from approval to access: innovative cancer treatments continue to be just beyond reach
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cancer patients with insurance don't have to wait as long to access innovative therapies, causing significant inequities due to long access timelines.
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in canada, universal healthcare allows people with cancer to access treatment either free of charge under provincial health plans or at a relatively low cost compared to other countries.
while at first glance, this may seem like a viable way for anyone who develops cancer to get the best treatment without having to worry about dollars and cents. however, when new treatments developed through innovation arrive in canada—often offering better overall outcomes—the process from approval to clinic is lengthy, sitting at roughly one to two years.
for patients, that two-year time period could be more time than they have to wait.
“if we went back 35 years or something like that, we would probably hear that we have made some forward progress,” said dr. christopher hillis, malignant hematologist, chief of oncology at hamilton health sciences, interim vice president, oncology and site executive at the juravinski hospital and cancer centre, and president of the canadian hematology society. “but it has not necessarily made things faster.”
when broken down even further by province, as they make the final decisions on when and how new treatments are allocated and funded, the entire process becomes even more complicated.
according to dr. hillis, smaller provinces may find it more difficult to find funding, whereas those in the territories may have to move altogether to get treatment in ottawa or another large city where it’s more readily available.
“there is a disparity broadly,” he said. “even funding of different drugs in different areas can have different rules. so, if you live in vancouver and you’re diagnosed with a condition that i treat quite commonly, chronic myeloid leukemia, what drugs the hematologist there has access to and are funded is different than what i have access to and are funded in ontario, and that’s within the same country.”
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dr. hillis works exclusively with blood cancers, but it isn’t just these types that are subject to the rules and long wait times. all cancers and their therapies go through the same rigorous process, a process that falls behind many, including the united states and europe.
dr. shannon salvador, practicing gynecological oncologist at the jewish general hospital and president of the society of gynecologic oncology of canada, has seen her patients with gynecological cancers face the same wait times.
“when you’re sitting there looking at that (wait times), and patients know that it is there and it is available, but they can’t afford it, they can’t access it, it’s extremely frustrating for everyone.”
the financial disparity in canada’s cancer treatment access
after health canada has approved a drug for use, people can access it much faster as long as they have the right insurance or money in the bank.
because of this, a significant gap in care for those who have higher means to support cancer care continues to exist. for example, if a drug gets approved and goes through the regulatory processes and is available for sale at pharmacies but isn’t yet publicly funded, the person with the insurance can get the treatment, but the person without will continue to have to wait, even when the drugs could significantly alter both patients’ outcomes.
health canada offers a compassionate release program to address the inequity some canadians may face. still, it’s not always easy for a cancer patient to tap into this resource.
“it does take some extra paperwork and effort on behalf of the treating physicians and their clerical staff to be able to get those through, but it’s encouraging to at least know it’s there,” said dr. salvador.
dr. hillis notes that it’s because of generous pharmaceutical companies that these programs exist. these companies essentially back access to these drugs with their own funding, while the entities that decide on pricing and funding together continue to negotiate on pricing.
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however, that well eventually runs dry, and that can happen before provincial funding comes into effect and “that’s where the gap emerges,” according to dr. hillis.
“it’s tricky because it’s one thing when you’ve never had access to therapy because it’s just never been funded,” he said. “then it gets taken away, and then you have to wait. that is a really uncomfortable position for physicians because you’ve seen benefit for your patients … you’ve seen promise in the drug and now you have to wait the many years for it to get funded within the system.”
compassionate funding until an agreement has been reached between manufacturers and government bodies could fill these gaps, but in the end, it’s still a business, and pharmaceutical companies have to recoup their investment to continue providing new and innovative medicines.
“if i were running the drug company, i would say at some point this has to end because the government will be like, ‘well, if you’re going to get compassionate, why would i fund this? i’ll worry about funding the things that don’t have compassionate.’ so there’s got to be a little bit of a game of chicken there, which i understand, but patients get caught in the middle.”
too much innovation for an unprepared system
currently, for a drug to get approved and access in canada, it has to jump through several hoops. first, it needs to go through health canada for assessment of its safety, benefits, quality and efficacy.
each province and the canadian drug agency also have to review the drug and submit their recommendations to public funding bodies. once it goes through those processes, it’s sent to the pan-canadian pharmaceutical alliance (pcpa) to negotiate with the manufacturer on price, so the two parties can reach an agreed-upon price before making a final funding decision.
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only after all that has happened can patients then access the drug through the universal healthcare system.
sometimes that process runs smoother than others, and in other cases, a drug gets roadblocked at negotiations. another issue with passing through drugs is the sheer number of innovative treatments that are being manufactured today.
“this is all aiming toward what we’re now calling precision medicine,” said dr. salvador. “instead of just blanket throwing chemotherapies or treatment agents at everyone, we’re now trying to analyze their individual tumours. what are the molecular changes in their tumour, specifically, that we can target and then offer them a treatment based on that?”
as medical researchers and drug companies continue to learn more about what drives disease, as well as what can halt it, a bottleneck of administrative red tape can occur.
“there was such an influx of medications for a while that things were coming rapid and fast, and the health canada system was not prepared for the situation,” said dr. salvador. “as they got these rapid requests coming through their system, they just didn’t have the capacity to be able to deal with this.”
she also notes that it went from getting maybe tens of requests each year to hundreds, and the system simply couldn’t keep up.
“it would end up being a red tape bureaucratic nightmare just trying to get through all the requests.”
making moves toward better access for cancer patients across the country
according to dr. hillis, things are moving in the right direction as evidenced by the sheer number of conversations he’s had surrounding access to cancer treatments in the country.
“i’ve talked to more about this with people in the last three months than i have in three years and that’s a good thing,” he said. “the fact that it’s on people’s mind and we’re talking about it and we’re saying that, yeah this isn’t right. the degree of waiting is just not appropriate, which always makes change happen faster, which is a good thing.”
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he also wants canadians to know that, while cancer treatment access continues to be an issue, if they are diagnosed now and receive care, it won’t be “substandard.”
“i absolutely, fundamentally believe we have one of the top cancer systems in the world, and that’s because we have incredibly smart, incredibly hard-working people within the system who do their best to ensure that the outcomes for our patients are just as good as they can be elsewhere.”
with a higher level of awareness and interest in the topic, the canadian drug agency has also begun the zero-target initiative, which aims to get drugs approved and available with no time lag.
dr. salvador notes that the aspirational initiative proposes that the canadian drug agency’s review and health canada’s review are conducted simultaneously, reducing the time it takes for both to get what they need to get done. eventually, they hope to streamline the entire process by working on funding approvals and agreements in advance, enabling immediate access or zero days between when drugs get the go-ahead and patients can get the medication they need.
“when we have things that we look at that are so obvious that this is going to get approved, it just makes sense just to do them all at the same time… so it’s the shortest length of time between approval to access as possible,” she said.
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