Need a new, better drug to tackle a serious illness? In Canada, you have to ‘fail’ on an old drug first - National Post

Josh Berman had reached a point where he was in so much pain he could barely sleep. He couldn’t work and was plagued by fatigue that made even simple tasks unbearable.

Diagnosed with ulcerative colitis in 2021, a form of inflammatory bowel disease (IBD) that causes inflammation and ulcers to form in the lining of the large intestine, he had lost blood and was stranded at home by his 20 to 25 daily trips to the bathroom.

“It really becomes kind of an all-encompassing disease at that point,” said Berman, now the president and CEO of Crohn’s and Colitis Canada. “It can be scary.”

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The medication that has finally given him his life back has been available since his diagnosis. But Berman couldn’t access it until roughly six months ago. First, he had to show that the prescribed meds he was taking didn’t work.

Will Florence, a stagehand, has been forced out of the job he loves due to epilepsy that cannot be controlled with medications. He needs a costly procedure known as vagus nerve stimulator implant surgery, which involves inserting a pacemaker-like device that sends electrical currents to the brain to reduce seizure frequency and severity. He will only be able to obtain this once he can prove his current medication won’t keep his seizures under control.

Both have faced setbacks in treatment for two serious afflictions because of what are referred to as “fail first” drug policies — known in health care as “step therapy.”

They, and many others, want to see these policies change.

The principle behind step therapy is simple. When new drugs are developed they can come at a hefty price. Challenged by the high cost, provincial governments set rules under which older, conventional — and cheaper — therapies must be shown to “fail” before a patient can be covered under provincial health plans for anything newer and costlier.

“Government tries hard to provide access in the most sensible way possible with the resources we’ve got,” said Graham Statt, a former assistant deputy minister for Pharmaceutical and Supplementary Benefits in Alberta’s Ministry of Health.

“These are not easy decisions. Government payers aren’t cheap or mean, but they’re trying to make really rational decisions that include cost effectiveness and the broader sustainability of the health-care system, which is important,” said Statt, now a pharmaceutical consultant and former vice-chair of the Pan-Canadian Pharmaceutical Alliance.

In many cases, however, older drugs don’t provide the same benefits as newer, more potent, more expensive therapy. And delayed access to newer drugs while a patient is stuck on an older one can cause long-term harm — to both the individual and the health-care system, some experts say.

The economy also suffers if people don’t get the best treatment quickly, they say. For people in Canada living with chronic disease, $122 billion is lost in indirect income and productivity each year, according to the Public Health Agency of Canada.

Berman says he had to play the part of a lab rat with less effective, less expensive medications before he was finally placed on one that actually helped him.

Will Florence, shown in Peterborough, Ont., in June 2026, has been unable to work as a stagehand for two years while he awaits approval for expensive surgery to control his epilepsy. Photo by Peter J. Thompson/National PostFlorence hasn’t gotten even that far in tackling his epilepsy.

“I always thought I was a bit of an active dreamer, and I was a long-distance runner as a kid, so my parents always used to think I was just running in my sleep. That’s what (epilepsy) looked like originally,” he said.

Until he began injuring himself while sleeping.

“It got so bad that the girl I was seeing at the time, she saw me have some really, really bad ones. I split my head open off the wall,” he said.

When he did finally get a diagnosis, he lost his ability to drive and work at his “dream job,” as he puts it. Even with several medication changes, he has yet to experience any relief from the frequency and severity of his seizures.

“My doctors are great, but it’s annoying that I have to go through each of these stages of different medications when I know there’s a surgery option that I could have had two years ago, but because we have this system where it’s like, ‘No, you got to do this first … then we can offer you surgery.’”

“It’s very demoralizing,” said Dr. Dalia Rotstein, a neurologist at St. Michael’s Hospital in Toronto, who specializes in multiple sclerosis (MS) and demyelinating disease — conditions that damage the protective layer around nerve cells known as the myelin sheath. “We want to provide compassionate care on a daily basis. These neurologic inflammatory diseases often come on in young adults just starting their careers and their families, so it’s a challenging point in life,” says Rotstein, who is also an associate professor at the University of Toronto.

“To be saddled with a chronic disease and diagnosis, it can be devastating, and often people are already living with difficult symptoms … then if they’re told they’re on a less effective drug, that’s hanging over their head. They’re living in fear that they might have another attack at any time.”

