Health Committee on April 30th, 2007

[The Chair, Conservative, Rob Merrifield]

I call the meeting to order. I want to thank the witnesses for coming forward, and we'll ask the members who are in the room to take their seats so we can get started.

First of all, this is the fourth meeting we've had on the CDR, the common drug review, with the beginning of our series on prescription drugs.

The witnesses today are from Cancer Care Ontario, the Cancer Advocacy Coalition of Canada, Princess Margaret Hospital, Canadian Breast Cancer Network, and the Colorectal Cancer Association of Canada. We'll start with Debbie Milliken from Cancer Care Ontario.

I want to thank the rest of the panel for being here. I'll introduce you as I yield you the floor, but we'll start the meeting with you, Ms. Milliken.

[Debbie Milliken, Director, Provincial Drug Reimbursement Programs, Cancer Care Ontario]

Thank you very much for the invitation to make a presentation to the Standing Committee on Health. I'm participating today as a representative from Cancer Care Ontario, and I currently hold the position of director of provincial drug reimbursement programs at Cancer Care Ontario.

Cancer Care Ontario is an independent government agency that's responsible for planning cancer services, developing and implementing quality standards and practise guidelines, as well as reporting on cancer system performance to the public and clinical and administrative leaders. We also act as the chief advisor to the minister in Ontario on all issues related to cancer.

In my presentation today I plan to describe the drug approval process for oncology drugs in Ontario, our experience to date with the CDR, and the challenges that we have with respect to evaluating cancer drugs for funding. In addition, I'll provide you with some information concerning the newly established joint oncology drug review, or JODR. Please keep in mind that the JODR is a provincial-territorial initiative being led by the Manitoba and Saskatchewan governments and that Cancer Care Ontario is a participant in that initiative.

[The Chair, Conservative, Rob Merrifield]

Excuse me.

[Christiane Gagnon, Bloc, Québec, QC]

Could the witness possibly speak more slowly, to give the interpreters a chance to keep pace?

[The Chair, Conservative, Rob Merrifield]

Perhaps you could speak a bit more slowly. The interpretation is having a difficult time keeping up.

Carry on, please.

[Debbie Milliken]

In Ontario, cancer drugs are funded through a variety of mechanisms. Drugs that are given in the hospital intravenously are primarily funded through our provincial IV cancer formulary, called the new drug funding program, a program that's administered by Cancer Care Ontario on behalf of the Ministry of Health and Long-Term Care.

Older medications given intravenously are paid for through hospital global budgets. Community-based medications are reimbursed, for eligible recipients, through our Ontario drug benefit program. As well, some people have private insurance or pay out of pocket for their cancer medications if given in the community or orally.

Ontario's oncology drug review process, which I'll refer to as the CED-CCO, or the committee to evaluate drugs-Cancer Care Ontario, process, was established in 2005 in response to a number of issues we had in the province. The first was the significant expenditure gross of over 30% that we were experiencing at a time when many new anti-cancer agents were in development and close to launch that we knew would cause increased pressure on our new drug funding program.

Traditionally, we didn't use health economic analysis in terms of trying to make decisions for formulary funding. We also saw there was an opportunity to improve the consistency in terms of policy decisions for the two publicly funded formularies in Ontario--the Ontario drug benefit program and the new drug funding program--and sought to bring together the process for approval of both programs.

This was a collaboration of the Ontario drug benefit program and Cancer Care Ontario, which was intended to create a single oncology drug review process that would build on the strengths of both of the current processes. From the Ontario drug benefit side, we built on their expertise of using pharmaco-economics in the review process, as well as their experience in handling manufacturers' submissions. From the Cancer Care Ontario side, we built on the expertise from our disease site groups on the clinical side and made use of our guideline development process through our program and evidence-based care that uses systematic review of the clinical literature in the evaluation.

The process allows for both pharmaceutical manufacturers and Cancer Care Ontario disease site experts to make a submission for reimbursement. There is a link to the common drug review process for community-based medications, but not for intravenous medications.

The joint CED-CCO oncology subcommittee first evaluates the clinical and economic evidence and makes a funding recommendation to our committee to evaluate drugs, and that committee is the committee that considers the broader context of oncology agents in the context of other therapeutic areas and makes the final recommendation to government. In Ontario, our executive officer makes the final funding decision.

Our subcommittee for oncology is made up of medical oncologists, internists, ethicists, pharmacists, and health economists. In the near future we'll be adding patient representatives as well.

The experience is limited to date with respect to the oncology drugs that have been evaluated since our joint CED-CCO process was implemented in 2005. Cancer Care Ontario has no direct experience with the CDR recommendations in informing the new drug funding program decisions, since the CDR does not currently evaluate intravenous drugs given in hospitals.

On the Ontario drug benefit side, we have experience with four orally administered cancer drugs that have been reviewed through the CDR and decisions made for the Ontario drug benefit formulary. In all four cases, the reimbursement decision of Ontario was consistent with the CDR recommendation.

The CDR reviews are considered a part of the CED-CCO process. They're one of a number of inputs that are considered by our subcommittee and, finally, by the committee to evaluate drugs.

A number of challenges face us in terms of being able to properly evaluate cancer drugs. Regardless of the process that's used, often clinical evidence required to make confident decisions regarding a drug's true value is not necessarily available. Ideally, we would like the level of evidence to come from multiple phase 3 trials, or randomized control trials. Often what we have is non-comparative data from what we call phase 2 trials. Often the relevant comparators we'd like to see aren't used in clinical trials, or the trial may not reflect our current practice patterns in Ontario or the rest of Canada.

It's unclear how unproven surrogate end points, such as response rate or tumour shrinkage or disease pre-survival, relate to the more important end points that decision-makers would like to see, such as survival and quality of life. And these are required for determining the true value for money of a new therapy.

