Health Committee on May 30th, 2016

[Dr. Durhane Wong-Rieger]

It depends on the drug. When they're first approved by Health Canada, most of the private plans will make them available based on Health Canada's approval on the basis of safety and efficacy. They then have to go through CADTH and other negotiations to get on the public plan. So it depends. In the cases where the public plan makes them available, then they are accessible—sometimes in the same way and sometimes with more restrictions and criteria. Obviously, one of the benefits is that the reimbursement may be better because there isn't necessarily a private copay. There are more drugs that do not make it into the public plans, and sometimes it takes many years to get them into the public plans. The Fabry's example was one of the cases where for two years patients with private insurance were already benefiting, and it took us that much longer. It depends on the drug, the circumstances, and sometimes the criteria.

[Rachael Thomas, Conservative, Lethbridge, AB]

Would you be able to say more about one or the other at this point?

[Dr. Durhane Wong-Rieger]

The private plans will make any kind of second-generation innovative therapy available more quickly. The limitations come from the way in which the health technology assessments review the drugs for rare diseases. Like with Fabry's, they use a traditional method, and I think, as many of the other speakers have said, the level of certainty in terms of data is not there. They need a lot more post-marketing. They're going to be more niched even within that patient population. Not every drug works for everybody, so you have small patient populations.

What we have been able to do—and the private plans need to catch up with what the public plans are doing—is create the criteria for access. Similar to what everybody else has spoken about, and as Robyn indicated, within the rare disease access, no drug gets administered without good post-market monitoring. In fact, many of them are administered only through specialized clinics and very named physicians. It is not the case that anybody could write a prescription for a rare disease drug. In some respects, as I think Robyn said as well, we don't utilize all the resources that are available to monitor and track them. As Professor Herder was talking about, the limitations are definitely there, but it's not because we don't have the mechanisms. We do, but we don't employ them. I think those are where the challenges are. In some respects the public drug plans are providing appropriate access, but they're just slow about it. In many cases it takes a long time for them to set up the mechanisms.

[Rachael Thomas, Conservative, Lethbridge, AB]

As Mr. Herder referenced and you now are referencing, there are no results-based data, or very little in my understanding, with regard to making the decisions concerning orphan drugs and whether or not they would be included.

Mr. Herder, you said that when we make these formulary decisions going forward, they should not be politically based, but results based. If we don't have those results for orphan drugs, then how are we to make those decisions? Are you suggesting that orphan drugs should not be included in the formulary? If that isn't what you are suggesting, then I wonder where we draw the line in terms of what is going to be included and what is not going to be included in the formulary going forward.

I would ask this question of both Dr. Wong-Rieger and Mr. Herder.

[Dr. Durhane Wong-Rieger]

In many respects, we don't expect them to be included in formularies in the same way common drugs are. The formulary implies that almost anybody can prescribe it, unless the drugs are quite restricted. We believe there needs to be, for most of these drugs, managed-access programs. We believe they need to come in with, as Professor Herder was talking about, clear criteria for who gets access. We need to have start-stop criteria and know if the patients fit the criteria. What's happening is that in many cases these start-stop criteria in Canada are very impoverished relative to those in the rest of the world.

The other thing that's so important is that we need to be part of international monitoring. In this regard, I just came back from the European Congress on rare diseases, and I just came back from ISPOR in Washington and HTAi. There is not enough of such monitoring in Canada with these rare-disease drugs. We need to be much more in sync with what is happening in Europe—and I mean Europe even more than the U.S. This is the problem with our not having an orphan drug regulatory formulary. Our drugs don't come in at the same time. They come in with different conditions sometimes. We start to collect evidence, but we only have a small amount of evidence. We bring in the drugs on the basis of the evidence that Health Canada and the international community can approve in terms of safety and efficacy. We then continue to collect evidence and we continue to reassess. We reassess on an individual basis—

[Rachael Thomas, Conservative, Lethbridge, AB]

I'm sorry, I'm going to cut you off there—

[Dr. Durhane Wong-Rieger]

Okay, yes.

[Rachael Thomas, Conservative, Lethbridge, AB]

—just so Mr. Herder has an opportunity to respond to this question. Thank you.

