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--