Alex Shved is 37. He has metastatic melanoma, a wife, and two daughters under two. His cancer has progressed through several treatments. He is now fighting for access to lifileucel, a therapy that takes immune cells from a patient’s tumour, expands them, and returns them to fight the cancer.
Most of the attention has gone to Ontario’s decision to deny out-of-country funding. What caught my attention happened earlier.
Shved’s oncologist recognized that he could be a candidate for the therapy. Lifileucel has been authorized for sale in Canada, though Ontario does not yet fund it. The oncologist raised it anyway, explained why it might matter, and applied for funding so Shved could receive it in Florida. The full account was reported by Allison Jones of The Canadian Press.
That is good oncology.
I do not know the oncologist’s name, but I am impressed by the care behind that decision. It takes clinical confidence to tell a patient about an option the health system cannot yet deliver. It also takes generosity. The conversation may create frustration, more paperwork, and a fight the clinician knows they may lose. This oncologist had it anyway, because the patient deserved to know.
The awkward conversation
I have had versions of this conversation many times.
A treatment receives authorization from Health Canada. Canada’s Drug Agency may issue a positive reimbursement recommendation. Provincial funding has not arrived. Sometimes the manufacturer provides free or subsidized access while the process moves forward. Sometimes there is no program. Sometimes the program ends before public funding begins.
These are uncomfortable conversations. You may be telling someone that a relevant treatment exists and then explaining that you cannot give it to them. I understand why a clinician might focus on the options that can be delivered today. There is only so much uncertainty a patient can carry, and adding an inaccessible treatment can feel more frustrating than helpful.
There is also a cost to leaving it out.
A formulary tells us who will pay for a treatment today. It does not settle every clinical question. The patient may still want to understand whether the treatment fits her disease, what it might offer, and whether there is another route to access it.
Dr. Joel Lexchin, a professor emeritus of health policy at York University, told The Canadian Press that it takes an average of 730 days for a treatment to move from Health Canada authorization to a provincial funding decision. Some of that time belongs to government review and negotiation. Some depends on when the manufacturer submits its applications.
For a patient with progressing cancer, those are months in which the disease may change. Someone fit enough for a cellular therapy today may no longer be fit enough when the funding process ends.
What uptake numbers leave out
A recent Canadian study looked at 124 patients who met the trial criteria for adjuvant pembrolizumab after kidney cancer surgery. Fifty-two percent were referred to medical oncology. Just over 19 percent received at least one dose.
At first glance, that looks like straightforward underuse. The rest of the data makes the picture more interesting. Among the referred patients who did not receive pembrolizumab, 63 percent declined after an informed discussion with their oncologist.
That is a useful distinction. A patient who hears the numbers and declines has made a decision. Treatment was considered and the answer was no. Uptake data records only that the drug was not given.
We cannot assume that every patient who was not referred missed the conversation. The study cannot tell us everything that happened in each clinic. It does show how little the final prescription count tells us about the decisions that came before it.
Was the option presented? Did the patient decline? Was the expected benefit too small? Was treatment clinically unsuitable? Was access the barrier?
Those questions matter more than the prescription count alone.
A new kidney cancer decision
Kidney cancer gives us a current example.
In June, the FDA expanded the indication for belzutifan with pembrolizumab after surgery for certain patients with clear-cell kidney cancer at increased risk of recurrence. The phase III results were published in July.
At two years, 80.7 percent of patients receiving the combination were alive without recurrence, compared with 73.7 percent receiving pembrolizumab alone. Grade 3 or higher adverse events occurred in 52.1 percent of patients receiving the combination and 30.2 percent receiving pembrolizumab alone. Overall survival has not yet differed significantly. The results were published in the New England Journal of Medicine.
I can see why a patient would be interested. I can also see why she might hesitate. The combination produced a seven-point difference in disease-free survival at two years, with considerably more serious toxicity and an unanswered overall-survival question.
We recently added the pembrolizumab and belzutifan option, with its supporting evidence, to Precision Path: Kidney. The system applies that evidence to the individual patient’s recurrence risk. A patient near the lower edge of eligibility is having a different conversation from someone with a much higher baseline risk.
The treatment may not yet be funded where she lives. The information is still relevant to her decision.
What the conversation makes visible
Clinical decision support can keep emerging options in view as their evidence, regulatory status, and funding status change. It can also record when an option was presented, how much benefit it might offer the individual patient, what the patient decided, and whether access stood in the way. Across many patients, those discussions begin to show clinically meaningful demand before prescription data can capture it.
A utilization count of zero tells us very little when a treatment is unavailable. There may be few eligible patients. Clinicians may find the benefit unconvincing. Patients may decline after understanding the tradeoffs. They may want the treatment and have no way to obtain it. A structured record helps separate those possibilities. It also gives a fuller account of the care: the option existed, it was considered, and the reason it was not used is clear.
That brings me back to Shved’s oncologist. They looked beyond the treatments currently funded in Ontario and gave their patient an honest account of the option they believed was relevant. I am impressed by that. The conversation did not secure the treatment, though it gave Shved the information needed to pursue it. It may also help make the unmet need visible to the people deciding whether the next patient will have access. Funding can lag behind the evidence. Patients should still be allowed to know what the evidence says.
Dr. Henry Conter is a Medical Oncologist and Hematologist at William Osler Health System and the founder of Kesis & Sisters. He trained in Medical Oncology at MD Anderson Cancer Center and spent six years at Hoffmann-La Roche in progressively senior roles spanning oncology clinical development, portfolio strategy, and medical and regulatory affairs, across both national and global functions.