Pharmacare

'A tough policy conundrum': U of T expert on the long wait for a national pharmacare strategy

Christopher.Sorensen — Fri, 29 Mar 2019 18:05:01 +0000

'A tough policy conundrum': U of T expert on the long wait for a national pharmacare strategy

Christopher.Sorensen Fri, 03/29/2019 - 14:05

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Gregory Marchildon, a professor at the ��߲ݴ�ý's Institute of Health Policy, Management and Evaluation, says Canada is a half-century overdue for a national pharmacare strategy (photo by Alexandru Titeu)

Rebecca Biason

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Institute of Health Policy Management and Evaluation

Dalla Lana School of Public Health

Pharmacare

The recent federal budget pledged to move forward on a national pharmacare strategy. That potentially includes the creation of the Canadian Drug Agency, a national drug agency that would “take a co-ordinated approach to assessing effectiveness and negotiating prescription drug prices on behalf of Canadians.”

But there's a caveat: The budget only committed to giving Health Canada $35 million over four years to further support the development of the idea.

The budget also earmarked $1 billion per year over two years, plus $500 million per year ongoing, to help cover the cost of drugs for rare diseases – funding that isn’t slated to begin flowing until 2022-2023.

“We are 50 years overdue for a national pharmacare strategy – we have attempted to create one before, have withdrawn it twice, and now the possibility of one looks extremely fragile,” says Gregory Marchildon, a professor at the ��߲ݴ�ý's Institute of Health Policy, Management and Evaluation and an expert on pharmacare.

Marchildon, who is also the director of the North American Observatory on Health Systems and Policies, believes the government could choose from a few options if it is willing to endure some short-term financial pain in order to reap long-term cost benefits.

“We could have a single-payer, universal and national plan, where no matter what province or territory you lived in, moved to, or travelled in, your drug coverage would be the same,” says Marchildon.

“This pan-Canadian option, governed by strict federal standards, would have very few barriers to access – or none.”

A second option, according to Marchildon, could involve a “multi-payer system in which employment-based insurance plans are subsidized by the government.”

Marchildon spoke with writer Rebecca Biason about the current patchwork system in place and why, from a public policy perspective, developing a national pharmacare plan remains so elusive.

What is our pharmacare system like right now?

It is an uneven plan, governed separately by each province and territory with a lot of variation in terms of which drugs are covered and added to the Canadian Drug Association (CDA) formulary, as well as the cost of co-payments. In many provinces, it is only once individuals retire that they really see how minimal their coverage is. Unsurprisingly, the richer the province and the larger the population, the more comprehensive the drug plan and the less co-payments are required. The difference between coverage in Ontario and the Atlantic Provinces, for example, would be quite glaring.

How would better and universal coverage be beneficial?

Currently, 20 per cent of Canadians are going without medications because of the lack of coverage and the high cost of drugs. With a truly universal single-tier system, comprehensive coverage of an essential list of medications would be available for everyone regardless of income or place of residence across the country. There would need to be strict evaluations of which drugs could be included in the CDA formulary with drugs being tested for both their performance effectiveness and cost effectiveness.

Additionally, provincial and territorial governments, through the CDA, would have the ability to negotiate harder and more effectively with pharmaceutical companies to reduce drug prices.

For example, if the CDA sought to purchase a drug, say, for an inoculation against a disease like the flu, where it would be distributed directly to the public, bulk purchasing could be done in the public interest and at a low cost.

What does the future of pharmacare look like for Canadians?

The recent federal budget announcement shows that the government has spread money across lots of different places but there has been no focus on any big initiatives. You need to have a focused budget to successfully bring about a pharmacare program. There has been little strategic discussion on how a program would be implemented but the federal committee on pharmacare is emphasizing collaboration with provinces, leading us to believe that the federal government does not want a pharmacare initiative to fall on their shoulders alone.

Pharmacare has always been a tough policy conundrum. It is hard to fix a system that seems to be working for folks in the middle class, even at a high cost. Some people may not recognize the stress and strain of those who do not have private plans. Those individuals who are low income – and often marginalized with no access to private insurance plans – do not have a voice and are not given the opportunity to express how difficult it is for them to purchase essential medications.

