The Decibel - The bureaucracy slowing down access to life-saving pharmacare

Episode Date: November 21, 2025

For cancer patients, every day of treatment is critical. But the best care possible is not always reaching patients quickly. Despite Health Canada approving a drug treating an aggressive blood cancer, a complex web of organizations, insurance plans and negotiations over drug pricing means it’s still not available in Canada.Globe reporters Kelly Grant, who covers health, and Chris Hannay, who covers the business of health care, tell us what is holding up life-changing drugs and why Canadian patients are the ones left with the consequences.Questions? Comments? Ideas? Email us at [e-mail] Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

When I started a treatment, it was very rough on me. The first night, I would take the treatment. I would not sleep the whole night. I pretty much spend the whole night inside the bathtub. For some reason, the warm water would help me feel a little bit better. That's Jazz Vellich, speaking about his chemotherapy treatment. Jazz is fighting a blood cancer called multiple myeloma. The cancer cells start off in your bone marrow,

and attack the bones from the inside. But before it debilitates you, this form of cancer can present as something much more common. How I found out is I had back pain. I work in construction, so I assumed it was related to the heavy lifting and whatnot. But the pain started getting progressively worse. Tanya Vellich is Jazz's wife.

We went several times to emergency in December of 2022. And because of his age, he was discharged fairly quickly with no tests. He was just given Tylenol 3 for the pain and told to rest and come back if the pain doesn't go away. But the pain didn't go away. And then it just got worse. It just did not want to get better. It just got worse over time. Like, as time passed, it just got worse and worse up to a point where I couldn't walk anymore, right?

I couldn't move. I was literally in bed pretty much dold it. A month later, Jazz's neighbor brought him to the emergency room where she worked as a nurse. Later that day, after several tests, he was told he had cancer. It was shocking. I was not expecting that answer at all. It was very shocking. I do not think that at all. I wasn't even in the back of my head. For the last 22 months, Jazz has had multiple treatments. He was in different types of drugs and different types of drugs to handle the side effects of the drugs that he was on.

So there was pain drugs, stomach drugs, chemotherapy drugs, steroids, you name it. He was at one point in time, I think he was taking 15 different types of drugs. He currently receives a weekly chemotherapy treatment to keep his cancer under control. Pema is only going to work as long as it works. It can change at any moment in time. And then what are we left with? Except there is another option for jazz. It's a drug called Carvicti.

There's only one problem. It's not available in Canada. Kelly Grant and Chris Hennay looked into why this is the case. Kelly covers health for the globe, and Chris reports on the business of health care in Canada. They're on the show to explain Canada's process for getting new drugs to patients, why it can take so long and what options remain for Jazz and Tanya. I'm Madeline White, filling in for Cheryl Sutherland.

And this is the decibel from the Globe and Mail. Hi, Chris, hi Kelly. Thanks so much for joining me. Thanks for having us. Thanks. So to start, I want to learn a bit more about the cancer that Jazz Vellich is living with. It's called Multiple Myeloma. How rare is this form of cancer?

It's fairly rare. It's not the rarest type of cancer, but to give you a sense of the numbers, the Canadian Cancer Society and Statscan and the public health agency just put out their big every two-year report on cancer in Canada. And they're estimating that there will be about 4,300 Canadians diagnosed with multiple myeloma or myeloma. It's kind of called both, more commonly now, just called myeloma. Anyway, if you want to compare that number to some of the more prevalent cancers, they're expecting 32,900 people to get lung cancer, for example, and 31,900 to get breast cancer. So myeloma is rare compared to those big common cancers. And is it a particularly deadly form of cancer? It was a particularly deadly form of cancer, and it still is.

it is considered incurable, but it's one of those cancers where there have been a lot of really encouraging breakthroughs, mainly with new drugs. And so in the last 10 to 20 years, survival rates have gone up fairly impressively for myeloma, but there are still an estimated 1,750 people who are expected to die of that cancer this year. Wow. Okay, so given that it is incurable, how do doctors treat it? This is one of these cancers where there are a lot of different treatments that are offered sort of in a cascade. So fairly commonly, if patients are healthy enough and young enough, they will be given a stem cell transplant, usually with their own stem cells. There are also targeted therapies, chemotherapies, some new immunotherapies. And the idea is

that they will try a drug for as long as it keeps the myeloma under control. And when one modality stops working, they'll offer another until patients basically run out of roadway. And I understand that there is kind of a newer treatment out there, something called a CAR-T treatment for this cancer. Can you tell me about that? Car-T is a really advanced type of bespoke immunotherapy. And when I say bespoke, what I mean by that is that it's a drug that's made from an individual patient's cells and then given back to them. So what happens is they basically take somebody's blood and then genetically engineer their T cells, which are sort of like the soldier cells within a patient's immune system. They genetically engineer them so that they can identify and kill the cancer cells.

