This Quebec ideology – a matter of principle, clearly, so don’t look for a rational explanation – also includes the astonishing fact that this is now the only Canadian province that has not instituted testing of all newborns for the presence of CF. And that is baffling in the sense that there is  clear and unequivocal evidence from countries that have implemented NB testing for CF  many years ago that this actually saves the healthcare system money in the long run,  in addition to making a significant difference to the quality of life and life expectancy of folks with CF. But I digress …

Looking at how a pan-Canadian deal for Kalydeco was eventually brought about – I can’t do much better than quoting the following from a Toronto Star article written by Rob Ferguson on June 2nd, when it referred to the Kalydeco situation as   “a political football in recent months, with the cystic fibrosis community pressing the Ontario government for help and Liberal Leader Kathleen Wynne — now in the middle of an election — saying the province couldn’t afford it without a lower price from Vertex Pharma, the Boston-based maker of the drug.” As well, the article states that: “Provincial health ministers took the issue into their own hands in April, pledging to hold a meeting with Vertex instead of leaving the negotiations in the hands of bureaucrats. That meeting was held four weeks ago in Toronto.”

Clearly, this meeting proved to be the game changer, but it would be quite unfair to blame the civil servants tasked with reaching an agreement on price with Vertex for the more than two years it took to get to this point. As we stated here earlier, in a post titled Negotiating a Price for Kalydeco, on December 21, 2013: “… they are doing so with one arm tied behind their backs.” In the absence of any kind of political will to make this happen, they were simply not a position to move their bottom line unless they were told to do so from above.

With the federal refusal to renew the Health Canada Accord and the dismissal of the Canada Health Council by cutting off its funding in 2014, the pan-Canadian Pricing Alliance notwithstanding, there simply wasn’t the organizational clout in terms of a national mandate to make things happen. What was needed, clearly, would be some leadership at the political level to break the impasse in the negotiating process and bring a pricing agreement about.

We saw one effort to provide that kind of leadership in December last year, when Nova Scotia Health Minister Leo Glavine stood up for CF patients in his province to suggest their province would go at it alone in funding Kalydeco. We can only imagine the pressure he faced from the inside when he was forced to retreat from that position on behalf of the pan-Canadian Pricing Alliance.

In the end, it was Alberta’s Health Minister Fred Horne – representing the lead province in the pan-Canadian Pricing Alliance – who pushed the deal through with Vertex after he personally invited and met with Vertex representatives and some of his own colleagues in Toronto to get the matter settled for all of Canada.

Finally, we would be severely remiss if we didn’t recognize and congratulate the Vanstone family from Beeton, ON – Beth Vanstone and her 12-year old daughter Madi with CF – for their brave and persistent fight to keep Kalydeco in the media, and for confronting and keeping the pressure on local politicians to make the life-saving Kalydeco deal happen, and not only for them, but for all Canadians!

“While we had a lengthy discussion, we have not yet reached an agreement with the
provincial and territorial governments, despite the fact that our proposal is as good as or
better than the agreements in place in 15 countries around the world where people with
CF are receiving the medicine through public reimbursement,” said Stuart Arbuckle,
Executive Vice President and Chief Commercial Officer for Vertex. “We are extremely
disappointed that today’s meeting did not result in an agreement to allow the eligible
children and adults with CF in Canada to receive this medicine through public
reimbursement. People with CF are still waiting for access to KALYDECO, and this
process is taking much longer than they expect and deserve.”

Based on the meeting, both parties have committed to further discussions this week.

In Canada, we continue to provide KALYDECO at no charge to people with CF who are
very sick as part of a compassionate use or expanded access program while we wait for
provincial and territorial governments to make a decision regarding public
reimbursement. Vertex will continue to provide the medicine to these patients while
reimbursement discussions are ongoing. Further, for the patients receiving KALYDECO
under private insurance in Canada, Vertex will continue to provide patient support
services, including financial assistance to eligible patients who need it.

KALYDECO was approved by Health Canada in November 2012.

While the case around the public funding of Kalydeco might be considered unique because of its astronomical cost, the fact that  Canadians end up paying more for prescription drugs than other countries is apparently not unusual at all, as was  pointed out  in the April 2013 issue of Health Affairs by researcher Steve Morgan, a health policy expert at the University of British Columbia.  He claims that Canada is missing out on brokering deals with pharmaceutical companies the same way fellow nations are. Morgan interviewed policymakers from nine countries similar to Canada, including Australia, Austria, Germany, Italy, the US and the UK.

