Temporary access process

1. The pCPA recognizes the need for patients to have timely coverage for treatments. We work to balance the need for early public coverage and availability of sufficient evidence. 
2. The pCPA recognizes the need to establish a unique process and funding mechanism where patients, physicians, and other interested parties are made aware that coverage of the medication is:
   • Temporary
   • Conditional on manufacturers’ agreement to a risk-share agreement
   • Subject to change depending on evidence from subsequent reviews
3. The pCPA requires cost-effective pricing in any risk-share agreement with manufacturers. This helps ensure sustainability and proper management of public funds in the temporary funding period and beyond.
4. If a manufacturer participates in the TLR pathway, and the pCPA opts to enter a pTAP negotiation, the manufacturer is required to participate in pTAP.
5. Drug manufacturers are required to follow the timing and expectations set out by the TLR and pTAP pathways, including a final reassessment application to Canada's Drug Agency (CDA-AMC) and a final negotiation.
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 patients started on medication during the temporary period, where for any reason public funding isn’t continued beyond the temporary period.
8. The pCPA will continue to work collaboratively with the CDA-AMC and Health Canada.

1. Drug products eligible for consideration under pTAP must have received a TLR and must meet all 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 3 trial is being planned 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 won’t exceed 3 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 doesn’t guarantee the pCPA will agree to the drug entering pTAP. The pCPA will assess each file individually and determine whether it’ll pursue a negotiated agreement while further evidence is developed. There may be instances where the pCPA doesn’t negotiate a temporary risk-share agreement.
3. For temporary coverage, drug products are required to be priced according to established cost-effectiveness to offset clinical uncertainty. A risk-share agreement between payer 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 doesn’t 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. 
   2. The CDA-AMC final recommendation is “do not reimburse”. 
   3. The CDA-AMC provides a final recommendation to reimburse, but pCPA negotiations don’t 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.

In 2023 we engaged with clinicians, patient groups, and industry to develop and obtain feedback on a set of principles and conditions for pTAP. 

A total of 9 clinicians, 27 patient groups, and representatives from 3 industry associations (BIOTECanada, Innovative Medicines Canada and RAREi) participated in the online stakeholder engagement sessions. We also received 31 written submissions, representing a multitude of members across Canada. 

Overall, partners were supportive of pTAP. We heard the following concerns:

• For drugs that treat very small populations, it can be difficult for manufacturers to commercially justify a phase 3 trial because of trial requirements. Partners wonder whether real-world evidence and other types of evidence could be considered for pTAP.
• The CDA-AMC’s cost-effectiveness measures can be unreasonable and unrealistic, making it challenging to reach pTAP deals with manufacturers.
• Risk sharing between payers and manufacturers should be better balanced.
• Flexibility in timelines for generating evidence may be needed to address unforeseeable disruptions or delays. 
• TLRs and pTAP could create an unintended consequence over time, if manufacturers think they can do away with higher-quality clinical trials because they are no longer needed to secure public reimbursement.
• Partners in patient groups and manufacturer communities hoped for additional opportunities to inform the development and evaluation of pTAP, to ensure the process works for everyone. 

Building on this feedback, we continued to work out details with the 3 industry associations that participated in the engagement sessions. We introduced the final principles and conditions for pTAP in April 2024.

As a pilot project, pTAP is subject to regular monitoring.The pCPA will coordinate with the CDA-AMC in an assessment of both the TLR and pTAP processes. Any changes to the process because of evaluation will be communicated in advance.

Within 20 business days of the CDA-AMC providing the draft review report, the pPCA sends an interim letter of acknowledgement to the manufacturer letting them know that the drug is now under consideration for negotiation through pTAP.

In this phase, we gather additional information or clarification from partners, including:

• The manufacturer
• CDA-AMC and INESSS
• Clinicians
• Patient groups
• Jurisdictional review committees
• Others as required

Once this phase is complete, we send a letter to the manufacturer to let them know if we’ll:

1. Engage in negotiations through pTAP;
2. Place the file on hold; or
3. Close the file without negotiating. 

Negotiations lead(s) reaches out to the manufacturer to initiate a structured and time-limited negotiation process prior to the TLR recommendation from the CDA-AMC.

pTAP negotiations proceed as follows:

• The pCPA presents an offer with the assessed cost-effective price and rationale for how it was calculated (see FAQ for how we consider value in pTAP pricing). 
• Within 20 business days of receiving the pCPA’s offer, the manufacturer responds either to accept and proceed with an interim pTAP letter of intent (LOI), or to present a counterproposal addressing all the items in the pCPA’s desired terms.
• Within 10 business days of receiving the manufacturer’s response, the pCPA responds to accept the offer and proceed with a pTAP LOI, to present a counteroffer, or to decline the offer. 
• Within 10 business days of receiving pCPA’s response, the manufacturer responds again either to accept pCPA’s counterproposal and proceed with a pTAP LOI, or to decline and close the file without agreement.

