We’re exploring options to expand the early negotiation process (ENP), and we’re seeking input from our partners. With the expansion of the ENP, more public drug plan participants could benefit from earlier coverage of new drugs that can improve quality of life. This public consultation will examine 2 proposals to expand the ENP, and we will ensure that people with lived experience, clinicians, and manufacturers can share insights that will inform our decisions.
Early negotiation process expansion options
We are requesting feedback on the following 2 ENP expansion options through a survey and/or consultation webinar.
Option A: Health Canada’s Priority Reviews
Health Canada’s Priority Review of Drugs apply to a new drug submission or supplemental new drug submission “for a serious, life-threatening or severely debilitating disease or condition for which there is substantial evidence of clinical effectiveness that the drug provides:
- effective treatment, prevention or diagnosis of a disease or condition for which no drug is presently marketed in Canada; or
- a significant increase in efficacy and/or significant decrease in risk such that the overall benefit/risk profile is improved over existing therapies, preventatives or diagnostic agents for a disease or condition that is not adequately managed by a drug marketed in Canada.”
Option B: Health Canada Advance Consideration under the Notice of Compliance with Conditions policy (AC-NOC/c)
Health Canada’s Advance Consideration under the Notice of Compliance with Conditions (AC-NOC/c) policy applies to:
- “New Drug Submissions (NDS) and Supplemental New Drug Submissions (S/NDS) for a serious, life-threatening or severely debilitating disease or condition for which there is promising evidence of clinical effectiveness based on the available data that the drug has the potential to provide:
- effective treatment, prevention, or diagnosis of a disease or condition for which no drug is presently marketed in Canada; or
- a significant increase in efficacy and/or significant decrease in risk such that the overall benefit/risk profile is improved over existing therapies, preventatives or diagnostic agents for a disease or condition that is not adequately managed by a drug marketed in Canada.
- Abbreviated new drug submissions and supplement to an abbreviated new drug submissions in instances where the Canadian reference product still holds the NOC/c status.”
Share your feedback on the options to expand the ENP
Your feedback will help shape the future of the early negotiation process. You can submit your feedback through a survey and/or a consultation webinar.
Survey
We invite you to share your feedback on the options being considered to expand the ENP through a 15–20 minute survey.
The survey will close on Friday, September 11 at 5 p.m. ET.
Webinar
We invite you to join 1 of 4 consultation webinar sessions that will take place in August. Each 1-hour session will provide an overview of the 2 options to expand the ENP and will include time for questions and answers.
If you have any questions about the survey or consultation webinar, please contact us.