Standard negotiation process

How a brand-name drug enters the pCPA process depends on whether it’s a new or existing drug. See the biosimilar review process for information about the initiation phase for biosimilar drugs.

New drugs

Our involvement begins once the CDA-AMC or INESSS publishes a final reimbursement recommendation. Manufacturers don’t need to notify us when a new recommendation is posted.

If the reimbursement recommendation is positive, we send a letter of acknowledgement (LOA) to the manufacturer letting them know that the drug is now under consideration for negotiation. At this point, the manufacturer may choose to complete an executive summary submission (ESS).

We don’t engage in negotiations when reimbursement recommendations are negative or “do not reimburse.” In this case, we send an LOA to the manufacturer confirming that we’re aware a reimbursement recommendation has been issued, followed by a close letter confirming that we’re not pursuing negotiations for the drug.

Existing drugs

The negotiation process is also initiated by a reimbursement recommendation for new indications, or approved uses, of existing drugs, which are products that are already reimbursed by 1 or more public drug plans.

We may initiate negotiations for other existing drugs under various circumstances, including line extensions — when a manufacturer introduces a new version of an existing drug such as a new strength, alternative dosage form, or way of administering the drug. See the negotiation process guidelines for more information about line extensions and other circumstances that might prompt negotiations for existing drugs.

In this case, we reach out to the manufacturer to determine whether they want to engage in a negotiation. If they agree, we send them a letter of engagement (LOE). If the manufacturer isn’t interested in negotiating, the process ends there. 
 

In this phase, public drug plans confirm their interest in participating in a negotiation for the drug, and the pCPA coordinates the collective consideration of evidence (see the negotiation process guidelines for more information about factors that may be considered). We may gather additional information or clarification from partners, including:

• Manufacturer 
• CDA-AMC and INESSS 
• Clinicians 
• Patient groups 
• Jurisdictional review committees 
• Other interested parties, as required 

This informs the negotiation approach (including eligibility for expedited negotiation pathways) and prioritization decisions.

We send a letter to the manufacturer to let them know if we’ll:

1. Engage in negotiations through the standard negotiation process or one of our expedited negotiation pathways. 
2. Place the file on hold pending additional HTA information or other drugs that are relevant to the negotiation (for example, combination therapy).
3. Close the file without negotiating.

The negotiation lead(s) reach out to the manufacturer to outline next steps and initiate negotiation activities. They may request that the manufacturer submit a proposal to outline an offer and desired terms.

Negotiation lead(s) from the pCPA and the manufacturer work together to determine the negotiation format, including when and how often to meet, based on product requirements. Negotiations typically take place via teleconference.

We aim to finalize standard negotiations within 90 business days from the LOE. However, many factors can impact negotiation timelines, and both negotiating parties play a critical role in meeting timelines. See Timelines section below for more information.

In some cases, negotiations may be paused if there’s likely to be a period of inactivity or if certain issues need to be resolved between the pCPA and the manufacturer. When that occurs, we send a hold letter to the manufacturer, and the pause is reflected in our negotiation database with an accompanying status note indicating whether the pause was requested by the manufacturer or the pCPA.

This phase either concludes with negotiated terms (like price and eligibility conditions for coverage) or ends without an agreement if the manufacturer and the pCPA can’t reach alignment on terms.

When a negotiation concludes with an agreement, we create a letter of intent (LOI) detailing the agreed upon terms and conditions.

When an agreement isn’t reached, we send a close letter to the manufacturer letting them know that the negotiation is concluded without an agreement. The manufacturer may later submit an unsolicited offer to reinitiate negotiation, when appropriate.

* First HTA reimbursement recommendation, either CDA-AMC or INESSS 

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.