Health Committee on May 2nd, 2007

[Dr. Karen Philp]

Yes. There have been four diabetes-related drugs reviewed by the common drug review. All four have been recommended, no listing. Fortunately, or unfortunately, Ontario and Veterans Affairs Canada have been proactive and actually listed all of these drugs anyway.

There may be a bit more paperwork, because they don't necessarily list them openly.

[Patrick Brown, Conservative, Barrie, ON]

So Ontario listed them, but not the CDR?

[Dr. Karen Philp]

That's right. They're conditionally listed on the Ontario formulary.

Other provinces are still reviewing them as well, like Alberta, Manitoba, and P.E.I. These drugs go through another review process after they leave CDR, and they don't necessarily listen to the CDR recommendation at all. It used to be a joke that if CDR said yes that still meant no provincially, and if CDR said no it meant no. But that's not what's happening in diabetes; it's all over the map. People are doing their own thing, so we're not sure of the value of CDR when the provinces don't appear to be listening to their recommendations.

[The Chair, Conservative, Rob Merrifield]

Thank you.

Go ahead for a quick answer, and then we'll go on.

[Durhane Wong-Rieger]

I think you asked about the innovative therapies. They're for a lot of different disease categories. I think the common factor is that they're mostly considered to be “first in class” so they're a new therapy. They are for cancers and some of the rare disorders. We've had some breakthrough therapies for diabetes as well. The problem, as we said, is that the common drug review process uses a very narrow yardstick. If it is a therapy, they compare it to an existing therapy. If it's cheaper than the existing therapy, they will approve it.

Their process is inherently biased, so drugs that primarily get recommended are those for which there's already a category of drugs. They compare them and just compare the costs. They're already biased against drugs coming in for which they don't have an automatic cost comparison.

The other thing they look at is long-term evidence in clinical outcomes. When you're a new therapy, a first in class, you're not going to have those. These are often therapies for people who may be resistant to the current treatments. For instance, with the renal cancer groups, these are patients who actually have very advanced kinds of cancer for which no other therapies are available. Nexavar, for instance, was the first new treatment for kidney cancer in 12 years. Again, there isn't that long-term evidence.

So the process they use, which they seem to be very proud of, in fact uses a very narrow set of assessment tools, when in reality health technology assessment includes a whole range of tools that they absolutely ignore.

[The Chair, Conservative, Rob Merrifield]

Thank you very much.

Madam Gagnon.

[Christiane Gagnon, Bloc, Québec, QC]

I would like to follow up on the issue raised by Mr. Brown.

Ms. Philp, you stated that all the new diabetes drugs had been rejected by the CDR analyst. Why? Was cost a factor?

When the CDR official came before us to explain the program and its effectiveness, he told us that this type of decision regarding new drugs was made when only one or two new molecules had been added. It was not felt that this improved the quality of life of individuals.

Could you give us some examples of drugs that would improve the lives of people living with diabetes, even though those drugs were rejected?

I'm thinking along the same lines as Mr. Brown. The drugs appear to be assessed on the basis of their effectiveness, and we're being told that adding one or two molecules to some drugs does nothing to enhance their effectiveness. Therefore, they are not recommended for listing.

Provinces reject drugs for another reason, and that is, their ability to pay for the drugs.

Do the provinces not apply any pressure? The fact that they cover 70% of the cost of CDR means that no authority is given to have the drug covered by a drug plan.

This is a two-part question. Could you please respond?

[Dr. Karen Philp]

All of the drugs that have been reviewed by the common drug review were approved by Health Canada as being safe and effective, upon their reading of the scientific and clinical evidence. Because the Patented Medicine Prices Review Board is responsible for ensuring that Canadians don't pay more than they should for their medications, the median price of seven countries is selected as the maximum price point for a company to sell that drug in Canada. They then send all of that information to the common drug review.

Because of the lack of transparency and openness at the common drug review, we don't know what else they're looking at. That's where we lose the trail, because they won't tell us. Then CDR makes their recommendation and their application goes to the provinces. You're absolutely right, that's where provinces look at their budgets and say, “Can we afford this medication? Can we afford to provide it to our citizens in our province?” At that stage a decision is taken that we can or can't afford it.