Some trials also incorporate crossover designs, which may mean that decision-makers again never have the information they need to make a confident decision from a clinical perspective. If the clinical data isn't strong, the pharmaco-economics will likely be modelled around numerous assumptions, creating a large degree of uncertainty concerning its actual cost-effectiveness for a new therapy.

The key issue is not necessarily the process used for decision-making, but rather the question of what the decision-making threshold should be in assessing the new therapies where the data may be incomplete or unclear, to ensure that Canadians receive good value for money and that this is balanced with the needs of individual patients and our societal values.

In Ontario, we have a number of initiatives under way through our drug system secretariat to better inform decision-making and optimize access for oncology medications. These include our transparency initiatives and initiatives to improve public engagement in the process through the development of a citizens' council and participation of patients on our committees. We're trying to address these evidence gaps through conditional listing proposals and working with industry on partnership agreements. Cancer Care Ontario is also in the process of developing a pharmaco-economics unit to improve the quality of the economic data used in the decision-making process.

There are clearly a number of benefits to establishing a national oncology drug review process that would allow for all provinces to have local funding decisions informed by a single drug evaluation based on a rigorous review of both clinical and economic data. Certainly a single process creates the potential across the country for more consistent decision-making. It reduces duplication and maximizes resources and expertise across Canada. Certainly it provides a single review process for all oncology medications, regardless of how the drug is given, whether it's given orally or intravenously, or the location of treatment, whether it's in the hospital or in the community setting.

I want to talk a little about the joint oncology drug review. It is a provincial-territorial government initiative being led by Manitoba and Saskatchewan. Cancer Care Ontario is participating as part of the overall Ontario contribution to that effort. During the one-year interim JODR, submissions for all oncology products will be made to the Ontario CED-CCO process and considered as a submission to all participating jurisdictions. Each jurisdiction will continue through the JODR process to make the final funding decision.

There are four phases to the JODR initiative. The first was the memorandum of understanding phase, where all provinces signed on to the initiative, other than Quebec.

The second phase, which is the one we're in now, is the observation phase. All of the provinces will have the opportunity to review the Ontario process to learn from it and understand how it works.

In the third phase we hope to incorporate reviewers from other provinces and start to engage linkages with other national initiatives, such as the Canadian Partnership Against Cancer.

The fourth and final phase is the evaluation phase, where recommendations will be made to the provincial-territorial deputy ministers on the potential for a permanent process going forward. There's a governance structure, with a steering committee that includes an observer from the common drug review. There's also an advisory committee that will include membership from the cancer agencies. It hasn't been initiated quite yet.

Finally, from the perspective of the CDR, the Canadian Expert Drug Advisory Committee will not be deliberating or making funding recommendations during the interim process. However, the CDR will continue to provide clinical and pharmaco-economic reviews that will be used, as needed, as part of the JODR process for drugs that would normally meet the definition of a CDR review.

Thank you.

[The Chair, Conservative, Rob Merrifield]

Thank you very much.

Now we'll move to the Cancer Advocacy Coalition of Canada. We have William Hryniuk, the director and past chair. The floor is yours.

[Dr. William Hryniuk, Director and Past Chair, Cancer Advocacy Coalition of Canada]

Thank you very much, Mr. Chairperson, and thank you for inviting us.

First, we would congratulate the government for transferring the cancer drug portfolio from the CDR to the joint oncology drug review, JODR.

Let me place our credentials before you. The Cancer Advocacy Coalition of Canada is a non-profit organization comprised of cancer survivors, physicians, scientists, and cancer system administrators drawn from coast to coast across the ten public health care systems of Canada. Our board members have personally received cancer treatments and services, or have delivered the services to individual patients, or have administered cancer services on a regional basis, or have organized and conducted clinical research on a national basis, or have studied cancer prevention on an international basis. Not one of us is paid for our work on CACC. Board members are listed at the back of the presentation.

I am the immediate past chair and formerly a practising medical oncologist, a cancer researcher, and a director of university-based cancer centres in Canada and the United States.

The Cancer Advocacy Coalition is dedicated to ensuring that the spectrum of cancer control activities in Canada proceeds in an optimal fashion. Each year we investigate various aspects of cancer prevention, screening, treatment, supportive care, and research in Canada, and we publish the results in our annual report cards on cancer. You'll observe consistent differences in the amount of money provincial governments have allocated to cancer control, which we believe have resulted in the differences in cancer mortality in those provinces.

We have also shown how access to life-saving cancer drugs is very unequal and inconsistent among the provinces. We're therefore grateful for your attention to the process for cancer drug approval and to the Government of Canada for establishing the Canadian Partnership Against Cancer as a means of redressing these interprovincial differences.

Now to the point of the hearing: why was CDR unable to comprehensively evaluate oncology drugs and how can JODR do better? First of all, the committee of CDR, which was judging these drugs, was unable to deal with the complexity of oncology problems. Committee members were prevented from accessing the best knowledge about each new treatment and were therefore unable to judge data in context.

Let me explain. There are over 150 types of cancer. For each type of cancer there are several stages. For each stage there are several treatment options. These options constantly change as new trial data pours in almost daily. It is increasingly difficult to maintain the knowledge required to judge what is the state of our medicinal treatment in any given situation at any given time. This requisite knowledge is, arguably, best held by the investigators who actually do the clinical research establishing drug effectiveness. Yet the CDR committee was prohibited from hearing from those investigators.

As I understand it, the prohibition was based on the premise that the judgment and the advice of the investigators would be tainted by their affinity with the trial results or with their affiliation with the drug company sponsoring the drug application. By this reasoning, CDR committee members could not trust the testimony of trial investigators.

