This page provides details about the executive summary submission (ESS) form for manufacturers, including how and when to submit it, and examples of the type of information that may be included in each section.

 

What’s the ESS form?

The ESS form is an optional early submission that manufacturers can use to highlight key facts and considerations that might inform or facilitate negotiations.

The form was created in collaboration with industry associations to help manufacturers ensure the pCPA has early visibility into key information during the consideration phase and to streamline early discussions and context-setting for negotiations. ESS is an emerging process that is subject to ongoing refinement. Sections of the form may evolve based on manufacturer feedback.

View the ESS form

Confidentiality

All information provided in the ESS form is treated as strictly confidential. It’s used solely to support the negotiation process and won’t be shared outside the pCPA unless explicitly directed otherwise. 

When and how to submit

The ESS form can be completed once a drug has received a final health technology assessment (HTA) reimbursement recommendation and before negotiation begins. The pCPA typically invites the manufacturer to complete the ESS form in our letter of acknowledgement (LOA), confirming that its drug is being considered for negotiation.

If a manufacturer chooses to complete the ESS form, it must follow the following parameters:

  • Information must be limited to the sections included in the ESS form
  • The completed form cannot exceed 4 pages 
  • The form must be sent by email within 3 weeks of receiving the LOA 

Email us your completed form

What to include in each section

Please note that the examples provided here reflect information that may have been considered in past negotiations. It doesn’t indicate agreement with the information provided or commit the pCPA to any specific outcome or decision.

Section A: HTA highlights

Summarize the key points from the HTA recommendation

You may wish to include:

  • Key considerations or clarification points from Canda’s Drug Agency (CDA-AMC) or the Institut national d’excellence en santé et en services sociaux (INESSS)
  • The HTA reimbursement recommendation, verbatim, if helpful
  • Notable differences that may exist between CDA-AMC and INESSS recommendations
  • A brief overview of clinical evidence, parameters, and populations of interest
  • Summary of relevant international HTA recommendations

Section B: Economic factors for consideration

Provide a clear snapshot of the economic context

You may wish to include: 

  • A summary of your 3-year budget impact analysis (BIA), including eligible patient populations and coverage across jurisdictions (including Québec)
  • BIA reports and models (as submitted to the HTA bodies) may be shared with the pCPA
  • Your incremental cost utility ratio (ICUR) base case
  • Key elements of your pharmacoeconomic model
  • Reimbursement status in other countries, including access criteria and relevant international price comparisons

Section C: Jurisdictional considerations

Highlight differences across jurisdictions that may affect implementation

You may wish to include:

  • Coverage or reimbursement mechanisms, such as limited use or prior authorization
  • How comparator products are assessed
  • Any unique implementation considerations, such as differences in funding across jurisdictions or any special storage, distribution, or administration requirements 

Section D: Other factors

Provide additional context that may support well-informed discussions

You may wish to include:

  • Details about patient support or compassionate access programs, including program description, services offered, and number of patients enrolled
  • Diagnostic or companion testing considerations, including existing clinical capacity and institutional certification requirements across regions
  • Key risks or uncertainties, including those related to uptake, geographic variability, or market dynamics
  • Unique product characteristics not captured in the HTA reports
  • Any specific comments about product availability, such as method of distribution
  • Any specific questions for the pCPA