Health Committee on Nov. 6th, 2018

[Heather Logan]

I'm not sure that I can answer that question.

[Tom Kmiec, Conservative, Calgary Shepard, AB]

How much of your budget comes from the federal government versus provincial governments?

[Heather Logan]

Most of our budget comes from the federal government, but there is a mechanism to access those, to provide those funds by the provinces. The majority of the funding comes through the federal government. It isn't the only source of funding. We also have a small amount of funding through revenues from the pharmaceutical industry as part of the submission process, as well as funding directly from some provinces for programs like pCODR.

[Tom Kmiec, Conservative, Calgary Shepard, AB]

If the federal government is paying most of the way, why aren't you subject to some type of parliamentary review—the Auditor General, the Official Languages Act and things like that?

[Heather Logan]

There certainly are opportunities to review CADTH's work and make sure that we're aligning with the needs of our customers. Most recently, as an example, there was a review of all eight federally funded pan-Canadian health organizations and CADTH was part of that.

There were discussions, interviews and assessments of how we conduct our work and what the outcomes of that work are, and opportunities to think about what a future orientation for the drug review and approval system might look like.

[Tom Kmiec, Conservative, Calgary Shepard, AB]

May I ask you about your board? You mentioned that it's the deputy ministers of the different provincial health departments who are on the board. Do any of them have a relationship with pCPA? Do they sit on the same board? Do they work with pCPA? Are they the same members?

[Heather Logan]

Our customers are the deputy ministers of health, but our board includes some deputy ministers, some assistant deputy ministers and some researchers, ethicists and clinicians, so it isn't just deputy ministers of health. Some of the assistant deputy ministers who are on our board are also affiliated with the pCPA governing council, which provides oversight to the pCPA office.

[Tom Kmiec, Conservative, Calgary Shepard, AB]

For some them, then, there's an overlay. This means that the body that is designed to approve and recommend then sends it to pCPA, which then undertakes negotiations on behalf of the different provincial drug programs or health programs. Some of them are the same people.

[Heather Logan]

That is correct.

I would just clarify that the recommendations that come through either CDEC, which is the CDR expert review committee, or pERC, which is the pCODR expert review committee, are entirely independent of the board of directors. They're entirely independent of the clinicians and the patients who provide input. They are developed independently.

[Tom Kmiec, Conservative, Calgary Shepard, AB]

For any of the reviews, are there legislated timelines in the review process?

[Heather Logan]

Not to the best of my knowledge. They are our own established timelines and we adhere to those in almost every instance.

[Tom Kmiec, Conservative, Calgary Shepard, AB]

In your presentation, you talked about moving from an assessment to management. Who gave you that authority to undertake that? Was it the provincial government? Was it the federal government? Or was it just a decision internally?

[Heather Logan]

The transition to a health technology management strategy or enterprise reorganization came from several different things that happened simultaneously. In the federal government budget in 2017 there was additional money provided to CADTH to support that transition to an HTM strategy. That was probably the biggest impetus to allow us to put people and processes in place.

[Tom Kmiec, Conservative, Calgary Shepard, AB]

That begs the question: did the federal government initiate that, then, or was it something that CADTH requested from the federal government in that budget?

[Heather Logan]

It was both. It is both. We knew that this was something we needed to do. As a health technology assessment organization, the process has typically been to review each drug as it comes forward and to make—

[Tom Kmiec, Conservative, Calgary Shepard, AB]

Forgive me, but I'm going to have to interrupt you. I have a very limited amount of time and I have a lot of questions written down.

Can you tell me why in your decision-making in the recommendations....? I'll give you a specific example. In the case of Spinraza, you gave criteria for the recommendation that fall within the kind of jurisdiction you've laid out. Why is it that you look at price instead of just efficacy? It seems to me that price is a question for the PMPRB when it's a patented medicine, and then for the pCPA during drug negotiations, not for the people who do an assessment or the management and a review of whether this is efficacious for patients or not.

Why is price being considered? In the case of Spinraza, the recommendation was “substantial reduction in price”. That doesn't seem to have anything to do with whether this works for patients or not.

[Heather Logan]

Each of our expert panels has a deliberative framework that tells the committee how to consider its review process in making funding recommendations. Cost-effectiveness and clinical impact are central to that discussion. In fact, cost-effectiveness is an assessment that equalizes how we assess those drugs and technologies across the system to ensure value for Canadians.

