pCPA Temporary Access Process (pTAP)

The pCPA recognizes the importance of ensuring patients have timely access to innovative drugs and treatments.

The drug reimbursement process in Canada is complex and requires many steps. Assessing new drugs for safety, together with negotiating prices with pharmaceutical manufacturers, can result in a long wait for some patients.

The pCPA recognizes the need to address this and adapt to a changing drug reimbursement landscape. Together with our partners, we have designed a process, called pTAP, that will allow patients to have temporary access to some drugs earlier. pTAP will apply to any drug products that follow the time-limited reimbursement recommendation (TLR) pathway from Canada's Drug Agency (CDA-AMC). These are new, innovative drugs that show early promise and have been given conditional regulatory approval while ongoing longer-term, confirmatory trials are in progress.

The pCPA engaged with clinicians, patient groups and industry to develop a set of principles and conditions for pTAP. This collaborative process reflects our strategic plan (2022–24) and our guiding principles of accountability, inclusion, openness and transparency to guide our interactions with partners and the community.

pTAP Stakeholder engagement

Please note that pTAP is a pilot project and will be subject to regular monitoring and assessment. Any changes to pTAP will be communicated in advance.

PTAP principles
  1. The pCPA recognizes the need for patients to have timely access to treatments. We work to balance the need for early access and availability of sufficient evidence.
  2. The pCPA recognizes the need to 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 manufacturers’ agreement to a risk-share arrangement
    • subject to change depending on evidence from subsequent reviews
  3. The pCPA requires cost-effective pricing in any risk-share agreement with manufacturers. This will ensure sustainability and proper management of public funds in the temporary funding period and beyond.
  4. If a manufacturer participates in the TLR pathway, they are required to participate in pTAP.
  5. Drug manufacturers are required to follow the timing and expectations set out by both the TLR pathway, including a final Canada's Drug Agency (CDA-AMC) recommendation, and pTAP.
  6. Québec subscribes to the pCPA’s principles governing time-limited evaluation and interim coverage, subject to a re-evaluation when additional data becomes available. In the case of Québec, file admissibility and evaluation of promising therapies will be the sole responsibility of the Institut national d'excellence en santé et services sociaux (INESSS). In this context, data submission from the manufacturers must be carried out simultaneously both to INESSS and the CDA-AMC, for the initial submission and the re-evaluation based on additional data.
  7. Drug manufacturers are required 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.
  8. The pCPA will continue to work collaboratively with the CDA-AMC and Health Canada.
pTAP conditions for participation
  1. Drug products eligible for consideration under pTAP must have received a TLR and must meet all of the following criteria:
    1. The drug has been issued a Notice of Compliance with Conditions (NOC/c) by Health Canada, or is currently undergoing review through Health Canada’s advanced consideration process under the NOC/c policy.
    2. A phase-III trial is being planned and/or conducted in the relevant patient population at the time of the submission to Canada's Drug Agency (CDA-AMC). The completion date of the study will not exceed three years from the date of the target expert committee meeting.
    3. The drug manufacturer must be willing to commit to file a reassessment application with the CDA-AMC in accordance with the time frames specified in the procedures for the TLR.
    4. The evidence-generation plans described in Health Canada’s qualifying notice are expected to address the gaps in the evidence identified by the CDA-AMC's expert committee.
  2. A TLR from the CDA-AMC does not guarantee the pCPA will agree to the drug entering pTAP. 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.
  3. For temporary access, drug products are required to be priced according to established cost-effectiveness to offset clinical uncertainty. A risk-share agreement between payor and manufacturer is required.
  4. Funding during the interim period is considered temporary. Funding beyond the interim period is subject to the final CDA-AMC reassessment recommendation and the final pCPA negotiated agreement.
  5. During the pTAP interim period, the pCPA may engage in negotiations for an agreement that will take effect after the final CDA-AMC recommendation has been issued.
  6. Manufacturers must agree to submit for reassessment — regardless of outcome of clinical trial — within the designated period of time, as prescribed by the CDA-AMC. 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.
  7. The manufacturer will assume funding for patients who started on the drug during the pTAP interim period if:
    1. The manufacturer fails to comply with the CDA-AMC reassessment; or
    2. The CDA-AMC final recommendation is to not reimburse; or
    3. 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
    4. The CDA-AMC final recommendation further restricts criteria, which results in patients becoming ineligible for public funding.
  8. If the CDA-AMC has issued a TLR for a drug, the pCPA and public drug plans require the manufacturer of that product to follow the principles and conditions outlined above.
pTAP negotiations process overview

The pTAP negotiation process involves the manufacturer and the pCPA engaging in time-limited, good-faith discussions. The purpose of the pTAP negotiation is to ensure that an appropriate temporary risk-share agreement is in place during the time when more clinical evidence is being generated and collected. 

