Evidence of meeting #54 for Health in the 39th Parliament, 1st Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was cdr.
A recording is available from Parliament.
3:35 p.m.
Conservative
The Chair Conservative Rob Merrifield
We'd like to call the meeting to order.
We have a very interesting set of witnesses today who are going to testify, some here in the room, and we have Dr. Miyasaki from Toronto.
Doctor, do you hear us? Are we coming through all right?
3:35 p.m.
Dr. Janis Miyasaki Associate Clinical Director and Chair of the Technology and Therapeutics Assessment Subcommittee, American Academy of Neurology, University of Toronto
Yes, I can hear you fine.
3:35 p.m.
Conservative
The Chair Conservative Rob Merrifield
At this stage we will bring our witnesses forward and allow them to present. We'll allow all the witnesses to present first and then we'll move into questions and answers. So I'll introduce you and give you the floor at the appropriate time.
This is pursuant to Standing Order 108(2), a study on prescription drugs, the common drug review. I believe this is our sixth meeting on the common drug review.
We have with us someone from York University, and we have some individuals. We also have the University of Toronto, by video conference; Best Medicines Coalition; and Ward Health Strategies. Now we'll introduce you individually as we yield you the floor.
We'll start with York University. We have Joel Lexchin from the School of Health Policy and Management. You've been to our committee before. I recognize the face; the name I'm sometimes fuzzy on.
Thank you for coming, Professor. The floor is yours.
3:35 p.m.
Dr. Joel Lexchin Professor, School of Health Policy and Management, York University
Thanks very much for the opportunity to appear here.
My name is Joel Lexchin. I'm an MD. I teach health policy at York University, as you pointed out. I also work as an emergency physician, and I have authored a number of books prescribing guidelines for general practitioners and emergency doctors.
What I want to present now are the results of some research that I have undertaken with a colleague of mine, Barbara Mintzes.
There's been a lot of criticism about the decisions the CDR, the common drug review, makes. We wanted to compare the decisions that CDR makes to decisions made by comparable bodies in other countries, for the same drugs, with the same indications.
Initially, we identified 47 drugs that CDR had made decisions on, up to the end of September of 2006. We set up a series of criteria for how we would choose the comparator agencies. They had to evaluate at least half the drugs the CDR did. They had to publish material on their websites, in either English or French. And there were a few other criteria that I won't go into.
We ended up with two organizations, the Pharmaceutical Benefits Advisory Committee, or PBAC, which is in Australia, and the Scottish Medicines Consortium, which is in Scotland.
Out of the 47 drugs that the CDR had evaluated, the Australian body had looked at and made recommendations on 31, and the Scottish agency had made recommendations on 29. The recommendations broadly fall into three categories from each of these organizations. The first is fund without restriction, the second is fund with restriction, and the third is no funding at all.
When we look at the drugs that are in common between CDR and the Australian group, there are 31, as I said, and between CDR and the Scottish group, there are 29. When you look at these three different categories, you find that all the agencies do the same thing. The percentage they recommended for full funding is broadly the same, the percentage they recommended for restricted funding is broadly the same, and the percentage they entirely rejected is broadly the same.
The second thing we did was to look at individual drugs. Were the recommendations for the individual drugs the same or not? We found that although some of the recommendations for the individual drugs were the same, there wasn't a lot of agreement among the Canadian agency and the other two, nor was there in fact much agreement between the Scottish agency and the Australian agency. We concluded that in applying the criteria all three agencies do, which is looking at the clinical effectiveness of the product and doing pharmaco-economic analysis, they're all equally as lenient or as strict in broad terms.
For individual drugs, they take into consideration things like what price the drug is being offered at in the individual country, what other drugs are available in that country for the same condition, what the prices of those are, and how many people are affected with the disease. They then make their decisions. Because these are locally based decisions, you would expect them to be different from country to country.
The conclusion from this piece of research is that the CDR is not out of line with other international agencies that do the same thing--in other words, that use a combination of clinical data and pharmaco-economic analysis in making their decisions. They don't make the same decisions as other agencies, but they don't make them because of local factors. In fact, the three agencies we examined all make different decisions about the same drugs because of local factors.
