Good afternoon, Mr. Chair and members of the committee.
I'd also like to thank you for inviting us back for a second appearance, and I hope we can help you and contribute further to your study. I am Dr. Jill Sanders, the CEO and president of CADTH, and I'm joined today by Mike Tierney, vice-president responsible for the common drug review, here to answer any additional questions.
As Mr. Wright has already noted, over the past few weeks this committee has heard various points of view from a wide range of groups and individuals regarding the common drug review. It continues to be our position that the CDR program is not only working but it is working very well, and this position, as you've just heard, is supported by the federal drug plans, the 13 provincial and territorial jurisdictional stakeholders, and the majority of the independent experts who have appeared before you.
Yes, there are challenges in this complex and crucially important element of the drug reimbursement continuum in Canada, but I am pleased to note that throughout the past three-year history of the common drug review, it has shown it has made changes and it will continue to evolve to meet the challenges on behalf of Canadians.
I'd like to take a minute just to reiterate the critical elements, the critical stages of the CDR process, because I feel this is important to provide context for some of the other remarks I will be making.
As you know, the process starts with a drug manufacturer making a submission for their new drug to the CDR, and that includes clinical data and an economic evaluation.
The CDR program then establishes a review team of both internal and external experts that include clinical specialists with direct expertise related to the drug under review. This review team is engaged at all stages of the review process. Using vigorous and universally accepted processes, the review team conducts the independent systematic review of the available published and unpublished clinical evidence, and it appraises the cost-effectiveness of the drug, including both cost and value to Canadians, based on the economic model provided by the manufacturer.
The manufacturer is then provided with a copy of the reviews for comment and the CDR responds to any of the manufacturer's comments.
CEDAC, which is the independent committee that makes the recommendations comprising its clinical and scientific experts and two public members, reviews the noted materials and makes a listing recommendation. The members of that committee are nominated and selected by a national nominating committee, which ensures a balance of expertise, including medical, scientific, clinical practice, economic and evaluation expertise, and public representation. The membership of CEDAC is not selected along geopolitical lines.
CEDAC itself may also choose to call upon some experts who may not have already been called to the process, and they may also ask for additional information to be brought forward if they feel there is a need.
The CEDAC recommendations and reasons are sent to the manufacturer and the drug plans in confidence ,and we have what we refer to as an embargo period, during which the manufacturer may request a reconsideration based on specified criteria and the drug plans can ask for a clarification. The final recommendations and reasons are sent to the manufacturer and drug plans and released publicly, or if a reconsideration is requested, CEDAC undertakes this process.
I hope you find this quick summary helpful in demonstrating very briefly that the CDR process affords equal opportunity to all parties to have extensive input into the process--the manufacturer, the drug plans, the experts, and the expert advisory committee that comprises some public members.
This notwithstanding, it is still important to ask if there is room for more improvement. Our response would be yes, of course. In fact, under the leadership of Minister Clement, the co-chair for the FPT Ministerial Task Force on National Pharmaceutical Strategy or the NPS, many of the areas of improvement sought by those appearing before this committee have been identified in the NPS report that was issued last September.
This NPS report sets out clear recommendations, all of which are aimed at further harmonizing reimbursement decision-making among the federal, provincial, and territorial jurisdictions and thereby supporting more consistent access for Canadians to safe and effective drugs.
The framework for action outlined in the NPS report will guide much of the future work for CDR. Nonetheless, we continue to be open to exploring different avenues for improvement of the ongoing work on behalf of Canadians.
Chief among these is the issue of increased transparency. The CDR has, as Mr. Mr. Wright has just noted, set new standards of transparency for drug reimbursement in Canada and internationally. We still continue to make enhancements in transparency. As Mr. Wright has noted, work is well under way to implement the initiatives arising from the evaluation of fall 2005.
In addition to these concrete measures already in progress, we remain open to other possibilities to increase transparency and will take forward options for consideration to the participating drug plans. These may include, for example, consideration for industry, patients, and other stakeholders to play a role in the CEDAC process, and a review of the current reconsideration, or what some would term “appeal”, process.
It is important when considering these potential changes that the aggressive CDR timelines, which facilitate timely patient access and have all been met to date, are not compromised. In addition, there are cost implications, and these must be evaluated with the participating jurisdictions.
It is equally important to note that transparency must be applied to all sides of the equation, as Mr. Wright has noted, if we are to improve on current processes. In other words, and as briefly mentioned, industry submissions to both Health Canada and CDR should be made public. The justification for the price of individual drugs should be provided, and patient advocacy groups and those who develop clinical guidelines should disclose the nature of their relationship with the industry.
