on prior claim/medication history, diagnosis codes (ICD-10), and/or claim logic; supply limits may be in place. Approvals may be based on prior claim/med history, ICD-10, or claim logic and supply limits may apply.

5/1/2026effective dateLatest

Policy effective date.