Our conclusion is that what the CDR is doing is a good thing. They're doing an appropriate job. The drugs they reject are rejected because of things that are specific to Canada. It's the same for the ones they approve. They are approved because of factors specific to Canada. It's the same thing for the other agencies.
Thanks very much.
3:40 p.m.
Conservative
The Chair Conservative Rob Merrifield
My researcher is asking if you could provide us with the study you referred to.
3:40 p.m.
Professor, School of Health Policy and Management, York University
Unfortunately, when I was coming up on the train with VIA, one of the train attendants spilled water on the computer. I now have a dead computer, at least for a couple of days. Once the computer is resuscitated, I'll be happy to send a version, but it probably won't be until next week.
3:40 p.m.
Conservative
The Chair Conservative Rob Merrifield
That's fine. We appreciate that very much. We understand the complications of this new modern era in technology. We live with it every day. That would be great.
We'll now move on to our individual presenters.
We have with us Mr. David Bougher. Mr. Bougher is a former member of the federal-provincial-territorial pharmaceutical issues committee. We actually go back quite a ways.
This is the second time you've presented before this committee, I believe, but the first time on CDR. You go back to our days in provincial government in Alberta. It's good to have you with us. You're sharing your time with Linda Tennant, who is a former member of the federal-provincial-territorial pharmaceutical issues committee as well. It's good to have you with us.
The floor is yours.
3:40 p.m.
David Bougher Former Member of the Federal, Provincial and Territorial Pharmaceutical Issues Committee, As an Individual
Thank you very much, Mr. Chairman.
Our thanks to the committee for the opportunity to present our perspective on the common drug review. Linda and I will be speaking from a prepared text, following which we will provide a number of recommendations that are contained in the text but which we would like to highlight for the committee.
We are here as former drug plan managers and pharmaceutical policy advisors to our respective governments in Ontario and Alberta, and as Canadians interested in whether the common drug review is serving the interests of patients. We are not here to provide data, the results of research studies, nor are we here to support the position of any particular interest group.
As drug plan managers, we both supported the creation of the common drug review as a valuable tool in streamlining drug reviews and coordinating drug program activities across the country to the advantage of Canadians. We continue to support CDR, and the views that we express are intended as suggestions to strengthen the CDR process in order to promote its ongoing success.
One of our primary functions as former drug plan managers was to serve as the liaison between the minister and the committee of scientific experts who provide advice on what drugs should be covered under our drug plans. We're therefore very familiar with the issues and the problems that face governments and expert committees, as well as other interested parties, in trying to make the best decisions on behalf of patients and program beneficiaries.
Expert advisory committees on drug funding for individual programs have considerable power, and this is even more so for the Canadian expert drug advisory committee under the CDR. A recommendation not to list or cover a drug is adhered to in almost all cases, in view of the ministers' commitment and agreement that no means no and yes means maybe.
It is essential, therefore, that CEDAC and the CDR maintain the highest possible level of satisfaction and endorsement, not only by governments but by all other interested parties. The CDR must remain relevant to everyone affected by its recommendations in order to ensure its future success.
It is well established and widely accepted that, in principle, sound evidence should be the basis for decisions on health care and drug funding. However, not all evidence is as clear nor as extensive as we might like it to be. And not all drugs lend themselves to the same level or type of scientific research and study.
In addition, most studies are carried out before funding decisions are made, and experience in the real world may not match study results. It is widely acknowledged that an insufficient number of studies are carried out in real world situations once a drug has been approved for marketing. It should also be noted that manufacturers fund all but about 10% of the drug studies that are carried out.
Experience in working with expert committees reinforces the view that Canada is among the top countries in the world in scientific expertise, and that drug programs have access to a range of highly dedicated and knowledgeable people. That being said, it must be acknowledged that expert committee members bring their own biases and views to the discussion of the evidence, according to their professional experience and opinions.
Since much scientific evidence is open to interpretation about the value placed on the perceived benefit, it is not surprising that different individuals and committees present different advice to governments. These differences are extremely perplexing to decision-makers, patients and families, health care providers, and manufacturers. It is difficult to accept that a committee in one province can come to an opposite conclusion from that of a committee in another province or country.