Granted, the various parties would have had different perspectives, but surely some knowledge exchange could have occurred and could have benefited the Canadian public. After all, these investigators are physicians who not only have the requisite knowledge to place the treatment results in proper context, but it is safe to assume they also have the interests of their patients at heart and a commitment to improve treatment for those patients. Otherwise, they wouldn't have done the study in the first place. We therefore strongly urge that the investigators who conduct the pivotal studies be allowed to contribute to the process of adjudication of drugs by JODR.

The JODR, as you've heard, is a process in which eight other provinces allow the Ontario committee to evaluate drugs, hereinafter called Ontario CED, to conduct all the oncology drug reviews on their behalf. The Ontario CED derives its oncology advice from a subcommittee comprised of oncology experts from Cancer Care Ontario and other representatives. There now arises a transparency problem as the responsibility for adjudicating cancer drugs is transferred to the CED because the identity of the members on its oncology subcommittee is shielded from the public. Among the reasons for this concern is that oncology subcomittee members may be subjected to undue pressure, or perhaps even bodily harm, if they render negative judgments about particular drugs. If that is the reason, it would be an entirely unique one in the annals of public service in Canada. I am sure you can judge the weight to be given to such a premise compared with the need to know the credentials and the competencies of the committee members. We therefore ask that the identities and credentials of JODR oncology subcommittee members be readily available to the public.

The third concern we have about the process followed by the CDR committee is the lack of transparency surrounding its judgments. We strongly suspect that the JODR, left to its own devices, will follow the same pattern of reporting. We therefore ask that you ensure that JODR make public the detailed explanations of why it renders particular judgments.

Central to the issue of lack of transparency is the lack of a robust economic model for judging cost-effectiveness. Regardless of whether it's CDR or JODR that is rendering the judgment, it is regarding the reference frame within which cost is addressed that we take issue. The new cancer drugs result from huge efforts in basic and clinical research and are therefore expensive. Cost-effectiveness must factor into their deployment.

Cost-effectiveness has usually been expressed in terms of the incremental cost for each quality-adjusted life year gained. Better methods of expression must be employed. To adequately judge the cost-effectiveness, additional factors must be taken into account. These include the cost of alternative, older, and less-effective but still expensive treatments; the cost of not treating the condition, which will result in more doctor visits, emergency room visits, and hospitalizations; the cost to society in the lost tax base and loss to the GDP from failure to adequately treat otherwise functioning cancer victims; the loss to the community from loss of its leaders; and above all the heavy emotional and economic cost to families from the loss of their loved ones.

We hasten to add that the entire western world is wrestling with the issue of cancer drug costs; however, somehow almost all other jurisdictions have come to very different conclusions compared to the CDR and have released many more drugs for general public use. On page 34 of our 2004 report card we give a detailed, broadly based, and comprehensive suggestion about how to approach this critical aspect.

We therefore strongly urge that the JODR embrace much more broadly based economic models when deciding whether or not a drug is cost-effective.

That immediately raises the next area of concern--the lack of representation by cancer patients. Individuals must participate to give strong voice to the millions of past, present, and future cancer victims in Canada. I have to remind the committee that for everyone in this room, the risk of developing cancer is now over 40%. Surely, patients are the stakeholders whose voice must be strongly heard.

My own experience with committees in 35 years of academic medicine and health care administration has taught me at least this: when well-informed patients are present, the tone, the content, the direction of discussion, and the final conclusions are very different from when patients are absent. We see this deficit in the CDR is now being redressed, but it still promises to be a major deficit in the JODR.

We therefore ask that you insist that well-informed and effective cancer patient representation be on the oncology subcommittee of JODR.

There arises the issue now of the type of evidence that guides the deliberations of both CDR and JODR. We strongly support the need for results from properly conducted studies. Randomized trials have been the driving force behind continued progress in cancer treatment. In fact, one of our own board members, Dr. Tony Miller, established the National Cancer Institute of Canada's Clinical Trials Group over three decades ago, and this group has since achieved international recognition.

However, you should be aware that in the case of adult cancers, randomized trials are conducted on a sample of only 3% of the patients, and the results are extrapolated to the remaining 97%. The effectiveness of the drug on the general population could be quite different from that predicted by the randomized trial results.

We therefore ask that community-based follow-up studies be routinely conducted after approval by a JODR to determine whether the results are those predicted from pre-approval studies.

We would like to raise one final issue. The CACC has investigated and published the fact that across Canada there are marked differences in the guidelines advising doctors in cancer treatment, even though the guidelines were developed by oncology experts analyzing ostensibly the same medical database.

There's a pressing need for national uniformity and guidelines for cancer treatment and for monitoring whether they're being adhered to and whether they are having an impact. The province with the most comprehensive approach to this aspect is British Columbia, which incidentally also has the best treatment outcomes and the lowest cancer mortality. Cancer mortality is dropping in British Columbia like in no other province in Canada. The rest of Canada would do well to follow B.C.'s lead.

Cancer treatment guidelines could be developed at the national level through the newly created Canadian Partnership Against Cancer, but it will require your attention and encouragement to ensure that the partnership proceeds strongly in this direction.

As it stands now, without such national guidelines, even when JODR approves a drug, the provinces don't have to pay for it based on their own biases. In such cases, as far as the cancer patients in that province are concerned, the JODR may as well not exist.

Thank you.

[The Chair, Conservative, Rob Merrifield]

Thank you very much for your contribution to the committee's deliberations here.

We'll now move on to Dr. Jennifer Knox, oncologist, University Health Network, Princess Margaret Hospital.

Thank you.

[Dr. Jennifer Knox, Oncologist, University Health Network, Princess Margaret Hospital]

Thank you very much, Mr. Chairman and members of the Standing Committee on Health, for letting me come today and talk about my concerns about drug funding. In particular, I'm going to talk about kidney cancer treatments and how recent CDR decisions are really going to get in the way of our Canadian patients being treated with what is now a global standard of care and how these decisions also impact on us as physicians, our primary obligation to provide care and benefit to our patients.