Fail-first or step therapy policies were introduced in provincial health programs in the early 2000s and adopted by private insurers in the mid-2010s. These policies came into force just as more effective treatments began to emerge for many debilitating conditions. Exceptions to the step-therapy policies can be granted, but the process is cumbersome.

In British Columbia, the policy that determines which drugs will be allowed is called the Special Authorization (SA)/Limited Coverage. In Alberta, it’s called Restricted Benefit/Automated Step Therapy; in Saskatchewan it’s called Exception Status/Automated Adjudication. Both Alberta and Saskatchewan track drug products and claims to ensure that patients are prescribed lower-cost drugs before being offered more expensive, perhaps more effective, ones.

In Manitoba, patients and drugs are tracked using clinical markers to determine if they’ve tried and failed first on medications that have not adequately controlled disease. That policy is known as Part 3 Regular Benefits/Exceptional Drug Status (EDS).

Ontario’s Limited Use (LU) codes and Exceptional Access Program (EAP) contain “Reason for Use” codes that apply to drugs when a patient obtains them from the pharmacy; the codes will be applied only after the physician makes it clear that the patient has failed on other drugs. Physicians must submit extensive data about a patient’s failed attempts on other medications.

Atlantic provinces share resources from the Atlantic Common Formulary. New Brunswick and Prince Edward Island use Special Authorization; Nova Scotia uses Exception Status/Criteria Codes; and Newfoundland and Labrador offers a blend of Special Authorization and Coded Benefits. Each essentially states that if there is a similar drug with a lower price, it must be taken first. The Northwest Territories, as well as the Yukon and Nunavut, are also subject to these policies.

... I’m really angry at all the time that was wasted, my time, my family’s time, my doctor’s time.

“Alberta’s drug benefit programs are designed to ensure Albertans have access to safe, effective treatments while supporting responsible use of public health care dollars,” said Jaye Lang, press secretary for Primary and Preventative Health Services with the Government of Alberta.

Kevin So, a spokesperson for B.C. Health, said in an email that “B.C. has a rigorous drug review process to help ensure publicly funded drug coverage is sustainable, fair and effective. Coverage decisions are evidence-based and consider a drug’s health benefits and cost-effectiveness compared with established treatments.”

Queries to the Ontario and Quebec governments weren’t answered.

Pharmaceutical companies, too, would like to see fail-first policies loosened. Regulatory approval from Health Canada is already slow, they say, and step therapy makes the entire process to get their new drugs to patients take even longer. Meanwhile, they can simply market their newer medications elsewhere.

“Canada, when you look at the globe, represents about two per cent of the market share for pharmaceuticals. It’s tiny. The two per cent could be shifted somewhere else,” said Bettina Hamelin, president and CEO of Innovative Medicines Canada, a national association that represents pharmaceutical and vaccine companies in Canada. “The decision is more and more, we go to those jurisdictions who are willing to pay for the innovation, who value the innovation, who provide access to their people.”

What are some of the “better drugs” patients would like quicker access to? Drugs known as biologics have been around for more than 100 years. But those that really target ailments such as inflammatory bowel disease (IBD), rheumatoid arthritis (RA), multiple sclerosis (MS), and rare diseases didn’t start reaching the market until between 1993 and 2017, with interferon beta-1b the first in 1993 for MS.

These inflammatory illnesses are driven by the immune system attacking various parts of the body. For example, rheumatoid arthritis occurs when immune cells attack the joints, whereas IBD attacks the gastrointestinal tract. Current drugs used for such conditions, such as corticosteroids, suppress the immune system entirely, so that the area of the body experiencing damaging inflammation shuts down, too.

Modern biologics, which are complex and therefore expensive to produce, work differently. Instead of shutting off all inflammatory pathways, some of which keep the body safe from infection and disease, they target the disorder at its source.

There are also biosimilars, which act like biologics but are cheaper. These are often offered first (though some are not recommended because they could cause harm depending on the patient’s specific health issues and other medications they are taking).

“We are in a much better position to predict which drug might work better for a certain patient,” said Hamelin. Drugs being developed are now more tailored to individual patients’ needs, she said.

What about traditional, older drugs? One non-biologic drug, 5-ASA (5-aminosalicylic acid, mesalamine), was developed in the late 1930s and remains a first-line option for treating ulcerative colitis. Along with 5-ASA, corticosteroids and immunosuppressants carry annual costs ranging up to roughly $4,000 per patient, covered by provincial plans, insurance or the National Pharmacare program.

