Pathways to Timely Drug Access

April 8, 2026

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Three fast-track programs have got the ball rolling. Let’s keep the momentum going.

Nothing ever stays the same, either in life or in drug access. This past year alone has seen two new expedited access programs launch in Canada, while established programs have grown deeper roots. These programs promise to deliver life-changing treatments to patients more quickly, with fewer bureaucratic hurdles. While it’s too early to give a definitive verdict on their impact, the forward momentum itself is cause for optimism. 

Here, we review and summarize three core programs that are changing the drug access landscape in Canada: Time-Limited Recommendations (TLR) and the pan-Canadian Pharmaceutical Alliance Temporary Access Process (pTAP), Funding Accelerated for Specific Treatments (FAST) in Ontario, and the pan-Canadian Pharmaceutical Alliance Early Negotiation Process (pCPA ENP). These programs can be difficult to understand, even for experts in the field, so we’ve explained how they work, which drugs they are covering so far, and how much difference they can make.

Canada’s Accelerated Drug Access Pathways at a Glance

	TLR-pTAP1-4	Ontario FAST6,7	pCPA ENP8
Organization	Canada’s Drug Agency (for TLR) and the pan-Canadian Pharmaceutical Alliance (for pTAP).	The Government of Ontario Ministry of Health	The pan-Canadian Pharmaceutical Alliance.
Objective	To provide a time-limited HTA recommendation for drugs with evidence uncertainties (TLR); and to speed up negotiations for TLR drugs (pTAP).	To provide early public listing for high-priority cancer drugs, while pricing negotiations are underway.	To provide an expedited pricing negotiation pathway for high-priority cancer drugs.
Eligible drugs	A subset of the drugs that receive NOC/c approval are eligible. NOC/c has primarily been granted for cancer drugs.	Project Orbis cancer drugs with a positive CDA-AMC final HTA recommendation.	Project Orbis cancer drugs submitted for HTA review at either CDA-AMC or INESSS.
Volume	2 drugs to date, for an average of 1 per year.	8 drugs to date, with 7-10 anticipated each year.	Information not available.
Access impact	2 files have been listed so far, respectively ~9 and ~15 months earlier than the historical average.	Up to 9 months earlier than the standard process.	Up to 6 months earlier than the standard process.

TLR: Time-Limited Recommendation
pTAP: pan-Canadian Pharmaceutical Alliance Temporary Access Process
FAST: Funding Accelerated for Specific Treatments
ENP: Early Negotiation Process 

A refresher on TLR-pTAP, a dual-action pathway

In 2023, Canada’s Drug Agency (CDA-AMC) introduced the TLR category to provide an HTA pathway for new treatments that target unmet needs.¹ Some drugs that receive a notice of compliance with conditions (NOC/c) from Health Canada – often therapies that target niche populations or conditions with limited treatment options1 – are eligible for the TLR process.

By definition, NOC/c drugs have incomplete or uncertain evidence of efficacy, despite showing promise. As such, the TLR category requires pharmaceutical sponsors to fill in evidence gaps with phase 3 clinical trial data through a resubmission, to be completed within 3 years from the date of CDA-AMC’s expert committee meeting.¹

Alongside this program, the pCPA developed the pTAP mechanism to speed up pricing negotiations and potential listing agreements for TLR drugs.² pTAP requires manufacturers to agree to a temporary risk-sharing pricing arrangement, which may change depending on the subsequent evidence that comes in.³

Taken together, the TLR and pTAP processes represent the first Canadian pathway for early access. The first drug to receive a TLR, the diffuse large B-cell lymphoma drug Epkinly, went on to get listed in Ontario 306 days after Health Canada approval, shaving off almost 50% from the historical average for oncology drugs.² The pathway’s gears rolled even more smoothly for the cancer drug Enhertu, with just 117 days between approval and public listing,⁴ and the drug has recently completed the reassessment portion of TLR, and received a positive draft recommendation from CDA-AMC.⁵