I'm a medical oncologist at Princess Margaret Hospital. I'm also a kidney cancer researcher and specialist, and I'm someone to whom many oncologists refer their patients for opinions, and I do a lot of research. But I can tell you today that I'm not speaking just for myself; I'm speaking for at least 30 kidney cancer specialists across the country who I met with on the weekend and who have signed a statement, which--I apologize for not having it translated--I'll get to you later. These are key thought leaders and kidney cancer specialists who really share my concern. For example, Dr. Martin Gleave, who's head of CUOG, the Canadian Urologic Oncology Group; Dr. Simon Tanguay, who works as a researcher in Montreal and McGill; Dr. Peter Venner, who runs the Cross Cancer Institute in Edmonton, and many others.

Basically, kidney cancer is not one of the big four. It's not breast or lung or colon or prostate cancer, so it doesn't get quite as much attention. It's also been a very difficult cancer to look after for many years because, essentially, nothing worked. It was a terrible disease.

If you have metastatic kidney cancer, which is essentially what most people who present end up having, your average survival is about a year. We did many clinical trials for years, and essentially chemotherapy, radiation, nothing really works. And along came this revolutionary new idea, this antiangiogenesis, which you probably heard about, which really means we've got these therapies now where we can't get at the cancer, but we can prevent the cancer from attracting blood vessels that feed it. It doesn't get rid of the cancer, but it stops it from spreading and metastasizing, which is essentially what kills the cancer.

This was science fiction 10 years ago and now we have real agents. Someone is going to get a Nobel Prize for this. Thankfully, some of the drugs that have come along first in their class, that are what we call these antiangiogenesis inhibitors, actually are pretty much home runs in kidney cancer.

The first drug that came along with evidence of survival was Nexavar, and then soon after that came the drug Sutent. Both of these drugs have recently been reviewed by CDR, and they advised that they not be funded in provinces, based on their understanding of the data and their cost-effectiveness analysis, which I think is very flawed.

I need to talk a little about how clinical trials are done. We strive hard to meet ethical standards, so it has to be reviewed through an ethics board, and patients give informed consent. Then usually, in the cases I'm talking about, the new treatment is compared to a standard of care. So the control arm is what would be your best and then the new drug.

In the case of the first example, Nexavar, what happened was kidney cancer patients who had already tried something and were progressing and in trouble were randomized to this trial. It was blinded, and they either got the Nexavar pill or a placebo. Then toward the end of the accrual of the patients, there's something called a data safety monitoring committee, which is independent, and this was also in dialogue with the FDA in the U.S.

One of the end points we look at is called progression-free survival, and you get information about this before you get information on overall survival. Progression-free survival says how long has this patient lived before their tumour has grown in a significant way, and that in itself is an important end point.

Basically the curves were so different at that point that we were advised to un-blind our patients. I hate to say this so bluntly, but anybody who was still alive on placebo could then have a chance to cross over and get the drug. Something like this doesn't happen very often in medical oncology. I remember when we got the message; the excitement was amazing.

I want to tell you about one of my patients, because it helps. Statistics don't tell the stories very well. I had this 46-year-old man with advanced kidney cancer. He was on the trial, but it turned out he was on the placebo and he was dying. We were setting up his hospice care. He came in to see me, which was probably going to be for the last time, and it just happened that the crossover logistics had worked out so that his wife had been delivered the bottle of the Nexavar pills that day--such irony. She asked, “What should I do?” I said, “Well, if he's well enough to swallow, what's the harm? Try to take it.”

He swallowed these pills and slowly started to get better. He came back to see me at about the eight-week mark, and I said, “You know, you're really looking better.” He said, “My pain is better and I'm feeling more hungry.”

We took a CAT scan, and lo and behold, he had a response, and it was shrinking. He went on probably to have another year, probably 10 months, under complete control by that drug, but then he progressed and died.

If you look at the clinical trial data, he's on the control arm and he's counted as control arm. You can actually see the point in time at which this crossover happened. The curves, which were further apart--so the difference was greater--start to come together. None of us would ever argue that that was the wrong thing to do; that was the ethical thing to do, and the whole world has embraced this as a positive trial.

When the CDR reviewed this data, they basically said we don't like this progression-free survival end point, and because the survival is not so great now, despite this crossover, we just don't have confidence that the drug is that different.

There's all kinds of different statistical analysis you can try to do to get the truth of what the true difference would have been, but there's nobody who treats kidney cancer, no expert in the world, who doesn't believe that drug had a meaningful impact on the survival of those patients. It's just that it's awfully hard to put a number on it. Then when you calculate cost-effectiveness and take the smallest number you can possibly get in terms of the benefit and put a big price tag on it, of course it doesn't look like it's that beneficial.

I have lots of other stories, but I want to mention that I came today for moral support with one of my patients, Mr. Clark, who had metastatic kidney cancer for three years. He knows the average survival is one year. He is looking very well. He got that drug through the mechanism of the clinical trial, and he wouldn't be here today, alive, if he hadn't gotten that drug. So the statistics don't tell all the stories.

The next drug that came along was Sutent. It has a similar mechanism of action, but we don't really know what the differences are between these drugs. It was tested in a slightly different patient population, patients who had never been treated before. Once again there was a remarkable separating of the curves, so much so that it went forward for licensing very quickly. The survival data had not matured yet. Then, of course, patients cross over; they move on to other therapies, and the survival curves come together.

Those are the two drugs that have been recently reviewed. In oncology circles, the way we think about these drugs is that they are home runs. We're not curing these patients with advanced disease, but this is the biggest thing that's happened in 30 years, and it has the potential to really build momentum to understand more and to make further progress.