The funding recommendations and decisions made by expert advisory committees, such as CEDAC, are based on cost-effectiveness rules that are complex and considered somewhat arbitrary by some parties. As with differences in interpretation of scientific studies, there are differences in opinion about what constitutes cost effectiveness.
This committee has already heard how these differences have led to different funding decisions on cancer drugs, for example, between British Columbia and other provinces.
It is these differences that brought governments to the decision to create the common drug review.
Moving on to a discussion of the effectiveness of CDR, the evaluation of CDR released in the fall of 2005 concluded that the founders—that is, governments—were pleased with the results, while industry and consumer groups had serious concerns. CDR met its timelines for reviews, refined the review processes, and achieved a level of transparency not seen in some other public drug plans.
While CDR has met its original objectives, there are some overarching issues that have not been considered and that lie within the domain of participating federal and provincial governments. It appears that some duplication or extension of drug reviews occurs because “yes” recommendations may be taken to local expert committees for further analysis, the application of special criteria for coverage, or for information and discussion. The extent to which local committee reviews duplicate CDR’s work should be studied further, and, as CDR expands to include other drugs, the roles and functions of these committees should be evaluated. It is likely that some follow-up work will always be needed at the local program level in order to operationalize CEDAC’s recommendations.
While decisions on implementing CEDAC recommendations lie within the domain of governments, the “no means no” policy adopted by ministers has been fairly rigorously adhered to. This means that CDR is in fact, one could say, making listing decisions for the drug plans in the case of drugs rejected for funding. Some exceptions have occurred where certain individual drug programs are funding some drug products on a case-by-case basis, however.
Given the impact of CEDAC recommendations, it is incumbent upon CDR to ensure that its processes are continuously re-evaluated, taking into account all stakeholder comments and concerns. Any review of expert committees, in general, should take into account the amounts that governments invest in drug programs and their rising share of health care budgets. Expert committees are a valuable tool in the ongoing management of large and costly drug programs.
On the issue of access to new medicines, a particularly important question for the discussion today is whether Canadians are being well served by the CDR in terms of their access to new medicines. The CDR processes ensure that rigorous standards of evidence are consistently applied in arriving at recommendations for listing drugs. However, it is important to consider whether the same standards of evidence can and should be applied to all drugs.
An example at the extreme end of the cost spectrum is expensive drugs for rare diseases. Some of these products can cost more than $100,000 a year and may be the only treatment option that's available. In some instances, because of factors such as the nature of the disease and the size of the population, it may be difficult or impossible to meet the standards of rigour applied by CDR. So the question is whether the current model or approach can be applied fairly and consistently to all classes of drugs.
Drug plan costs are largely driven by categories of drugs used in high volume, such as drugs for reducing cholesterol. For example, in Ontario, in the fiscal year 2005-06, drugs for cardiovascular and central nervous system treatment accounted for fully 50% of costs for the Ontario drug benefit program. It is therefore important to consider the collective or cumulative financial risk posed by new and expensive medicines relative to the overall cost drivers in the health system.
Let us say here that we are not suggesting that drug prices are appropriate in many or even most cases. We share the widespread concern of governments and others that drug prices seem to be inordinately high and difficult to justify in some cases. Our only comment is that all interested parties must continue to challenge manufacturers to provide an adequate rationale for a drug price and to be open to negotiation on prices in a number of areas.
Some governments provide access to drugs that are not recommended for funding by CDR, such as Ontario, whose legislation allows the minister to pay for drugs not on the provincial formulary. As a result, some drugs with no recommendations are being reimbursed in a few programs but not in others, thus creating further inequities in access to treatments for Canadians. Drug plan decisions give rise to a number of questions. Is the Ontario process or that used by the federal drug plan to provide case-by-case coverage a reasonable approach as a form of appeal to a CEDAC recommendation, or should CEDAC identify criteria for patient access to some drugs, resulting in a qualified or a partial yes recommendation?
Conditional recommendations may provide an opportunity to broaden the scope of decision-making while further evidence is gathered. If drug development is viewed as a continuum, real-world use may be the only way in which answers are obtained to some of the questions posed by CDR, such as the need for long-term safety and effectiveness data. An effective Canadian model for drug review and evaluation for coverage under public drug programs in Canada needs to provide access where the evidence is relatively weak owing to the difficulty in conducting broad-based trials in certain disease groups, while at the same time ensuring that data are collected and that outcomes are measured to confirm the benefits as well as the risks.
