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.