Limited coverage drugs – apomorphine hydrochloride

Last updated on February 6, 2024

Generic name

apomorphine hydrochloride

Strength

10 mg/mL, 3 mL

10 mg, 15 mg, 20 mg, 25 mg and 30 mg

Form

pre-filled pens

sublingual films1

Special Authority criteria

Approval period

For the acute, intermittent treatment of hypomobility “off” episodes (“end of dose wearing off” and unpredictable “on/off” episodes) in patients with advanced Parkinson’s disease and the following criteria are met:

  • Prescribed by a neurologist or internal medicine specialist with experience in the diagnosis and management of Parkinson’s disease

AND

  • Used as adjunctive therapy in patients who are receiving optimized Parkinson’s disease therapy (levodopa and derivatives and other adjunctive Parkinson's medications) that are still experiencing "off" episodes

Indefinite

Practitioner exemptions

  • None

Special notes

  1. Treatment with apomorphine sublingual film should be discontinued unless an improvement of least 3.25 points is achieved in the Movement Disorders Society Unified Parkinson’s Disease Rating Scale Part III (MDS-UPDRS III) score measured within 30–60 minutes after a titrated dose is achieved. This assessment should occur not more than one year after apomorphine sublingual has been titrated to a stable and tolerated dose. The maximum amount required should not exceed five films per day or 90 mg in total (whichever is reached first)

Special Authority request form(s)