It's given as a one-time treatment. So that's very different from the kind of cascade that I just described. And in the case of myeloma, there hasn't been CAR-T treatment available in Canada yet. There are some other versions of CAR-T that are available in Canada for leukemia and lymphoma. But for myeloma, this is new. Okay. And so what's this drug called then, even though it's not available here in Canada? It's called Carvicti. Chris, let's bring you in here. So how does a new drug like Carvicti get into the Canadian health care system? The process for getting new drugs into the Canadian health care system is really complicated. There's a whole battery of government and quasi-government agencies that a drug company has to get approval from before Canadian patients

can have access to it. So just at a broad level, what these agencies are trying to do is number one, try to figure out, is this new drug safe for people to take? Does it pose any health risks? And does it treat the condition it's supposed to treat? So that's kind of the first big step. And then there's agencies that are looking at, okay, we know it can work. How does it work in comparison to other things? Is it any better than any other treatments that are available? Maybe where in the line of treatments should this drug be used? And then there's kind of a really big step, which is the price negotiation. So when a drug company is bringing a drug to market, it comes in with what it's called a list price, the kind of sticker

price for this drug. But public health plans, because they're covering millions of Canadians, can negotiate better prices. They can negotiate discounts off of the drug price. And that process can take a while. And so who is doing this negotiating? Like, are each of the provinces and territories doing it? Or, like, is there a federal agency? How does that work? So years ago, all the different public health plans in Canada used to negotiate separately. And there's about 14 different jurisdictions here we're talking about. So there's the 10 provinces that all have their public health plans, the three territories, and then there's some federal ones covering health plans for First Nations and Inuit and for

veterans. About a decade ago, they all kind of came together and decided, we should negotiate together. This will be more efficient. We'll get better prices. And they formed a group called the Pan-Canadian Pharmaceutical Alliance. And right now, when new drugs come to Canada, that's the group that negotiates with a drug company over what price the public will actually pay. Okay.

And so the reason why they kind of banded together is because they essentially have more leverage because they're representing more patients. Is that the idea? Exactly. And then let's zoom in specifically on this Carvicti drug. What happened with that drug in this process? Yeah. So Carvicti got approved by Health Canada in early 2023.

And then it was examined by Canada's drug agency, which is a nonprofit funded by the government where. Our experts try to look at how does this drug compare to other drugs that are already on the market or other standards of care that are available. In this case, CDA recommended the drug with some discount off the list price because the list price for Carvicti is very high. It is one of the most expensive drugs. The list price from Johnson Johnson was $632,455. Oh, my goodness. That is a lot of money.

Yeah. And so then in late 2023, the file was picked up by the Pan-Canadian Pharmaceutical Alliance, the body we talked about that represents all the public health plans. And so the PCPA, as they're known, and Johnson & Johnson negotiated over the price of Carvicti back and forth for about two years. And finally, this September, both parties said, look, we're just not coming to a deal. The negotiations are off. I want to get into that a little bit more in a second. But before we get there, Kelly, can I ask you, why? Why does this treatment cost so much money?

So the way that drug companies set prices is, I think, always a little bit of a mystery. You will often hear that the price essentially boils down to what the market will bear. In this case, this is a treatment where the most recent clinical trial results have shown that about a third of the patients who took it five years later had no detectable cancer, which for a myeloma treatment, again, for an incurable cancer. It was a very impressive result. Is that to say they were cured by this treatment then? I think cure is perhaps a bit of an overstatement, and you will find that doctors in the myeloma space are rather reluctant to use the C word. But they were very impressed with the results of Carvicti and what it has shown capable of doing, not for all patients, but for

some patients. And so the other wrinkle, I think, was. with Carvicti is that it is a one-time treatment. So oftentimes when drug companies are looking at, you know, how much money can we make off a drug. They find there's a lot of benefit for their bottom line to a drug that patients will have to take for years or for the rest of their lives. I think it is trickier to figure out how to price a drug that will only be given once. This is very complicated as well. You know, it's not synthesizing a simple chemical pill, right? It is. It's genetically engineering the T cells of each individual patient. So it is a complicated drug. All that being said, I think a thing that's really important to understand is that the list price is not ultimately what public drug plans would wind up paying if they ever came to an agreement on this drug. The PCPA and drug companies go behind closed doors. They hash things out. Most of the time they come out with a deal. But we in the public never know what that real price is. So think of that list price less as a, this is what governments will ultimately pay. And more, this is like the sticker price on a car at a used car lot. And we all know the price is going to get negotiated down. Right.