It would be ideal for political parties in this election year to deliver a blueprint plan that shows an active discussion about the appropriate design of pharmacare and what we might achieve with a single-payer system. The public could then make a true choice and it would help to alleviate confusion around this debate.

We have a faint hope through both the upcoming June report from the federal committee on pharmacare and the budget, but what the reality will be for the future of Canadian phamacare seems both vague and very distant.

NAFTA negotiations may threaten pharmacare: U of T expert

noreen.rasbach — Mon, 10 Sep 2018 18:26:32 +0000

NAFTA negotiations may threaten pharmacare: U of T expert

noreen.rasbach Mon, 09/10/2018 - 14:26

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The ongoing NAFTA renegotiations could put a Canadian national pharmacare program in jeopardy, and could have a particular impact on Canadians who need expensive arthritis drugs, says U of T's Joel Lexchin (photo by Shutterstock)

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Around 91 per cent of Canadians want a national pharmacare plan, according to a recent national poll, so they don’t have to choose between buying groceries or paying for drugs to keep them healthy.

The same public opinion survey has also found that prescription drug access and affordability are issues for almost 25 per cent of Canadian households.

But depending on what happens with the ongoing North American Free Trade Agreement (NAFTA) renegotiations, the cost of such a pharmacare plan could go up, possibly dramatically.

This has to do with something called intellectual property rights (IPRs). Usually when talk turns to IPRs people think about patents. But there’s also something called data protection.

The data that’s being protected is information about the effectiveness and safety of drugs that comes out of the clinical trials that brand name drug companies do when they want approval to market a new drug.

Generic drugs essential to pharmacare

The data is the private property of the brand name companies and can’t be used by anyone else, including generic companies, for a period of time.

It would be very costly for generic companies to do the original testing all over again, and it would also be unethical because the results of the trials are already known. So generic companies use the data once it’s no longer protected.

Data protection is not a sexy topic, but it’s important in determining how quickly some low-cost generics can reach the market. The presence of generics keeps public drug plans affordable and will be essential for any pharmacare plan.

Right now, seven out of every 10 prescriptions are filled with generic drugs, but paying for generics only uses up 21 cents out of every dollar that is spent on prescription drugs in Canada. A generic prescription is about one-third the price of a brand name one.

Patents already mean that brand name drugs are on the Canadian market for more than 12 years without any competition. When patents run out, generic drugs can be sold, but sometimes patents expire before the data protection period is up. Until the data protection period ends, there can’t be any generics. What’s more, unlike patents, data protection can’t be challenged in the courts.

Ten years of data exclusivity

Canada used to offer five years of data protection but both the lobby group for Big Pharma here and in the United States found that time period unacceptable.

In the end, as a result of the lobbying efforts by the pharmaceutical industry, Canada amended its regulations on data protection to allow for eight years of data exclusivity. An extra six months is possible if the company marketing the drug is able to determine that children need the drug.

Now comes word that in the bilateral United States-Mexico NAFTA talks, there was an agreement that biologics will have 10 years of data exclusivity.

Biologics are injectable drugs that are used to treat various forms of arthritis, Crohn’s disease and ulcerative colitis (inflammatory bowel conditions), multiple sclerosis and a variety of other diseases.

Biologics can be very effective but they come with a high cost.

Big money spent on biologics

According to the latest report from the Patented Medicine Prices Review Board, a federal agency that sets a maximum introductory price for new patented medicines, biologics accounted for seven of the top 10 patented drugs in Canada based on the amount spent in 2017.

No. 1 on the list is infliximab (Remicade), used in the treatment of rheumatoid arthritis and ulcerative colitis, among other illnesses. The average annual cost for a course of treatment with Remicade is close to $29,000 and, in total, just shy of $1 billion was spent on this one medicine alone in 2017 by patients, provincial drug plans and private insurers.

No. 6 on the list is etanercept (Enbrel) also used for various forms of arthritis. The average annual cost for Enbrel is $13,600.

But for some of these biologics, there is the rough equivalent of a generic, known as a “subsequent entry biologic (SEB).” Whereas a single dose of Enbrel costs $406, a single dose of its SEB is only $255 – more than a third less expensive.

If the U.S. pushes Canada to accept the same data protection period that Mexico did, then data protection here goes up by another 1.5 to two years. Then we might very well be spending a lot more on some biologics, because the SEBs will be delayed.