One of my big concerns is not only with the CDR recommending they not be funded and provinces then following that. It's that, first of all, the patients are not going to get what the world considers to be a standard of care. Our patients are no longer getting good therapy. The second issue is that as investigators, how do we go forward--especially as Canadian investigators--in trying to ask the next questions? How do I build on that? All the next trials are going to be about what you do next.

Our patients won't be eligible for those trials because they didn't get the first line. Some patients are getting it paid through private insurance, but most Canadians don't have that kind of insurance, so many are not getting coverage. It's a very difficult thing as an oncologist to speak with your patient and say, not only do you have a bad disease, which is terminal, but we actually know about some new therapies that could prolong your life, but we're not going to be able to give them to you here in Canada. I'm going to fight for you, but I don't know how it's going to work out.

I'll end just by saying we're very unusual here in Canada in not embracing these drugs for funding very quickly. As far as I know, Nexavar, which is the first one that came along, is being reimbursed in Austria, France, Germany, Greece, Ireland, Italy, the Netherlands, Sweden, Spain, Switzerland, the United Kingdom, and the U.S.

I've always been so proud of our Canadian system and our health care system, and we've been real leaders in the world in clinical research, but if we allow this sort of thing to continue, we're really going to fall off very quickly, and our patients will be really woefully under-cared for.

I'll stop there.

[The Chair, Conservative, Rob Merrifield]

Thank you very much for that information.

We'll now move on to the Canadian Breast Cancer Network, and we have Diana Ermel, president, and Jackie Manthorne, executive director.

I don't know who will....

[Diana Ermel, President, Canadian Breast Cancer Network]

Thank you so much for having us here today. We appreciate it.

We have handed out a little blue folder with my notes. Sometimes I go off my notes, so you might want to be looking at them to follow along.

I really am privileged to be here.

The Canadian Breast Cancer Network is a network of survivors who represent all issues around breast cancer in Canada. We're made up of groups and individuals concerned about breast cancer, and we represent their concerns. We have 225 partner and member groups across Canada, and our board is composed of individuals who have been diagnosed with breast cancer. We know we are one of the top four, but we also know our issues apply to everybody diagnosed with cancer.

Right now, according to the Canadian Cancer Society's 2007 statistics, there are 162,600 people living in Canada who have been diagnosed with breast cancer in the last 15 years. That is a low number, because I know people who have been diagnosed more than 20 years ago. Over 22,000 women will be diagnosed with breast cancer this year and 5,000 women will die of breast cancer this year. It's the leading cause of cancer deaths in young women aged 20 to 49. It's second to lung cancer in older women, and once we get to be 70, it's the third leading cause of death. We're superseded by lung and colorectal cancer. We just want to live to be 70.

Our responses to your questions are really from the patient perspective. They're based on three values: equality, accountability, and inclusiveness. When we talk about equality, as I've said in my notes, we want timely and equal access to the best medications for all Canadians diagnosed with cancer. When we're talking about timely access, we mean that once a medication has been approved in Canada, a patient shouldn't have to be waiting and waiting to receive it, to have it funded. Equal access means that across Canada there cannot be differences. It should not depend on where we live in Canada or our social economic status whether or not we have access to medications. We want access to the best treatment, not just something that happens to be out there that maybe isn't as good as something else.

Accountability is about this whole decision-making process in terms of how drugs get funded, how they get put on the provincial formulary. It has to be just, it has to be fair, and it has to be transparent. We don't see it being any of those at this point in time. The accountability is in relation to not only the people on committees reviewing the drugs, but also to the provinces that follow up on those recommendations.

Inclusiveness, as other speakers have said, is about meaningful consultation and engagement of all stakeholders, including informed patients and health care providers such as oncologists and pharmacists, in the decision-making process. This has to be meaningful; it has to be real. We have to recognize that the decisions that are made about whether or not cancer drugs are funded most directly affect patients and their oncologists, and Dr. Knox spoke to that quite eloquently. When we're diagnosed with cancer we are in a partnership with our physicians. It is horrible to hear stories about frustrated people who can't have access to treatment and their physicians who can't help them.

In terms of your questions about the CDR and what we understand about it, we don't believe it has improved access to approved medications. There remains an unacceptable time lag from the time a drug is approved until it shows up on a provincial formulary. There is some transparency in that decision-making, but the actual criteria upon which decisions are based are not apparent to the average Canadian. Provincial reviews continue to follow the national reviews. That is obviously, in our minds, a duplication of effort and it delays decision.

There's absolutely no obligation on the part of provinces to follow through on recommendations from the CDR. We know they pretty much follow through on recommendations not to list a drug, but they definitely don't always follow through on listing one.

This whole process seems to be driven by economic considerations instead of health considerations. Fewer than half of the reviewed drugs were recommended, and also, we know this process isn't tailored to the new drugs, the targeted agents and the biologics.

Despite some improvements in terms of transparency and including patients, we know there are a growing number of Canadians, depending on where they live, who have to make a choice between quality of life, more years of life, or depletion of their financial resources and leaving their families bankrupt.

It's a terrible, terrible decision to make: “Shall we spend all our money to keep me alive for another 10 months, or shall I go quietly?” We don't want to go quietly. It's unacceptable in Canada that this is happening, and it is absolutely devastating that this disparity is increasing.

In terms of cancer medications and treatment for cancer, we have seen how this disparity is played out across the provinces. Bill Hryniuk's group has done a lot of work on that, and they have shown us the differences in what drugs are covered.

The idea of having one national strategy to look at oncology drugs seems to be a really wise one on the surface. The concept has potential and opportunity to eliminate regional disparity and to make sure that all patients receive the drugs they need.