When the cost-effectiveness ratio is exceedingly different from what would normally be funded, the expert review committee provides guidance that would help pCPA understand what would make that therapy come in line with other therapies that are being approved in the Canadian system. It's guidance to pCPA—

[Tom Kmiec, Conservative, Calgary Shepard, AB]

I'm sorry to interrupt you again. My point is that there already are two bodies that look at price: the trademark, patented-medicine side, which is represented by the gentleman to your right, and then the pCPA, which negotiates on behalf of the public drug program.

What I see too often is that CADTH says yes, but with substantial price reduction and for a limited patient population, as in the case of Spinraza. I have constituents who do not get access to it because the provincial government says, “You can't have access to it because you fall outside of it. Oh, and negotiations are ongoing.” They still can't get access to it.

It just seems to me that there is a disconnect, which is why I asked you the question in the beginning: How closely are you tied to pCPA? Shouldn't there be either a dual process, where negotiations are started earlier, or early on, along with the review; or should there be more parliamentary oversight, so that parliamentarians—if we're footing the bill, the taxpayer is paying for this—have more oversight over what you are doing in order to streamline the system?

[Heather Logan]

I would respond in two ways. There is more alignment across the drug review and approval system now than perhaps at any point in history. We do work very closely with pCPA, with PMPRB, with the provinces, with Health Canada and INESSS. I would say it's better than it's ever been.

I would also say that this new proposed supplemental process will begin to address many of the issues you've talked about, so having an opportunity for conditional listing, for example, having an opportunity to negotiate price and to conduct both the regulatory and the HTA assessment almost in parallel, has never been done in this country. We're moving in that direction, so I think you're going to start to see some of those things happen.

[The Chair, Liberal, Bill Casey]

You're over time, but I'm going to let you go because we were a little over time on this side. We'll just have one last question and one quick answer.

[Tom Kmiec, Conservative, Calgary Shepard, AB]

Trevor Richter is the current director of CADTH common drug review, and he wrote an article in 2018, “Characteristics of drugs for ultra-rare diseases versus drugs for other rare diseases in HTA submissions made to the CADTH CDR”. It's available on Orphanet.

In it, he acknowledged the higher rate of negative HTA recommendations for ultra-rare disorders, and suggested it may be warranted to apply different standards when evaluating these therapies. Do you agree with Mr. Richter's assessment? If so, what is CADTH doing?

[Heather Logan]

In my presentation, I specifically articulated some of those challenges. Drugs for highly complex, specialized, ultra-rare and rare diseases are often plagued by a number of problems. They have insufficient evidence, so we have limited confidence in the ability of that drug to have the kind of clinical impact being proposed, among other factors.

We are working with the EDRD working group to not only address it at a systems level, but to start to recognize that there may be a very small group of drugs that have to be put through a supplemental process so that we can provide access while the system is still generating new knowledge.

These drugs are expensive and there are risks associated with every drug, so there is a balance between speed and confidence in our ability to list those drugs. We are working with the provinces. We've also implemented a number of things already to start to address some of those, like these clinical panels that I mentioned in my presentation. In the review process we can convene clinical panels for small targeted diseases where we need to hear directly from clinicians, and that information can then be fed directly into the expert review committee, so it would—

[The Chair, Liberal, Bill Casey]

I have to end it there, but thanks very much. We are quite far over.

Mr. Davies.

[Don Davies, NDP, Vancouver Kingsway, BC]

Thank you, Mr. Chair.

Thank you to both witnesses for being here.

Mr. Clark, you stated that the mission, or the raison d'être of the Patented Medicine Prices Review Board is to protect Canadians from excessive pricing. You've also pointed out that we have the third-highest prices among the OECD countries. In fact, I've actually heard they are the highest prices in the world.

Would it be fair to say that we are not meeting the goal of protecting Canadians from excessive pricing?

[Douglas Clark]

That's a great question. We are doing the best we can with the tools currently at our disposal, but it's for that very reason that we are trying to move forward with these quite ambitious reforms that I alluded to.

I would say today, no, we are not doing a very good job, but it's because the landscape has changed so dramatically, as I also alluded to in my presentation. When the PMPRB was established, arguably those drugs we were regulating were within reach of the everyday consumer. They treated common ailments. They cost $100 to $1,000 a year. Eight of the 10 top-selling patented medicines are biologics, they're complicated, and so a whole different framework is necessary to—