CurrentCareSourcePolicy N/A

Onapgo (apomorphine subcutaneous infusion) — Coverage Criteria and Prior Authorization

Defines prior authorization, coverage criteria, and dosing for Onapgo for treatment of motor fluctuations in adults with advanced Parkinson's disease; applies to prescribers and payers managing medical benefit coverage.

Policy Summary

PayerCareSource

PolicyOnapgo (apomorphine subcutaneous infusion) — Coverage Criteria and Prior Authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateMay 28, 2025

Key ActionObtain prior authorization and document neurologist involvement, prior carbidopa/levodopa trial, and prior or current use of another treatment for 'off' episodes.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearstandard approval duration

98 mg/daymax daily dosing

≥30min study age

−2.55 hWeek 12 Δ 'off' time

Recommended Authorization Criteria

FDA-Approved Indication — Initial Authorization

Policy Summary

PayerCareSource

PolicyOnapgo (apomorphine subcutaneous infusion) — Coverage Criteria and Prior Authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateMay 28, 2025

Key ActionObtain prior authorization and document neurologist involvement, prior carbidopa/levodopa trial, and prior or current use of another treatment for 'off' episodes.

SourceLink

On This Page

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Initial Approval for Parkinson's Disease (Onapgo): A) Patient is diagnosed with advanced Parkinson's disease;

Initial Approval for Parkinson's Disease (Onapgo): B) Patient is experiencing 'off' episodes (examples include muscle stiffness, slow movements, or difficulty starting movements);

Initial Approval for Parkinson's Disease (Onapgo)

ONE of: i. Patient had significant intolerance to carbidopa/levodopa, according to the prescriber;
ONE of: ii. Patient had inadequate efficacy with carbidopa/levodopa, according to the prescriber;

Initial Approval for Parkinson's Disease (Onapgo): D) Patient has previously tried or is currently receiving ONE other treatment for 'off' episodes (examples include entacapone, rasagiline, pramipexole, ropinirole, tolcapone, cabergoline, selegiline, Ongentys (opicapone), or Xadago (safinamide));

Initial Approval for Parkinson's Disease (Onapgo): E) Medication is prescribed by or in consultation with a neurologist;

Approval details: Approve for 1 year; dosing: up to 98 mg administered as a subcutaneous infusion every day.

Requests for doses outside the documented dosing will be considered case-by-case by a clinician.

Authorization, Documentation, and Step Therapy Requirements

Prior Authorization

Prior Authorization Recommended

Prior authorization is recommended for medical benefit coverage of Onapgo. Approval is recommended when the patient meets all required clinical criteria. Initial approval requires Onapgo to be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., neurologist). Approvals are provided for the duration noted in the policy; requests for doses outside the established dosing will be reviewed case-by-case by a clinician.

Step Therapy

Step Therapy / Prior Treatment Requirement

Patient must have tried oral carbidopa/levodopa and meet ONE of the following: documented significant intolerance to carbidopa/levodopa or inadequate efficacy with carbidopa/levodopa, according to the prescriber. In addition, the patient must have previously tried or be currently receiving ONE other treatment for 'off' episodes (examples include entacapone, rasagiline, pramipexole, ropinirole, tolcapone, cabergoline, selegiline, Ongentys (opicapone), or Xadago (safinamide)).

Documentation Required

Required Clinical Documentation

Prescriber specialty documentation must show Onapgo is prescribed by or in consultation with a neurologist. Documentation should include diagnosis of advanced Parkinson's disease and evidence the patient is experiencing 'off' episodes, records of prior carbidopa/levodopa trial with reason for intolerance or inadequate efficacy, and documentation of prior or current use of at least one other therapy for 'off' episodes. Approvals should follow dosing guidance in the policy (up to 98 mg subcutaneous infusion daily).

Denial Risk

Denial Trigger — Non‑listed Indications

Requests for Onapgo for indications or circumstances not listed in the Recommended Authorization Criteria are not recommended for approval.

Key Definitions

inv-10: Off episodes — definition and examples

DefinitionPeriods when Parkinson's symptoms return or worsen between doses of levodopa

Common examplesMuscle stiffness, slow movements, or difficulty starting movements

Clinical contextThese 'off' episodes are a feature of motor fluctuations in advanced Parkinson's disease

inv-11: Onapgo — definition (apomorphine subcutaneous infusion; brand Onapgo)

DefinitionApomorphine subcutaneous infusion (brand Onapgo)

Drug classDopaminergic agonist continuous subcutaneous infusion

IndicationTreatment of motor fluctuations in adults with advanced Parkinson's disease

OpenPayer

Onapgo (apomorphine subcutaneous infusion) — Coverage Criteria and Prior Authorization

Recommended Authorization Criteria

Billing and Dosing Codes & Limits

Authorization, Documentation, and Step Therapy Requirements

Clinical Background

Key Definitions