Health Committee on May 2nd, 2007

[Patricia Davidson, Conservative, Sarnia—Lambton, ON]

So what happens at the end of the three years?

[Durhane Wong-Rieger]

Well, this is the disaster of it. Even Dr. Laupacis, when this was presented to him, said, there's no way we're going to learn, with the small number of Fabry patients in Canada, whether or not either drug is more effective, or more importantly, at the end of three years we're not going to have that definitive evidence that we need. This can only be done internationally.

[Patricia Davidson, Conservative, Sarnia—Lambton, ON]

So since the son was involved in clinical testing in the States, is that evidence being used here as well?

[Durhane Wong-Rieger]

That is evidence being collected by the manufacturer as part of their post-market surveillance, and it's a post-market registry.

We're suggesting that, in fact, we should not set up a separate registry, which is what has happened as a result of this agreement, and that we should all be part of this international registry, because that's where you're going to get the bulk of the information to know whether these drugs are safe and effective. Unfortunately, again, because we were dealing in isolation, separate from what's happening in the international community, we've ended up with what I consider to be, quite frankly, a very expensive exercise--a time-delayed exercise, because there had to be a research protocol and it had to go to each one of the five central hospitals to be approved. I mean, two and a half years later, we're only getting our very first patients enrolled under that research protocol, and the evidence that will come out of it will actually have no real benefit because it is not part of the international registry.

[Patricia Davidson, Conservative, Sarnia—Lambton, ON]

So none of this evidence, then, goes back to the CDR and is used by CDR as a—

[Durhane Wong-Rieger]

No, CDR said this was useless, quite frankly. They thought it was useless. It was a political solution--I hate to say it--to a very badly handled situation. Honestly, it cost about $1 million extra that we would have rather seen go into the actual funding of the treatment, letting the patients be part of an international registry.

[Patricia Davidson, Conservative, Sarnia—Lambton, ON]

Okay.

To Karen, I think you said that there were different clinical conclusions between your research and CDR's research. What did you mean by that? Did it show a different benefit? Did it show a different cost?

What did you mean by different clinical conclusions?

[Dr. Karen Philp]

Insulin glargine, which is also known as Lantus, is recommended in our clinical practice guidelines, which are developed by our professional volunteers. In 2003 they recommended that for nocturnal hypoglycemic patients who suffer from going into comas at night, their physician should consider putting them on insulin glargine as a third line.

So they weren't saying if you have diabetes, right away—

[Patricia Davidson, Conservative, Sarnia—Lambton, ON]

Who's they?

[Dr. Karen Philp]

The health professionals.

It's all based on the science. This is what the published peer-reviewed clinical trials and research showed. If you have trouble with going into lows while you're asleep, then your physician should seriously look at using insulin glargine as a way to keep you stable.

When the recommendation came out of the CDR not to list, we were very surprised. We wrote letters saying, “This is what our review of the science shows.” We illustrated what each country did. We said, “It's listed in all these countries. How did you reach a different conclusion?”

Well, we chatted with them, and we could not agree. They couldn't give us the information. One of the challenges has always been that they will say it's not cost-effective. We say, “Well, okay, share with us the economic information that you have to make that decision,” and they'll say, “No, we can't, because industry has made us sign a confidentiality agreement. We can't release that information to you.” We then go to industry, and we say, “Will you share the economic analysis with us?”, and industry says, “No, CDR won't let us share it with you.”

We can't find the economic rationale that they used, so we can only surmise that they're using the same studies as we used to come up with a cost-effectiveness number that says it's not cost-effective. And that seems to be their main recommendation—it's not cost-effective, and it's not useful.

[The Chair, Conservative, Rob Merrifield]

Thank you very much.

We'll now move on to Ms. Susan Kadis.

[Susan Kadis, Liberal, Thornhill, ON]

I understand one of the purposes of the CDR is to have uniform standards across Canada. Clearly, Mr. Howlett, you're representing something very different in terms of where you live accords what drug you receive. We've heard evidence today and on other days. You believe there's been a failure by the CDR and actually an obstruction or an impediment to access for patients with a variety of diseases. To what do you attribute that? What would be the motivation, when it was set up, to actually be more beneficial, more efficient, and more uniform across Canada and to go toward a national pharmaceutical standard?

[Dr. Karen Philp]

The common drug review is where federal, provincial, and territorial drug plan managers sit at the table, but the recommendation they make is to the provinces on the participating plans. They actually decide what to put on the formulary according to the plans.

They look at the impact on the provincial budgets. For Atlantic Canada, where they don't have the tax base or the population numbers, it's extremely difficult for them to afford to put on more drugs. For access in Alberta, they list 12 of the 17 drugs that have been approved. It's Ontario, with the full listing of only six, that we have a question mark around, in particular. It depends on where you live and on the provincial decision as to whether or not the drugs are listed.

Until the common drug review takes everyone to the table and does a bigger analysis on what should be available for questions of fairness, in our view, you're always going to have this challenge. It is why we consistently ask for a national catastrophic drug plan, because it's the only way we're going to get to a consistent national standard.

[Susan Kadis, Liberal, Thornhill, ON]

You referenced clinical guidelines, if doctors are prepared to set clinical guidelines and approve drugs accordingly.