Our concern is, what's the added value of the common drug review? What is the added value they're bringing to the table, when we can't see what they're bringing to the table? That's why we'd love a review to tell us there's good stuff happening there, and there's a reason why they're making their decisions. We would be supportive if we knew what the reasons were, but we just don't know. That's the lack of transparency and accountability.

We do know that if a decision is made that's contrary to our clinical practice guidelines—our review of the evidence—we have no avenue of appeal. We can't say we don't understand why they made this decision. Only the company can appeal a decision, and it goes right back to the very same individuals who made the original decision. So how can you have confidence in this system? It has flaws.

So if you could review it and let us know that it's working effectively and there should be more transparency, we would go back to supporting it, because we think it is the foundation for a national catastrophic drug plan.

That's where we're at. Does that answer the question?

[Christiane Gagnon, Bloc, Québec, QC]

Do you have anything to add? No.

I would like to ask a question and I do not know who should respond.

On February 22, 2007, the provinces and territories established a common oncology drug review called the JODR.

Is this the joint oncology drug review or is it another stage of the process? The provinces have just announced another stage called the joint oncology drug review and it will focus on oncology drugs. Could you respond?

[Durhane Wong-Rieger]

Quite frankly, I don't think we object as much in terms of what the common drug review does, and it isn't as if there's a complete duplication.

What's happened is that the common drug review has taken over a pharmaco-economic assessment that the provinces used to have to do anyway. Only a few provinces were able to do it. So what they said was, okay, let's bring it all together. As Karen said, it was a good idea in spirit; we don't need to have 17 jurisdictions doing this.

The provinces were then supposed to take up the information and make some decisions around the budgetary impact. That didn't happened, and that's a concern.

Now, regarding JODR, instead of the recommendation coming out of the CDR.... They're still going to do the assessment and go to each cancer agency to say, okay, do you want to list it, or not? The cancer groups got together and said, let's have one common process that in theory will pick up the recommendations from the CDR and take them to the next step, which is to look at what in fact our ability to do it is, based on the number of patients, etc. They would then make a common decision as to whether to list it, going towards a bit of what Karen was talking about, in terms of—hopefully—a national standard.

I think the problem is twofold. First, as you've heard over and over, the CDR uses a very narrow process, so very few drugs actually get recommended. This is a problem for cancer patients, and certainly for some of us who are looking at the rare cancers.

This goes back to Steven Fletcher's question. You used to get very advanced and very good expertise from places like B.C. They said, we are going to disregard that; obviously this is not a good recommendation that the CDR is giving us. We're going to go ahead and list it.

Where you have some good expertise provincially, you get some uptake. You also get some of the ability to leverage and play one off the other, etc., except that this is not the way you really want to run a drug plan. But that has happened.

In theory, is JODR a good idea, a bad idea, or a total duplication? Not really. On the other hand, in practice, you get bad recommendations coming out of the CDR.

With JODR, it's the same as with some of the provinces. You still have to go back and do some other kind of reassessment.

For instance, in Ontario, we know that the Committee to Evaluate Drugs does kind of a first level of what the CDR does. They don't just take it and say, thank you very much, good job, and we'll sort of move with it. They do their own bit of pharmaco-economic assessment.

So there has been duplication. In theory, if they had more confidence in the CDR, they would be able to pick it up.

Alberta has announced that they're not going to do that anymore. Alberta said, we will take the recommendations that the CDR gives us and implement them. I think patients are really frightened about that, because the recommendations coming out of the CDR are so lousy.

In some respects, the hope was...you get to Ontario, and sometimes you can have some hope that they will make a more enlightened decision, or that JODR will make a more enlightened decision. We've seen that happen, even with rare drugs. Some were turned down by the CDR, and the province said it would pick them up.

The problem is twofold. One is a lousy process coming out of the CDR, and there is a lack of confidence among the provinces in terms of what to do about it.

So there are still two steps of the process that would need to be done, but the problem is that there's a huge amount of overlap in the middle. Would one seamless process be better? Probably.

[The Chair, Conservative, Rob Merrifield]

Thank you very much.

Mr. Fletcher, then Ms. Brown.

