Molecular Imaging Task Force urges Ontario to ensure health system is ready for era of personalized medicine
Ontario is establishing itself as a world-leader in cancer genomics research, but the province needs to do more to ensure its health care system is ready to take full advantage of advances in molecular oncology.
Ontario’s Molecular Oncology Task Force released its report and recommendations on January 26. The report’s authors noted that genetic testing for cancer holds a lot of promise – it is one of the important biomedical advances flowing from new knowledge about the human genome that will allow doctors to tailor therapies to patients’ individual genetic characteristics, allowing for more effective treatments and fewer side effects. These advances are collectively known as personalized medicine.
Molecular oncology refers to the application of genetic knowledge to predict a patient’s predisposition to cancer, to diagnose and monitor cancer or predict prognosis, or to improve cancer treatments with personalized therapies. There are three main types of genetic tests, two of which are relevant in oncology: cytogenetic tests, which involve analysis of chromosomes; and molecular tests that analyse DNA and RNA. (The third type, metabolic tests involving proteins and enzymes, is used in other areas of medicine, but not yet widely used in oncology.) Over the past half-decade, there has been a rapid growth in the number of molecular oncology tests available to doctors and there are many more tests on the horizon.
The task force recommends that Ontario promote translational research to accelerate development of personalized diagnostic tools and therapies. Their report praised the Ontario Institute for Cancer Research (OICR) and called on other Canadian funding agencies to follow the Institute’s lead in promoting and funding research projects that “translate” basic science for use in the clinic.
“Our goal is to bring 100 per cent of discoveries to patients in Ontario. At OICR, we understand the need to do the translational research that will get these discoveries to patients, and we have committed to recruiting four pathologists who will help move this work along,” explained Dr. Tom Hudson, OICR’s President and Scientific Director of OICR, at a media event to announce the task force’s recommendations. “In Ontario, we’re doing some of the best cancer research in the world. We want to close the gap between this research and what’s happening in the clinic.”
The report also notes that for some types of cancers, use of molecular diagnostic tools is already standard practice.
“Molecular oncology is no longer a vision for the future, it is reality. It’s what we’re using in the clinic today,” said Dr. Suzanne Kamel-Reid, chair of the task force. “Health professionals are excited about using advances in molecular oncology to provide the best care possible, but we’re finding that the system hasn’t kept pace with the advances in genetic and molecular testing.”
Once new tests are introduced, use of them tends to grow steadily for several years. To keep pace with the increase in demand, hospital-based laboratories throughout the province have increased both their capacity and the range of tests they offer. The laboratories are provincially accredited to ensure quality standards are maintained, but there has been little co-ordination and planning as new tests have been introduced.
The task force found there is no clear path for evaluating new tests and bringing them into clinical service, meaning that there is no standardization across the province for determining which tests should be offered. As new tests are introduced to the clinic, it is often up to individual doctors to make decisions about which ones to offer to patients. This system can also lead to under-referral for genetic testing, since there is no central source of information for doctors outlining which tests are available.
To solve this problem, the task force recommends Ontario immediately establish a provincial oversight body for molecular oncology services in Ontario, which would be responsible for system-level planning and advising stakeholders on approval of new tests and de-listing of obsolete ones, as well as other issues related to molecular oncology. It also recommends the province establish and fund an information-sharing system for referring physicians.
The task force also looked at quality assurance. At the news conference to announce the recommendations, the President and CEO of Cancer Care Ontario, Terry Sullivan, explained that Ontario’s clinical laboratories are already covered by a solid quality assurance system. Existing protocols would prevent the types of serious errors in basic laboratory testing that have drawn much attention – and criticism – to the cancer systems in other provinces, most notably Newfoundland.
However, molecular testing is a relatively new field, with fewer established standards and best practices than other laboratory services. With dozens of new tests being invented each year, it is difficult to track which laboratories are conducting which type of test, and even more difficult to determine whether they have the proper equipment and qualified personnel. The task force recommends that the government implement a mandatory approval process for each type of test to ensure only accredited laboratories with credentialed personnel perform clinical testing.