Look at it. It will include all cancer medications now, not just the oral medications. It will include medications that patients take home, and it will include the intravenous medications. It will be a rigorous review, best use of expertise, no duplication of effort, decisions will be made based on evidence, it will shorten the wait time for funding, provinces will be collaborating, and it may actually improve the mechanism for pricing and negotiations with industry. So it sounds wonderful.

But when I look at my Saskatchewan government's press release about the JODR, my Minister of Health, Len Taylor, who is a wonderful man, says, in two quotes from him, that in Canada we require “a consistent”—yes, we do need something that's consistent—“rigorous review of the clinical effectiveness and cost-effectiveness” of new cancer drugs. That's fine, but what does that mean, and how does that translate? And who looks at that information, and what decisions do they make? If they make the best decisions for the citizens of Canada...oh, oh, the next quote says, “final coverage decisions will remain the responsibility of each jurisdiction”. So we do not see how there is going to be anything better than the bad stories we've heard about the CDR. The JODR will not achieve its potential if it's just merely a more complex iteration of the CDR process.

We at the Canadian Breast Cancer Network are very concerned that this process is going forward and may be entrenched in our decision-making for how drugs are funded in Canada. We don't have a lot of issues right now, as people with kidney cancers do, but we know there are going to be more and more new targeted, biologic, first-in-class medications coming out that will actually save our lives, and from what we can see, people with breast cancer will be denied access to them, or if they are allowed access, they will have to pay dearly for that access.

So our concern about the JODR is that the model on which the interim review process is based will not result in decisions that maximize the health of Canadians with cancer. We have read and heard from many sources, but the process doesn't value the recommendations of expert oncologists at this point in time.

Cost-effective analyses do not provide information that decision-makers need to make funding decisions that will maximize health gains from available resources. They just don't. That is not what is needed. It's too simple. There are many other factors that need to go into making these decisions.

It won't ensure access to needed medications for Canadians diagnosed with cancer, and it will just result in increased suffering and untimely deaths for some Canadians.

We are concerned so much that this is yet another cost-containment initiative, that that is the priority. They talk about a commitment to a consistent standard of care, but that does not translate into a commitment to a quality standard of care.

The cost of having cancer right now is horrendous, and on top of that, if you have to pay $35,000 for your course of treatment, it's completely unacceptable.

CBCN did a national survey back in 2004, looking at the financial costs of having breast cancer. In the package we handed out there's a little green booklet telling you about those results. On page 10, it says that 66% of respondents reported they had to pay for their drugs in some way or another. And these respondents are not the marginalized people in society. They're not the people who are poor and don't know how to go from one day to the next. So that's a huge number.

We don't understand, other than from a dollar-driven agenda, why the other provinces have agreed to follow a process that results in less access than their citizens now enjoy. The Ontario model has resulted in funding for very few drugs, as compared to other provinces. We don't understand why the model being adopted is not that of the province with the best record of providing access to drugs. The B.C. model funds the most drugs for patients. We are very concerned that patients are considered last, if at all.

Decisions are going to be made about the lives and quality of life of Canadians without any understanding of the perspective they have on these decisions or their involvement in making these decisions. Patients and families must be considered, and their physicians' opinions must be considered too.

Treatment options will be determined by where people live in Canada, not by evidence. Patients will be denied access to quality drugs. Patients who can afford drugs to continue living will access those drugs; patients who cannot afford such a luxury will die.

We don't know what the answer is to this problem. We know that it is not acceptable in Canada to have this going on. Patients must come first. Whatever system is in place for making these decisions, it must be one in which quality of life is prolonged and lives are saved. Equal access to cancer drugs requires federal funding to ensure equality, and it also requires a systemic change in thinking about the value of extending and saving human lives. All stakeholders must work together to ensure no Canadian receives less than the best possible care.

We want to see a transparent and just system where patients can move seamlessly from a clinical trial to ongoing access to needed medications, where patients are not denied access to needed drugs, and where no Canadian must choose between hope or bankruptcy or dying.

Thank you.

[The Chair, Conservative, Rob Merrifield]

Thank you very much.

We'll now move on to the Colorectal Cancer Association of Canada and Dr. Barry D. Stein, president.

[Barry Stein, President, Colorectal Cancer Association of Canada]

It's Barry. So I'm not a doctor; I'm a lawyer, actually, but close enough.

For those of you who don't know me, my name is Barry Stein. I'm the president of the Colorectal Cancer Association of Canada. For those of you who don't know me, you should be coming to our parliamentary colorectal cancer breakfast. Many of you have, so you should tell them how good the food is, actually. It's well worthwhile coming.

One thing about going last is that you're fed with the luxury of hearing all the other witnesses. I know you want to hear individual testimony. However, I find myself being in full agreement with the witnesses today, and in particular the very heartfelt and true and accurate story told by Dr. Knox. I didn't know that she was going to be testifying certainly on this story today, but I have to tell you that as it applies to renal cancer, it applies to colorectal cancer, and it will apply to all cancers. I can corroborate that in legal terms. That is a very true and accurate story that was represented.

The Colorectal Cancer Association of Canada is a national not-for-profit association dedicated to awareness and education of colorectal cancer. We deal with support of patients and their families, and we promote effective screening across the country, as well as timely access to effective treatment. Of course, it's the latter of those issues that I will deal with today.

In Canada, so that you understand the numbers...and if you haven't come to the parliamentary breakfast, you'll get your lesson now. I won't ask you if you've been scoped until the end, but we do that at our parliamentary breakfast. In 2007 an estimated 20,800 Canadians will be diagnosed with colorectal cancer, and unfortunately, 8,700 Canadians will die from it. It affects men and women almost equally. Overall, colorectal cancer is the second leading cause of cancer death in Canada. However, it is also highly preventable, treatable, and beatable, if caught early. And if we are to properly treat and effectively beat colorectal cancer, we urgently need access to the effective medications within the treatment guidelines.