At the same time, the small number of drugs eligible for TLR-pTAP limits its population-level impact. Recognizing the opportunity to broaden the program’s scope, stakeholders have suggested expanding eligibility and allowing more flexibility in the type of evidence used to bridge the gaps.²

Provincial pioneer: Ontario FAST

Canadian patients currently wait close to two years for public coverage of new medications, a full year longer than in other developed countries.⁶ “Patients die because of the delay between the evidence and the access decision,” says Dr. Sandeep Sehdev, a medical oncologist, Assistant Professor at The Ottawa Hospital Cancer Centre, and drug access thought leader.

Ontario’s FAST program, a 3-year pilot introduced in late 2025, aims to bridge this gap by trimming the funding lag time for select cancer drugs by up to 9 months.⁷ The program makes Ontario the first Canadian jurisdiction to fast-track promising new cancer drugs. “We’re accelerating access to life-saving therapies across the province, bringing hope, peace of mind, and transformative care to those who need it most,” said Sylvia Jones, Ontario’s Deputy Premier and Minister of Health, when the program launched.⁶

“The FAST program brings hope, peace of mind, and transformative care to Ontarians who need it most.”

Silvia Jones
Deputy Premier and Minister of Health Province of Ontario

Eligibility for FAST is limited to Project Orbis cancer drugs with a positive final recommendation from CDA-AMC. An international initiative spearheaded by the FDA’s Oncology Center of Excellence in 2019, Project Orbis uses the power of regulatory collaboration across participating countries to facilitate review of novel cancer treatments identified as having a high unmet need.⁹ While most Orbis drugs are expected to qualify for FAST, the program will consider each file individually. It may exclude some highly complex treatments (such as CAR-T), treatments that require complex negotiations, and treatments eligible for other accelerated pathways.⁷

Here’s how FAST works⁷: during the interval between CDA-AMC’s final positive HTA recommendation and the conclusion of pricing negotiations between the pCPA and the drug manufacturer, the province lists the drug in question on their formulary, making it available to patients. After this interim period, continuation of public listing will depend on the outcome of the pCPA pricing negotiations. If public reimbursement comes to an end, the manufacturer must continue to fund the drug for patients who began treatment during the interim period.

To date, eight cancer medications have received accelerated funding through FAST (see table). While six of them were supplementary submissions to Health Canada, meaning drugs already approved for different medical conditions, the breast cancer drug Itovebi¹⁰ and the brain cancer drug Voranigo¹¹ are novel therapies. “We applaud the province’s leadership in recognizing the urgent access needs that patients face every day,” says Kimberly Carson, president of Breast Cancer Canada.¹²

So, how fast is FAST? In an analysis of the figures available for the 8 drugs in the program to date, the time from regulatory approval to Ontario listing ranged from 91 to 524 days (the average from NOC to first Canadian listing is 598 days).^4,13,14

How fast is FAST? Progress review^{4, 10-14}

Molecule	Brand name	Indication	NOC to Ontario listing (days)
Osimertinib	Tagrisso	Non-small cell lung cancer	162
Darolutamide	Nubeqa	Prostate cancer	91
Nivolumab + ipilimumab	Opdivo + Yervoy	MSI-H, dMMR	135
Nivolumab + ipilimumab	Opdivo + Yervoy	Hepatocellular carcinoma	216
Asciminib	Scemblix	Chronic myeloid leukemia	105
Acalabrutinib	Calquence	Mantle cell lymphoma	176
Inavolisib	Itovebi	Breast cancer	394
Vorasidenib	Voranigo	Grade 2 IDH-mutant glioma	524

dMMR = deficient mismatch repair; IDH = isocitrate dehydrogenase; MSI-H = microsatellite instability high.

