Panel 6: Presidents’ Roundtable
Panel Description: This session brought together general managers from three innovative pharmaceutical companies operating in Canada to explore their insights on how the current reimbursement environment is impacting their company, its decision-making and patient access.
Moderator: Barbara Jaszewski
Panelists: Peter Brenders, Brian Canestraro and Ben Faienza
Barbara Jaszewski: CAHR 201 has been a great way to get a fast introduction to all the changes that are happening in Canada. I don’t represent any company or consulting contracts. I do not work for government, I used to be in academia where I worked in health economics and cost-effectiveness analyses. But I have to say, since I’ve come back to Canada I’ve had to wait to get my OHIP and I feel more the pain of the cash paying part of the system. I find that I am able to appreciate the discussion from a variety of perspectives including; an academic perspective, a global perspective and implementing pricing policy, and coming back to Canada as a patient.
Goals and Priorities
I wanted to understand what the objectives were for all of these changes. We agree on the goals but I don’t know if we all agree on the priorities of the goals. For example, lower list prices…. So, I ask the question who benefits? Not necessarily taxpayer or government. Lower real prices? Consistency of prices? Consistency of decisions? Lower cost for drugs which is different than prices.
I heard increased cost-effectiveness, increased access, earlier access but did not hear anything about adaptive pathways. Europe is quite strong on adaptive pathways. I heard predictable costs, maximize the health of patients, increased RD investment but might not work, simplify the system, less drugs negotiated through the pCPA etc. You can imagine that if you are trying to optimize a system you really do need to prioritize. I did hear transparency as an objective and the term “reporting fatigue” which struck a note with me.
How is Canada viewed in the world?
The good news is Canada actually has quite a few Canadians in global teams because we have an interesting yet complicated system. When you go to global you have experience with private insurance, public insurance, a sophisticated health system and a conduit of health economists second only to the U.K. As Market Access folks that is good news.
As its been recognized the Canadian contribution of revenue is quite small. We won’t be a driver of global price policy per say. However, from an intellectual point of view, Canadians can have an important impact. The UK is only 4% of the market. Yet NICE often has an important impact in cost-effectiveness and HTA. So too can Canadians.
HTA & Decision Making in Canada
I was very heartened to hear what Tammy said about CADTH’s role. CADTH has always been open to industry comment so this idea of shifting to management is very welcome on the world stage. If we continue in this vein of just developing one hurdle after another you will hear from the GMs that is will become difficult to predict the business case. More and more the market access folks are having an important contribution on the world stage. They are helping design clinical trials which helps get the product to market earlier.
For a company to explore those small patient populations there has to be a return on that investment, so you will be challenged with thinking of clever ways to get that value. It won’t be the old way. I think we have gone the gambit on cost-effectiveness. Thresholds are not being used, they are not solid. These decisions are tough and not about decisions around thresholds of $50,000/QALY.
For example, I came across a drug for ALS where the patients in the US wanted access to this drug only available in Japan and Korea. So the FDA did the strange thing of requesting the data from Mitsubishi due to patient rallying and approved the drug at 10x the price as Japan and Korea. Part of that logic is that in Japan and Korea it is also indicated for stroke. Canadians need to be clever when evaluating products. With that I want to introduce the panel, they have all had quite a bit of Canadian market access experience.
Brian Canestraro: Very nice setting of the table of how Canada is different. There is not a day where I am not level setting and explaining what Canada is about.
“The world needs more Canada, but does pharma?”
I’ve worn many hats across the industry of pharma. You can grow rapidly with the introduction of innovative products and emphasize how key having market access capability is to build an organization here in Canada. The first part of 2014 signaled that more branded negotiations were to take place by the pCPA and I remember explaining to my organization that we had seen more changes in the previous six months than in the last six years. The events of this past year (2018) continues to emphasize how rapidly the pharmaceutical environment in Canada and market access is evolving.
Intercept is a 450-person company, and as GM we had to do a lot of work to sell why Canada and why now. This complexity around the market access here in Canada has elements of both the U.S. and European systems. The latitude I needed to build a business in Canada involved bringing in a market access team and establishing market access as a key enabling capability. We have had a very productive and collaborative experience with the pCPA. Having not done it in a couple years, you look in and start to wonder why it is taking so long and you can begin to get frustrated. Then you realize the Office has done a great job of reaching out to clinicians and understanding the clinical value which led to a rapid and productive negotiation.
If there is room for improvement you are held to alignment across all the jurisdictions, waiting on them is frustrating from our perspective and I am sure they are frustrated as well. If there is an appeal for improvement, it would come in the form of establishing a true governance framework and accelerating decision making.
Ben Faienza: UCB Canada reports into the international markets region and UCB is using a model where most of the Country Representatives have market access experience. I started in the public sector working at Alberta Health and there was an opportunity in Ontario with Miles pharmaceuticals. This was in 1994 and when economic evaluations of pharmaceuticals were coming to the forefront. On a return flight from Toronto to Calgary, someone tapped me on the shoulder and asked me about the blue book and it was Dr. Allan Detsky from University of Toronto. He said payers were trying to incorporate economics into the decision making process. We have come a long way in terms of where we are right now.
Time in Market and Challenges in Explaining the Canadian Environment
Pricing is important, but my concern is more around the time to listing and the increasingly complicating pricing and reimbursement system in Canada.
It is difficult to explain our system in a concise way because it is complicated. There is a difference between pricing and reimbursement decisions here. There is this wide separation and we are introducing more processes which complicate it further.