The reality is that for some new drugs the scientific evidence that demonstrates value isn't available for various reasons, such as the small number of patients in the case of rare diseases or the lack of evidence of long-term safety and effectiveness. Individual manufacturers have a role to play in working with governments to support access to products so that governments are not alone in assuming responsibility for meeting patient needs. Partnerships based on improving patient outcomes may offer options to the current all-or-none approach.
Mr. Chairman, I'd like to refer--
3:50 p.m.
Conservative
The Chair Conservative Rob Merrifield
We're having a bit of a problem because we had allowed 10 minutes for both of you and you're considerably over time. So if we could just be very tight on the second presentation, we'll allow that, but I won't let you go more than five minutes.
3:50 p.m.
Former Member of the Federal, Provincial and Territorial Pharmaceutical Issues Committee, As an Individual
We just have a few more minutes, Mr. Chairman.
3:50 p.m.
Linda Tennant Former Member of the Federal, Provincial and Territorial Pharmaceutical Issues Committee, As an Individual
What I'll do then is jump to some recommendations that we prepared, and I'll try to speak fairly quickly.
As CDR expands its mandate, role, and operations, everything should be subject to regular independent review to ensure that it remains efficient, effective, and relevant to all interested parties. In other words, we're saying CDR shouldn't rest on its laurels. It should continue to be subject to review, and by the way, by independent parties.
3:50 p.m.
Bloc
Christiane Gagnon Bloc Québec, QC
You are going too fast. You have a translator and he can't follow you. It's okay if you want to talk fast, but he won't follow you.
3:55 p.m.
Former Member of the Federal, Provincial and Territorial Pharmaceutical Issues Committee, As an Individual
A wee bit more slowly?
3:55 p.m.
Conservative
The Chair Conservative Rob Merrifield
If you could just decelerate a fraction, we'll continue. Go ahead.
3:55 p.m.
Former Member of the Federal, Provincial and Territorial Pharmaceutical Issues Committee, As an Individual
My apologies.
In addition, then, to a regular review of CDR and its activities, we would also suggest that individual direct programs, expert advisory committees, should be the subject of regular review to make sure that, on an ongoing basis, individual drug programs are not duplicating or overlapping the CDR process but rather they are complementing each other.
CDR should be encouraged to expedite and expand its plans to increase transparency. The success of these measures should be evaluated after six to 12 months. Transparency is always a major public concern today, as we know, on all fronts. CDR should also evaluate the experience of the addition of two public members to CEDAC. CDR should examine the roles and experience of the citizens' councils in the United Kingdom and Ontario, where in fact they have provided an additional mechanism for public input to the expert advisory process.
CDR should incorporate processes for qualified or conditional recommendations by CEDAC. Such recommendations could take into account the challenges that some drugs present in meeting standards of evidence and the potential for benefiting a patient population with limited or no other treatment options.
CDR should consider the use of subcommittees in certain specialty fields in order to broaden the expertise applied in certain drug reviews.
Our last point is that all governments should work together to expedite the implementation of studies that present real-world evidence and answer key questions that may be raised in the evaluations by CDR. In other words, we shouldn't just look at the evaluation before the drug is implemented for funding purposes, but rather after the drug has been on the market for some time.
Thank you for our opportunity. May I make one more comment, please? We just want to say that as former drug plan managers, we have the highest respect for the staff and expert advisers of CDR, CEDAC, and other expert advisory committees in this field. We know first hand their commitment and the difficulties they face in trying to bring forward recommendations that promote the best possible care for Canadians in this highly complex and very controversial field.
Thank you very much.
3:55 p.m.
Conservative
The Chair Conservative Rob Merrifield
We want to thank you very much.
We'll now move on to the University of Toronto. We have with us, by video conference, Dr. Janis Miyasaki, associate clinical director and the of the technology and therapeutics assessment subcommittee of the American Academy of Neurology.
The floor is yours and you have ten minutes. We look forward to your presentation.
3:55 p.m.