If we want a national pharmacare system, then we need to make sure that our negotiators don’t give in to any American demands about medical data protection.

Joel Lexchin is an associate professor of family and community medicine at the ��߲ݴ�ý, professor emeritus of health policy and management at York University, and an emergency physician at the University Health Network.

This article was originally published on The Conversation. Read the original article, including his disclosure statement.

U of T expert on pharmacare and the 'chaotic world' of Canadian drug prices

noreen.rasbach — Mon, 19 Mar 2018 20:30:27 +0000

U of T expert on pharmacare and the 'chaotic world' of Canadian drug prices

noreen.rasbach Mon, 03/19/2018 - 16:30

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Could universal pharmacare reduce excessive drug price hikes in Canada? Eric Hoskins, former Ontario minister of health, will chair a federal advisory council to implement a national pharmacare plan (photo by Andrew Francis Wallace/Toronto Star)

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The cost of a life-saving drug to treat cystinosis – a rare disease affecting probably 100 people across Canada – is soon to rise from $10,000 per year to more than $300,000 annually.

The new form of the drug, Procysbi, contains the same active ingredient as the old form of the drug, Cystagon. It differs only in that it contains a new coating, enabling a slower release of chemicals into the body.

Reforms to the Patented Medicine Prices Review Board (PMPRB), a federal agency that sets a maximum introductory price for new patented drugs, could help rein in this type of increase.

But a coalition of patient groups, some partially funded by drug companies, want Canada’s health minister and Health Canada to stop this reform process. They argue that lowering drug prices in the manner proposed could limit access to new drugs.

The drug companies are backing them up.

Canadians pay the price

According to Pamela Fralick, the CEO of Innovative Medicines Canada (IMC), the lobby group representing the multinational drug company subsidiaries operating in Canada: “The proposed changes would negatively affect patients by slowing and limiting access to new, life-saving medicines and vaccines, and will have consequences for investment and employment in Canada’s life science sector.”

IMC and its predecessors have been making the same type of veiled threat since the early 1970s, when Manitoba introduced its public drug formulary, a list of drugs the province would cover.

With a national pharmacare plan, all Canadians would benefit from lower drug prices (photo by Shutterstock)

While there are drugs that are not sold in Canada, the reason is the relatively small Canadian market, not the price.

In fact, when it comes to paying for prescription drugs, only the United States and Switzerland outspend Canada on a per capita basis out of 31 industrialized countries in the Organization for Economic Co-operation and Development.

There are now 19 drugs on the Canadian market that cost $50,000 or more per year, compared to just six a decade ago.

And, contrary to what IMC claims and what the patient groups seem to believe, only one in 10 new drugs are actually major therapeutic improvements.

Increase of 3,000 per cent

The dramatic rise in the cost of treating cystinosis – a genetic disease that causes kidney damage – reflects the dysfunctional nature of the way Canada controls drug prices.

Up until now, the treatment has been a product called Cystagon that must be vetted by Health Canada on a patient-by-patient basis since it’s not approved for sale in Canada. Now the newer version of the drug, Procysbi, made by Horizon Pharma – and taken twice instead of four times daily – is being marketed in Canada.

With the advent of Procysbi, the cheaper Cystagon will no longer be available to Canadian patients. Under the current rules enforced by the PMPRB, Procysbi is treated as a “breakthrough drug,” which is why the 3,000-per-cent price increase was permitted.

Again, the only difference between Cystagon and Procysbi is the latter has a special coating enabling its release into the body more slowly.

All of the basic research and development of Procysbi was financed by patient groups, not drug companies. Horizon Pharma has not publicly offered any reason for the price it plans to charge. The company is going to offer the drug for free for a limited time, but what happens when that option ends?

This isn’t the first time there’s been sticker shock about drug prices in Canada. In September 2017, the PMPRB ordered Alexion Pharmaceuticals to lower the $700,000 annual cost of Soliris, used in the treatment of rare blood disorders.

The pan-Canadian Pharmaceutical Alliance, a coalition of provincial and federal drug plans, bargains with companies for lower prices and is in negotiations with Horizon Pharma. But even if it can secure a discount, that will only apply to what provincial drug plans pay.

Private drug plans and people paying out of pocket, assuming anyone could actually afford Procysbi, will not get the discount.