Experience to Date
We have negotiated three files and are working on the fourth. The one that was quite interesting and successful; we had a product which initially had a negative recommendation. Before the pCPA, we had individual listing agreements in place with the jurisdictions so as we approached this file with pCPA the challenge was how do you get all the jurisdictions together on the value proposition.
In recognizing the different listings in place, we offered a couple of options so they could pick the one that best suited their needs. We tried to keep it simple and keep to our commitments. We tried to be responsive and for the most part, it was a successful outcome. It probably took a little longer than it should, but that is part of creating new processes. Maybe we do not need this elaborate process for all the files. If we can reallocate those energies to critical areas it may be more useful.
Peter Brenders: In the life of the GM; we’ve gone through seven negotiations but there are changes afoot in Canada. It is simple in some respects; do you do and achieve what you said you would achieve? Before you launch a product, there are years where you build a case prior to bringing it to market. You have an assumption on how the product will play out, but recently it has become ill-defined and unknown. Health Canada is good with its processes, but the rest of the system it is unclear. We received an “active” in February but we have yet to receive a call. What is active and what are the expectations coming out there? As a GM, how do I develop my plan to tell my boss?
Uncertainty in the Ecosystem
That uncertainty is real. The PMPRB uncertainty is deathly scary. As a GM I can design a plan around private plans, but with PMPRB uncertainty I don’t know if I have any Canadians and I’m unsure how to proceed. And I understand the savings component and wanting investments but as a corporation that invests over 20% of revenue in R&D, in the end, is there an interest in Canada?
The ecosystem is a great piece to understand from the biology point of view. In 1958 in China there was the great sparrow campaign. China was struggling to feed the population and they found the sparrow could eat a lot of grain and decided to wipe them out. One thing they learned is sparrows eat other things and the insects had a feast. It did not solve the problem it made it worse. 45 million people died of starvation… was that due to that campaign?
We want to bring great therapies to Canadians and in this world of uncertainty what are going to be the downstream ecosystem effects that we might not see until much later?
Brian Canestraro: I agree, but to a less extreme extent. The example I gave is based on the way the market used to work. The suggested PMPRB changes introduce a tremendous amount of uncertainty and I cannot keep going back to head office and saying I don’t know. Companies make a conscious decision to come to Canada and don’t have to come. A lot of our days are built around showing why they should come here.
Barbara Jaszewski: As GMs who have been in this market you are used to seeing some change and expect some change. What would you like to see in the change that would facilitate the win-win solution?
Brian Canestraro: For me, you need to prove why we need change. There is a lot of work taking place with respect to the PMPRB but to what end? What is the evidence that pricing in Canada is an impediment to patient access? No one has convinced me yet that Canadian pricing is the root cause of any access issues. If it is true that 10% of Canadians cannot access drugs, is this because of pricing or is it because of lack of clarity regarding how to navigate the reimbursement environment? If I am a patient and know how to navigate the system is it an unaffordability issue with my provincial deductible? Then that is less a pricing issue and more a systems and program education issue for patients. OHIP+ for individuals less than 25 years is a prime example that we can learn from. If you are going to contemplate changes then you need to be mindful that the pharma ecosystem reaches far and wide. It requires more consultation and thought.
Barbara Jaszewski: One thing I have noticed is the number of steps in the Canadian system which affects predictability. I am just wondering if you have any comments on what you would want to see to get a more equitable agreement?
Peter Brenders: There is complexity out there and many different steps. I am concerned when there are many steps and they are under-resourced. Can they work to a predictable level? You cannot set up a system that does not work. As much as we voice the concerns we still need to come up with solutions. Maybe we should fundamentally rethink some things as well.
Ben Faienza: For me, the big issue is price certainty.
Barbara Jaszewski: Is it price certainty or revenue certainty?
Ben Faienza: Its launching in the market and having some certainty about the launch price for your product. With the proposed PMPRB changes, companies will need to complete full HTA packages before a launch price is known. For most companies, they want to know the price for the Canadian market before making all the investments to launch into the market.
We have a very fragmented market in terms of private insurance and public systems. It feels like we are trying to create a pricing and reimbursement model that is suited for a national pharmaceutical program, but a national system does not exist. You need to make an important policy decision around that – do you make a national system or do you allow it to function the way it does now and maybe become more regionalized?
I think that value is a purchaser decision. The decisions we’re making now don’t really involve purchasers and you place too much emphasis on economics and don’t allow purchasers to look at the full picture.
Barbara Jaszewski: Who do you mean by purchaser?
Ben Faienza: The pCPA is an agency for the purchaser but they represent over 60 Federal/Provincial/Territorial programs. The programs Alberta has are different than Ontario so it is difficult to get consensus. We have variation province to province.
Brian Canestraro: Every company is different, and access is difficult. In our reality, we act as affiliates of larger organizations and if we are able to price for value that fits the Canadian environment, then we can accelerate local access. The biggest change in access is not only the ability to secure access upon product launch, but more than ever, the increasing need to defend the value of a product across the life cycle.
Peter Brenders: If we have a system that allows for the adoption of new products, now we start to get ethical questions of do we do a clinical trial in a country where we will never bring the product to market? We need to keep Canada open and active.
Jeffrey Hoch: The first take-home lesson is we need to work together and maybe we could just try. Second, main idea there seems to be a lot changing and maybe we do not have all the answers so we need to continue the conversation. Third, we need to separate what we want to do from how we want to do it. If we think about high drug prices is that the problem or is that what we are going to use to make something better.