It's kind of like their opening offer to a certain extent. I think that's a good way to look at it. Okay. So, Chris, let's come back to the negotiations that collapsed. What do we know about why that happened? Well, these price negotiations, number one, are secret. it. There's not a lot of details of what happens behind closed doors that comes out. In fact, when we're talking about these discounts, we don't know. These are closely kept secrets. The

pharmaceutical companies don't like to actually really advertise what discounts they're giving to these drugs because there are a lot of these companies, almost all of them, are operating globally. They're operating in different countries. And so they don't necessarily want it to come out what discounts they're giving to Canadian health plans because then when they bring the drug to to Germany or the United States or wherever else, that's, you know, great information for those public health plans to have. Right. They could demand that price.

Exactly. So all that to say, you know, with these negotiations over Carvicti, we don't know a lot. What we do know is that they couldn't come to an agreement on what the price should be. What we do know is that at least some of the provinces and the PCPA were on board. The parties have told us that much. But we don't know for sure how many provinces wanted to come to a deal. So because these negotiations collapsed, this treatment is not available here in Canada. But, Kelly, is it available elsewhere?

It is available in some other countries. Public health plans do cover it in 13 countries. That's according to Miloma, Canada, which is a patient advocacy group. One of them is the United States. A couple of others, just to give you some examples, are Spain, Belgium, and Portugal. So I want to bring this back to Jas Felich. Did he know this treatment existed as he's been dealing with all of this? He read about it on long.

as often happens when patients are diagnosed with the type of cancer and they're learning about it. And he had a stem cell transplant. The stem cell transplant didn't work for him. So in December of 2023, he had a conversation with his oncologist about this as an option. The oncologist agreed and also felt it would be his best shot. And since then, he and his family have been waiting for the treatment to become available in Canada. So how do they react when they found out about the collapse in negotiations. I think it's fair to say they were crushed. They had really been hoping that this would give Jazz a new lease on life.

He has been taking weekly chemotherapy that has meant he's too sick to work. He's doing his best to be a father to their two kids and a husband to his wife. But when you're that sick all the time because you're on weekly chemotherapy, it makes your day-to-day life really hard. and Jazz and Tanya had been hoping that a one-time infusion of Carty would free him from that chemotherapy without end. What Carty means to my husband and to me, frankly, and probably to many other people that are going through this disease, is that it's potentially the only curable therapy for my husband. and it's hoped to have a normal life again. One day, it's just so disappointing to know that there is something available, proven to work. And people across the world are getting it, but because of where we live, we're not able to access it.

It's really disheartening to know that in Canada's health. care system that other countries are praising are really great. It seems like a political game that you have to play, and there is no guarantee that you will win and that you will have access to life-saving drugs. After the break, we dive into why Canadians wait so long for drugs that Health Canada has declared safe. Think you can beat the stock market? Now's your chance to prove it. Get in on the Globe and Mail Tradeoff,

a stock market simulation game. Here's how it works. You trade with fake cash, use real-time market data, and learn from the Globe's investing insight to make virtual trades, and you have the chance to win a grand prize of $5,000 in real cash.

Just go to globe and mail tradeoff.com. Rules apply and registration ends on November 24th. Get in the game today at globe and mail tradeoff.com. So this is obviously a heartbreaking situation for Jazz and Tanya and their family. Does this kind of collapse in negotiations between the PCPA and drug makers happen often? It does not, especially not in the oncology space. The numbers we got from the PCPA was that 92% of their negotiations for cancer drugs,

have ended with an agreement. Now, those numbers were as of August 31st. So that was before the Carvicti talks collapsed. Hmm, okay. The other thing that's kind of shocking to me about this story is that the negotiations lasted for so long. Chris, I think you said it was something like basically two years. Is that normal for negotiations to take that long?