In contrast, newer biologics — often referred to as “blockbuster drugs” — can cost anywhere from $13,697 to $29,855 per year per patient, depending on the severity of illness, number of patients using the drug, and market competition between pharmaceutical companies.

In Will Florence’s case, the one-time cost of surgery could be upwards of $20,000, whereas standard epilepsy drugs can cost up to about $4,000 — if only they worked for him. But they don’t.

For another ailment, multiple sclerosis, starting treatment at the lowest drug level was once standard to avoid possible harmful side-effects from newer drugs. But fresh evidence about emerging drugs and earlier intervention is now seen by many experts as a better way to minimize disease activity and progression.

The more highly effective drugs used for MS can, in some cases, cost upwards of $40,000 to $50,000 per year, said Rotstein.

Rotstein uses the example of cladribine, one of the newer drugs to treat MS, and approved by the FDA in the United States in 2019. It is approved in Canada for two uses: relapsing-remitting multiple sclerosis (RRMS), the most common form of MS, and hairy cell leukemia (HCL), a rare type of blood cancer.

It’s only taken for two years “and then often patients can remain disease-free and off medication long-term after that,” Rotstein said. “So, there’s a higher cost up front, yes; the longer-term perspective is that you can be off medication and do very well.”

Unfortunately, “the decision-makers are usually just looking over the one to two years,” Rotstein said, adding that when patient care is delayed, disease progression worsens, and costs rise through more intensive and longer-term treatments, lost employment and wages, and disability needs.

“Fail-first” policies weren’t developed to hurt patients, Statt stresses. While in part they were designed to keep costs at a reasonable level, they also reflected caution at an earlier time when the clinical evidence didn’t yet support the case for funding more advanced, higher-cost medications.

“(Governments) want to say yes. The problem is, because you have a finite budget, any ‘yes’ decision you make, you say ‘no’ to somebody else,” said Statt. “That’s the hard part with the public payer. It’s figuring out what to say no to because of all the yeses that you decided. And so, if you can create a step therapy-type program, which isn’t necessarily a no, but a ‘not yet,’ that’s usually pretty attractive.”

Dr. Mina Tadrous, associate professor at the Leslie Dan Faculty of Pharmacy at the University of Toronto, understands why hearing that you have to fail at one drug to be able to get a newer one can be frustrating, but says it’s not cut and dried. Society is conditioned to believe that new equals superior, and that can skew perspectives, he says.

“I can understand the optics of it, but the reality is in the machinery of all of that, it’s been found that usually that older thing works just as well, and I would just like to let people know that not all new drugs are better,” he said. “I think we need to be very careful that we don’t fall for the classic trap that new is always better.”

Dr. Laura Targownik, a University of Toronto gastroenterologist, participated in research indicating that a group of Crohn’s patients with earlier access to a newer, costlier drug had lower rates of hospitalization and surgery, by about half, than a group that didn’t. Photo by Peter J. Thompson/National Post“I think our governments are generally trying to be good stewards of the health-care system, which means trying to treat patients who have disease with the most cost-effective therapy,” said Dr. Laura Targownik, division director for Gastroenterology and Hepatology at the University of Toronto and a practising gastroenterologist and researcher.

Yet much modern research has shown the value of many newer drug therapies. So, advocates ask, should government funding policies focus mostly on less expensive drugs hoping they will help patients, or should they support more expensive options from the start, in the hopes that these help more people more quickly?

“In a lot of other settings internationally, years ago, there’s been access to these high-efficacy drugs from the get-go, but in Canada, there’s been a slowly evolving process,” said Rotstein.

In some cases, the slowly evolving process means spending much more money. For example, one specific drug for the neuroinflammatory condition known as neuromyelitis optica spectrum disorder (NMSOD), a central nervous system disease, can cost upwards of $500,000 per year per person.

“So, is that feasible to offer to every patient in a socialized system?” asks Rotstein. “Probably not, but I (also) don’t think physicians would necessarily choose that drug for every patient.”

Doctors would not prescribe more expensive drugs simply because governments loosened step-therapy policies, advocates argue.

“We’re asking the government to remove and to allow the doctors to have that informed decision with their patient, to have that discussion and see what the best treatment is in the interest of the individual,” said Kate Lee, vice-president of Research and Patient Programs at Crohn’s and Colitis Canada. “It may not be advanced therapies, but it will allow them not to go through that hurdle and for them to have that freedom to make a choice that makes the most sense to the person.”