Associate Clinical Director and Chair of the Technology and Therapeutics Assessment Subcommittee, American Academy of Neurology, University of Toronto
Thank you, Mr. Chairman and the committee, for the opportunity to speak to you regarding my experiences both with CDR and the Ontario drug benefits program and in my role as a clinician-investigator, a clinician of patients with serious neurodegenerative diseases and an investigator in evidence-based medicine.
I'd like to disclose that I did apply for a position as a standing member of CEDAC. They didn't accept me, but I bear no hard feelings about that.
I have acted as a consultant to the Ontario drug benefits program as well as a consultant to the common drug review.
I have found that the process is very rigorous; they provide rigorous evidence-based reviews of drugs. However, I also feel there could be some improvements made to the process.
Also, I want to state that participating in drug and technology development is crucial to maintaining quality in Canadian health care and that evidence-based medicine and pragmatism are both needed in drug funding decisions.
First, my experience with the CDR is as a medical expert, not as what is known as a methodology expert. A methodology expert would be someone, typically with a PhD, who has expertise in guideline- or evidence-based medicine.
In my role, because I do have a background in writing guidelines for the American Academy of Neurology, I have been able to meet some concerns about what the appropriate designs and outcome measures of studies should be. However, I would also state that the American Academy of Neurology is very advanced in the development of critical appraisal, and other such specialties may not have experts who are similarly equipped to deal with the CDR's concerns. Therefore, studies that may have good evidence to show efficacy might be otherwise discounted.
I feel that there is a need for the CDR to take this clinical relevance into account and also to admit that often we do not know the value of quality-of-life outcomes or the appropriate outcome for studies. I think we all have to be honest and admit that even in evidence-based reviews there is some consensus contained in deciding how we are going to phrase the questions and gather the evidence, in grading the evidence, and then in interpreting the evidence.
Participation in drug and technology development is crucial in terms of maintaining and retaining the best academic physicians and scientists in medicine and science. If they are not able to participate in these activities, we will lose that great resource. In particular, I am aware that one company has closed down its neuroscience division and has stated it will not market any further neuroscience drugs in Canada. This concerns me as an investigator as well as a physician. I want to be able to provide my patients with the best possible care for a very serious illness.
Finally, there's the question of pragmatism in evidence-based medicine. Certainly, in our process at the American Academy of Neurology we have taken a strictly evidence-based approach to our guidelines. What we have heard from our members is that they would like to know, what is the clinical relevance, and what doesn't the research show? That speaks to the fact that even clinicians need to know the context they're making these decisions in. What are the potential factors that should change your interpretation of the evidence? That is something that any drug policy agency needs to take into account as well.
Because my experiences have allowed me to look at both sides of the coin, I still have a lot of faith in the common drug review. I think they do a wonderful job of evaluating the evidence, but I also feel that pragmatism needs to enter more into their decisions.
Thank you.
4 p.m.
Conservative
The Chair Conservative Rob Merrifield
Thank you very much.
We will now move on to the Best Medicines Coalition. Louise Binder is chair and Linda Wilhelm is an operations committee member.
The floor is yours.
4 p.m.
Louise Binder Chair, Best Medicines Coalition
Thank you to the committee for inviting me to speak today on the topic of the common drug review.
I'm presenting on behalf of the Best Medicines Coalition. There is a description of the organization in our submission.
I'm also HIV-positive, and I have been working in public health policy in this area for many years.
The coalition and the HIV community have been following the common drug review since its inception. We have concluded that the common drug review is a good idea gone very wrong. We have also concluded that the common drug review, in its present configuration, cannot be fixed.
I submit that the common drug review has failed in fundamental ways to meet its stated goals or to carry out its mandate with a process that meets even the most rudimentary rules of natural justice. In general, it is not providing cost-effective decision-making to the participating provinces. It does poor, shortsighted pharmaco-economic analyses. It unnecessarily duplicates the work of many provincial review processes. It duplicates costs. It has processes that are not transparent, inclusive, or patient-friendly, thus missing much relevant data in making its decisions. And it has no appeals process.
Instead of providing you with a barrage of facts and figures and charts to back this up, I'm going to take my time to tell you the story of one drug--a drug I know very well--and its journey from clinical trial through reimbursement coverage. I believe it will graphically prove my claims about CDR.