National pharmacare a solution

A national pharmacare plan could help to bring some order to the chaotic world of Canadian drug prices. Everyone in the country would be covered under a public plan and benefit from the lower drug prices that would be achieved.

Pharmacare doesn’t necessarily mean that drugs will sell for pennies. But based on the experience in other countries, we will be much better off.

If companies don’t like the price being offered, then they could still try to sell their drugs to those who could afford them, but the market would typically be very small, encouraging the companies to lower prices.

However, Finance Minister Bill Morneau doesn’t seem interested in a universal pharmacare plan, preferring to try to fill gaps and add to the patchwork in the existing system, although now he seems to be backing off from his initial comments.

Perhaps people with cystinosis should ask Morneau to cover their costs.

Joel Lexchin is a board member of Canadian Doctors for Medicare, professor emeritus of health policy and management at York University, and associate professor of family and community medicine at the ��߲ݴ�ý.

This article was originally published on The Conversation. Read the original article.

National pharmacare plan a step in right direction for Canadians: U of T expert

noreen.rasbach — Tue, 06 Mar 2018 05:00:00 +0000

National pharmacare plan a step in right direction for Canadians: U of T expert

noreen.rasbach Tue, 03/06/2018 - 00:00

Rebecca Biason

Topic

City & Culture

Dalla Lana School of Public Health

Health

Pharmacare

The federal government has set in motion a possible national pharmacare plan by creating an advisory council as part of last week's budget.

Although Ottawa has yet to attribute funding to the program, setting up a national advisory council, chaired by Eric Hoskins, Ontario's former minister of health and long-term care, is a serious step in the right direction, said health policy expert Gregory Marchildon, a professor at the Institute of Health Policy, Management and Evaluation (IHPME).

“National pharmacare addresses the unfinished business of Medicare, including not only improved access to medications for the working poor and part-time workers, but also lowered drug costs, and increased mobility for workers looking for jobs in other provinces. These individuals would no longer be limited in terms of career movement by their drug coverage in a particular region or employment benefit plan,” said Marchildon, who is also director of the North American Observatory on Health Systems and Policies.

According to Marchildon, a national coverage plan could fit one of two models: a single-payer plan implemented by the provinces and territories under a set of federal standards similar to our current Medicare coverage, or a federal program that is regulated, financed, and administered by the federal government, and provided to Canadians directly.

“Now is the time to develop a comprehensive structure, as the differences in federal, provincial and territorial coverage plans grow, and as the breadth and depth of coverage in private, employment-based drug plans continues to decline,” he said.

Rebecca Biason of IHPME in the Dalla Lana School of Public Health spoke with Marchildon about the next stages in the process of a national pharmacare plan.

What does the advisory council need to focus on to move forward?

The Parliamentary Committee on Health is about to release its report on a national pharmacare program. Assuming the all-party committee recommends in favour, there may still be a need for a follow-up study on how a national plan might work so that we can construct the best administrative machine and determine what national pharmacare would look like in terms of the breadth and depth of coverage.

Watch Gregory Marchildon on CTV National’s federal budget coverage

The breadth of coverage would likely have to be broad as we take into consideration the variety of current plans available throughout the country. Any proposed pharmacare plan would have to meet the expectations of those living with fairly good private or public coverage.Hopefully the recommendation would be to provide better coverage than that which the majority of Canadians have at present.

What about co-payments or deductibles?

This is probably the most difficult decision when it comes to building a national plan, and falls under the depth of coverage. The council would need to decide whether certain medications are free at the point of access, or whether they will require co-payments or deductibles. A tiered system might even be discussed, with classes of drugs, some free, some needing a minimal payment, and others a more substantial co-payment.

How does Canada compare with other countries?

Countries like Australia and New Zealand already have national drug coverage plans, but they are managed in different ways, such as by agencies or Crown corporations while many European countries already have drug coverage worked into their universal health plans. The council will need to assess the way these countries have structured their plans and determine what will be most suitable for Canadians.

What are some of the barriers ahead in creating a comprehensive plan?

Pharmaceutical companies are going to be affected, as drug prices fall and cost controls come into effect under either coverage model. These companies can choose to work with the new plan, and maximize their benefits including providing drugs at lower prices but gaining the benefits of a larger market as more people have access to the medications they need. Or, they can choose to fight national pharmacare from the beginning.

