Health Committee on April 25th, 2007

[Penny Priddy, NDP, Surrey North, BC]

Well, not always.

I'd like to ask this question particularly of Mr. Nakagawa. Because British Columbia appears, anyway, throughout the country to be a standard that's often held up as having one of the best formularies, etc.—whether that's accurate or not, I'm not sure—and having been the minister of health there, I'll just take it that's true. I heard the statistics Dr. Sanders talked about in terms of how many recommendations are actually followed by the provinces once you've made the recommendation. I'd be curious if that is consistent in British Columbia, or whether that's higher in terms of recommendations that you accept.

[Robert Nakagawa]

We have a high degree of concordance. In fact, what I was told is that in all cases but one we had accepted the recommendation of the common drug review, and when I asked what that one was and the reasons for it, I was told the original recommendation was to not list. British Columbia looked at it and thought there might be some specific criteria that could be applied for a patient to receive the drug. Subsequently, the common drug review relooked at it and identified specific criteria.

So I feel that we have in fact followed the recommendations in 100% of the cases.

[Penny Priddy, NDP, Surrey North, BC]

Okay, thank you.

Dr. Manns—or it doesn't matter to me, whoever can best speak to this around transparency.

I did hear, Mr. Tierney, what you said around the plan to publish a lay version of your decision and the reasons for your decision. If I were a drug company, or if I were a patient group, I might say the recommendations may be something like “We didn't recommend it because we didn't think it was safe”, or “It might have side effects on your kidney”, or whatever, without really getting into the transparency of the data. I understand intellectual property and all of that, but I want to know how far you're going to be able to go with the transparency that really gives people an understanding of the reason that a drug may have been either rejected or approved, but beyond what we might read on a prescription label that we get from the pharmacy.

[Mike Tierney]

There have been situations, certainly, when, in trying to explain our recommendations, we have not been able to refer to unpublished and commercially confidential information. We have confidentiality guidelines in place that manufacturers agree to and we agree to. They have the opportunity to review our recommendations in an embargoed form before they're publicly released, and they can request that certain sections of that be removed.

We have stuck to that agreement, both in terms of talking about confidential price information that's submitted to us or confidential clinical data that are submitted. As we move forward, we would like to continually try to release more information so that our decisions are more transparent.

[Penny Priddy, NDP, Surrey North, BC]

How many, among the drugs that are submitted to you, would come with unpublished data?

[Mike Tierney]

That's quite variable. There is always some form of published information. I don't think there's ever been a situation when we've not been able to refer to some published information. But with many of the drugs—I would say the majority of the drugs—some of the information we're looking at is unpublished and has been submitted to us in confidence by the manufacturer.

[Penny Priddy, NDP, Surrey North, BC]

But your recommendations could certainly include the published information and would reference it?

[Mike Tierney]

Yes, and we do that.

[Penny Priddy, NDP, Surrey North, BC]

Okay.

I guess I'll go back to Mr. Nakagawa, if I may. I know people have explained this in different ways. Dr. Sanders has talked about it in her report.

The fact that there are seemingly two reviews—the one you do, and then the province does another one--that's the perception. I wonder whether anybody might like to comment for me on why CDR does the review and then you do another piece when you receive it—other than for reasons of your own budget.

[Robert Nakagawa]

Actually, most of our review does not redo the work that the common drug review has done. They do a very thorough and wonderful job of reviewing and critically appraising the literature and then providing that information for the province. We do not redo that.

[Penny Priddy, NDP, Surrey North, BC]

So you do no work that's done by CDR?

[Robert Nakagawa]

We do not redo that work.

What we do is look at the drug within the context of other drugs we currently fund for the same purpose within British Columbia—how it fits within that therapeutic group. We'll take a look at what the budget impact of implementation will be for the province and make a determination as to whether we feel it is affordable for British Columbia and whether there are any other overriding policies that we have adopted, within pharmaceutical services or within the province, that would have an impact on our being able to implement the recommendation of CADTH. But we do not redo the evidential, critical appraisal process.

[The Chair, Conservative, Rob Merrifield]

Okay. Thank you very much.

We'll now move on to Ms. Davidson.

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

I'd like to thank the presenters for being here today.

Mr. Nakagawa, I have a question for you. On the bottom of page two of your presentation, you talk about CDR having “successfully fulfilled its initial mandate” and say this is “evident in the approval given by the Conference of Deputy Ministers to begin a staged expansion of the program” and that “in the future, another possible area of expansion” could be drug class reviews, and so on.

My question is, can the mandate be enhanced at any time, and how does that process happen?

[Robert Nakagawa]

First, thank you very much for your question. I think it really speaks to the degree of comfort and the confidence we have in the common drug review that we do feel it's appropriate to expand and do more work of the same level and importance for us.

The process for that expansion is largely held within CADTH to determine, first getting direction from the provinces. When we recommended things from the national pharmaceutical strategy, our process was to make those recommendations through the deputy ministers, for the deputy ministers to give due consideration to the recommendations we were suggesting, and for us to make sure there was adequate information to justify the value of those changes, as well as get a good idea for both what it would ultimately end up costing CADTH as an organization and, as we as jurisdictions pay for it, what the cost for each of the jurisdictions would be to meet those objectives.

So we work through the deputy ministers of health as well as the CADTH board in coming to an understanding of where the priorities are and in what direction the CDR would be expanded.

Dr. Sanders or Dr. Hunt may wish to expand on that.

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

I think that fairly well answers it.

Then the recommendation goes forward to the funding bodies, and they then approve the funding for the enhanced recommendation. Is that correct?

[Robert Nakagawa]

Yes, that's essentially the process.

[John Wright]

Yes, it will flow through, and the deputy ministers, who are the owners of the corporation, will consider it and go from there. That's exactly what happened with the recent expansion to include new indications for old drugs and an increase in the budget to $5.1 million for 2007.

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

So then the federal portion comes to us—

[John Wright]

Yes, the 30% that the federal government contributes to this exercise.

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

—in the Department of Health budget for approval?

[John Wright]

That's correct.

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

Okay. I have another question, if I have some more time. I guess I do.

I don't know who to ask this of, but when assessing the cost-effectiveness of a drug for which there's no comparison, a first-in-class drug, what criteria do you use for that?

[Dr. Braden Manns, Chair, Canadian Expert Drug Advisory Committee, Canadian Agency for Drugs and Technologies in Health]

That's difficult. We should just say at the start that when we're looking at a new first-in-class, they're often recommended by Health Canada on the basis that their potential benefits outweigh any safety issues. When we're looking at it, just to give you an example, often these first-in-class agents are approved based on their evidence of effectiveness on non-clinical end points.

For instance, concerning a medication that we looked at for patients with kidney failure on dialysis who had elevated parathyroid hormones, we knew from studies that patients who had elevated parathyroid hormone levels had a higher risk of breaking their bones and dying. This new medication was released that showed it could lower that level of parathyroid hormone.

Actually, as a physician, I know that patients don't care about their parathyroid hormone level. They want to feel better, they want to live longer, and they want to prevent complications from happening.

But the evidence, when it's brought to Health Canada, is at a relatively early stage. So we have this information that it makes a reduction in this laboratory test, but no information as to whether it makes people feel better or live longer. Some of these medications, this one in particular, came with a price tag of about $4,000 to $23,000 per year. So there's a tremendous amount of uncertainty in trying to determine whether a reduction in a laboratory test will produce clinical benefits.

We've seen in people with acute heart attacks that if they have lots of ventricular premature beats, that says they're at higher risk of dying. We have a class of—

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

So how many of these would have been approved that have come before you?