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"A decision for CAR-T is a decision about patient access to a potentially life-saving therapy," says Dr.
Jennifer Bell, Senior Bioethicist in the Department of Clinical and Organizational Ethics at UHN.
"It cannot be taken lightly."
Chimeric antigen receptor T-cell therapy (CAR-T) is a breakthrough therapy for the treatment of advanced blood cancers. It has the potential to cure or prolong the patient's life expectancy when facing a dire situation with no other treatment options.
However, barriers, such as the steep cost, the need for specialized resources and a limited number of treatment centres, prevent CAR-T from being used widely.
A study from UHN researchers,
Mitigating inequity: ethically prioritizing patients for CAR T-cell therapy, explores creating a fair path for patients in need of CAR-T. Equity in cancer care is an important issue in Canada and globally, and is the theme of 2024 World Cancer Day on Sunday, Feb. 4: "close the care gap."
In Ontario, only three centres, including Princess Margaret Cancer Centre, provide CAR-T therapy for adult patients. Several CAR-T products, which cost about $500,000, can be covered by Ontario Health funding if the patient meets the eligibility requirements set by Health Canada, but the clinical care cost remains substantial.
Resource utilization is high, with the need for inpatient beds, cell collection and laboratory processing facilities, specially trained clinical care staff, high-cost medications to combat side effects, staff to oversee cell-related quality control, and more.
Last year, 60 adult patients at the Princess Margaret received the therapy, and demand is on the rise.
'Urgent need' to decide on formal process to review patient priority
Apart from high institutional resource use, CAR-T manufacturing may also pose a challenge.
Eligible patients with approved funding from Ontario Health need to have their T cells collected at one of the three centres and shipped to a manufacturing location in the United States. The T cells are genetically engineered into CAR-T cells with the ability to target a patient's cancer cells before they are shipped back and infused into patients.
As demand for CAR-T treatment outpaces manufacturing capabilities and health care infrastructure, this creates a dilemma for clinical care providers at cell therapy programs, forcing them to decide which patient receives the next coveted treatment spot.
"Currently, there is no clear prioritization framework," says Dr.
Christine Chen, Clinical Director of the Cell Therapy Program at the Princess Margaret and a clinician investigator at the cancer centre. "Oftentimes, the patient who gets pushed to the top of the list for the next spot is the one with the most vocal advocate.
"There is an urgent need to set up a formal process to review all the factors that should be weighed when deciding on priority."
Researchers at UHN, led by Drs. Jennifer Bell and Christine Chen, have identified these factors and proposed a three-step ethical process to help equitably prioritize patients in need of CAR-T.
The first step of the process starts with medical experts at the disease site assessing the medical benefits of receiving CAR-T based on specific patient conditions.
If there is any potential for any medical benefits, then the second step is to evaluate the patients' safety risk for potential adverse effects and identify psychosocial factors that might be barriers for patients to adhere to the therapy.
Typically, after infusion of CAR-T, patients need to spend one to two weeks in the hospital and then at a place close to the hospital for at least 30 days to monitor adverse effects.
"The psychosocial part includes considerations such as, if this patient needs caregiver support and whether they need extra translation support etc.," says Dr. Bell, who is also a clinician investigator in the Department of Supportive Care at the Princess Margaret. "We are very fortunate to have excellent social work resources at the Princess Margaret and we are working collaboratively to address these issues."
The third step is a final discussion for prioritization, using the factors weighed in each prior step, but also incorporating medical urgency, such as how fast the patient is deteriorating. This discussion is performed at a weekly gathering of a multi-disciplinary Cell Therapy Review Committee to allow for a transparent and fulsome discussion of all patients awaiting CAR-T.
"This process is not meant to determine access or exclusion from CAR-T, but rather to prioritize the order in which patients proceed," says Dr. Chen, who is also an associate professor in the Department of Medicine at the University of Toronto (U of T). “For example, someone with a high likelihood of cure with a rapid pace of disease who is fit and functional, might jump ahead of someone less fit, perhaps suffering from prior chemo toxicities, and requiring optimized care before CAR-T."
Diverse working group helped develop three-step process
The new ethical framework was built upon an approach called Accountability for Reasonableness (A4R). A4R can guide decision-making and bring procedural justice in the context of resource scarcity.
"We live in a pluralistic society, where different people have different values and it may be hard to come to an agreement about what values should govern decision-making," says Dr. Bell, who is also an Education Investigator 2 at The Institute of Education Research (TIER) at UHN, and an assistant professor in the Department of Psychiatry and member of the Joint Centre for Bioethics at U of T. “What we can do is engage in a fair and democratic process to arrive at a decision.
"A4R is a process to make sure different voices and perspectives are being heard to identify criteria for decision making. It has been used extensively in other health care situations such as vaccine allocation during the coronavirus pandemic."
The team developed the three-step ethical process by gathering a diverse working group, including cell therapy team members, clinicians, social workers, nurses, pharmacists, trial physicians, lab staff, operations and Foundation staff, who collaboratively identified key criteria for prioritizing patients. A separate patient focus group was held to make sure patients felt comfortable sharing their voices.
"Adopting a framework guards against potential biases of clinicians and promotes a process considering what is fair for everyone, all things considered," adds Dr. Bell. "It strengthens patient trust in the health care system by ensuring decision-making is fair and transparent, that it is inclusive of patient input and provides the opportunity for appeals."
The researchers are sharing these decision-making tools openly, encouraging other institutions to adapt them for their unique circumstances. The goal is to promote justice in resource allocation for all potential CAR-T candidates in Canada and globally, fostering further research in this area to support fair access to life-saving therapies.
The team is working on bringing the framework into clinics and evaluating its usability.
"We hope this framework can enhance a national discussion so that it doesn't matter if you are in northern Manitoba, or if you are in downtown Toronto, you have equitable access to CAR-T cell therapy in Canada," says Dr. Bell.
This work was supported by UHN Foundation.