Health Committee on April 25th, 2007

[Mike Tierney, Vice-President, Common Drug Review, Canadian Agency for Drugs and Technologies in Health]

As a supplementary on that, the initial business plan for the CDR projected that we would be reviewing 25 new drugs per year. In the first two years of the CDR, that's what happened. In the past year, we received 40 submissions.

Why? I'm not quite sure. It could have been that Health Canada has now caught up on their backlog and those drugs have flowed downstream to us and CDR. So additional resources were applied in the past year to accommodate that increased workload.

[Bonnie Brown, Liberal, Oakville, ON]

Thank you very much.

Thank you, Mr. Chair.

[The Chair, Conservative, Rob Merrifield]

Thank you very much.

Now we'll move on to Madame Gagnon.

[Christiane Gagnon, Bloc, Québec, QC]

I have two questions, Mr. Chairman. The first is for Ms. Sanders and the other is for Mr. Nakagawa.

Ms. Sanders, you said that the Common Drug Review makes decision-making with regard to pharmaceutical products easier. You questioned the figures obtained by research and development witnesses who came before this committee. You feel that the Common Drug Review facilitates and speeds up decision-making. However, the number of drugs that fall under the Common Drug Review is lower than that in Quebec, that does not adhere to this program, and as a consequence provinces are accepting lower numbers of drugs on their markets.

You stated that 90% of the recommendations are accepted by the provinces. Those aren't necessarily meaningful results and don't necessarily back up your comments. Does this mean that there are provinces that choose to turn those drugs down? According to the numbers provided by the research and development experts, you also turn several down.

[Dr. Jill Sanders]

I'm not entirely sure I understand which figures you're referring to. The 50% recommendations from CDR that go to the provinces and then turn into 90% of the provincial decisions are the figures that we are certain of. The 90% is 90% of the decisions made within provinces.

In some cases, decisions haven't been made, and so this is where it can get a little confusing, if the decision hasn't been made yet. So that could contribute to some of—I'm not sure exactly.

[Christiane Gagnon, Bloc, Québec, QC]

In British Columbia the number is lower, 15%. In Quebec, 62% of new drugs are approved and are on the market. Numbers like 15% or 21%, depending on the province, are lower than the numbers approved in Quebec, in terms of new drugs available to patients. One of your goals is to make these drugs more accessible to the public. That is why I am asking you this question.

Do you deny these numbers? Do you think they are realistic? You have not improved the process for approving and marketing some drugs for patients. You defend your role, but the effectiveness of your role is somewhat questionable.

[Dr. Jill Sanders]

Of course, as you know, the Quebec process is separate from the common drug review and therefore their decisions are based on their own recommendations.

The range of the provincial decisions made averages 50%, and it's plus or minus about 3% to 5%. The range between the other drug plans that are members of the common drug review is fairly tight around that average of 50%. It's 50% plus or minus about 3% to 5%.

For Quebec, of course, we have to be careful because we're not comparing apples with apples. It's a different process. It operates under a different structure, and in Quebec, as with comparing to any other jurisdiction, whether it be abroad or within this country, we have to be careful that we understand what we mean by reimbursement. My understanding is--and I'm not sure whether I'm accurate on this--that there may be co-payment in the Quebec system. I'm not sure of that.

But these kinds of things can influence the reimbursement decisions. If we were to look at one jurisdiction to another, we do have to very carefully look at whether we're talking about exactly the same decisions that have been made. The 62% of Quebec versus the 50% average for the membership of CDR, I think, is the centre point of your question.

[Christiane Gagnon, Bloc, Québec, QC]

Yes.

[Dr. Jill Sanders]

As I said, we really can't compare separate processes, because Quebec is not part of CDR.

[Christiane Gagnon, Bloc, Québec, QC]

I realize that. In Quebec, there are more drugs that are covered by drug plans. I wonder where the problem lies. Is it because of the way you work? Health Canada can decide to approve a drug, but the opposite can happen when there is an assessment of the effectiveness of a drug compared to its cost. The opposite sometimes happens. Quebec does not have to go through those types of steps, and more drugs and products are approved.

Does the problem lie with Health Canada or with your organization? There appears to be some confusion. I'm trying to understand how the effectiveness of the Common Drug Review process compares to the amount of money being dedicated to improving its procedures.

[Dr. Jill Sanders]

We're going to have Mr. Nakagawa answer your question, and he may be able to offer a more conclusive answer.

[The Chair, Conservative, Rob Merrifield]

Go ahead.

[Robert Nakagawa]

Thank you very much.

I hope I'm understanding the question properly as well, but let me try, and you can advise me as to whether I'm answering your question.

When Health Canada does their reviews of drugs to provide market access to Canada, they do a comparison of the impact of the drug on health and safety and they compare it relative to a placebo. So they'll say, does this drug provide a therapeutic benefit more so than a placebo or does it provide more danger than a placebo? That's their test. If it passes those tests, they can provide market access to the country.

