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Leela Barham is a freelance health economist and policy expert. She has published in peer-reviewed journals and presented at national and international conferences. She has provided advice to the Department of Health and Social Care on policy on pricing of branded medicines to inform the negotiation of a successor to the UK’s Pharmaceutical Price Regulation Scheme (PPRS), the Voluntary Scheme for Branded Medicines Pricing and Access (VPAS), as well as worked with patient groups, the NHS, pharmaceutical companies and many others internationally on the economics of healthcare and pharmaceuticals. Contact Leela on firstname.lastname@example.org
Leela Barham talks to Dr. Brian O’Rourke, outgoing President and Chief Executive Officer of the Canadian Agency for Drugs and Technologies in Health (CADTH), about his 11 in years in the role.
In January 2009, Dr. Brian O’Rourke took on the role of the President and Chief Executive Officer at the Canadian Agency for Drugs and Technologies in Health (CADTH). With O’Rourke set to leave the agency in March 2020, Leela Barham sat down with him to talk about his legacy and his plans for the future.
Dr. Brian O’Rourke came to CADTH following his work as a Pharmacist and a Health Care Executive in the Canadian military. CADTH is an internationally recognized Health Technology Assessment (HTA) agency, providing evidence on drugs and medical devices. CADTH recommendations are not binding on the participating federal, provincial, and territorial drug plans across Canada, but reimbursement decisions made by the drug plans are congruent with CADTH recommendations 94% of the time, so CADTH is relied on heavily.
A 2017 evaluation of the agency by Health Canada1 concluded not only that the agency was still needed, but that it was aligned with government priorities, federal roles and responsibilities, was effective and efficient, and was one of the few HTA agencies that had proactively implemented systematic patient engagement. CADTH is a leader on the international stage too.
In fact, O’Rourke is keen to see CADTH’s staffers learn and collaborate with international agencies. CADTH and the UK’s National Institute for Health and Care Excellence (NICE) were involved in the work that led to the publication Value assessment methods for “single or short-term transformative therapies,2 from the Institute for Clinical Effectiveness Review (ICER) – a US based not-for-profit. O’Rourke explains why CADTH got involved: “I saw this as an excellent opportunity for staff from my agency to work with similar minded agencies. I jumped right on it.”
O’Rourke firmly believes that collaboration across agencies is the way of the future. “[The collaboration with ICER and NICE] is a harbinger of things to come.” This type of work, he says, is “an opportunity to really roll our sleeves up and work together. It’s a great example of that.”
The ICER and NICE work is a one-off, but under O’Rourke CADTH and NICE launched a parallel early scientific advice service,3 in February of this year. It’s something O’Rourke believes is a priority. “I think scientific advice is one of the most important things we need to be doing,” he says. It’s better to be forewarned of the promising disruptive technologies on their way. O’Rourke thinks that the advice can really help spot the innovation that we all want to see-“innovations that are beneficial to patients and sustainable to the system. We can impart to the manufacturers the important factors that payers need to see included in clinical trials, like quality of life measures, patient important outcomes, and the appropriate comparators.”
O’Rourke, who will have served 11 years at CADTH when he leaves in March 2020, reflects on the best parts of the job as well as those that were more challenging. “Like most people would say, the best part has been leading an outstanding organization with fantastic people.” He is proud of the work that CADTH does, and believes that it “makes a significant contribution to improving Canadian health care.” The work of CADTH is not easy and O’Rourke is keen to point out that it’s a team effort. “Through the years CADTH has built an outstanding team. There are a lot of brilliant and well-educated staffers, I’ve been watching them grow and develop through the years.” That bodes well for the agency for the future.
Adding in responsibility for the pan-Canadian Oncology Drug Review (pCODR) to CADTH’s to do list in 2014 is another indicator of the success of the agency; cancer is after all a high-profile area so only an agency seen as up to the task would be given the responsibility for assessing their clinical and cost-effectiveness.
CADTH, under O’Rourke, has also focused on doing those things that really add value. CADTH has stopped reviewing biosimilars, for example. O’Rourke explains that, “We weren’t really providing any added value to the decision-making. In some cases, we were delaying the ability for provinces to negotiate and list them.” That doesn’t mean the agency is not looking at biosimilars at all; in fact, the focus has moved to making sure biosimilars are used. “Government has asked us to do some work on biosimilar uptake. We’ve brought together some 100 people from all different sectors to have a conversation about this. We’re drafting the report now,” says O’Rourke.
It’s not been plain sailing for O’Rourke’s 11 years in the role. He describes the challenges he and the organization have faced over the last decade. “When I came to the organization, it was undergoing a government review to determine its ongoing relevance to the Canadian health care system.” That review determined that in order to remain useful to decision-makers, the agency needed to become better, faster, and smarter. Since that review, things have changed significantly: “We introduced four key principles for the success of CADTH: relevance, timeliness, quality, and impact, and we still live these values. CADTH has become ingrained into the culture of how drugs and other technology gets to the market in Canada,” he explains.
