A new, last-hope prostate cancer treatment has been approved by Health Canada but may be out of reach for most of the more than 4,500 men who die of the disease each year.
To make things worse, if the drug gets funding approval at the provincial level, our health-care system may not have the capacity to manage the anticipated wave of prostate-cancer imaging and treatment requests … unless you live in Quebec.
In August, Health Canada approved a new treatment, marketed as Pluvicto by Advanced Accelerator Applications Inc., a Novartis company, for men with advanced stage prostate cancer who are no longer responding to standard therapy.
Almost all prostate cancer cases are in men older than 50 and most are diagnosed in early stages, resulting in a five-year survival rate of more than 90 per cent. However, given its ubiquity – one in nine men are afflicted in their lifetime – it remains the third most common cause of cancer death in men after lung and colorectal cancers.
Despite Health Canada approval, Pluvicto, which is sold for as much as $27,000 a dose for a six-dose treatment cycle, is limited due to national and provincial drug reviews and funding processes.
Pluvicto belongs to a new class of drugs called theranostics that combine two components: one, the ligand, binds to cancer cells and the other is a radioisotope.
By exploiting immunology, theranostics allows medical personnel to see the tumor, treat it and see if it has responded to treatment. For prostate cancer, the ligand is a prostate specific membrane antigen that binds to prostate cancer cell membranes. Different radioisotopes can be added to the antigen to either image or treat the patient. Pluvicto is the treatment.
Pluvicto is administered by intravenous injection once every six weeks for up to six treatments depending on how well the patient tolerates and responds. Patients can go home after the injection and are given instructions on how to minimize radiation exposure to those around them.
Men treated with Pluvicto lived about four months longer, took about five months more to develop symptoms and had slower growing tumors, according to a study published in the New England Journal of Medicine.
The concept of “immunologically targeted” therapy has been around for more than a century. The 1908 Nobel Laureate Paul Ehrlich proposed immunological defence mechanisms against bacteria. He coined the phrase “magic bullet” that, along with personalized medicine, has now been applied to theranostics.
Pluvicto is being reviewed by the Canadian Agency for Drugs and Technology in Health (CADTH) with Feb. 16, 2023, the deadline for stakeholder feedback. CADTH will recommend whether the drug should be publicly funded.
Health Canada has approved Pluvicto and it can now be marketed. The Patented Medicine Price Review Board (PMPRB) “… reviews pricing information for all patented drug products sold in Canada.”
Although PMPRB has not released its price review for Pluvicto, the per treatment cost is about $27,000 in Quebec
Although PMPRB has not released its price review for Pluvicto, the per treatment cost is about $27,000 in Quebec, according to Francois Lamoureux, president of the Canadian Association of Nuclear Medicine. For comparison, the wholesale price per treatment south of the border is US$42,500.
The anticipated average number of treatments is 4.5, according to Lamoureux, resulting in a total average cost of $120,000 in Quebec. This is in line with the approximate cost of $135,000 to $270,000 for routine cancer chemotherapy.
But cost is not the only barrier to access. Patients will need a prostate cancer specific (PSMA) PET/CT scan before therapy, meaning they will have to compete with the ever-growing number of other cancer patients on the lengthy waiting lists for PET/CT scans.
Unlike the rest of Canada, Lamoureux says, Quebec has invested heavily in PET/CT scanners as well as recruiting and training nuclear medicine physicians and technologists, meaning the province is better positioned to handle the expected additional requests to image and treat prostate cancer patients, says Lamoureux.
In 2019-2020, Quebec provided more than half of all PET/CT scans done in Canada. Overall, Canada was 16th in annual PET/CT scans among Organization for Economic Cooperation and Development countries, at 3.3 PET/CT scans per 1,000 people. Using the same measures, Quebec would rank fifth, at eight PET/CT scans per 1,000 people, and Ontario 21st, at 1.6 PET/CT scans per 1,000 people. Denmark has the highest per capita number at 10.2 PET/CT scans per 1,000 people. Unless Pluvicto is covered by provinces or hospital pharmacies, there are limited options available for patients.
Enrolling in clinical trials is one. In B.C., about five research prostate cancer patients are treated every week, according to B.C. Cancer Agency’s Patrick Martineau. Another option is charging patients directly. Initio, a private diagnostic imaging centre in Burnaby, B.C., currently charges $3,200 for the diagnostic prostate specific PET/CT scan and is planning to offer Pluvicto, at around $27,000 plus a clinic/administrative fee per dose, in about two months, according to Phil Cohen, Section Head Nuclear Medicine, Doctors of BC.
Pluvicto is just the tip of the iceberg. There are many other theranostic products in the works that will put further strain on nuclear medicine departments that are already treading water to keep up with current demand.
Cutline info: The random black dots are where prostate cancer has spread. Uptake in the head and neck, liver, spleen, bowel, kidneys, bladder and blood vessels is normal. Image adapted and used with permission courtesy of Patrick Martineau, BC Cancer Agency.
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