The drug is tenofovir, or Viread. It's a non-nucleoside reverse transcriptase drug, called NNRTI, used in combination therapy with other antiretroviral drugs in HIV to keep the virus from proliferating. Research has shown that a combination of this class of drugs and two other classes of drugs will actually work to lower the amount of virus that can be created. It's not a cure, but it definitely has kept many people alive and well for much longer than before these drugs came along.
There are three main problems, though, with the drugs. They are generally toxic to the system--being lifelong chemotherapy--and they have very nasty side effects. One result is that people often have organ failure or other serious diseases because of the drugs. Another result is that some people can tolerate certain drugs and not others, and therefore can't take these drugs. They must find others that they can tolerate better instead of creating all these secondary problems. There's no such thing as one size fits all in this drug system.
These drugs also do not work forever. The virus, over time, changes or mutates so that the drugs no longer work. This is called drug resistance.
The last problem is that for reasons about which we can only speculate, some people respond to some drugs and not to others. This may be genetic makeup. It may be the type of virus they have. It's different in each person.
Thus, as I say, we need all the drugs we can get in our armamentarium at any one time.
I've actually made three drug switches myself, all due to liver toxicity, not failing treatments. The last drug switch left me so ill that I actually slept for nearly three months. I had to tough it through, though, because I had no other choices.
Enter tenofovir, or Viread, a drug that in trials worked well and appeared to have few side effects or toxicities.
Tenofovir is excreted through the kidneys rather than the liver, which is unusual. This means it takes pressure off the liver in some cases. In some cases, in only 1% to 3% of people, it is not tolerated. Otherwise it is well tolerated.
So tenofovir entered the nucleoside class of drugs, and it was compared against AZT in trials. AZT is a potent and effective drug, but it causes a lot of side effects and toxicities, including severe anemia, fatigue, nausea, and headaches. It also gives complicated lipid problems, high cholesterol and triglycerides, which can lead to heart attacks, strokes, and changes in body distribution that are quite disfiguring. Suffice it to say, it is not for everyone.
The clinical trials showed that tenofovir was every bit as effective as AZT, with far fewer side effects. In August of 2004, the therapeutic products branch approved it, asking only for further trials in naive patients. They approved it totally in patients who had already taken therapies.
Then it went to the common drug review and to the Quebec Conseil du médicament, and I want to quote the Quebec Conseil du médicament, because it made the right decision. It says:
The data show that combinations of antiretrovirals that include tenofovir demonstrate efficacy that is at least equivalent to other first line combination therapies for people with HIV who have never received antivirals. This combination also appears to have a safety profile that leads to fewer patients abandoning treatment. This is in addition to the known benefits of tenofovir: a single dose, which reduces the problems caused by forgetting a dose and improves treatment compliance; low potential for drug interactions due to the elimination pathway of tenofovir; and improved safety in regard to the lipid profile and lipodystrophy. In addition, United States guidelines recommend tenofovir as a first line treatment.
However, although this agent does offer benefits, it is currently the most expensive agent in its class. The Conseil...believes that the higher cost of Viread [tenofovir] is justified by its additional benefits. For this reason, it recommends Viread be transferred to the regular section of the...[list of medications].
Now, how did it fare at the CDR? Not so well.
CDR gave its decision in March 2006 after taking 210 days to review it.
By the way, the Conseil approved this drug in 161 days.
CDR didn't recommend tenofovir as a first-line therapy. It couldn't see any difference between the efficacy of AZT and tenofovir. It recognized that there were fewer withdrawals due to adverse events and recognized the convenience of a once-a-day regimen; however, it said it wasn't cost effective because it cost more money than AZT did.
Fortunately, many provinces didn't follow this advice. Ontario and British Columbia gave it “no conditions” for reimbursement, and Alberta said it was up to the physician to decide. Other provinces followed CDR.
So returning to my assertion that CDR has failed, why do I say it? Well, there's a poor understanding at the CDR, in my submission, of cost effectiveness, even at the most rudimentary levels. If the CDR had looked at toxicity and the side effects profile of AZT and had spoken to clinicians and patients knowledgeable in this area, they would have learned a lot more about the side effects and toxicity profiles that add to the actual cost picture. They would have learned that patients take many additional drugs to counteract the effects of AZT toxicities and side effects.