Going forward, FAST will aim to process 7 to 10 new cancer drugs per year, and Dr. Sehdev has called on Ontario to stretch the program beyond oncology and on other provinces to use FAST as a model.¹⁵

As expected for a pilot project, FAST will undergo periodic reviews to evaluate the patient experience and the program’s sustainability.⁷ “We want to prove this pathway works and delivers better outcomes in cancer patients,” says Gaby Bourbara, president of AstraZeneca Canada and chair of the board of directors of Innovative Medicines Canada, adding that the program seeks to move beyond oncology medicines – and beyond Ontario: “We want other provinces to be a part of this pathway and move things forward across the country so there’s health equity in terms of treatments.” ¹⁶

An Van Gerven, president of Pfizer Canada, echoes the sentiment. “A family in Halifax or Calgary deserves the same timely access to new medicines as a family in Toronto,” she says.¹⁷ She urges legislators in the country to “seize this moment to align on bringing innovations to patients faster and bring equity to patients nationwide.” Best case, the program proves its value and expands across time, place, and therapeutic areas.

“We want other provinces to be a part of this [FAST] pathway and move things forward across the country so there’s health equity in terms of treatments.”

Gaby Bourbara
President, AstraZeneca Canada

Earlier pricing negotiations: the pCPA’s ENP initiative

Recent performance improvements at the pCPA exemplify how streamlining core operational timelines can yield meaningful access gains at scale. Between 2020 and 2025, total negotiation times across all drugs declined from 11 to 6.5 months (a 41% reduction).¹⁸ The pCPA’s new ENP pathway, developed to expedite public coverage of some cancer drugs, may shave off these times still further.⁸

In its current incarnation, the ENP applies only to cancer drugs subsumed under Project Orbis.⁸ Through the program, eligible drugs can begin pricing negotiations right when CDA-AMC or its Quebec counterpart, INESSS, accept a HTA submission. This change can shave up to 6 months off the pCPA’s standard negotiation process, which starts after the final HTA recommendation is issued. Given that 2 out of 5 Canadians will face a cancer diagnosis at some point in life, the program stands to change many lives. What hasn’t changed: once the pricing negotiations conclude, it’s up to the manufacturer and public drug plans to move forward with a product listing agreement.

THE UPSHOT

With both ENP and Ontario FAST focused on decreasing timelines for Project Orbis drugs, it will be interesting to observe the synergies of these programs over the longer term. In the meantime, feedback from clinicians and patient groups suggests a strong interest in broadening eligibility criteria to include drugs approved under Health Canada’s Priority Review.^8,16

These initiatives represent a significant leap forward in drug access and serve as a great starting point for a future-state Canada-wide impact. Every month saved makes a difference to patients.

With the successful oncology access initiatives as a template, other drugs for patients with high unmet needs could also stand to benefit. A case in point: In October 2025, Health Canada granted a NOC to lecanemab, a disease-modifying drug indicated for a subgroup of adults with mild cognitive decline or early Alzheimer’s.¹⁹ A few months later, CDA-AMC issued a negative draft recommendation for the drug, citing uncertain benefits, adverse events, and budget impact as considerations in the decision.²⁰ (The drug costs about $30,000 per year, along with a resource-intensive infusion and monitoring protocol.²¹ )

Irrespective of CDA-AMC’s final recommendation, to be issued after stakeholder input, such complex scenarios invite us to address both the practical and ethical challenges of drug access: Which treatments do we consider important, and how do we balance budgetary constraints with fair access to all?

Bottom line: with innovative and life-changing therapies continuing to pour through the pipeline, Canada will need to establish nationwide funding mechanisms to support novel treatments. Canadian patients deserve it, and we’re on the right path.

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References

1.     Procedures for reimbursement reviews. Canada’s Drug Agency. September 2025. https://www.cda-amc.ca/sites/default/files/Drug_Review_Process/Drug_Reimbursement_Review_Procedures.pdf

2.     Wills A. J Pharm Pharmaceut Sci 2024, 07 October. https://pmc.ncbi.nlm.nih.gov/articles/PMC11493633/

3.     pCPA temporary access process (pTAP). pan-Canadian Pharmaceutical Alliance. https://www.pcpacanada.ca/pTAP

4.     20Sense original research.

