It behooves her to say that since I'm actually her supervisor.
But I do want to give her credit and go on record as saying that most of this work was done with her, but she's unable to be here. So I hope I can contribute meaningfully to your deliberations and decisions as you come to a close.
I will give you a bit of background on the sorts of work we've been involved in, so you understand the context.
Over the last few years, we've done a number of research projects funded by organizations such as CIHR, which Dr. Morgan mentioned, on differences in provincial formularies across the country—on differences in access to cancer drugs, in particular—and we've looked at international models of catastrophic drug programs, as well as how economic information is, or could be, used in the decision-making on drugs.
What's interesting here, and I suppose the reason I'm here, is some work we did on what I call existing centralized drug review processes around the world. Dr. Morgan has given some details on three of the countries we looked at. I'll try to limit myself to reporting on that, because since it's an international panel, I thought we'd start with that.
Our objectives were to identify the centralized drug review models in existence in the world, which we did about two or three years ago. Like foolish academics, we thought that if we were to do this while people were trying to construct the common drug review in Canada, it might actually help. But it has taken some time before anyone has paid attention to it.
We were looking at things such as the management frameworks, the governance, and the review processes and appeal mechanisms, if any. And we compared, where possible, certain common aspects of the review process itself. We did not look at things such as the effective times to coverage, the times to approval, or the number of drugs per country. Other people have done that; Dr. Morgan has done some work in this area. So that wasn't the focus of what we wanted to do.
What we found at the time was that there were 16 countries with predominantly publicly funded systems, where there were what we would call centralized drug review systems. I'll quickly run through the countries: Australia, Austria, Belgium, Denmark, Finland, Greece, Ireland, Italy, the Netherlands, New Zealand, Portugal, South Africa, Sweden, and the U.K. There are many different approaches and different models, in particular, because of the different health care structures. Some are old and some are newer.
Let me quickly go over what we found.
As far as the structure, governance, and role are concerned, there are different organizational models in the different countries for managing this common drug process, ranging from a government body within the ministry to a free-standing organization. So there is a variety of these models.
In seven of the sixteen countries, the body that is equivalent to CEDAC—the Canadian Expert Drug Advisory Committee, which is the review committee for the CDR process—developed recommendations regarding reimbursement, coverage, and listing of a drug. In seven others, they have a regulatory role and actually make the decision determining the fate of a drug, as far as coverage is concerned. In Norway, the body does both, depending on the nature of the reimbursement request. Some actually set the level of reimbursement; so this gets into the pricing part of this, which is not something we have here. Some are involved in other things, such as decisions regarding maximum usage guidelines, prescribing indications, and the like.
The membership of these CEDAC-like bodies, if I could call them that, typically contain physicians, both general practitioners and specialists; health economists; pharmacists; clinical pharmacologists; and government representatives from ministries, agencies, as well as from insurance funds in some countries. In New Zealand it's entirely comprised of doctors and clinical pharmacologists. This is not an academic question, because a key to the entire process is the structure and the membership of the decision-making bodies, and whose voice is heard. So we wanted to take a look at that.
In Australia, Sweden, and the U.K.—the U.K. organization being called NICE, as has been mentioned—there are public members as well, either citizens or taxpayers or patient representatives.
The membership numbers range from a handful of, I think, six in Greece to 60 in the U.K. The U.K. also involves epidemiologists and other methodologists, and it can be said to be the broadest representation of sectors in this entire process.
The coverage criteria also vary, depending on the system. Typically--and Dr. Morgan has mentioned some of this--the criteria include the therapeutic value of a drug, which means things such as clinical usefulness, efficacy, and if there is actually a treatment available for the condition already. The severity of the condition, the community need, and the potential public health impact are also criteria as indicated by these bodies. It's not very clear from public documentation how these are weighted. That would be a key aspect of combining these criteria.
In recent years there's been a huge growth in the interest of the cost-effectiveness of drugs by most of these centralized reviews. Incidentally, Canada has been one of the leaders in this area of cost-effectiveness--the use of cost-effectiveness methods and the development of cost-effectiveness methods for decisions on programs and health care in general, not just on drugs. Some countries consider only costs. Some countries exclude costs completely in their discussion.