Ten per cent of people on AZT get anemia; six per cent have to go off the drug. That means they go on to tenofovir anyway. Actually, many have failed AZT because of drug resistance, because they can't adhere to the drug. Many people who stay on AZT have to take a drug called EPO to counteract the anemia. That's expensive and was not taken into account.
People with lipid problems will either quit the drug, going on to tenofovir, or they will have to have surgery for “buffalo hump”, or fat distribution, which is paid for in the system. They also may get high cholesterol and triglycerides and often do, and they have to buy statins to deal with that.
They often have to take antidepressants, antianxiolytics, and psychotherapy as a result of being on this drug. Also, it disrupts sleep patterns, so many people on AZT take sleeping pills. Anti-nausea pills are also often required.
In addition to all those extra costs, there are more doctor's visits and, in extreme cases, hospital and emergency room visits.
None of these pharmaco-economic factors was taken into account by CDR, though they obviously were by Quebec. Thus, they are not actually giving good cost containment advice to the provinces. It is also out of step with the decisions in most developed countries and with published treatment guidelines for first-line treatments.
As I say, fortunately, some provinces have seen this. However, this begs the question about the value of CDR. It appears to be nothing more than unnecessary duplication, since all provinces with drug review committees have kept them going, notwithstanding CDR. They cost money to run, as does the running of CDR, at an amount which is not inconsequential--$5.1 million a year.
CDR has added an average of 26 weeks to the overall time it takes to get badly needed drugs to people. In the case of Viread, CDR took 210 days. So the total time it took for Ontario to get that drug on the formulary was 456 days; in Saskatchewan, 330; in Newfoundland, 330; on the federal formulary for Aboriginal people, 350; and in Quebec, 161.
Ontario has already recognized that CDR is very limited in its usefulness and has actually promised that all drugs for life-threatening conditions will be reviewed once TPD approves them, within three to four months, notwithstanding what CDR does.
It's true also that CDR was to create consistency of coverage for patients across the country, but that's pure pie in the sky. The province continues to do their own reviews, make their own decisions based on their analysis of the data and their drug budgets. CDR's opaque, non-inclusive process has led to its failure to some degree. If it would allow clinicians with knowledge about the disease area and patients to come in to give evidence and be part of their committees, they might learn something about the drugs they're reviewing.
Even an appeal process would be an improvement. Trying to get them to talk to you about drugs is like pulling teeth. You write and you write, and maybe if you write long enough, you might get a meeting with them. That certainly was my experience.
We make the following recommendations.
In the short term, we recommend that any further expansion of the mandate of CDR be halted. It should be frozen where it is.
A working group should be struck to develop and implement a plan to dismantle CDR and return to the previous system of provincial decision-making.
It must, of necessity, be an FPT group, obviously, but we would want other stakeholders, including patients and patient-driven community group representation, included. It has to have as its mandate a process to provide review committees in provinces that do not have them presently, and also a review of all the provincial review systems to ensure they're effective, efficient, transparent, and stakeholder-inclusive, so that we really do get the opportunity for some consistent analysis.
If this is outside the scope of the committee to recommend--and I hope it isn't--then at the very least it must recommend a working group of the type I've mentioned above to completely overhaul the CDR, top to bottom. The reporting relationship for CDR should be at arm's length from ministries of health.
It should include researchers, clinicians, and patients on its decision-making body, who are knowledgeable about the disease involved. It should allow all relevant stakeholders to have access to those bodies, and it should ensure that the time taken for review, including the decision by the provinces, should be no more than the time the provinces were taking for decisions before CDR.
The status quo or minor tinkering, in our view, is simply doing a disservice to Canadians and to the provinces that deserve the best pharmaco-economic advice available.
Thank you.
4:15 p.m.
Conservative
The Chair Conservative Rob Merrifield
Thank you very much.
We'll now move on to Elisabeth Fowler, the vice-president of health policy from Ward Health Strategies.
The floor is yours.
4:15 p.m.
Elisabeth Fowler Vice-President, Health Policy, Ward Health Strategies
That's me. Thanks.
Is Linda going to speak?