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!

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.

TORONTO – Canadians with cystic Fibrosis (CF) have been living with unequal access to treatment for a full year now as KALYDECO a life-saving treatment for this disease celebrates its one year anniversary of approval by Health Canada without wide spread public drug plan coverage. Some Canadians have been lucky enough to receive this medication through their private insurance, but others continue to wait for their provincial governments to provide coverage while their lung function deteriorates day by day. The longer that access to KALYDECO is denied to Canadian patients, the longer we support a two-tier system where only those with private insurance can gain access to this life saving treatment.

“All we are asking for is an equal chance for all cystic fibrosis patients to get access to the treatment they need” said Christopher MacLeod, Chair of the Canadian Cystic Fibrosis Treatment Council and a CF patient who is receiving KALYDECO through his private insurance. “Public coverage for KALYDECO in Canada has been stalled for too long now, and for many patients access delayed is access denied.”

There are over 100 Canadians suffering from Cystic Fibrosis in Canada for whom KALYDECO may be the only alternative to an eventual transplant. The mean age of those killed by this disease is 22. The Canadian Cystic Fibrosis Treatment Council is calling on provincial governments to step up and provide public coverage for KALYDECO before it is too late for those who need it. At this time the drug is only available through private insurers, or through Quebec’s Special Access Program.

“This is a treatment that has revolutionized the way in which Cystic Fibrosis care will be delivered, it’s a game changer in the fight against CF,” said Dr. Kieran McIntyre, doctor of Respirology and Cystic Fibrosis at St. Michael’s Hospital. “I have patients that need this medication but without private insurance will not be fortunate enough to begin therapy. We cannot continue to have patients who are excluded from the care they need.”

Canadians with CF have nothing to celebrate until provincial governments decide that a two tier system for drug access is not acceptable and that Canadians should not be denied life-saving medication solely because they do not have private insurance.

“I spent three of the six months before I started taking KALYDECO in hospital,” said Chris. “I’ve been on the drug for a year now and haven’t spent a single day of that in hospital. I’m one of the lucky ones, but there are many people out there who do not share my good fortune. I will not rest until there is equal access for all CF suffers. “

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Media Contact:

Chris MacLeod

Chair of the Canadian Cystic Fibrosis Treatment Council

647-381-4902

cmacleod@cambridgellp.com

KALYDECO was approved for use in Canada by Health Canada in November 2012 for people with CF aged six and older who have at least one copy of the G551D mutation in the CF gene. There are over 1,800 known mutations of the CF gene — the G551D mutation is just one of them and present in approximately 4% of Canadians affected by Cystic Fibrosis. And while there are roughly 100 people in Canada with the G551D mutation, at the present time there are only about 20 of them that fortunate enough to have access to this remarkably effective drug because of their private insurance plans. The remaining 80 patients are waiting and hoping for public funding.

This two-tier system is unfair and – in our opinion – un-Canadian! Countries such as England, Scotland, Wales, the Republic of Ireland and Northern Ireland have all found ways to publicly fund KALYDECO, and Canada needs to do the same. It is simply unacceptable that KALYDECO, the first medicine to work at the genetic level, is not covered by our governments while it is available to thousands of patients in other countries, and it is available to Canadian patients who have private drug plans.

If you would like to  advocate for public funding for KALYDECO, you can start by contacting your local Member of Provincial Parliament or Member of Legislative Assembly. They can than influence the people at Alberta Health who are leading the Pan-Canadian Pricing Alliance in the review of KALYDECO to act quickly to recommend that all provinces and territories publicly fund this break-through medication.