CurrentCignaPolicy IP0746

Parkinson's Disease - Onapgo

Policy governs prior authorization and coverage criteria for Onapgo (apomorphine subcutaneous infusion) to treat motor fluctuations in adults with advanced Parkinson's disease for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyParkinson's Disease - Onapgo

Policy CodePolicy IP0746

Change TypeNew policy

Effective Date

Next Review Date

Key ActionObtain prior authorization and approve for 1 year only if the patient meets all listed clinical criteria and dosing limits.

SourceLink

POLICY UPDATE CHANGES

New policy.

1 yearinitial approval duration

98 mgmaximum daily dosing

1 pivotal trialsupporting trial(s)

IP0746policy id

Coverage Criteria for Onapgo (apomorphine)

Initial (FDA-Approved) Therapy

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

Onapgo initial approval criteria

A) Patient is diagnosed with advanced Parkinson's disease; AND
B) Patient is experiencing 'off' episodes; AND
Examples of 'off' episodes include muscle stiffness, slow movements, or difficulty starting movements.
ALL of the following
- One of: i. According to the prescriber, the patient had significant intolerance; OR

Policy Summary

PayerCigna

PolicyParkinson's Disease - Onapgo

Policy CodePolicy IP0746

Change TypeNew policy

Effective Date

Next Review Date

Key ActionObtain prior authorization and approve for 1 year only if the patient meets all listed clinical criteria and dosing limits.

SourceLink

On This Page

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Provider Actions and Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization is required for benefit coverage of Onapgo. Approve for 1 year if the patient meets all listed criteria and dosing. Extended approvals are allowed if the patient continues to meet the criteria and dosing. Requests for doses outside the established dosing will be considered on a case-by-case basis by a clinician. Initial approval requires Onapgo to be prescribed by or in consultation with a physician who specializes in the condition being treated.

Step Therapy

Prior Therapy Requirements

Patient must have tried oral carbidopa/levodopa and must have previously tried or currently be receiving one other treatment for 'off' episodes. Examples of other treatments for 'off' episodes include entacapone, rasagiline, pramipexole, ropinirole, tolcapone, cabergoline, selegiline, Ongentys (opicapone), or Xadago (safinamide). Approve when documentation shows either significant intolerance or inadequate efficacy to carbidopa/levodopa per the prescriber, and when one additional therapy for 'off' episodes has been tried or is being used.

Patient tried oral carbidopa/levodopa (document intolerance or inadequate efficacy)
Patient has tried or is currently receiving ONE other treatment for 'off' episodes (examples: entacapone, rasagiline, pramipexole, ropinirole, tolcapone, cabergoline, selegiline, Ongentys (opicapone), Xadago (safinamide))

Documentation Required

Prescriber Specialty

Because of the specialized skills required for evaluation and diagnosis of patients treated with Onapgo as well as monitoring required for adverse events and long-term efficacy, initial approval requires Onapgo to be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., neurologist for Parkinson's disease).

Initial prescription must be by or in consultation with a specialist in the treated condition

Denial Risk

Coding and Billing Compliance

Claims submitted for services that are not accompanied by covered code(s) under the applicable Coverage Policy will be denied as not covered. When billing, providers must use the most appropriate codes as of the effective date of the submission.

Background

Onapgo is a continuous subcutaneous infusion formulation of apomorphine indicated for the treatment of motor fluctuations in adults with advanced Parkinson's disease. Clinical efficacy supporting this indication comes from pivotal trials demonstrating reductions in daily "off" time and increases in "on" time without troublesome dyskinesia. Prior authorization is required and coverage is limited to the FDA‑approved indication; dosing is limited to up to 98 mg/day by subcutaneous infusion.

OpenPayer

Parkinson's Disease - Onapgo

Coverage Criteria for Onapgo (apomorphine)

Coding and Dosing

Provider Actions and Authorization

Background

Definitions