Background: About pTAP
The pan-Canadian Pharmaceutical Alliance (pCPA) recognizes the importance of access to innovative therapies along with the need to adapt to a changing drug reimbursement landscape.
The pCPA has developed a set of principles and conditions for a pCPA Temporary Access Process (pTAP) that will inform the negotiation process and potential product listing agreements for any drug products that follow the CADTH time-limited recommendation pathway. These are temporary reimbursement recommendations that will be contingent on a future reassessment within a specific time period, where future evidence is expected to address any uncertainty identified during the initial CADTH assessment.
In keeping with the pCPA Strategic Plan (2022- 2024) guiding principles of accountability, inclusion, openness and transparency to guide our interactions with partners and the community, the pCPA is engaging with clinicians, patient groups and industry regarding the pTAP principles and conditions to ensure alignment in values and processes.
pTAP Principles and Conditions
Starting in the fall of 2023, CADTH will introduce time-limited reimbursement recommendations for certain drug products.
The following Principles and Conditions outline the pCPA’s approach to a temporary access process with pharmaceutical manufacturers that will enable publicly funded access to patients during the evidence-generation period.
pTAP Principles
- pCPA recognizes the need for timely patient access to treatments and works to balance the need for early access with availability of sufficient evidence.
- Establish a unique process and funding mechanism where patients, physicians and other stakeholders are made aware that coverage of the medication is temporary, conditional on manufacturer’s agreement to a risk-share arrangement, and subject to change dependent on subsequent evidence review.
- pCPA will require cost-effective pricing in any risk-share agreement with manufacturers to ensure sustainability and proper management of public funds in both the temporary funding period and beyond.
- If a manufacturer participates in the CADTH time-limited recommendation pathway, participation in the pCPA Temporary Access Process (pTAP) is required.
- pCPA will require manufacturers to abide by the timing and expectations set out by both the CADTH time-limited recommendation process, including a final CADTH recommendation, and by the pTAP.
- Québec subscribes to pCPA’s principles governing time limited evaluation and interim coverage, subject to a reevaluation when additional data will become available. In the case of Québec, file admissibility and evaluation of promising therapies will be under the sole responsibility of INESSS. In this context, data submission from the manufacturers must be carried out simultaneously both to INESSS and CADTH, for the initial submission and the reevaluation based on additional data.
- Require drug manufacturers to provide coverage for any patient started on medication during the temporary period where for any reason public funding is not continued beyond the temporary period.
- pCPA will continue to work collaboratively with CADTH and Health Canada.
pTAP Conditions for Participation
- Drug products eligible for consideration under the pTAP should have received a CADTH time-limited recommendation and must meet all of the following criteria:
a. have been issued an NOC/c by Health Canada or are currently undergoing review through Health Canada’s advance consideration process under the NOC/c policy
b. a phase III trial is being planned and/or conducted in the relevant patient population at the time of the submission to CADTH and the study completion date will not exceed 3 years from the target expert committee meeting date.
c. the drug manufacturer must be willing to commit to file a reassessment application with CADTH in accordance with the time frames specified in the procedures for time-limited recommendations.
d. The evidence-generation plans described in Health Canada’s qualifying notice are expected to address the gaps in the evidence identified by CADTH’s expert committee. - A time-limited recommendation from CADTH does not guarantee pCPA will agree to temporary access. pCPA will assess each file individually and determine whether it will pursue a negotiated agreement in the interim while further evidence is developed. There may be instances where pCPA does not negotiate a temporary risk-share agreement.
- For temporary access, drug products are required to be priced according to established cost-effectiveness to offset clinical uncertainty and a risk-share agreement between payor and manufacturer is required.
- Funding during the interim period is considered temporary. Funding beyond the interim period is subject to the final CADTH reassessment recommendation and the final pCPA negotiated agreement.
- During the temporary access process, pCPA may negotiate for the period after when the final CADTH reassessment has been issued.
- Manufacturers must agree to submit for HTA-reassessment, regardless of outcome of clinical trial, within the designated time period as prescribed by CADTH. If the manufacturer does not submit updated clinical trial data within the agreed-upon time, then time-limited funding will be terminated and any existing patients will become the responsibility of the manufacturer.
- In the following situations, the manufacturer will assume funding for patients who started on the drug product during the interim period:
A. Manufacturer fails to comply with CADTH reassessment; or
B. CADTH final recommendation is to not reimburse; or
C. CADTH provides a final recommendation to reimburse, but pCPA negotiations do not result in a long-term agreement between pCPA and the manufacturer; or
D. CADTH final recommendation further restricts criteria which results in patients becoming ineligible for public funding. - If CADTH has issued a time-limited recommendation for a product, pCPA and public drug plans require the manufacturer of that product to abide by the principles and conditions outlined above.
pTAP Questionnaire
As part of our engagement with pCPA stakeholders we are inviting written input through the below questionnaire.
Deadline to provide input into the questionnaire is Friday, August 18th, 2023.
Before completing this questionnaire, we encourage you to first:
- familiarize yourself with the pTAP and the pCPA’s draft principles and conditions and
- review the questionnaire in its entirety.
Please ensure that your recommendations and explanations are captured within the body of the submission. Information provided through links or reference to other content will not be considered to form part of the submission and may only be reviewed for further interest.
Please note, this written input is considered a public document and may be referred to in reports made publicly available by the pCPA, as well as potentially being posted on the pCPA's website. The written input will not be associated with any specific organization or individual in any publication. Please do not include any personal information or personal health information within the body of your submission.
The pCPA has retained the firm of Pathway Strategies to help with this process of stakeholder outreach for the pTAP. Should you have any questions about the questionnaire, please email them directly to Dennis Chan of Pathway Strategies at [email protected]