Negotiation leads from the pCPA and the manufacturer work together to determine the negotiation format as appropriate. Negotiations typically take place via teleconference, and the frequency of meetings follows the steps outlined in pTAP.

In addition to establishing an interim price, pTAP negotiations also involve establishing an appropriate risk-share agreement while long-term, confirmatory studies are still in progress. This process relies on time-limited, good faith discussions between our negotiation team and manufacturers.

In a successful negotiation, the manufacturer and the pCPA establish a temporary confidential public-drug-plan price that applies to patients who meet eligibility criteria as set out in the TLR. If the negotiation is unsuccessful, the drug won’t go any further in pTAP.

We aim to finalize pTAP negotiations within 40 business days from the LOE. However, many factors can impact negotiation timelines, and both negotiating parties play a critical role in meeting timelines. See the Timelines section below for more information.

Once terms are mutually agreed upon, the pCPA creates a pTAP LOI detailing the temporary agreement. This will be in effect until a final, long-term agreement is negotiated (as prompted by final positive HTA reimbursement recommendations following reassessment).

Note: A pTAP file can’t be completed until the final CDA-AMC TLR is issued. If the negotiation concludes before that, we don’t announce outcomes or execute the pTAP LOI (if applicable) until the TLR is published. A successful pTAP negotiation is conditional on the final TLR. 

* The outcome of the negotiation and pTAP LOI (if applicable) is not announced until the final CDA-AMC TLR is issued.

The pCPA is accountable for timeliness in the initiation and consideration phases. Later phases are joint targets shared with manufacturers. We track timeline deviations, gather feedback from participants, and use the data to improve process efficiency. Check out our performance dashboard for our latest timeline metrics.  

CDA-AMC describes a time-limited reimbursement recommendation as “a recommendation to publicly fund a drug or drug regimen for a certain period of time on the condition the manufacturer will conduct ongoing clinical studies that address uncertainty in the evidence and that we will conduct a future reassessment of that additional evidence.”

You can find more information, including process details and drug eligibility on the CDA-AMC website.

Setting a cost-effective price is complex, with several factors that need to be accounted for, including how serious the conditions is and how much the drug improves outcomes for patients. 

There is a range of acceptable cost-effectiveness thresholds for pTAP drugs, whether they’re standard or specialized products. We then adjust for disease severity and incremental clinical benefit, applying predetermined weighting. 

Disease severity is the amount of future health a person is expected to lose due to a condition when receiving the current standard of care in Canada. This is a common concept that has been applied in other countries with similar healthcare systems.

Incremental clinical benefit is the additional positive impact on patient health compared to the current standard of care, like improved survival, function, or quality of life. It’s frequently used in cost-effectiveness analyses as a measure of a drug’s added value over existing alternatives, in relation to its price.

Standard vs. specialized products

A specialized product may be considered where a drug:

• Treats a rare disease
• Treats a severe rare disease (one that shortens life or significantly impacts quality of life)
• Uses new technology to address a major unmet need compared to existing treatment options

A standard product is any drug that doesn’t meet the criteria for a specialized product. 

If you’re planning to submit for a TLR recommendation and pTAP, we can help determine whether your drug would be considered a specialized product.

Contact us

Any patients who have been granted public coverage of the drug during the pTAP agreement period 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 3 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”
   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 this occurs, the manufacturer assumes coverage of existing patients (according to pTAP conditions) and this coverage will continue until the prescriber and the patient determine the drug is no longer required.

A TLR from the CDA-AMC doesn’t guarantee the pCPA will agree to negotiate for a drug. We assess each file individually and determine whether to pursue a negotiated agreement while further evidence is collected. There may be instances where we don’t negotiate a temporary risk-share agreement.

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.

These scenarios will be managed on a case-by-case basis. Any decisions to go beyond the 3-year time frame for evidence generation will be discussed among relevant parties.

Each public drug plan is responsible for making listing decisions according to its own timelines and procedures.

Once there is a pTAP LOI, each participating public drug plan may enter into jurisdiction-specific product listing agreements (PLA) with the manufacturer. With a PLA in place, the drug may be listed on the drug plan’s public formulary, making coverage available for eligible people enrolled in the plan.