[Dr. Karen Philp]

Right now the Canadian Diabetes Association issues world-class clinical practice guidelines for the prevention and management of diabetes in Canada every five years. Those guidelines go out to every single practising physician in Canada. The problem is often that the physicians are very busy or they know their patients have low incomes and can't necessarily afford the drugs they might want to have.

I'm going to drop that line of thinking. I'm sorry.

We know that 50% of people with type 2 diabetes in Canada are not at the recommended target according to the scientific evidence. The physicians are making the best choices they can make, but they are obviously struggling to make it happen as well. We think one solution might be something like academic detailing, and we are talking to other provinces about this. British Columbia had a pilot. In Atlantic Canada, they have academics who sit down with the physicians and explain what the new drugs are, how they work, and what might be best for their patients.

The other thing we recommend is something that both B.C. and Ontario do, which is to have flow sheets for diabetes patients that give them a series of prompts according to our clinical practice guidelines. They ask those questions of their patients every time they come in. They get $100 from the provincial payment system, it goes into administrative data, and it ends up in the national diabetes surveillance system.

From our perspective, it's a beautiful little model to make sure they're managing patients according to clinical practice guidelines.

[Susan Kadis, Liberal, Thornhill, ON]

If I have another minute or two, Mr. Chair, I'm particularly concerned in regard to patients accessing new therapies. In consideration of the investment we made in research, and you and other guests have referenced it before, are Canadians with diabetes not benefiting from new therapies because of CDR or other mechanisms?

[Dr. Karen Philp]

Yes. The answer is yes.

[Susan Kadis, Liberal, Thornhill, ON]

Where do they go if they can't get them?

What are they doing for the low-income seniors you talked about? What do they do? What is their ultimate alternative, or do they have one?

[Dr. Karen Philp]

They don't have an alternative, but they come to us and ask for our help. We train them to be advocates and send them to your office.

[Susan Kadis, Liberal, Thornhill, ON]

Thank you, Mr. Chair.

[The Chair, Conservative, Rob Merrifield]

Thank you very much.

We'll now move on to Patrick Brown.

[Patrick Brown, Conservative, Barrie, ON]

Mr. Chair, I have questions for all three groups today. I'll ask them first, then feel free to let me know your responses.

For the Diabetes Association, you mentioned concerns with the delay in duplication. I know many MPs, a few months ago, had the pleasure of having some kids with type 2 diabetes, I think it was, come up and visit our offices to express different things that we need to do federally to assist their concerns. I had a constituent, Rebecca Morrison from Barrie, who mentioned a few things, obviously including more research. But also, one of the things she expressed concern about, as did the group with her, was the CDR.

Now, in terms of the delay in duplication, from your perspective, how does this inhibit assisting in combating diabetes? Is it the delay or is it the waste of resources? Could you expand a little bit on that?

In terms of the Fraser Institute, I didn't hear anything about the financial cost of duplication. I was really hoping we might get a bit of that perspective from your organization, if you could touch on that.

And for Durhane Wong-Reiger, I'm happy you're here today. I've actually heard very good things about you from John and Nancy McFadyen. I appreciated your input on the rare diseases. I have heard that once in my constituency office too, where there was a case where the CDR formed a bit of a hurdle on that.

You mentioned 14 therapies that were unable to be utilized. If you could expand a bit on that, I was interested in what areas that was in, and what diseases, to maybe give the committee a bit of a glimpse of how this might have been a roadblock, and what type of people it affected.

[Brett Skinner]

I would like to ask the chair for permission to leave early today. I have to catch a flight, and I had mentioned it to the clerk, actually, in advance of the meeting. So if that's okay, I would like to go first and then, after this answer, perhaps exit.

In terms of estimating the costs of the delay, if there was no CDR, it would be only a few million dollars saved. So the real cost is in the impact on patients and any additional expenditures on health care that wouldn't have been necessary if people could have accessed drugs sooner.

We simply haven't done that analysis at the institute. We've just started to measure the problem and to engage in the public debate about the value of the CDR and some of the impacts of delays and so on, and access to medicines. I look forward to doing that analysis in the future.

I would focus your attention on what the greatest impact on costs would be on lost health opportunities for patients and what that means for expenditures overall in the health budget.

[Dr. Karen Philp]

Before the CDR, there were three steps. There was Health Canada, the Patented Medicines Prices Review Board, and then it went out to the provinces.

Now we have Health Canada reviews for safety and efficacy, Patented Medicines Prices Review Board reviews for the price, and the CDR reviews both of their studies and brings in some additional studies from the pharmaceutical industry or a manufacturer of the drug, we think, and then they make their recommendation.

Then the provinces continue to do the same reviews they used to do. They all had, if you remember when they set up the common drug review, promised to dismantle their review processes. They haven't. In fact, Ontario has increased and enhanced its drug review process. So we already have an example there where they're actually making their review processes at the provincial level stronger. B.C., in response to the Auditor General's report and a George Morfitt report from 2004, are also looking at other models for their drug review processes. In fact, they're looking to Oregon.

It seems to us that the common drug review was supposed to take away a layer, and it's not; in fact, it's just added another layer. So how is that not duplication and delay?

[Patrick Brown, Conservative, Barrie, ON]

But in terms of those who are suffering, for example, the constituent I met with type 2 diabetes, how is this hurting them? When we're thinking about our constituents, are there potentially available drugs that are being delayed two years, or drugs that are being turned down that someone like her, a constituent like that in my riding, is not going to be able to have access to because of the CDR?

Is that where your concern lies?