With lives on the line, Canadians’ access to the newest medicines face numerous hurdles
In 2003, Kathleen Barnard was told she had a few months to live. She had Stage 4 melanoma at a time when treatments were practically nonexistent.
But Barnard wasn’t ready to give up. She learned about a life-saving innovative medicine being used in the United States and applied for a clinical trial in Canada and today she is cancer free.
There have been a number of breakthroughs in treatment options for melanoma and other cancers and rare diseases since she first received her diagnosis. While it’s good news on the research and development front, it doesn’t guarantee these medicines will be readily accessible for patients in Canada, or that there will be adequate funding to cover costs that could reach into the tens of thousands of dollars. Despite advances made in how we treat disease, many barriers still stand between patients and these new therapies.
There are a number of reasons for these hurdles. Both the cost of research and the time for approvals is escalating, and a rigid reimbursement process and specific restrictions pose additional barriers. It must also be factored in that medicine costs are just one area competing for healthcare budget dollars. All these issues limit a patient’s options and access to potentially life-saving medicines.
Many medicines that were tested on patients who had run out of options have now become standard as frontline treatments, says Dr. John Kuruvilla, a haematologist with the Princess Margaret Lymphoma and Myeloma Site Group in Toronto. “As things have evolved, however, governments have demanded higher-level evidence to support approval of funding for drugs, and the costs have gone up. Drugs are either not getting approved for funding or it’s taking much longer.”
Even when a new, potentially life-saving medicine does make it through the reimbursement process, there are restrictions that could limit options for patients who need more than one medication. “Targeted combinations are becoming the new standard in treating cancer,” Dr. Kuruvilla says. “Usually chemotherapy regimens are given in combinations of two to five drugs depending on the disease and setting, but with novel targeted drugs come much bigger price tags, with some treatment courses easily costing $100,000.” This means, he adds, that even when a reimbursement review shows a medicine has merit, the conclusion tends to be that the benefit doesn’t merit the increase in cost — and the patients are the ones who lose out.
Louise Binder, health policy consultant with Save Your Skin Foundation, says things are only getting worse. “The reality for many cancer patients is that combinations of drugs work best, yet the government will only pay for one and not the other.”
Another problem is that different government healthcare budgets are managed in distinct siloes, Binder says. “There is no recognition within a project that a drug might be saving money somewhere else. Yet there are so many economic values to society.” Those benefits include cost savings in reducing time spent in hospitals and getting people back to work more quickly.
One stumbling block is that provincial governments use a cost formula, in which reimbursement is based on getting a good price. As health economist Christopher McCabe, PACEOMICS project leader at the University of Alberta explains, “What that means is healthcare dollars, like any other dollars, can’t be spent twice. If we have to pay for a new drug, and the government does not have enough to cover it, it will have to give something up from another area of healthcare. But we don’t know what that would be, because those decisions are made at different levels within the system. It could be in funding hip replacements or mental health services. It would be beneficial to know where cost savings would occur, because everybody is affected by these decisions.”
This results in hard choices to make for bureaucrats. In Ontario, New Brunswick, PEI and Newfoundland, for example, governments won’t always pay for oral cancer medicines for some patients, representing a lost opportunity as these medicines are more convenient and easier to administer than intravenous medicines.
Adding to these challenges is the lag in getting funding approval, Dr. Kuruvilla adds. “In some cases, drugs that have been approved and used in Europe and the U.S. never get funding here. It’s disheartening to see colleagues not being able to use drugs after pivotal studies have been completed — and it leaves patients with fewer good options for newer available drugs that may change their outcomes dramatically.”
With more new medicines coming to market and an aging population in need of them, the way things are constructed is simply not sustainable, Binder says. “I say, let’s reconstruct it. It’s a mess for patients and they are dying. It is literally a life and death decision.”