CurrentCignaPolicy IP0532

Parkinson's Disease - Ongentys

Cigna prescription drug coverage policy for Ongentys (opicapone capsules) as adjunctive therapy to carbidopa/levodopa in patients with Parkinson's disease. Defines prior authorization, prescriber specialty, preferred product criteria by plan type, approval duration, and noncovered uses.

Policy Summary

PayerCigna

PolicyParkinson's Disease - Ongentys

Policy CodePolicy IP0532

Change TypeTitle revision; removal of 'off' episodes requirement

Effective DateJun 15, 2025

Next Review Date

Key ActionPrior Authorization is required for Ongentys; approve for 1 year when criteria are met.

POLICY UPDATE CHANGES

Updated coverage policy title from Opicapone to Parkinson's Disease - Ongentys.

Removed criterion requiring patient experience 'off' episodes.

Annual Review dated 06/15/2025 stated 'No criteria changes.'

1Approval Duration (years)

2Plan types with same criteria

carbidopa/levodopaRequired Concomitant Medication

Coverage Summary & Scope

Scope: This policy covers Ongentys (opicapone capsules) as an adjunctive treatment to carbidopa/levodopa for patients with Parkinson's disease experiencing motor fluctuations. Prior authorization is required and approvals are provided for 1 year when the specified criteria are met.

Background: Ongentys is a peripheral, selective, reversible catechol-O-methyltransferase (COMT) inhibitor indicated as adjunctive therapy to levodopa/carbidopa for patients with Parkinson's disease who experience 'off' episodes. The policy defines prior authorization, a prescriber specialty requirement (prescribed by or in consultation with a neurologist), preferred product criteria by plan type, approval duration, and noncovered uses. The policy record notes a title change in 07/01/2024 and that criteria were unchanged as of the Annual Review on 06/15/2025.

Initial Therapy Criteria (FDA-Approved Indication)

Preferred Product Criteria by Plan Type

Approve for 1 year if the patient meets ALL of the following (A, B and C):

ALL of the following

Patient is currently receiving carbidopa/levodopa therapy
The medication is prescribed by or in consultation with a neurologist
Because of the specialized skills required for evaluation and diagnosis and monitoring, approval requires prescription by or in consultation with a physician who specializes in the condition being treated.
Preferred product criteria are met for the product(s) as listed in the plan-specific table
See plan-specific preferred product criteria (Employer and Individual & Family Plans).

ref": "b1_0

title": "FDA-Approved Indication - Parkinson's Disease (Approval for 1 year)"

Continuation Therapy Criteria

Continuation/renewal: Prior authorization approvals are provided for the duration noted (1 year) when initial criteria are met. The policy requires prior authorization for Ongentys and states all approvals are provided for the duration noted (1 year) when the patient meets the listed FDA‑approved indication criteria.

Not Medically Necessary / Exclusions

Not Medically Necessary

Ongentys for any other use is considered not medically necessary.

Use not meeting the FDA-approved indication and the policy criteria above

Ongentys for any other use is considered not medically necessary when the use does not meet the FDA‑approved indication and the policy criteria.

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for prescription benefit coverage of Ongentys. All approvals are provided for the duration noted (1 year) when the coverage criteria are met.

Documentation Required

Prescriber specialty requirement

Ongentys must be prescribed by or in consultation with a neurologist (a physician who specializes in the condition being treated).

Documentation Required

Evidence of prior therapy or current use

For preferred product criteria, document either failure, contraindication, or intolerance to entacapone (Comtan generic) or that the patient is currently receiving Ongentys.

Billing Rule

Receipt of samples

Receipt of sample product does not satisfy any criteria requirements for coverage.

Clinical Evidence & References

Evidence: Prescribing information — Ongentys capsules prescribing information, Neurocrine Biosciences; February 2025. Guideline review — International Parkinson and Movement Disorder Society evidence-based review (Mov Disord. 2018;33(8):1248-1266). These sources are cited in the policy and support the efficacy of Ongentys for treatment of motor fluctuations when used adjunctively with levodopa/carbidopa.

Definitions & Background

Ongentys is described as a peripheral, selective, and reversible COMT inhibitor indicated as adjunctive treatment to levodopa/carbidopa for Parkinson's disease patients experiencing 'off' episodes. The policy references evidence‑based guidance noting Ongentys is efficacious and clinically useful for motor fluctuations.

Preferred product criteria (definition): Plan‑specific requirement that is met by failure/contraindication/intolerance to entacapone or current receipt of Ongentys.

Revision History

07/01/2024Title change

Title change recorded in Annual Revision dated 07/01/2024. Updated coverage policy title from Opicapone to Parkinson's Disease - Ongentys.

07/01/2024Removal of criterion

Removal recorded in Annual Revision dated 07/01/2024 and represents a material change: Removed criterion requiring patient experience 'off' episodes.

06/15/2025Annual ReviewLatest

Confirms criteria unchanged since last revision. Annual Review dated 06/15/2025 stated 'No criteria changes.'