As payers, the federal, provincial, and territorial governments have a different test, because we recognize that for most diseases or for many diseases that are experienced within Canada there are already existing therapies. So if we have effective therapies for the treatment of asthma, then our comparator isn't no treatment at all; it may well be what the standard of care is for asthma. Then we will consider whether the additional amount that we would pay for a new drug is worth the additional benefit that we receive from it.

Quebec is not part of the common drug review process, and so what we see is that they have taken a look at the evidence in perhaps a different way, have interpreted things in perhaps a different way, and have come to a decision that makes sense for Quebec. But it's using a different informational base than the common drug review uses. It really is what we were experiencing before the inception of the common drug review process for the rest of the country. People would come to different decisions despite the same drug being reviewed.

Does that help to answer your question?

[The Chair, Conservative, Rob Merrifield]

Okay—

[Christiane Gagnon, Bloc, Québec, QC]

The chairman said yes. That's life.

[The Chair, Conservative, Rob Merrifield]

—her time is gone now. Thank you very much.

Mr. Fletcher, you have five minutes.

[Steven Fletcher, Conservative, Charleswood—St. James—Assiniboia, MB]

Thank you, Mr. Chair.

I have two questions for the committee, and I'll allow the witnesses to self-identify who will answer.

First, the CDR was established to inform government about which drugs to publicly reimburse. What do you see as the major challenges or barriers to carrying out the CDR mandate, and how are they being addressed?

Second, how have the results of previous CDR evaluations been addressed—for example, the recommendation to increase transparency in the CDR processes? Are there any other challenges to implementing change?

Thank you.

[The Chair, Conservative, Rob Merrifield]

Go ahead, Jill.

[Dr. Jill Sanders]

I referred to some of the challenges. In particular, I mentioned the expensive drugs for rare diseases, and I probably should have said drugs for rare diseases, because frankly, the challenge around drugs for rare diseases doesn't entirely relate to their cost; it relates equally to the methodologies that are used for the assessment and evaluation of drugs that require data. The data sets for rarer diseases are based on smaller populations, and therefore there are challenges around methodologies, and I mentioned that in my presentation.

This is an area that the national pharmaceutical strategy task group is looking at, and the likelihood is that a different specialized approached should be taken for drugs for rare diseases, based on that, irrespective of the cost. Data sets are different, and we need to look at that.

However, what has happened to date, of course, is that the 13 owners and operators on common drug review agreed, in the establishment of the program, that all new drugs would go through the common drug review. There is not a bypass at this point in the system. The members of the common drug review agreed that all new drugs would go through common drug review before a reimbursement decision. Therefore, that is what happens currently.

This is a challenge, and therefore, as we move along with the national pharmaceutical strategy, looking at some of these challenges, we may see changes in the future.

[Steven Fletcher, Conservative, Charleswood—St. James—Assiniboia, MB]

Mr. Wright or Mr. Tierney, do you want to address the first or second question?

[Mike Tierney]

I can address question number two, if you wish.

There was an agreement when CDR was established to do an evaluation of the program after one year, and EKOS Research carried out that evaluation. Out of that evaluation, which included input from drug plan stakeholders, from academics and health professionals, from the pharmaceutical industry, and from patient and consumer groups, there were four key recommendations. The first was to increase public involvement in the process; another one was to increase transparency; the third was to publish lay versions of our recommendations and reasons for our recommendations; and the fourth, to look at ways of tailoring our drug reviews for drugs of different complexity.

On the issue of public involvement, as Dr. Sanders indicated in her remarks, we've added two members from the public on our Canadian Expert Drug Advisory Committee. They were trained and oriented to the committee in November 2006.

On the transparency initiatives, in the coming year we've been given funding and support to move ahead with publication of minutes of CEDAC meetings and to publish summaries of the full drug reviews on both the clinical effectiveness and health economics of the drugs. We'll also be publishing lay versions of our recommendations and reasons for recommendations in the coming year.

On the issue of tailored reviews, we have encountered that some drugs are new and very complex and represent new innovations in a therapeutic area. Others are so-called “me-too” drugs or may just be combinations of drugs that are already on the market. We've now moved forward with different ways of evaluating those drugs, based on the level of complexity, both on the clinical side and on the economic side.

[Steven Fletcher, Conservative, Charleswood—St. James—Assiniboia, MB]

That's fine, Mr. Chair.

[The Chair, Conservative, Rob Merrifield]

Okay, thank you very much.

We'll move on now to Ms. Priddy. The floor is yours. Just speak.

[Penny Priddy, NDP, Surrey North, BC]

Thank you, Mr. Chair. I always thought that would be my role, anyway, but thank you for that.

[The Chair, Conservative, Rob Merrifield]

Everything in moderation.