[Prof. Matthew Herder]

If I indicated what you're suggesting, I might have misspoken. What I meant to say was not that we would adopt any kind of blanket rule about excluding these, but instead, in the case of orphan drugs, or drugs that target rare diseases, the evidence base is that much more limited at the time of approval by Health Canada. Ongoing monitoring to decide whether to pay for them and then continuously after that is that much more important. It's not that we would adopt any kind of blanket rule about in or out because they treat rare diseases, but rather the ongoing evidence collection is an imperative.

[Rachael Thomas, Conservative, Lethbridge, AB]

Robyn, you look like you have something to say to this. Yes? Would you like to weigh in?

[Dr. Robyn Tamblyn]

No.

[The Chair, Liberal, Bill Casey]

Mr. Davies.

[Don Davies, NDP, Vancouver Kingsway, BC]

Dr. Tamblyn, I'll begin with you. You've conducted research to measure the impact of the number of hospitalizations caused by the fact that people do not pay for the drugs they needed. You've elaborated a bit on that. I have two questions. Can you quantify that for us, if you have any numbers, and would a universal system of the type you described assist in that regard?

[Dr. Robyn Tamblyn]

Yes, we did quantify it. You're going to ask me to remember the numbers, right?

[Don Davies, NDP, Vancouver Kingsway, BC]

Ballpark figures.

[Dr. Robyn Tamblyn]

It depends upon the sub-population we looked at. We were looking at those on social assistance and seniors. For seniors with cognitive impairment, it increased their hospitalization rate three-fold. For those on social assistance, the biggest hit was for people with severe mental illness, where their hospitalization rate within the six months of the introduction of this policy went up six-fold. It was quite devastating, especially when drugs work. If it's a statin, you have to wait awhile for things to happen. When it comes to a drug for mental illness, or when it comes to an asthma pump, you see things happen faster. We only followed this for nine months after the policy reform, to look at what the policy-induced non-compliance did to the population. I can only comment from that perspective.

Whenever people have looked at outcomes, when it comes to cost-sharing, number one, you always see a reduction in the use of essential medication when you do it. Number two, if you believe those medicines work—take the subset that do work—and you look in the short term for things where it works like your insulin pump, you're going to see complications happen quickly.

[Don Davies, NDP, Vancouver Kingsway, BC]

So it would be fair to say that were we to bring in some form of universal access for essential medicine that works, we would see significant savings in—

[Dr. Robyn Tamblyn]

Absolutely. There's no doubt in my mind that you would.

[Don Davies, NDP, Vancouver Kingsway, BC]

Okay.

Now, if I have your system correct—pardon my oversimplification—your suggestion is that in a universal system we provide, for free, access to essential effective medicine.

[Dr. Robyn Tamblyn]

Yes.

[Don Davies, NDP, Vancouver Kingsway, BC]

And then a copay for medications that are what...?

[Dr. Robyn Tamblyn]

They would be like therapeutic equivalents to treat the same thing. There are probably about six categories of medications to treat uncomplicated hypertension, so I would put the one that is the most cost-effective in the value basket and put the others in a copay basket. You can actually make a conditional listing on top of that, as suggested here, where the conditional listing is that “you show me that this person has that or has failed this kind of treatment before and therefore I'm going to pay for it”.

That has administrative overhead on it in terms of someone having to manage that program. Payers in the U.S., for example, have a lot of those kinds of programs, and they change them practically weekly.

It's really to say this: can we at least get our value out of a system by giving free medication for absolutely essential diseases and the most cost-effective drug to treat that condition in that category? Yes, we agree that others could equally work, but we have something that will work and we want to pay and negotiate the best price for it.

[Don Davies, NDP, Vancouver Kingsway, BC]

Okay.

Dr. McCabe, when did the U.K. bring in their universal coverage?

[Dr. Christopher McCabe]

I believe it was with the establishment of the NHS in 1948.

[Don Davies, NDP, Vancouver Kingsway, BC]

In 1948? One of the raging debates going on between witnesses in this committee, I think, is whether bringing in universal pharmacare would cost us billions of dollars or save us billions of dollars. I'm wondering if there is any research in the U.K. on the experience of what happened there.