Yeah. So there's a lot of numbers that get thrown around in this space. When Kelly and I reported on this, what we're kind of relying on here is data from a team of researchers that includes Mina Tadros at UFT and some people from a government agency. I'll explain in a few minutes. So what their data shows is that typically the average time for a drug to be approved by Health Canada is being safe to the point at which public health plans are willing to pay for it is about two and a half years. Wow, two and a half years. Okay. Kelly, do we know how many drugs kind of get caught up in this process at any given time?

To give you just one number, the PCPA process, which again, that's just one of the agencies that is involved in this process. Yeah, that's the group that's doing those pricing negotiations we talked about. Right now they've got 38 open files. Okay, so quite a few. Is this just a problem in Canada, Chris? And if it is, like, why is it such a problem in Canada? All right. Well, the Canadian system for drug approval is very long and complicated.

And I'm just going to explain it. I'm going to lay it out now. Okay. Let's go. I want listeners to get their notebooks, their pens. Yep. There's going to be lots of acronyms. We're going to have a quiz later. Sounds good.

Gotcha. Okay, perfect. All right. So here's the gauntling. We're going to start with Health Canada. So Health Canada is the first one. That's a government department. Those are the ones looking at the safety and effectiveness of the drug.

People probably know that one. Yes. I think we've all heard of Health Canada. Yeah. Okay, some of the other ones you almost certainly have not heard of unless you work in these industries. Gotcha. Next, I mentioned earlier the Canada's Drug Agency that's a nonprofit paid for by the government. Those are the folks who work with experts and patients to develop recommendations around the drugs.

Essentially, they study the drugs, they compare it to other things that are available, other treatments that are available, and come up with recommendations about whether they think public health cancer should cover it. And if so, how? Like what line of treatment should it come? How much of a discount should they be seeking? Canada's drug agency, despite the name, is not actually all of Canada. It is most of Canada. It does not cover Quebec.

Quebec has its own agency that does this called Anness. CDA and Anness do a form of assessment called a HTA, a health technology assessment. Okay, wow, we got an alphabet soup going on here. Yeah, what's the acronym account we're up to? We're going to keep track. Don't know anymore. And then once those recommendations are done, then it goes to the PCPA, which we've been talking about, which is also another nonprofit that gets its funding from its members. The review by the CDA has many steps.

It's typically, according to the data we have, the average is about eight months for it to do its work. The PCPA also averages about eight months to do its work. There's also delays in between. So once an agency finishes its work, there can often be a period of a few months. until the drug company then gets its application together and applies for the next leg of the journey. Once those pricing negotiations are done, the PCPA, then there's another few months of negotiations that happen. So the PCPA comes up with the price, but then each of those public health plans have to individually sign contracts with the drug company. And each of those different provinces work at different speeds.

And so they have to sign those contracts before people can get access to the drugs. And, hey, there's another agency, too. I haven't even talked about this one. Oh, God. Okay. All right. There's a federal government agency. This one is, these are federal employees called the patented medicine prices review board.

The PMPRB, they're federal employees. They're a quasi-judicial body. They don't add to the timeline. They're just sort of like lurking, watching what's happening during all this. And what happens is they can intervene if the price is, like, is excessive. Excessive is the word that's used in the law. And they compare the price to others in other jurisdictions, essentially. So they're watchdogs?

Yes. So, okay, I can see how this adds up to two and a half years on average very quickly. Can you give us some context? Is this normal in other countries or do they have quicker processes? Yes. Canada has one of the longest, if you compare us to a lot of other developed countries, we have one of the longest times that it takes for a drug to be reimbursed by public plans. But, you know, there's trade-offs. So you talk to people, other experts in the industry, Canada takes longer, but often gets better prices.

So the PCPA says that it saved $4 billion on patented drugs last year, for example. And so there's other jurisdictions. So in one case, you know, one that comes up a lot in discussions is Germany. Germany does not have these delays. It's very fast. Essentially, once the German equivalent of health Canada says a drug is safe to use, patients can start using it. They can start using it while German plans negotiate prices. The tradeoff there is that if those negotiations fall through, as we know that they do occasionally, those public health plans have to be okay with taking those drugs away from patients who have been having access to it this whole time.