They are more than capable of sowing the seeds of doubt about the development of the plan and its impact on job losses, particularly in Ontario and Quebec, where most Canadian pharmaceuticals are manufactured. They can also lobby or otherwise influence politicians, ministers, provincial governments or other groups who might oppose such a plan.

There will likely be a very long road ahead leading into the 2019 election and the establishment of national pharmacare.

Health minister says drug costs are “way out of control” but change is on the way

sgupta — Mon, 18 Jan 2016 06:15:10 +0000

Health minister says drug costs are “way out of control” but change is on the way sgupta Mon, 01/18/2016 - 01:15

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Alan Dean Photography)

Alan Christie

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Alan Christie

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Dr. Jane Philpott brings years of U of T experience to a crucial cabinet position

Dr. Jane Philpott would love to be in Addis Ababa in a few weeks to see the first students graduate from a family medicine program she was instrumental in establishing while at the ��߲ݴ�ý.

Unfortunately, she will have to miss the graduation. She is too busy running Canada’s health-care system.

In November, Prime Minister Justin Trudeau named Philpott minister of health. It is perhaps the most important portfolio in government, after the prime minister and finance minister and an extraordinary achievement for a neophyte MP elected to the riding of Markham-Stouffville.

It was a remarkable posting in another way: she is the first medical doctor to become federal minister of health.

Philpott’s connection to U of T goes back to the 1980s when she spent a year doing a fellowship with Dr. Jay Keystone on tropical medicine after completing her family medicine residency at the University of Ottawa.

In 2012 she completed her master’s degree in public health at U of T and holds a clinical, part-time appointment with the department of family and community medicine at U of T at the rank of associate professor.

“I had an absolutely fabulous experience studying as a mature student at U of T,” Philpott told U of T News. “It was very helpful at that stage of my career.

“I can’t say enough about the Faculty of Medicine. I worked with a lot of outstanding colleagues over the years. And as a graduate student, the amount of courses available was absolutely stunning.

“My experience really deepened my understanding of the health-care system and health policy. It was tremendously enriching for me both personally and professionally.”

Another enriching experience was her leadership role in the Faculty of Medicine’s Toronto Addis Ababa Academic Collaboration.

Election 2015: National plan needed for Canada's aging population

sgupta — Mon, 21 Sep 2015 16:49:15 +0000

Election 2015: National plan needed for Canada's aging population sgupta Mon, 09/21/2015 - 12:49

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(photo by Benny Lin via Flickr)

Alan Christie

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Alan Christie

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Pharmacare should be part of a seniors strategy, U of T experts say

While the main political parties are shying away from an evidence-based national seniors strategy that would include a country-wide pharmacare program to pay for prescription drugs, two U of T professors are passionately advocating for a plan on behalf of older Canadians.

Dr. Samir Sinha, an assistant professor of medicine, and Dr. Danielle Martin, an assistant professor in the department of family and community medicine, are regular members of a CBC television news panel that discusses health care issues. Other members are Dr. Jacob Udell of the Faculty of Medicine and Dr. Peter Lin, who was the medical director at the Health and Wellness Centre at U of T Scarborough for seven years.

When asked on air what the most important issue is in the federal election campaign, Sinha said a national seniors strategy. Martin's choice was pharmacare. The two are intertwined.

In an interview with U of T News, Sinha explained the need for the national strategy. Martin responded via email to questions about pharmacare.

Pharmacare

'A tough policy conundrum': U of T expert on the long wait for a national pharmacare strategy

NAFTA negotiations may threaten pharmacare: U of T expert

Generic drugs essential to pharmacare

Ten years of data exclusivity

Big money spent on biologics

U of T expert on pharmacare and the 'chaotic world' of Canadian drug prices

Canadians pay the price

Increase of 3,000 per cent

National pharmacare a solution

National pharmacare plan a step in right direction for Canadians: U of T expert

Watch Gregory Marchildon on CTV National’s federal budget coverage

Health minister says drug costs are “way out of control” but change is on the way

Read more about TAAAC

Read more about pharmacare

Election 2015: National plan needed for Canada's aging population

Read more Election 2015 coverage from U of T News