5.     CDA-AMC draft recommendation for Enhertu. March 2026. https://www.cda-amc.ca/sites/default/files/DRR/2026/PC0425-Enhertu-DG04_DRAFT_Recommendation.pdf

6.     Ontario fast-tracking access to six breakthrough cancer drugs. Government of Ontario. January 22, 2026. https://news.ontario.ca/en/release/1006950/ontario-fast-tracking-access-to-six-breakthrough-cancer-drugs

7.     Funding Accelerated for Specific Treatments (FAST) pilot program. Government of Ontario. Oct. 8, 2025.https://www.ontario.ca/page/funding-accelerated-specific-treatments-fast-pilot-program

8.     Early Negotiation Process (ENP). pan-Canadian Pharmaceutical Alliance. https://www.pcpacanada.ca/enp-pathway

9.     Project Orbis. US Food & Drug Administration. Jan. 27, 2026. https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis

10.  Itovebi® (inavolisib) marks milestone as the first breast cancer treatment funded through Ontario's new faster access program. Cision. Feb. 24, 2026. https://www.newswire.ca/news-releases/itovebi-r-inavolisib-marks-milestone-as-the-first-breast-cancer-treatment-funded-through-ontario-s-new-faster-access-program-827694141.html

11.  Ontario becomes the first province to publicly reimburse the first targeted oral therapy for adults with Grade 2 IDH-mutant glioma. Cision. Feb. 27, 2026. https://www.newswire.ca/news-releases/ontario-becomes-the-first-province-to-publicly-reimburse-the-first-targeted-oral-therapy-for-adults-with-grade-2-idh-mutant-glioma--842363324.html

12.  BCC Industry News. Breast Cancer Canada. February 2026. https://www.linkedin.com/posts/breastcancercanada_access-to-care-shouldnt-wait-ontarios-activity-7432542863218913280-Zd3y  

13.  IQVIA Market Access Metrics. December 2024.

14.  Lau C et al. Curr Oncol 2025;32:235. https://doi.org/10.3390/curroncol32040235

15.  Rare Disease Day 2026 webinar. Canadian Organization for Rare Diseases. February 27, 2026. https://www.youtube.com/watch?v=u5pOZKJGI7U

16.  Innovative Medicines Canada. 2026. https://www.linkedin.com/posts/innovativemedicinescanada_the-fast-program-marked-a-major-step-forward-activity-7424783933206319104-Juvr/

17.  Why it’s time to speed up access to life-changing cancer therapies. The Globe and Mail. Nov. 27, 2025. https://www.theglobeandmail.com/life/adv/article-why-its-time-to-speed-up-access-to-life-changing-cancer-therapies

18.  Wills A, Lau CY. J Pharm Pharm Sci 2026;29:1. https://www.frontierspartnerships.org/journals/journal-of-pharmacy-pharmaceutical-sciences/articles/10.3389/jpps.2026.16236/full

19.  Alzheimer Society of Canada’s Response to Health Canada’s Approval of Lecanemab. October 27, 2025.https://alzheimer.ca/sites/default/files/documents/ASC%20Response%20to%20Health%20Canada%E2%80%99s%20Approval%20of%20Lecanemab%20EN.pdf

20.  CDA-AMC draft recommendation for Leqembi. February 2026. https://www.cda-amc.ca/sites/default/files/DRR/2026/SR0822-Leqembi_DRAFT_Rec.pdf

21.  Grant K. Globe and Mail. February 19, 2026. https://www.theglobeandmail.com/canada/article-public-drug-plans-shouldnt-cover-new-alzheimers-drug-canadas-drug/#comments