To ensure compliance, the task force proposes that any new standards be tied to funding, which is standard practice for other regulations in the health care system. They also recommend the government develop a comprehensive and competitive approach to funding to achieve the best value for dollars spent on molecular oncology. The task force estimates that Ontario spends approximately $32 million each year on molecular tests, but they caution this number is likely an underestimate, and is certain to grow as demand continues to increase.
Ontario’s funding model should be responsive to fluctuations in demand for services, and incorporate the cost of risk assessment and genetic counselling into budgets for genetic testing, the task force said. It should also take into account the increasing strain that molecular tests are putting on hospital budgets, particularly when the tests are tied to new drugs.
“More and more often, we’re seeing indications for new drugs that are tied to biomarkers. This means they require molecular testing to determine whether the patient will benefit or is at risk of side effects,” explains Tom Hudson, President and Scientific Director of OICR. “This allows for more precise treatments, and it also eliminates unnecessary side effects and costs to the health care system.”
However, funding for new treatments only covers the medication itself, while any associated testing is covered by the hospital’s global budget. If a patient is prescribed an expensive new treatment, the hospital is usually not affected because the province covers the cost of the drug. But if a new drug requires an expensive molecular test, the hospital could find itself with an unexpected expense.
“We found that the current funding model is not sustainable,” said Kamel-Reid. The task force recommends that the government look closely at this issue and consider strategies for remedying the situation.
Concrete benefits
To illustrate the benefits that existing molecular tests can bring to patients, the task force invited Richard Field, a cancer survivor from Oakville, to share his experiences at a news conference announcing the recommendations.
“For me, molecular tests were an important stage at every step of my diagnosis and treatment. First, they established that I have leukemia. Then another test determined I could not receive a bone marrow transplant,” he said.
Field enrolled in a clinical trial and was placed in the control group that received the standard treatment rather than the drug being studied. More molecular testing showed the standard treatment wasn’t working for him, so his oncologist had him switched to the study group, which meant he would receive a promising new drug called Gleevec.
“After more molecular testing, it became apparent that the disease was starting to change course. Based on these tests, my doctors advised me that my prognosis had started to change,” Field said.
All of the 14 people who started the Gleevec trial, including Field, were not expected to survive. However, several years after the end of the trial, five people of the patients are still alive. Their disease isn’t cured, but it has subsided to the point that they can live as though they are disease-free. “I know that when I die, I will still have leukemia – but I will not die from leukemia,” he said.
(Gleevec has since been approved in Canada and other countries as a first-line treatment for leukemia.)
The task force recommends that Ontario:
1. Immediately establish a provincial oversight body for molecular oncology services to oversee system planning for these services in Ontario; and to advise key stakeholders on test approval, delisting of obsolete tests,
funding, licensing, accreditation, credentialing, quality assurance, location of services, and to ensure
alignment of oncology services with all other genetic services.
2. Implement a mandatory approval process for each genetic test performed by laboratories in Ontario and administered by the appropriate regulatory agencies to ensure that only appropriately accredited and
licensed laboratories with credentialed personnel are reporting and interpreting laboratory results that impact patient care.
3. Ensure that each genetic test performed by a laboratory meets rigourous quality assurance criteria and is regularly subjected to proficiency testing (external validation).
4. Establish and fund an existing or new information-sharing mechanism to ensure that critical information
is readily available to referring physicians and the public regarding availability of tests, how to refer, what data the test will yield, its limitations, patient eligibility criteria, specimen handling guidelines, and clinical
management.
5. A comprehensive and competitive approach to funding should be established that addresses dynamic volumes and variation in complexity of testing and clinical care, as well as the costs associated with risk assessment and genetic counselling. Funding should capture province-wide utilization of testing and clinical services and be linked to quality and utilization data.
6. Promote translational research and establish an “advance notice” process to ensure the system is prepared
to implement new tests and technologies when evidence warrants.
