Factors delaying the public listing of drugs in Canada

Presented at ISPOR 2025, May 13–16, 2025 and at CAHSPR 2025, May 26–29, 2025

Étienne Gaudette, Shirin Rizzardo, Kevin R. Pothier, and Mina Tadrous

Objective

The time to public listing for new drugs in Canada has been criticized, citing decentralized public payer structure and institutions leading to a prolonged listing process. We aim to identify and analyze key factors contributing to delays in the time-to-listing.

Approach and data

We use a cohort study approach to examine the 160 prescription drugs with a first Canadian public listing between 2018 and 2023. We document time-to-listing components, timeline exceptions, reimbursement recommendations, and negotiation results using the Canadian Institute for Health Information’s (CIHI) Formulary Coverage tool, Health Canada’s Notice of Compliance (NOC) database, Canada’s Drug Agency (CDA-AMC) Reimbursement Review reports, and the pan-Canadian Pharmaceutical Alliance’s (pCPA) Brand Name Drug Negotiation Status website. Time-to-listing is defined as the time from the NOC, which grants market authorization for a new drug, to the earliest date at which the drug is added to a public drug plan formulary.

Results

1. How long does it take for new drugs to be publicly reimbursed in Canada?

• On average, new drugs are added to a Canadian public formulary 906 days (29.8 months, SD 640 days) after receiving the NOC (Figure 1).
• For most drugs, the process entails completing five key steps, with durations ranging from 1.5 months to 7.9 months.

Figure 1. Average time in months to reach key steps of the listing process

2. What are the main factors delaying the listing process?

• Five common factors are identified, associated with delays ranging from 68 days to 3 years (Table 1).
• Of these factors, late manufacturer submissions for CDA-AMC review—despite pre-NOC submissions being permitted since 2012^{Footnote 1}—are the most common and account for 49% of overall delays.
• Drugs not impacted by delaying factors (streamlined process) are listed on average 17 months (518 days, SD 214 days) after the NOC, while drugs impacted are listed on average 39 months (1,179 days, SD 697 days) after the NOC (Figure 2).

Table 1. Factors causing delays during the listing process

Step	Streamlined process average duration	Factors causing delays (% contribution to overall delay)
Manufacturer submission to CDA-AMC	127 days before the NOC	- Late submission: 44% of drugs are submitted after the NOC, with post-NOC submissions occurring 368 days later on average (49% of overall delay). - No submission: 6% of drugs are not submitted to the CDA-AMC. These drugs have an average time-to-listing of 1,614 days (20% of overall delay).
CDA-AMC review	236 days	- Queued review: 5% of drugs are placed in a queue due to capacity constraints, adding an average 68 days to the review process (1% of overall delay). - Negative recommendation: 12% of drugs receive a "Do not list" recommendation after CDA-AMC reviews manufacturer submissions, adding 652 days on average from the first recommendation to public listing (22% of overall delay).
pCPA negotiation engagement	177 days
Negotiation	215 days	- Unsuccessful negotiation: 6% of drugs with a positive recommendation undergo a first negotiation that concludes without an agreement, or negotiations are not pursued, adding 490 days on average from engagement to public listing (7% of overall delay).
Public drug plan listing	107 days
Overall	518 days	The average delay is 661 days for drugs impacted by one or more factors.

Data source: CDA-AMC, CIHI, Health Canada, pCPA.

Note: NOC = Health Canada Notice of Compliance; CDA-AMC = Canada’s Drug Agency; pCPA = pan-Canadian Pharmaceutical Alliance. The average time-to-listing of drugs not impacted by delays is lower than the sum of individual components due to 3% of drugs being listed prior to completing all steps.

Figure 2. Distribution of time-to-listing by drug group

Conclusions

Adding new drugs to public formularies takes over 2 years on average in Canada. Although Canada’s Drug Agency (CDA-AMC) review processes and pan-Canadian Pharmaceutical Alliance (pCPA) negotiation times have been criticized for contributing to slow access, the average time-to-listing masks important variations and is skewed by identifiable factors that cannot be exclusively ascribed to the CDA-AMC or pCPA.

These delaying factors include manufacturer decisions on whether and when to submit to CDA-AMC, negative listing recommendations that appropriately safeguard public resources until cost-effectiveness is demonstrated, and unsuccessful price negotiations, which reflect a shared responsibility between manufacturers and public payers represented by the pCPA.

Limitations

The methods are observational, and unobserved factors may contribute to differences in time-to-listing between groups. The time-to-listing measure considers the earliest date at which a province added the drug to its public drug plan formulary; subsequent listing in other provinces may take several additional months. Reviews conducted by the Institut national d’excellence en santé et en services sociaux, which serves a similar role to the CDA-AMC for Québec, are excluded from the analysis. The reasons for unsuccessful price negotiations are not publicly available.