CurrentNeighborhood Health Plan of Rhode IslandPolicy 5464-A

Ongentys (opicapone) prior authorization

Prior authorization criteria for coverage of Ongentys (opicapone) as adjunctive treatment to levodopa/carbidopa for members with Parkinson's disease experiencing 'off' episodes. Affects providers prescribing Ongentys to Neighborhood Health Plan of Rhode Island members under CVS Caremark criteria.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOngentys (opicapone) prior authorization

Policy CodePolicy 5464-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization and document trial and inadequate response to, or intolerance/contraindication to, generic carbidopa/levodopa/entacapone or entacapone plus levodopa/carbidopa.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsDuration of approval

1FDA indication(s)

2Alternative prior therapy paths

Coverage Criteria for Ongentys (opicapone)

Initial Authorization

Covered when ALL of the following are met:

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOngentys (opicapone) prior authorization

Policy CodePolicy 5464-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization and document trial and inadequate response to, or intolerance/contraindication to, generic carbidopa/levodopa/entacapone or entacapone plus levodopa/carbidopa.

SourceLink

On This Page

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Indication: The requested drug is being prescribed as adjunctive treatment to levodopa/carbidopa in a patient with Parkinson's disease experiencing 'off' episodes

Prior therapy requirement: One of the following prior therapy conditions is met:

ALL of the following

Prior therapy alternatives: Patient has experienced an inadequate treatment response to a trial of generic carbidopa/levodopa/entacapone or generic entacapone used in combination with a generic levodopa/carbidopa product
Patient has experienced an intolerance to generic carbidopa/levodopa/entacapone or generic entacapone used in combination with a generic levodopa/carbidopa product
Patient has a contraindication that would prohibit a trial of generic carbidopa/levodopa/entacapone or generic entacapone used in combination with a generic levodopa/carbidopa product

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. The requested medication will be considered for coverage only when it is prescribed as adjunctive therapy to levodopa/carbidopa for a patient with Parkinson's disease who is experiencing "off" episodes.

Adjunctive to levodopa/carbidopa for PD patients with "off" episodes

Step Therapy

Step Therapy Requirement

A trial of and inadequate response to specific generic therapies is required prior to approval unless there is documented intolerance or a contraindication.

Required trial: generic carbidopa/levodopa/entacapone OR generic entacapone used in combination with a generic levodopa/carbidopa product
If the patient has an intolerance or contraindication to the required agents, document this in the prior authorization submission

Denial Risk

Documentation and Denial Risk

Document supporting clinical information showing the indication and prior therapy status. Requests may be denied if the medication is not being used as adjunctive therapy to levodopa/carbidopa for "off" episodes or if there is no documentation of trial and inadequate response to the required prior therapies (unless intolerance or contraindication is documented).

Denial risk if not prescribed as adjunctive to levodopa/carbidopa for PD patients with "off" episodes
Denial risk without documentation of inadequate response to required prior therapy unless intolerance/contraindication is shown

Definitions

Off episodes — definition and relevance to indication

DefinitionPeriods when Parkinson's disease medications are not working well, resulting in return or worsening of PD symptoms.

Relevance to Ongentys (opicapone)'Off' episodes are the FDA‑approved indication for Ongentys as adjunctive treatment to levodopa/carbidopa.

Clinical implicationPatients experiencing 'off' episodes may require adjunctive therapy to extend levodopa efficacy and reduce motor fluctuations.

Coverage linkageRequests for Ongentys must document that the patient is experiencing 'off' episodes to meet prior authorization criteria.

Exclusion noteUse of Ongentys for indications other than adjunctive treatment in PD patients with 'off' episodes is not supported by these criteria.

OpenPayer

Ongentys (opicapone) prior authorization

Coverage Criteria for Ongentys (opicapone)

Provider Actions, Prior Authorization, and Documentation

Definitions

Background