“There should be more leeway in the system because we need to consider every patient and the person who’s best positioned to do that is a physician,” says Rotstein.

Some question whether the current step-therapy approach actually saves the health-care system — and the taxpayer — money.

Targownik participated in research examining access to a commonly used biologic for Crohn’s disease. The research team aimed to find out who was able to access these drugs within two years of their diagnosis, who had to wait longer than two years, and what the outcome of both groups was in the following five years.

The study concluded the group that had earlier access to the newer (and more expensive) drug had lower rates of hospitalizations and surgery, by about half, when compared to people who experienced delayed care. This led to lower long-term costs for each patient, it concluded.

Delaying administration of the better drugs also harms patients in a different way, says Targownik.

Another study sought to find out whether delayed administration of more effective drugs could make a disease harder to treat later. It concluded that if people don’t get the right drugs in a timely manner, they can develop scar tissue and other problematic signs of disease progression that make treatment more challenging.

Data from Britain found that 75 to 82 per cent of people who got more effective and more expensive drugs from the outset for IBD were in remission by the end of the year. If 85 per cent of people on these more expensive drugs reach remission, total costs for care over time are likely to be significantly cheaper, says Targownik.

Biologic drugs account for $4.7 billion of public drug spending in Canada, and that number would rise if more people were prescribed these advanced drugs. But if the drugs lower disease progression, could they end up reducing overall health-care costs?

I was always struggling kind of day to day, hour to hour, week to week with symptoms.

According to Lee, the answer is yes — in the long run. Health ministries need to think holistically.

“If you see just from a siloed perspective, just the drug budget, yes. It might increase. But if you see it from a systems level, it won’t increase. If anything, it might decrease because surgeries, hospitalizations are very expensive,” she said.

Patients who are unable to work during the time they go through fail-first steps with medications are also not able to contribute to society financially, as is the case with Florence. He’s been out of work for two years and now lives on disability benefits while he waits for proper treatment.

“I’d be contributing a lot instead of being a weight on the system,” he said. “It’s infuriating.”

Older drugs for many diseases are on the market because they do work in many cases. But for many, they’re often not long-term solutions.

“Some people get on prednisone (steroids), and then they feel better, but the prednisone is only temporary and then they’re back with another flare in four months,” said Targownik. “You’ve got to get sick twice to get treated properly.”

“I think we all know long-term use of steroids is definitely not good for us. There’s so many bad side-effects that can happen,” said Lee.

Berman is an example. He started on steroids to get a quick hit at the symptoms, and then a 5-ASA medication called Pentasa, which is designed to reduce inflammation in the gastrointestinal tract. The steroid medication helped reduce his symptoms at first, but had downsides.

Both he and his wife noticed personality changes from his medications. “It definitely impacted some relationships that I had.”

Berman described having a “shorter fuse” which damaged his interactions with his young kids and his spouse. He wasn’t there “nearly as much, both in mind and body” for his kids.

“You don’t get that time back,” he said.

At its worst, this kind of side-effect is called steroid-induced psychosis, and as many as 62 per cent of patients on prednisone suffer a version of it. These effects can impact relationships so heavily that patients plead with their doctors to be put on something else.

“There’s all these costs that we can’t really put our finger on, but our patients will tell us, ‘My spouse doesn’t want me to go on prednisone again,’” said Targownik. “These are the stories we hear.”

Josh Berman, who was diagnosed with ulcerative colitis in 2021, is now president of Crohn’s and Colitis Canada. Photo by Peter J. Thompson/National PostPeople on prednisone can also experience weight gain, weak muscles and bones, thinning skin and a reduced ability to fight infection.

When Berman was given a second medication, it also helped, but he “never got into full remission.”

“I was always struggling kind of day to day, hour to hour, week to week with symptoms,” he said. “There’s always this uncertainty of like, ‘Hey, I have this trip scheduled for two months from now. Will I be able to go, and will I feel good when I’m there?’ I have my daughter’s recital … It’s that significant level of uncertainty and those baseline, non-advanced therapies … don’t get you into that spot where you’re in deep remission.”

His lower-but-livable quality of life didn’t last. It exploded into suffering and symptoms spanning more than a month.

“The next thing you know, I’m going to the emergency room and saying, ‘Hey, I need some help here.’”

He was pumped full of steroids yet again to try to get the inflammation under control.

According to some, physicians sometimes develop workarounds to get medications into the hands of patients they believe would benefit from quicker access to better drugs.