The first step before participating in pTAP is for a manufacturer to participate in the TLR pathway with Canada's Drug Agency (CDA-AMC). From there, the process is as follows:

Step 1: Once a manufacturer receives the initial economic report from the CDA-AMC, the pCPA will evaluate the drug to decide if it will pursue a negotiated agreement with the manufacturer. If the pCPA does not pursue a negotiated agreement, the drug will not go any further in pTAP.

Step 2: If the pCPA decides to pursue a negotiated agreement, a structured negotiation process will be initiated, prior to the TLR recommendation from the CDA-AMC.

Step 3: If the negotiation is successful, a temporary confidential public drug plan price will be established that applies to patients who meet eligibility criteria (as set out in the TLR). If the negotiation is unsuccessful, the drug will not go any further in pTAP.

Step 4: The temporary agreement will be in effect until a final (long-term) agreement is negotiated, as triggered by a positive final health technology assessment (HTA) recommendation.

Any patients who have been granted public coverage of the drug during the pTAP negotiation process will continue to be covered by the public drug plan until such time that one of the following events takes place:

  1. Confirmatory evidence is NOT submitted for HTA after three years (or a time that has been agreed to by the pCPA).
  2. Confirmatory evidence does NOT show a clinical benefit after a final HTA review. This includes:
    1. a final HTA recommendation of “do not reimburse”; or
    2. a recommendation that is more restrictive than the initial HTA funding criteria.
  3. The pCPA and the manufacturer are unable to reach a final (long-term) agreement.

If any one of these events is triggered, 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.

pCPA Temporary Access Process (pTAP) flowchart

pTAP pricing

The pCPA understands and recognizes the complexity of calculating cost-effective pricing and the need to account for other factors in the assessment of pricing.

For drugs that are following the time-limited reimbursement recommendation from Canada's Drug Agency or are following pTAP pathways, there is a range of acceptable cost-effectiveness thresholds depending on disease severity and incremental clinical benefit. This applies to both standard and specialized products.  

Adjusted cost-effectiveness is applied consistently with all products using a predetermined weighting of disease severity and incremental clinical benefit.

Differences between standard and specialized products

A standard product is any product not considered a specialized product. A specialized product refers to any product where the following may be taken into consideration:

  • Treats a rare disease.
  • Treats a severe rare disease (one that shortens life or severely impairs quality of life).
  • Uses new technology to address a significant unmet need compared to existing options.

Disease severity  

Disease severity is defined as the future health lost by people living with the condition under standard of care in Canada. Other countries with healthcare systems similar to Canada use disease severity in their application of cost-effectiveness.

Along with disease severity, the pCPA will also consider the magnitude of clinical benefit when applying pricing standards.

For any manufacturer considering submission for a time-limited reimbursement recommendation as well as pTAP, the pCPA can provide information on whether it will be treated as a specialized product. 

Drugs subject to pTAP
FAQ

  • Q: Why did the pCPA develop principles and conditions regarding time-limited reimbursement recommendations from Canada's Drug Agency (CDA-AMC)?

    A: 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.

  • Q: Will products that go through pTAP be expedited through jurisdictional drug plans?

    A: 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.

  • Q: What happens to a patient who starts a treatment should public funding for that treatment be stopped due to a subsequent negative review?

    A: 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.

  • Q: Will the pCPA engage in negotiations with all manufacturers who participate in the CDA-AMC time-limited reimbursement process?

    A: 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.

  • Q: The conditions will make it difficult for any manufacturer to sign on to an agreement. What good is taking all this effort to develop a process that ends up resulting in no deals?

    A: 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. 

  • Q: What happens if a manufacturer declines to go through pTAP after going through the TLR pathway?

    A: 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.

  • Q: How long will negotiations take for pTAP? Will it follow the same target timelines as pCPA negotiations?

    A: 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. 

  • Q: What if manufacturers require more time to generate and gather the required clinical evidence?

    A: 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.

  • Q: How quickly will patients be able to get access to pTAP drugs once the interim agreement is reached?

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

  • Q: What is a structured negotiation process? Can you share more details?

    A: 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.