ModifiedCentenePolicy CP PMN.245

Clinical Policy: Opicapone (Ongentys)

Defines medical necessity, prior authorization, step therapy, and dosing requirements for opicapone (Ongentys) as adjunctive treatment to levodopa/carbidopa for members with Parkinson's disease experiencing OFF episodes. Applies to Centene-affiliated health plans and their providers.

Policy Summary

PayerCentene

PolicyClinical Policy: Opicapone (Ongentys)

Policy CodePolicy CP PMN.245

Change TypeAdded step therapy bypass for Illinois HIM (effective 1/1/2026)

Effective Date09.01.20

Next Review Date

Key ActionSubmit prior authorization with supporting clinical documentation showing the member meets initial or continued therapy criteria.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for Illinois HIM per IL effective 1/1/2026 and noted in 3Q 2025 annual review.

50 mg/dayMaximum daily opicapone dose

6 monthsInitial approval duration

12 monthsContinued therapy approval duration

Commercial, HIM, MedicaidLines of business

State Medicaid precedence

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Coverage Criteria

Initial Therapy

Covered when ALL of the following are met for initial approval

Initial Approval Criteria: 1) Diagnosis of Parkinson's disease.

Initial Approval Criteria: 2) Prescribed by or in consultation with a neurologist.

Initial Approval Criteria: 3) Age greater than 18 years.

Initial Approval Criteria: 4) Member is experiencing 'off' time on levodopa/carbidopa therapy (see policy appendix).

Initial Approval Criteria: 5) Prescribed in combination with levodopa/carbidopa.

Initial Approval Criteria: 6) Failure of two of the following adjunct drugs, each from different classes, unless contraindicated or not tolerated: (a) COMT inhibitor (entacapone, tolcapone), (b) MAO-B inhibitor (rasagiline), (c) Dopamine agonist (ropinirole, ropinirole ER, pramipexole, pramipexole ER).

Initial Approval Criteria: 7) Dose: 50 mg per day; do not exceed 1 capsule per day.50 mg/day

Approval duration: 6 months

Initial Approval Criteria: Operational note: For Illinois HIM requests, the step therapy requirements do not apply as of 1/1/2026 per IL HB 5395.

Continuation Therapy

Covered when ALL of the following are met for continued therapy

Continued Therapy Criteria: 1) Member is currently receiving the medication via the Centene benefit or previously met initial approval criteria (or qualifies under state continuity of care provisions).

Continued Therapy Criteria: 2) Member is responding positively to therapy (clinical benefit demonstrated).

Continued Therapy Criteria: 3) If a dose increase is requested, the new dose does not exceed 50 mg per day and does not exceed 1 capsule per day.50 mg/day

Approval duration: 12 months

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with applicable off‑label use policies (for example, CP CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP PMN.53 for Medicaid) or per the member's evidence of coverage.

Coverage under this clinical policy is provided as a guide to medical necessity and is subject to all terms, conditions, exclusions, and limitations contained in the member's coverage documents (for example, evidence of coverage, certificate of coverage, policy, or contract of insurance), as well as applicable state and federal requirements and Health Plan‑level administrative policies.

Use of opicapone for non‑FDA approved indications without sufficient supporting documentation is considered not authorized (not medically necessary). Requests for off‑label use must include adequate evidence of efficacy and safety per the applicable off‑label use policies or the member's benefit documents.

Dosing and Product Information

Opicapone single dose — 50 mg PO QD at bedtime

Standard dose50 mg orally once daily at bedtime

Maximum daily dose50 mg per day (do not exceed 1 capsule/day)

RouteOral (PO)

Administration timingTaken at bedtime

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approval is contingent on meeting initial or continued therapy criteria including diagnosis, prescriber specialty, and required documentation. Providers must request prior authorization per the Health Plan's procedures.

Prior authorization may be required for related agents referenced in the criteria (see policy drug list).
Approval duration: up to 6 months (per criteria).

Note

Prior Authorization Determined by Plan Documents

The clinical policy is a guide to medical necessity only. Final prior authorization and coverage determinations are controlled by the member's plan documents (e.g., evidence of coverage, certificate of coverage, policy, contract of insurance) and applicable law.

Step Therapy

Background

Opicapone (Ongentys) is a catechol‑O‑methyltransferase (COMT) inhibitor indicated as adjunctive treatment to levodopa/carbidopa for patients with Parkinson's disease who are experiencing OFF episodes. The approved dosing regimen is 50 mg once daily (one capsule per day), taken at bedtime, with product availability in 25 mg and 50 mg capsules.

Definitions

OFF episodes (off time) — Return of PD symptoms when levodopa effect wears off

DefinitionReturn of Parkinson's disease symptoms (bradykinesia, rest tremor, or rigidity) when the levodopa treatment effect wears off after each dosing interval.

Clinical contextRepresents motor fluctuations between 'on' time (symptom control) and 'off' time (symptom recurrence)

Typical featuresBradykinesia, rest tremor, rigidity

COMT — Catechol-O-methyl transferase

Full nameCatechol-O-methyl transferase

AbbreviationCOMT