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.