Product Details

Kynmobi

Apomorphine Hydrochloride
25 mg
Sublingual Film


DIN/PIN/NPN

02500299

Manufacturer

Sunovion Pharmaceuticals Canada Inc.

Formulary Listing Date

2022-08-15  

Unit Price

9.5400

Amount MOH Pays

9.5400

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

N04BC07

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Parkinson’s Disease Treatments

Apomorphine SL

  • Brand(s): Kynmobi
  • Dosage Form/Strength: 10 mg, 15 mg, 20 mg, 25 mg, 30 mg Sublingual Film
  • Effective date: August 15, 2022

Initiation Criteria:

For the acute, intermittent treatment of patients with Parkinson’s disease (PD), who meet all of the following criteria: 

  1. Apomorphine sublingual (APO SL) is used as adjunctive treatment in patients receiving optimal PD treatment1 with levodopa and derivatives with at least one of the following2:
    Dopamine agonist (DA)
    Monoamine oxidase-B (MAO-B) inhibitor
    Amantadine derivatives

  2. Despite receiving optimal treatment1, the patient continues to experience “off” episodes.

  3. Patient is under the care of a neurologist experienced in PD. 

1Optimal treatment is defined as receiving maximally tolerated dose of a levodopa-based therapy (e.g., levodopa/carbidopa or levodopa/benserazide) AND at least one of the following:

  • a DA (e.g., pramipexole, bromocriptine, pramipexole, ropinirole, rotigotine) for at least 4 weeks OR
  • a MAO-B inhibitor (e.g., rasagiline, selegiline) OR
  • amantadine. 

2Case-by-case consideration may be provided for patients receiving optional PD treatment with levodopa and derivatives AND a catechol-O-methyltransferase (COMT) inhibitor and who have a documented contraindication/intolerance to a DA, MAO-B inhibitor, and amantadine. 

Renewal Criteria:
Renewals will be considered in patients who continue to benefit from therapy and who do not develop unacceptable toxicities or intolerances while on APO SL.3

3Treatment should be discontinued in patients who do not demonstrate an improvement of at least 3.25 points in the Movement Disorders Society Unified Parkinson’s Disease Rating Scale Part III (MDS-UPDRS Part III) score measured within 30 to 60 minutes after a titrated dose is administered. Assessments should occur within 1 year after APO SL has been titrated to a stable and tolerated dose. 

Exclusion criteria:
Concomitant use with 5-hydroxytryptamine type 3 (5HT3) antagonists (e.g., ondansetron, granisetron, palonosetron).

Dosing: As per product monograph. Do not exceed five films per day or 90 mg in total (whichever is reached first). 

Approval duration for initial and renewal requests: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

View Monograph