This past March, the Colorectal Cancer Association of Canada organized a round table conference in Montreal on screening, as well as access to treatment, where about 150 individuals were in attendance. Some of the co-witnesses here were also in attendance at that round table, and I've marked in our notes the very broad spectrum of people—from government, cancer agencies, oncologists, and so forth, to patient organizations—who were present. These individuals, who came from across the country, came to express their views on access to cancer treatment, with a particular emphasis on colorectal cancer medications.

The broad base of participants at the round table, as well as our constituency of patients from across the country, has enabled me today to provide you with these comments.

Although the CDR, the common drug review, was set up with the intention of reducing duplication and providing equal access to expert advice for the Canadian public drug plans, the perception of patients is that there is a greater emphasis on cost containment rather than on ensuring patient access to important medications. This represents a difficult conflict for patients, who require timely and easy access to effective medications when they are in the most vulnerable of positions. Consequently, the CCAC believes that the accent on approval for cancer medications must be shifted from cost containment to providing patients with better access to effective treatments.

With the introduction of the joint oncology drug review, we have observed that there is a feeling of mistrust developing, largely generated by the seemingly non-transparent manner in the way it was set up. It was virtually sprung upon most of the population, and nobody actually heard about it...well, not everybody. I suppose some people heard about it, but the general population did not hear about it until it was a fait accompli.

There is an opportunity for the JODR to do it right, but we must be sure to capitalize on the lessons learned with the CDR. While we welcome the idea of a review group for oncology products, we're also concerned that this program will be another cost-containment process and this time aimed directly at cancer patients. That, of course, is not acceptable.

If the object is to bring equality to the approval of cancer drugs across the country, it must not be done at the expense of providing fewer medications to all patients. We should be looking to improve patient access to these new technologies that provide hope where none existed before.

Canadian cancer patients expect that they will receive the most effective medications, and in a timely manner, not simply based on the cost of these medications, but on the ability of these medications to extend their lives, improve the quality of their lives, and to produce better outcomes.

With respect to wait times, the Colorectal Cancer Association believes that a faster review process--not a less safe process, but a faster process--would result in fewer lives being lost to treatable diseases.

From the international perspective, we feel that the need to duplicate reviews already done in other countries is unnecessary and that an international joint review process would be more efficient. We feel there should be a harmonization of approval processes with other jurisdictions such as Europe and the United States. We could avoid delays and duplication by doing so.

In addition, we feel that all Canadians would benefit from having a unified drug approval process within Canada. That includes simultaneous approval of the processes of Health Canada and the provinces, to eliminate the consecutive wait times between Health Canada, whether it's the CDR or JODR, and the eventual provincial determination for eligibility for reimbursement. These delays, resulting from the different stages of approval, represent unnecessary roadblocks in the timeline of the treatment of cancer patients--needless to say, I reflect colorectal cancer patients today--where every day counts.

On a personal note, having had metastatic colorectal cancer since 1995, both to liver and to lungs, and having had to seek out-of-country health care to fight my disease at the same time as fighting in the Quebec courts for reimbursement, I know what it means to wait for treatment. I can tell you, it's no fun.

We believe we are at a crossroads in patient access to effective treatment in Canada. As newer biologics and small molecules and other expensive cancer treatments are used in the battle against cancer, provinces are struggling to determine whether they should cover these costs--whether or not they form part of the prescribed treatment guidelines.

At present the reality is that while patients in some provinces are already fortunate enough to have access to some of these new treatments, patients in other Canadian regions are forced to either pay the high costs of these medications--and you've heard some of those costs today, $35,000 and so forth--or they forego the treatment altogether. That, of course, is not acceptable.

We are saddened when we see patients across the country who are not receiving the optimal treatment for colorectal cancer in accordance with treatment guidelines because our governments are not reimbursing cancer treatments such as Avastin. As well, it is virtually impossible to get insurance in order to cover these types of medications. Just so we're in the same ballpark, when I refer to Avastin or bevacizumab, I'm talking about the same class of new antiangiogenics or tyrosine kinase inhibitors that Dr. Knox was talking about with Sutent.

We are just as saddened when we see the pharmaceutical companies that are not even launching effective treatments due to an inability to reach a price agreement with the Patented Medicine Prices Review Board, PMPRB. That was the exact case with Erbitux, and some of you may know it as the Martha Stewart drug. This drug was not launched in Canada because no price agreement could be reached.

Access to effective treatment should not be a matter of patients' financial resources. If the public purse cannot afford to provide treatment with existing resources, then alternate mechanisms must be found to ensure that Canadians are equally provided with the best possible treatments in a timely manner. However, access should not be equality at the lowest level. Canada must strive to achieve equal and timely access to effective treatments with the bar set as high as possible.

While patients may be prepared to accept the idea of setting limits on public funding of cancer medications, we feel that present limits are not acceptable and that it is not satisfactory to base approval purely on the costs of these medications. Broader social values must be incorporated.

Admittedly, it is difficult to find a consensus on setting limits to funding cancer drugs. However, the CCAC believes that any decision of funding must be evidence-based and benchmarked to other jurisdictions. It should be fair, transparent, and rational, and the review process must be simplified.

It is interesting to note that several participants at our round table conference felt that limits should not be set on cancer drugs, as they form a very small portion of the overall drug budget. As well, it was pointed out to me that in about two years, several of the major drugs that occupy a large part of the entire drug budget will soon come off patent, thereby adding the capacity to cover these new and expensive medications. In case you don't know what I'm referring to, some of the anti-cholesterol drugs and so forth that occupy about $1 billion of our drug money will be coming off patent, and we'll have an extra $500 million. You'll be able to say what a good job we all did because we have all this new money in cost containment. But the truth of the matter is, it won't necessarily have been from cost containment; it'll be from these drugs coming off patent.

