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The price of being pain free: Why are life-changing biologics out of reach for so many?

Oliver Sachgau's medication for juvenile arthritis costs $1,800 a month. (Darren Calabrese for The Globe and Mail)

A few minutes into my first high school gym class, my teacher pulled me aside to ask me if wanted to sit this one out.

Earlier that year at age 14, I had been diagnosed with juvenile arthritis. I walked like I had two broken ankles. Every movement with my swollen joints was accompanied by pain, and, though I tried to hide it, twitches in my face gave away how I felt.

I persisted, but by the time most of the kids had run the full 100 metres warm-up, I was still on my first 10. When I finally made it back, the other boys averted their eyes from the boy limping across the field.

Nine years later, I can walk normally. I can even run. I might even be faster than you.

The reason is a box of needles I keep in my fridge. The drug they contain, called Enbrel, effectively keeps my arthritis symptom-free.

It also costs $1,800 a month.

Until recently, I was covered under my family’s insurance plan. But now I’m struggling to get my drugs covered in any way.

I’m not a unique case. Enbrel is part of a class of medication called biologics. For those who take them, biologics can perform miracles. But their high cost, which is rarely mitigated by medical coverage, has created a unique situation for thousands of Canadians who want, but can’t have, their life-altering medication.

It’s affecting health plans, too. The most popular class of biologics, TNF-alpha drugs, which Enbrel falls into, are the most expensive drug class in all provinces and territories in Canada, except for Ontario, where they’re the second-most expensive. They cost Canada’s public health plans more than half a billion dollars in 2013, for about 30,000 beneficiaries.

To compare, one class of cholesterol-reducing drugs, which rank in the top three for cost consistently across provinces, cost public-health plans just more than $300-million for about 2.2 million beneficiaries. That’s $200-million less, for about 73 times the number of beneficiaries.

And while provincial governments, struggling to balance health care budgets, try to wrap their heads around how to cover these drugs, as well as cheaper quasi-generic versions on the horizon, people like me are left trying to figure out a system in flux, with our health tied to the outcome.

The cost to develop a biologic can exceed $1-billion. (Darren Calabrese for The Globe and Mail)

What are biologics?

Biologics are a unique class of drugs. While most drugs are chemicals that are created using standard procedures – think test tubes, centrifuges and Bunsen burners – biologics are produced by bacteria or cells that have been reprogrammed to do our bidding.

According to Leigh Revers, a senior lecturer in biotechnology at the University of Toronto, most drugs are chemically synthesized, meaning anybody with the right ingredients and equipment could make them, in theory.

“You and I could go off, and we could literally start making aspirin in our backyard. We could make the same stuff … that you can find in a pill … very much like Breaking Bad,” he said. Because the drugs are simple molecules, we understand the process for creating those molecules, he said.

Biologics, on the other hand, are not simple molecules. They have to be produced by living organisms, Revers said. A good example is insulin, considered to be the first biologic. It’s made by bacteria, implanted with a human gene. The bacteria effectively become little factories, churning out the insulin protein diabetics can use.

Enbrel is part of a class of biologics called tumour necrosis factor alpha inhibitors. In simple terms, Enbrel is a human-made antibody. Just like we can make bacteria produce insulin, we can make them produce antibodies we’ve designed, Revers said.

“You can introduce genetic information into certain cells, and those cells are then told how to make antibodies,” he said.

These antibodies don’t exist in nature. They’re designed by scientists, like a kid building an imaginary creature out of Lego blocks.

In my case, my body’s immune system is a little too eager, and it overproduces a signalling molecule called tumour necrosis factor alpha, or TNF-alpha. Enbrel contains a human-made antibody that connects to the TNF-alpha molecules and removes them. The inflammation goes away and I can walk again.

It’s an elegant solution for a complicated disease and it exists for more diseases than arthritis. Biologics have uses in inflammatory bowel disease, skin conditions and breast cancer.

The drugs have radically expanded treatment options for doctors, according to Dr. Edward Keystone, a professor for medicine at U of T, senior consultant of rheumatology at Mt. Sinai hospital.

“It has revolutionized the treatment of these diseases,” he said.

Arthritis is one of the diseases that has seen the largest impact by the introduction of biologics. Before they were introduced into the market, about 15 years ago, Keystone said there were about four conventional drugs to treat arthritis. If they didn’t help a patient, which Keystone estimates happened in about half of cases, there were very few treatment options left. Many of these patients were hospitalized frequently.

“That’s a disaster, when you think about it,” he said. Hospitals would have beds dedicated to arthritis patients. When Keystone was a resident, the hospital he worked at had 40 of those beds. Today, he estimates there are, at most, six left in the entire city of Toronto.

Oliver Sachgau was diagnosed with juvenile arthritis at age 14.

The cost of a revolution

The drugs aren’t cheap. Four doses of Enbrel, enough for a month, cost more than $23,000 a year. Remicade, another popular biologic, can cost anywhere from $1,300 to $2,500 for a single dose.

The drugs are this expensive because they’re extraordinarily hard to create, says Dan Martinusen, a clinical pharmacy specialist at the Vancouver Island Health Authority. A non-biologic generic drug, for example a chemical clone of Advil, costs $1-million to develop. A biologic can cost more than $1-billion.

This affects health plans. A report by the Canadian Institute for Health Information found that while public drug spending declined in many of the top drug classes in 2013, those savings were offset by increased spending on biologics.

TNF-alpha inhibitors, such as Enbrel, accounted for the highest proportion of spending of all drug classes, with a fraction of the beneficiaries of other drugs. Ontario public health plans spent $201-million on TNF-alpha drugs in 2013, for about 10,700 beneficiaries. By comparison, the next-most-expensive drug class, HMG-CoA reductase inhibitors, a type of cholesterol-lowering drug, had total spending of $179-million, for more than 1 million beneficiaries.