And I can see how that would give a drug company a lot of leverage in a price negotiation that's happening at the same time, essentially. That's a threat I don't think very many governments would want to follow through on. Yeah, it's one of the knocks you often hear against the German system. Huh. Okay. I want to zero in on one of these steps because it was so important in this Carvicti situation. That's obviously the price negotiation part. Kelly, can you tell me what are each side kind of thinking about in terms of the factors that they're weighing when they're negotiating? Let's start off with the PCPA. Yeah, I think the most important thing to understand with the PCPA is they are negotiating on behalf of public drug plans. So you've got each provincial, territorial, and federal plan, and they have a finite amount of money. I think this is especially important for some of the smaller provinces with smaller drug budgets. And so they're at the table in these negotiations, knowing that they only have a certain amount of money to spend on drugs.

And some of these very high-priced drugs for rarer diseases are really driving up these public drug plan budgets. So just to give you an idea, this is from a recent report that now in Canada for public drug plans, drugs costing more than $10,000 a year, accounted for about one-third of all public drug spending, but only about 3% of beneficiaries. So it's a lot of money for a very small number of patients. And these governments all have to live within their means, and that's what's happening behind the scenes of a PCPA negotiation. Right. So that's one side of the table. Let's look at the other side. Chris, tell me what are drug makers considering when they're in these negotiations?

Yeah. So as I mentioned earlier, these are global companies. They're operating all around the world. So they're concerned about what their pricing in Canada means in other markets. many of these are also like major publicly traded companies. Right. And they could be very important economically to where they're based. So, for example, you know, Nova Nordisk, maker of Azimpec and Wagovi.

Yes. Its value in the market is more than the entire country of Denmark where it's based. So these are companies that are very concerned about maintaining revenue. And, you know, as they say too, they need to be able to make a profit to ensure that new drugs are coming out, that they're coming up with new innovations, that there is a market incentive for them to keep innovating. But then I think about Jazz, Vellich. And obviously, in this situation, a treatment like Carvicti could change his life.

And these long wait times can create a huge problem for someone like him and other patients. So what are our government saying that they're going to do about this issue? Governments are acknowledging that this is a problem. The agencies that are involved in all of these steps acknowledge that it's a problem. and a bunch of them have plans in place, some of which have already begun, to try to speed up the process.

The main thing that everybody seems to agree on is as much as possible, let's try to do as many things at the same time as we can. So, for example, Canada's drug agency has a program they're calling Target Zero, where ultimately what they would like is to make their recommendation about whether a drug should be covered on the same day that Health Canada makes its approval. That's kind of like their North Star. Already, Canada's drug agency has a program and really encourages drug makers to submit to them and their expert committees as much as six months before the companies are expecting Health Canada approval. So that's an example of something where if we can have Health Canada and CDA, both reviewing the information at roughly the same time, then hopefully we can collapse some of these timelines. Another example of a government trying to speed up this process is Ontario announced in October that it was starting a pilot project for somewhere between 7 and 10 oncology drugs every year that are part of an international collaboration called Project Orbis. What Ontario wants to do there is start funding those drugs before the pricing negotiations are finished. Okay.

So is it possible that the Carvicti negotiations will resume at any point? It could. Both parties at the table say that they're willing to go back any time. It's just about maybe they need a little nudge. A group representing multiple myeloma patients is currently collecting signatures. They have thousands so far trying to urge the parties back to the table and we'll see what happens. And Kelly, just to end here, when you talk to Jazz and Tanya about all of this, did they have a message that they wanted to send to kind of both sides of the negotiation table? What they told me was that they really wanted everybody involved in this to remember that there are real people and real patients whose lives are on the line. And they were very much encouraging both governments and the drug companies to please remember the people who are at the heart of this. It would give me the freedom that I need to kind of return to being a husband and working, contributing to society, being myself. yeah i think that's probably my best route but there's a lot of us that can get our life back and integrate back into society and contribute once again i would really urge them to look at

the people's side of things because at the end of the day if you can save someone's life by giving them acts to the life-saving drugs wouldn't you want to do everything possible to do that. Kelly, Chris, thank you so much for sharing your reporting on this story. Thanks for having us. Thanks. My guests were Globe reporters,

Kelly Grant, who covers health, and Chris Hennay, who covers the business of health care. That's it for today. I'm Madeline White. The Decibel is hosted by Cheryl Sutherland. I produce the show, along with Michal Stein, and Ali Graham. David Crosby edits the show.

Adrian Chung is our senior producer, and Angela Pichenza is our executive editor. Thanks for listening.