Several groups at the round table conference also felt we had to get beyond the silo mentality of funding cancer drugs. The cost savings from other programs, such as prevention programs, etc., would make more money available for cancer drugs.

While opinions may vary on how limits for cancer drug funding should be set, as you've heard today, it was unanimous at our round table that there was an essential requirement for openness, fairness, transparency, and, perhaps most of all, accountability, as well as a greater public engagement at every level of the approval process, including the set-up of the process itself.

Patients cannot accept the refusal of the funding of medication if they do not understand the reasons for the refusal. This was one of the greatest criticisms of the CDR, and we hope this problem will not occur with the JODR.

If limits are set and certain medications are not to be covered, then patients must be provided with alternate mechanisms of funding for these medications. Failure to do so will mean Canadians will have to leave the country, as I did, to obtain standards of care for the treatment of colorectal cancer or other cancers in general.

There is an openness in Canada to discuss new and novel ways of funding to ensure that Canadian patients are not deprived of live-saving or life-prolonging medications. The round table produced some interesting and sometimes novel suggestions. For example, there could be shared costs of treatments for a period of time between pharmaceutical companies and provinces, whereby pharmaceutical companies would pay two cycles of treatment and, if the benefits were conclusive, the hospital or province would carry on with the rest of the payments.

Private insurance plans are seen as a major way in which access to medications could be increased. There is a growing consensus in this regard. For example, we could develop an expanded program based on what we have in Quebec. Employees are covered by private group plans, and when they don't have this coverage, the state then takes over.

Another possibility would be the setting up of a special federal cancer drug fund to assist provinces in the cost of these new and expensive technologies. This would encourage equality of access to all cancer medications across the country.

In conclusion, the common drug review or similar processes, such as the JODR, can only succeed in benefiting Canadians if they are committed to saving lives, improving the quality of patients' lives, and prolonging lives, rather than the emphasis being on cost containment.

Thank you.

[The Chair, Conservative, Rob Merrifield]

Thank you very much to all the witnesses.

We'll now move to the question and answer part of our meeting.

We'll start with Ms. Kadis. The floor is yours.

[Susan Kadis, Liberal, Thornhill, ON]

Thank you, Mr. Chair.

Thank you for your presentations today.

To your knowledge, has it always been that cost containment was the driving force in terms of what was covered and what was not covered previous to the JODR or CDR? Is this a new element?

[Barry Stein]

Is that question to me?

[Susan Kadis, Liberal, Thornhill, ON]

It could be, yes.

[Barry Stein]

My understanding is that was actually the point of having a CDR. Of course, while we wanted expert advice and the best advice to be distributed through a panel such as that, as far as I understood it, the emphasis was on advising the drug plans when to make these financial decisions. In other words, it's cost containment.

[Susan Kadis, Liberal, Thornhill, ON]

But is this a new element? Has it become more emphasized within the CDR and potentially the JODR?

[Barry Stein]

I think it started with the CDR. Well, it actually started in each individual province, with their individual plans. The provinces then got together and created the CDR.

[Susan Kadis, Liberal, Thornhill, ON]

I'm particularly concerned here, listening today.

I think there was a reference by Dr. Knox. In comparison with other countries internationally, I think you laid it out pretty well in terms of new therapies, which are really a new frontier. We listened to Dr. Susan Love several years ago. It's really coming to the forefront that people will increasingly live with cancer as opposed to dying from cancer. I think it's what you were getting at.

My concern is that Canada will not be a leader in this area. I'm hearing here that it's not the direction we're going in.

[Barry Stein]

One of the things I have to point out is that we are entering into a new era in the treatment of cancer with targeted therapies. Of course, there's a very expensive price tag that goes along with that. If we want to have access to these drugs, we have to find ways of funding them. Needless to say, in situations where pharmaceutical companies are not able to manage a proper return on their money, they don't even launch them, and that's what's happened in one case, at least.

To make a long story short, I think what's happening right now is we're entering into a new era, and we're faced with these high costs. For example, when I was first diagnosed with colorectal cancer the treatment was 5-Fluorouracil, and they were deciding whether to add a couple of components--Levamisole or Leucovorin. We were talking $500 a patient to start off with. Now we could be talking $150,000 patient for the full course of treatment. That's probably what started the ball rolling, but at the end of the day, that doesn't mean we should deprive Canadians of this newest technology, which actually is making a difference.

I'll point out that one of the slides that Dr. Jean Maroun has raised at our parliamentary breakfast on numerous occasions is childhood leukemia. If we don't continue to make these advances and progress along the way, we'll never get the cure.

[Susan Kadis, Liberal, Thornhill, ON]

Dr. Knox, can you comment on the issue of how we are comparatively throughout the world in terms of these new therapies?

[Dr. Jennifer Knox]

I think the point was made that up until very recently, as I said, we were doing very well. It's really just in the last couple of years...and the first really significant drug would be Avastin, which came along and prolonged life in colon cancer. It came at a big price tag, and that was the first decision that surprised us all a bit, that these weren't going to be covered. Four years ago we were doing just fine, relatively speaking, but in the last few years we've really been sliding off the curve.

I made this impassioned plea for kidney cancer basically because not only are these very good drugs, but they're the first. They're not “me too” drugs. They're not just adding a little something to what we already have for kidney cancer. We're going from nothing to these ones. I think we were all caught a little off guard that this was not found to be adequately cost-effective.

I know we're talking about a big picture here in terms of trying to find a way to sort out how we can afford these things and move forward as a first world country, but I think we also have to go back and fix these two recent problems. I would really hope that something could be done to get the provinces to fund those right now.

Sorry, I'm not answering your question, but yes, we are starting to be at real risk of not maintaining a first world standard of care in oncology--we really are.