“They say, ‘You know what, I’m going to prescribe this for you just so the government thinks I’ve given it to you, but just put it in the closet and come back to me in two weeks and say it didn’t work, and then we’ll get on the drugs,’” said Targownik.

Meanwhile, if a person has to try a drug that’s only 20 to 30 per cent effective for six months to a year and it doesn’t work, disease progression can worsen significantly, says Targownik. But if you start a patient with something that’s 80 to 90 per cent effective, you can change the course of the disease for the better rather than the worse.

(Seizures) got to the point where I’m literally flailing around from one end of the room to the other ... I just wake up in a pool of blood.

In conditions such as MS, people can experience an increase in brain lesions and symptomatic relapses, alongside permanent neurological damage, if not treated effectively from the start.

“If you put a patient on a less effective medication and there’s somebody with active disease, they could have a disabling attack, and at that point, they might be put on a more effective therapy, but they’re living with disability thereafter because we don’t have anything to reverse that disability,” said Rotstein. “For example, they might be living with impaired ambulation as a result, weakness in one of their legs … or loss of vision in one of their eyes.”

For Florence, continuing on a path of uncontrolled seizures could mean life and death.

“It gets worse and worse and worse, and it got to the point where I’m literally flailing around from one end of the room to the other, smacking off everything. I just wake up in a pool of blood,” he said.

He also has his liver health to worry about, because the drug he’s currently on isn’t easy on the body.

Programs such as time-limited compassionate access to advanced drugs are available to some patients through partnerships between drug companies, provincial health bodies, the federal government and health technology assessment agencies. Teresa Alfeld, a film director in Vancouver who lives with relapsing-remitting MS, is one of the people who have used such a program.

When first diagnosed, she was given special access to a new, more expensive drug immediately because she also has Type 1 diabetes and couldn’t take the traditional steroid treatment, which would affect her ability to control the diabetes. But later, her coverage was denied after she was already taking the effective MS drug, and the compassionate access program run by drug maker Novartis — which lasted for six months — ended.

Access to these programs often requires medical specialists to provide detailed letters to either drug companies or government programs.

Alfeld’s health team had fought to get her the correct drug right off the bat. But she and her team then had to fight again to maintain access to it.

The resources simply aren’t there for some medical professionals to fulfil compassionate access requests for patients, says Rotstein.

“That’s also dependent on the physician having time to do the appeal (to get access),” said Rotstein.

“If people are seeing a physician who’s a sole practitioner in the community, they don’t have those kinds of resources, and it’s very onerous to go through the appeal process,” she continued. “In our field, I don’t see many cases of compassionate access approved by the government … They don’t see these neurologic conditions as serious, although I can tell you in practice, they are extremely serious and they can cause lifelong disability and be life-limiting as well.”

Quebec has already eliminated fail-first policies for biologics use in the treatment of IBD. Ontario and many other provinces have not. Ontario and Manitoba did not respond to queries.

Teresa Alfeld is a film director in Vancouver who had to fight for access to drugs to treat relapsing-remitting multiple sclerosis (MS). Photo by Nick Procaylo/Postmedia NewsAlberta government spokesperson Lang said in an email: “Alberta regularly reviews drug coverage and listing criteria to ensure they reflect current evidence, clinical practice and patient needs. Clinicians can also submit feedback and evidence to support reviews of specific drugs or drug classes.”

“I think there’s a problem with the speed at which the programs are able to be responsive to changes in health care, which have really accelerated,” said Rotstein. “The pace is very slow in Canada, and that translates into the standard of care that we can offer our patients, with suboptimal results. So, if they can’t (move faster), to me, that’s a resource issue in terms of the review process and probably in terms of the funding that’s allocated from the provincial government.”

For Berman, finally getting on advanced therapy has meant he’s able to work and be a normal husband and father.

“When you’re in deep remission, IBD can kind of fade into the background of your life, and that’s a huge benefit to family life. But also economically, you’re not taking sick days, you’re able to get out there both to spend and to work. We can thrive in all aspects of our lives.”

Florence, who’s still in the waiting-game phase of his epilepsy treatment, hopes that he can access the surgery he needs soon.

“I’d love to have my life back. I’d love to be able to get a car and go about my normal life again. I’d love to be able to work again.”

Alfeld, meanwhile, had to fight tooth and nail to get ongoing access to the drug she needed. And while she has succeeded for now, the path toward getting there was nothing short of “exhausting.”