I would remind the committee that we wanted to go through an in camera session to deal with the steering committee meeting that we had yesterday

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

I have two questions. I would like both parties to answer the first, and then the final question is for the Canadian Diabetes Association.

First, with respect to the suggestions for improving the transparency and accountability of the CDR, you offer that all interested parties could provide CDR with recommendations of qualified reviewers for its consideration. Can you share with us what kinds of measures should be implemented to ensure that the process is free of conflict of interest prior to the initiation of the review? How do you think reviewers should be chosen?

Question number two is for the CDA. I gather that the CDA disagreed with the recommendations that the CDR made on four specific diabetes drugs. Could you be a bit more specific about why you think the CDR erred in its consideration of these drugs?

What I want to know is whether the objection is based on the concept of CDR-type reviews and reimbursement recommendations, or the manner in which CDR conducts its reviews.

[Dr. Karen Philp]

Can I answer the last one?

Basically, our objection is to the process. We have never, and will never, advocate for a specific drug. We have never asked CDR to re-examine drugs they've made a recommendation on, but over the last year and a half we have used the one drug that is recommended in our clinical practice guidelines to have some of the discussions around surrogate markers and all these other issues. We disagree with the process of CDR. Their recommendations are their recommendations.

On the process around the reviewers, right now the common drug review contracts reviewers to go through the literature and the clinical trials and draw up a summary of what the science says. Those people are confidential. That's fair enough. That's good. But you can never find out who they are, and you can never have the confidence that they're asking the right people to undertake these contracts.

We're suggesting that organizations like ours could be invited on an annual basis to give them a list of qualified experts on diabetes or endocrinology or even meta-analysis. It goes into a pool. They continue doing it the way they do currently, which is to look for the best-qualified person for the drug they're going to be examining. They contract that person. It doesn't have to be made public at that time; they just continue doing what they're doing. After they've made their recommendation public, a year later, without tying the individual to the study, they publish the names of those people they consulted over the last year. Then we can say they used them. It would give us a better sense of confidence that they're using the right people.

[Durhane Wong-Rieger]

We would actually take the process a whole lot further.

I don't know if people here recognize that Canada is probably the last bastion of these closed-door meetings. If you look at the U.S. FDA, when they have hearings around new drugs, they're televised, for goodness' sake. You can come in and testify at them. When the EMEA holds its reviews, they're open to patients and they're open to the public. You can actually sign up and be heard, depending on the particular drug, etc. Unfortunately, I think Canada remains in some kind of a backwater in terms of openness, transparency, and accessibility. To me, transparency means opening the doors and inviting people in.

Somebody mentioned that they understood we had the opportunity to make an appeal to the common drug review on the Fabry issue. I said no, we came in with pickets and the TV cameras and we kind of stormed the offices while they were having their meeting. We made enough of a fuss that Jill Sanders actually held a meeting with the patient groups. She insisted that we had no opportunity to see the committee members, but that she would listen and take our information to the people there. That is not a meeting. That's not transparency.

Transparency means having open access. If you want to have confidence in the process, open it up. Let people come in, and let people participate. I think that's the only way we're going to end up with a truly accountable process. The CDR says that it will publish minutes. That's much too late—after the fact. We know you can make minutes look like anything you want them to look like.

We all know what in camera sessions look like. If there's something that's truly confidential, close the doors. That's fine, nobody objects to that. But for goodness' sake, we have to get out of the dark ages and make the drug review process a truly accountable one.

Health Canada says they're going to try to do it, but they can't get the regulations to change in order to do it. Fine. We encourage them—

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

How do you choose the reviewers?

[Durhane Wong-Rieger]

How do you choose reviewers to sit on the committees?

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

Yes.

[Durhane Wong-Rieger]

I think there should be an open nomination process. I think everybody should get a chance to nominate people. In fact, the selection process should be open also, so all the stakeholders are able to participate. That's the only way you have true transparency: engage people in the process and make the process openly available to everybody.

[The Chair, Conservative, Rob Merrifield]

Thank you very much.

I want to thank you, witnesses, for coming forward and for your passion about this issue. We've heard a considerable amount on both sides, and we'll hear more as we continue this study. I want to thank you for coming.

Now, if there's no objection, we'll move in camera and finish up the meeting.

[Proceedings continue in camera]