pTAP Frequently Asked Questions (FAQs)

CDA-AMC has introduced time-limited reimbursement recommendations for certain drug products. 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 uncertainty identified in the initial assessment. You can find more information on this initiative on the CADTH website.

The pCPA recognizes the importance of patients having access to innovative therapies along with the need to adapt to a changing drug reimbursement landscape. As future reassessments through CDA-AMC time-limited reimbursement recommendations have the potential to impact pCPA negotiations, the pCPA developed a set of principles and conditions to approach negotiations for drugs that have followed the CDA-AMC process.

While the role of the pCPA is to conduct joint provincial, territorial and federal drug plan negotiations for brand name and generic drugs, any final funding decision is made under the authority of individual jurisdictional public drug plans. Jurisdictions will work through their respective drug review and listing processes that are required to reach a decision to list on their respective public drug plans.

• In the following situations, it is expected that the manufacturer will assume funding for patients who started on a drug during the interim period:

  • Manufacturer fails to comply with the CDA-AMC reassessment; or
  • The CDA-AMC final recommendation is to not reimburse; or
  • The CDA-AMC provides a final recommendation to reimburse, but pCPA negotiations do not result in a long-term agreement between the pCPA and the manufacturer; or
  • The CDA-AMC final recommendation further restricts criteria, which results in patients becoming ineligible for public funding.

  If any one of these events is triggered, public drug plan coverage of existing patients will be assumed by the manufacturer. Such coverage will continue until such time that the prescriber and the patient determine the drug is no longer required.

A time-limited recommendation from the CDA-AMC does not guarantee the pCPA will agree to negotiate for a drug. The pCPA will assess each file individually and determine whether it will pursue a negotiated agreement while further evidence is developed. There may be instances where the pCPA does not negotiate a temporary risk-share agreement.

We all recognize there are significant risks for both manufacturers and payers with providing coverage based on TLR recommendations. By establishing the pTAP process in consultation with the pharmaceutical industry, the pCPA anticipates that manufacturers and the pCPA will be successful in supporting access for patients. 

If a manufacturer participates in the TLR pathway, participation in pTAP is required. If a manufacturer declines to go through pTAP after going through the TLR pathway, the pCPA may choose to wait until a final HTA recommendation is provided by the CDA-AMC.

pTAP negotiations will not follow the target timelines for pCPA negotiations. Manufacturers can expect to engage in negotiations based on a defined schedule to minimize delay. 

These scenarios will be managed on a case-by-case basis. Any decisions to go beyond the three-year time frame for evidence generation will be discussed among relevant parties.

Upon reaching an agreement with the manufacturer, participating jurisdictions will then enter into jurisdiction-specific product listing agreements. 

A structured negotiation process for pTAP means a time-limited process that the negotiating parties will maintain during the negotiation. The process is designed to ensure momentum, as opposed to a protracted negotiation. Given the status of the pTAP (i.e. pilot initiative), we are expecting that refinements to the process will be necessary.