Product Details

Duodopa

Levodopa + Carbidopa
20 mg + 5 mg/mL
Intestinal Gel
100-mL Plastic Cassette

DIN/PIN/NPN

02292165

Manufacturer

AbbVie Corporation

Formulary Listing Date

2020-03-31  

Unit Price

169.8100

Amount MOH Pays

169.8100

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

N04BA02

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Parkinson’s Disease Treatments

Levodopa 20 mg/mL and Carbidopa 5 mg/mL Intestinal gel

  • Brand(s): Duodopa
  • Dosage Form/Strength: Intestinal Gel containing Levodopa 20 mg/mL – Carbidopa 5 mg/mL (100 mL cassette)

For the treatment of Parkinson's disease in patients who meet the following criteria:

  1. Experiences at least 25% of the waking day in the off state; AND 

  2. Has severe disability while in the off-state as assessed by a Movement Disorder Specialist; AND

  3. Has received an adequate trial of maximally tolerated doses of levodopa, with demonstrated clinical response; AND

  4. Has failed adequate trials of other adjunctive medications (entacapone, dopamine agonists, monoamine oxidase-B [MAO-B] inhibitors) if not contraindicated. Note that if a contraindication is deemed to be applicable to the patient, the requesting physician must state the contraindication and provide the rationale why it is considered a contraindication for the patient). 

Clinical details pertaining to the severity of the patient’s disability while in the off-state as well as a complete history of all previous and current medications (e.g., name, start date and duration of therapy, doses used, side effects, and response) must be included. 

Requests for treatment initiation will be limited to the physicians practicing in the following specialized movement disorder clinics: Ottawa, London, Toronto Western, Kingston, Baycrest and Hamilton. (Note: An Ontario specialized movement disorder clinic listed on the website of the Canadian Movement Disorder Group http://www.cmdg.org/AcrossCanada/acrosscanada.htm#que is acceptable) 

Exclusion criteria: Patients meeting ANY of the following criteria will NOT be considered. 

  • Patients who have a contraindication to insertion of a percutaneous endoscopic gastrostomy (PEG) tube 

  • Severe psychosis or dementia

Duration of Approval of Initials: 1 Year 

Renewals will be considered in patients who continue to benefit from treatment. The patient should continue to demonstrate a significant reduction in the time spent in the off state and an improvement in the severity of the disability in the off state. 

Duration of Approval of Renewals: 1 Year

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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