The situation repeats itself in all Canadian provinces. In British Columbia, TNF-alpha drugs cost public health plans $130-million in 2013, with about 7,800 active beneficiaries. The next-most-expensive class of drugs, commonly used to treat schizophrenia, cost $41-million, with 87,000 beneficiaries.

The report also estimated 22 per cent of drug spending was being done out of pocket.

That’s the situation I might find myself in. When I graduated university and stopped being covered under my family’s health plan, I registered for the Ontario Trillium Drug Program. It covers the cost of drugs relative to household income. But for a drug to be covered, it needs to be listed in the Ontario Drug benefit formulary, where Enbrel is only approved for severe psoriasis.

In a case such as mine, I can apply for exceptional access through my doctor.

I did. I got turned down.

Around mid-July of this year, I got a call from Enliven Services, a patient support program by Amgen, the company that makes Enbrel. They had just been informed that Trillium was not going to make an exception and cover my Enbrel. The reason Trillium gave was that I hadn’t exhausted all my treatment options. Though I had taken a drug called methotrexate before with no effect except for violent nausea, Trillium wanted me to try it again, this time in conjunction with another drug. If that didn’t work, I could re-apply for the exception. Since my Enbrel wouldn’t be covered, Amgen wanted to figure out my next steps.

That I had been turned down at all was news to me. I hadn’t received a letter in the mail, or a call from my doctor. Until Enliven called me, I was under the impression my application was still making its way through the bureaucratic circles.

I told Enliven I couldn’t afford the drug out of pocket. After paying for rent, student loan payments, food and living costs, I’m lucky if I can put a bit into savings. I could never come close to finding an extra $1,800 a month.

Almost a decade after Sachgau's diagnosis, he found the drug – Enbrel, a biologic – that let him walk, even run, once again.

A not quite generic alternative

There is another possibility. The patents on many biologics have recently expired, or are about to. This means other companies can start creating generic versions that will presumably be cheaper, and more likely to be covered by health plans. These drugs are called biosimilars or subsequent entry biologics (SEB) and they’re starting a boom in the biologics pharmaceutical industry. Companies are springing up, especially in the United States, hoping to create cheaper versions of biologics already on the market. Even Amgen is reportedly getting into the biologic business, Revers said.

There’s an important caveat here. SEBs are not called generics, because when it comes to biologics, there’s no such thing, Revers said.

Replicating a biologic is not as simple as making aspirin. If you wanted to create an SEB for Enbrel, you would have to replicate the process Amgen uses, or find another one that produces identical results, which means implanting a gene into cells that will produce antibodies. The process is important here. If you wanted to make an exact copy, everything, especially the cells producing your drug, would have to be identical.

“The cell lines that they use are doing the work, and we’re a lot less confident about people having the exact same cell lines,” Revers said.

Even then, you would get something close, but not exactly identical to Enbrel.

“Just because you have a bunch of grapes doesn’t mean you can make Château Lafite,” he said.

For that reason, switching over a patient from a biologic to an SEB is not as easy as switching someone from Tylenol to a generic version, Keystone said. Because relatively few clinical studies have been done, there are still questions of whether human bodies might respond differently to SEBs.

Until recently, Sachgau's drugs were covered under his family’s insurance plan. But now he's struggling to get them covered in any way.

How do you regulate an SEB?

This creates a problem for regulatory approval. If SEBs were generic, Health Canada can issue a certificate of equivalence, and the drug can be used in the same way as the original. But how do you approve something that’s kind of, but not exactly, generic?

For a biosimilar to be used in Canada, the patent for the biologic has to first expire. That’s happened in one case in Canada, for the biologic called Remicade. Its SEB is called Infliximab, though Remicade has also been referred to under that name.

The SEB then has to get approval from Health Canada, which has a new regulatory pathway dedicated to these drugs. In the pathway, Health Canada says SEBs are not generic from a regulatory standpoint, and can’t be switched with their biologic counterparts.

Health Canada can also choose to approve SEBs differently from their original biologics, effectively treating them like new drugs altogether. Infliximab, for example, has not been approved for all the same conditions as Remicade.

But these rules are still being figured out and might change. Revers said the rules might say no switching for now, but that arrangement will become “more casual” in the future.

“The world is going to get complicated,” he said.

But even if SEBs are prescribed to only those people who have never tried a biologic before, it might still bring down the price of all biologics, simply by having a more competitive playing field. But Martinusen said he expects the savings to be slim, in the range of 15 to 30 per cent. That’s not insignificant, but it still makes the drugs prohibitively expensive.

On the other hand, health plans may start only covering the cost of the SEB, even if the biologic is the prescribed drug, Martinusen said.

“You could see for many patients, that would press them to use the [SEB],” he said.

A creeping deadline

For me, what matters right now is getting access to my medication in the short-term.

A week after I learned my Enbrel had been turned down for the Trillium Drug Benefit, my advisor at Enliven told me I had qualified for long-term bridging. That means because I’m young and had high prospects for full-time employment with benefits (I didn’t tell them how rare that is in journalism), Amgen will give me Enbrel for free for six months. After that, they’ll re-evaluate my employment situation.

That’s where I’m at right now. My long-term bridging might get extended, but not indefinitely.

If I want Trillium coverage, I’ll have to stop my Enbrel and experiment with two other medications first. Because I’ve already taken one of the two with no effect, the chances of them working are low. Even so, I’ll have to take them long enough to prove to the government they don’t work, which could take up to a year.

In the meantime, provincial governments will keep figuring this out at a slow pace. But I know how painful a slow pace can be.

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