The PCPA was announced in September 2010 by the provinces and territories as a means to purchase the most expensive brand-name drugs, but as reported in the Canadian Pharmacists Journal of September 2012, only 2 products have been purchased that way. And so it appears that the provinces and territories continue to “strike up their own individual deals with drug companies, missing opportunities to garner better prices if Canada negotiated rebates while buying as a whole country.” This according to Morgan, as quoted by Carmen Chai  with  Global News back in April of 2013:  “The pricing of medicines is now a game of negotiation, similar to buying a car at a dealership. There is a list price equivalent to a manufacturer’s suggested retail price and then there are  secret deals that everyone negotiates from there,” Morgan said. He told Global News that Canadians pay the second highest costs for brand name drugs in the world, second only to the United States. He said the large countries with multilevel health care systems lose out on drug pricing. New Zealand, for example, is a much smaller nation but it leverages its universal drug plan to lower its prices.

Canada pays about 20 per cent more for brand name drugs. Meanwhile, countries that negotiate the supply of generic drugs pay 90 per cent less than we do, Morgan said.
Tylenol or Advil, for example, would be about a fifth more expensive in Canada, while their generic counterparts, acetaminophen and ibuprofen, would be marked up by 90 per cent compared to other countries’ prices.

This shortfall in our bargaining power ends up on consumers’ shoulders, said Morgan.
“Current differences in price mean that Canadians are spending literally billions of dollars more than they should on prescription drugs. If we do not learn to negotiate rebates as well as comparators around the world, we will continue to pay billions of dollars more per year than we ought to,” Morgan told Global News. Pockets of our population, such as seniors, the poor or the very ill, end up paying the most out of pocket expenses for their drugs.

Across the board, Canadians and Americans paid for the most for their drugs. Deals struck between countries and drug companies are confidential though, so they don’t set precedents for other countries to follow.

Link to complete Global News article:  http://globalnews.ca/news/473107/canada-losing-out-negotiating-lower-drug-prices-study-says/

It remains to be seen if other provinces will follow suit, or whether they will wait to see the outcome of the protracted negotiations between ministry of health officials in Alberta and Vertex; it is assumed that any agreement on a costing formula for this drug will be adopted across Canada (except, perhaps, for Quebec)

This affirmative action by Nova Scotia regarding Kalydeco today and the negotiations in Alberta with respect to its costs suggest that we don’t really have our act together as a country.  While we pride ourselves on the quality and range of social services afforded by Canadians (especially in relation to the U.S.), the federation that constitutes Canada as a nation allows for the fragmentation of these services so, depending on where you live,  you might not be able to enjoy the same degree of coverage.

While it is true that this hodgepodge of federal and provincial jurisdictions  are often able to coagulate remarkably well on behalf of its citizens, there are some areas – such as healthcare – where this fragmentation can be acutely demonstrated and has led to the most deplorable results, with Kalydeco being a case in point.

Lest we forget, already a year has gone by that Kalydeco was approved by Health Canada for use in Canada. Not until the announcement from Nova Scotia today have we had any indication as to when this horribly expensive drug will be covered by provincial drug plans. As a result about 80 Canadians with the G551D CF mutation, who do not have a private drug plan,  are deprived of the tremendous benefits that this drug has to offer.

The negotiations in Alberta for an across-Canada price for Kalydeco are being held under the Pan-Canadian Purchasing Alliance – an arrangement between the provinces (except Quebec) initially agreed on in 2010, and again in 2012 with respect to the bulk-purchasing of pharmaceuticals.  This alliance would have been coming up for negotiation as part of the renewal of the 2004 Canada Health Accord in 2014.

And therein lies the rub, as the Harper government has decided to let the accord expire. The Canada Health Accord is the mechanism intended to enable equal standards of health care across the country. However, by not renewing it, the federal government is signaling is isn’t really interested in that kind of pan-Canadian approach to healthcare.  This in spite of the fact that at one time the conservatives were making noises about joining the provinces in the implementation of a National Pharmaceuticals Strategy.

Not surprisingly, in a further move to dismantle any kind of national governance of public health systems, the Health Council of Canada has been given the boot. Its funding is being cut off and it will be effectively out of business in early 2014. The Health Council was established in 2004 at the recommendation of former Saskatchewan premier Roy Romanow following his report on the sustainability of the Canadian healthcare system. One of its jobs was to advise and monitor the development of a National Pharmaceuticals Strategy. The council has been told that – without the Health Accord – its services are no longer required.

It is in this context of jurisdictional fragmentation and a clear lack of political leadership in health care that the pricing strategy around Kalydeco is being decided.  Apart from what transpired in Nova Scotia today, where is the political will to underpin the costing negotiations to ensure that Canadians who are in urgent need of this life-saving medication will have access to it? Yes, there are lives at stake here!

Finally, we can gain no comfort at all from the knowledge that the only other time the provinces went through the Pan-Canadian Purchasing Alliance to approve an expensive drug (Soliris), it took two years from the day Health Canada approved it for the drug to be funded by the provinces. Let us hope that the great leadership demonstrated by Minister Glavine in Nova Scotia today will now re-energize the negotiation process in Alberta to a swift and successful outcome so all Canadians in urgent need of this medication will be able to benefit from it at the earliest opportunity.