Some agencies in addition look at budget impact, which is somewhat different from cost-effectiveness. Cost-effectiveness typically compares two things to determine the cost-effectiveness benefit of one over the other. In some countries, or at least in two countries, one criterion is whether the drug is self-administered, because the priority for that organization is not hospital-based drugs, so that becomes a criterion. There are countries that look at the alignment with government priorities and also the potential rate of misuse.
These are the general sets of criteria. The information to assess against these criteria, typically the controlled trials that Dr. Morgan talked about, are comparative studies with other therapies, and this bears repeating. Dr. Morgan made this point.
The question is asked: if Health Canada has already done a review, why should anyone else do a second review? I think fundamentally the objectives of those reviews are different. Even the data requirements will be different. Whereas Health Canada typically looks at trials, and they may be big trials and more often than not they use a placebo as a comparator, when it comes to reimbursement of coverage decision-making, it's to look at what alternative it's being compared against, what practical alternative there is. The trial information that Health Canada might have may not be there. That's a challenge for the common drug review, in any case.
The disease pathology, the incidence, the burden of the disease on society, and the potential public health impact are all bits of information that are used. As I said, economic evaluations are now strongly recommended in 13 of the 16 countries. Also, manufacturers are often asked to provide estimates of expected volume so that there may be budget preparation done for that.
I believe Dr. Morgan talked about the assessment and appraisal stages of the process. Assessment means looking at the data, and the information appraisal means judging that, and there's a separate body that does that.
Again, who does this in these different countries? It varies. Who can submit requests? In most countries it's the manufacturer or the marketing approval agency, the agency that approves for the purposes of sales.
In Australia a medical body, a health professional, or even an individual can request the review, but I'm not exactly sure how the priorities work there.
They also differ in who puts the information together, when it's put together, and so on.
Finally, they also differ in whether there are formal consultations with other groups during the process.
With regard to appeal, which is a bone of contention among some sectors, when we looked at it we saw that mechanisms for appeals of decisions were reported only for France and the U.K. But this may have changed. In the last couple of years there's been huge pressure on these bodies to open up the process and engage more people.
I'd just like to conclude by making five points that I think are relevant to what we've done in the Canadian situation.
First of all, in most countries there isn't a Health Canada-like review process in addition to the coverage review. If you look at these 16 countries, except for the U.K., Australia, and New Zealand, in many of them it's the same body that deals with both aspects of it, whereas we have separated, in a sense, through PMPRB, Health Canada, and the provinces, certain functions that relate to certain aspects of drug therapy. In some of these countries, it has evolved together, in a sense, and so there isn't that division.
Secondly, there isn't a provincial-type review in any of these countries, because the decision of the common drug review body there or the recommendation to a minister or ministerial committee is what's acted upon. So there isn't a second level of deciding whether to fund it or not. I think that does make a difference when people talk about length of time to listing.
Thirdly, the kinds of coverage decisions in these different bodies cover off a wide spectrum, and that is in part because of what I just said, which is the mixture of roles that these countries may have. In some cases the body actually sets the reimbursement level. It can say, we'll approve this drug at 65% of the prescribed level. Here, this is done by the provinces, and quite often by negotiating with manufacturers.
I think this is something I would like to leave the committee to think about. That is, there has been a lot of interested talk, at least, if not movement, to encourage broader involvement in this common drug review process. The U.K., for example, has a citizens jury that advises the entire work of NICE. I believe in New Zealand there's the Consumer Advisory Committee. The people are trying different ways of taking this process from what has been a technical, scientific, and clinical process to one that somehow incorporates values for people. It's a challenging situation and people are trying things, but I think the fact that the CDR now has public representatives is a great step. I'd say, go further and hold these meetings, just like your meetings, in public.
Finally, what may be touchy to some provincial governments is that when we looked at these CDR-type bodies, at least one of them is permitted to make delisting recommendations, which is that you go and look at drugs that are there, look at the basket of drugs, and if you are going to add a drug, is it possible to recommend removal of one?
I think part of the challenge is that when people get worried about the rise in expenditures for drugs, it's because hardly anything falls out at the bottom. The question has to be asked, not just of drugs but all health technologies: what do we have now that has been replaced and that we should de-invest in? I think it would be useful for the common drug review here to consider how that might be at least examined.
Thank you, Mr. Chair.