A second area I would like to speak about is the concern expressed by the pharmaceutical industry and their patient advocacy partners regarding access to innovative drugs and drugs for rare diseases. It has been said that CDR is a barrier to access of new treatments for patients. The fact is that in the five years prior to CDR, the largest drug plan in Canada--the Ontario drug benefit program--approved approximately 44% of the drugs they reviewed, which is just slightly lower than the 50% average that CDR has to date. These numbers are similar enough within the statistics to be considered very equal. The drugs recommended by CDR have also included new biologics for rheumatoid arthritis and psoriasis, seven HIV/AIDs drugs, three cancer drugs, and a new drug for life-threatening infections. In other words, the facts do not support the stated claim that CDR is a barrier to new treatments.
Further to the matter of access, I know you're aware that comprehensive recommendations to address this issue were contained in the NPS report. We will continue to work with the NPS to achieve its stated objectives pertaining to increased access, including a common national formulary; a national framework for expensive drugs for rare diseases, which we would like to see developed sooner rather than later; and post-market surveillance.
Once these directions and policies have taken place, many of the concerns you've heard about in the course of your study will have been addressed. However, you have been led to believe that CDR is the root cause of all of these issues. This is simply not true. The CDR is just one player, and as I believe you'll appreciate, it will take all of us working together to address these important issues. For its part, CDR is very willing and would look forward to continuing to work with the industry to establish how clinical trial evidence and economic analyses for drugs serving small populations can be best produced and then utilized in the drug reimbursement decisions. In other words, if we work together, it will be to everybody's benefit.
A third area of criticism you have heard repeatedly is that CDR is only about cost containment. Again, I feel it's necessary to set that record straight. The health outcomes of the target population group of the drug in question are of paramount importance when CDR undertakes a review. Cost-effectiveness is considered only once improved health outcomes have been demonstrated. And to be clear, our cost-effectiveness assessment does look at other costs within the health care system, such as doctor visits and hospitalization. And importantly, CDR does look at improvement in survival and quality of life for Canadians.
You've heard the testimony of at least two independent international experts that Canada is a recognized world leader in how it conducts its drug reviews because the CDR focuses on costs less than all countries except the U.K.
When Steve Morgan from the University of British Columbia appeared here as a witness, he responded to the statement that was made, that CDR is solely preoccupied with cost containment, and I quote: “Although CDR is criticized for that, I think it's patently incorrect, because Canada is one of the exceptions to the extent that it focuses on science rather than economics.”
At the end of the day, what the analysis must show is whether a new drug is clinically superior to existing comparable therapies and whether it represents good value for Canadians and the health care system. It is the full picture that is assessed, and we believe this is what the public, as taxpayers and patients, would expect.
The last area I will touch on relates to timely access. The CDR continues to meet the aggressive timelines established for it, and we're not a barrier to access. The CDR process currently makes up about one-third of the total time from a submission to Health Canada for licensing to a listing decision within a public drug formulary. CDR has no influence or control over the Health Canada licence approval timelines nor the drug plan decision timelines.
This said, we are continually looking at ways to build more efficiency into our system, and as a result, for example, CDR will continue to streamline its processes for less complex drugs. We will continue to work with Health Canada on collaborative review processes, and we will continue to encourage industry to make their submissions to us in a timely fashion.
These are just the beginnings of initiatives we at CADTH intend to carry out. As I've already noted, throughout the short history of the CDR, it has been shown that we have evolved and will continue to evolve to meet new challenges on behalf of Canadians.
If there has been one unifying thing during the past few weeks of often conflicting presentations, it is that the demands placed on Canada's publicly funded health systems in Canada are enormous. At CADTH we understand that achieving the balance of optimized care, accessibility, equity, affordability, and sustainability for all Canadians is every government's goal. This naturally means that difficult decisions must be made throughout the system. The CDR has played a positive role in assisting with the critical decision-making around pharmaceuticals.
At the recent CADTH symposium, Steven Fletcher, Parliamentary Secretary to the Minister of Health, addressed the reception on behalf of Minister Clement. Mr. Fletcher noted, and I quote:
Canada's new government is committed to supporting work to ensure that emerging technologies are not only safe but also effective and cost-effective. While most new drugs and technologies hold significant promise, it is important that we invest wisely in those products that can bring the greatest improvements to the health of Canadians.
We couldn't agree more. This statement speaks to the very core of CDR and its value to the Canadian health care system.
Before I conclude, Mr. Chair, I would ask if it's possible for you to take a few moments to tell us what the next steps are, the timelines, and what expectations you might have from us as the process moves forward.
Finally, thank you very much for your time. Thank you once again for inviting us back. As always, we're happy to answer questions. Thank you.