CADTH, like other publicly funded agencies not only in Canada but across the globe, has also had to deal with funding cuts. It was a challenge for the organization to deal with a 5 per cent across-the-board cut in 2013. O’Rourke admits “that hurt a bit. It’s never good to have to make cuts, and it was not a fun time.” Having to do more with less also lead to workload pressures. “We started to have a back-log of drugs to review. That became very challenging.”
Making CADTH more customer-focused is a legacy that O’Rourke will leave the agency with; it’s something that he wanted to improve upon from the beginning of his tenure. He explains, “The first thing that I tried to do when I came into CADTH was to institute a culture change, focusing upon our customers. I noticed that we were very research focused, and it took a long time to do the reports. Our customers are the decision-makers who need our recommendations.”
Customer centricity has become embedded into CADTH, O’Rourke believes. He noted that “all staff now understand that there is a customer waiting for the work that we do, but it is still based on good solid research.” Stakeholders matter at CADTH, he adds. “When I arrived, I recognized that we weren’t very good at engaging stakeholders.” A key focus has been patients. “The one stakeholder group we focused on early was patients. In 2010 we decided to launch patient engagement into the Common Drug Review submissions.”
CADTH has to a great degree blazed a trail when it comes to patient engagement in HTA. O’Rourke describes how the agency wanted to learn from others on how to “do” patient engagement, but that there wasn’t much to draw upon. “We looked around the world to see who was doing it. There were not a lot of best practices to base it on.” CADTH didn’t want to take the approach seen elsewhere of watching and waiting; the agency just wanted to “launch it.” He describes how the agency accepted that they had to “learn as we go.” CADTH’s success in patient engagement is also down to patient; “the patient groups that we engaged were incredibly helpful in our learning – we listened to them and evolved our processes accordingly,” says O’Rourke.
Industry is a key stakeholder too. O’Rourke believes in dialogue with technology sponsors, “There are still colleagues in the HTA community who don’t believe that we should talk to industry. I am not one of those. It is, of course, important to have principles to govern how those conversations happen,” he says.
O’Rourke describes how the agency has provided the mechanisms and forums for discussion.“We created an industry liaison forum. The forum meets twice a year and includes two industry associations – Innovative Medicines Canada and BIOTECanada - and member companies [of those associations]. And we have a similar forum for the medical device companies.” The forum is not the only route to engage with CADTH, or O’Rourke himself. “I will meet with a company’s Chief Executive on request,” he says. “The discussion can’t be on a drug under review, but it can be on broader issues.” CADTH also has an annual portfolio information session that is open to anyone, and CADTH also runs an annual conference each year and industry representatives are invited to attend and participate on panel sessions.
Another major change for CADTH under O’Rourke’s leadership has been the introduction of application fees for industry for reviews of their products. O’Rourke describes how the charges helped the agency tackle the backlog of reviews it faced in 2014 and move to a more sustainable financial position for the agency. “We launched an application fee for companies making submissions. It helped us address the back-log and created some funding stability.”
Industry fees cover 40 per cent of the cost for a review with government funding covering the remaining costs. The fee structure is also linked to performance; CADTH would have to provide a partial refund if they fail to meet the timelines for reviews. O’Rourke adds, “Since the introduction of fees, we’ve always met the performance targets. We haven’t had a submission that has not been done on time.”
There’s still work to do when it comes to the last major change O’Rourke highlights from his tenure. The agency has been making the shift away from a one-time decision focus to a life cycle approach. O’Rourke describes this as “going from a binary process of reviewing a technology at a point in time and saying yes or no, to a lifecycle approach.” He goes on: “That includes horizon scanning and early dialogue with sponsors. It includes conducting reviews at product launch and doing reassessments as evidence grows over time. That will allow decision-makers to consider re-negotiating the price or determining if they should place additional conditions on the use of the drug and maybe even considering dis-investment.” This life-cycle approach is where real-world data and real-world evidence will play an important role.
O’Rourke is unlikely to leave the Canadian, or the international, HTA stage (or indeed the HTA-related Twittersphere, being quite the tweeter). “I will stay engaged with the HTA community. I will support CADTH from the side lines and be a cheerleader.” He is already a member of the Scientific Advisory Council for the Centre for Innovative in Regulatory Science (CIRS), and the Chair of the ISPOR Health Technology Assessment Council. He adds, “I may do a little consulting from time to time as long as it doesn’t interfere too much with my golf game.”
O’Rourke will not however give his future HTA work the full time focus that he gave CADTH; he is definitely not looking for another full time job. He wants to take the opportunity to spend more quality time with his wife “who has put up with my 40 years of work.” Family time will also include time with his children and grandchildren. There will also be travel and hopefully, lots of golf.
Leela Barham is a researcher and writer on health and pharmaceuticals from a health economic and policy perspective.