UVic student‘s terrible disease poses a dilemma for health minister
Health Minister Adrian Dix is facing one of the most hellish dilemmas that governments confront. A student at the University of Victoria, Lilia Zaharieva, has cystic fibrosis.
The disease progressively clogs the lungs, making breathing increasingly difficult. Sadly, it is almost always fatal; average life expectancy is 35. Drug therapies can slow the onset of symptoms, but no cure is yet known.
Zaharieva’s case, however, is different, at least to a degree. She has an unusual variant of the disease called F508del-CFTR. And for this mutation, a drug called Orkambi was recently introduced.
Zaharieva was given the medication, and her condition improved. But her insurance company has withdrawn coverage, citing affordability, among other factors. A year’s supply costs $250,000.
Without Orkambi, Zaharieva’s doctors give her two years to live. And here is where Dix’s dilemma arises.
Orkambi isn’t covered by the province’s PharmaCare program, and the minister is standing by that judgment. He rests his decision on the advice of the Canadian Drug Expert Committee.
In June of last year, the committee examined the evidence from clinical trials. Here is what was found:
Orkambi increased lung function, on average, by only two to three per cent. Anything less than a five per cent improvement is considered clinically insignificant.
There have been no clinical trials that looked at Orkambi’s impact on long-term disease progression, on the need for lung transplantation or on mortality.
There are about 1,500 Canadians aged 12 or older who have this genetic variant. Providing each with the drug would cost $375 million a year.
On those grounds, the committee recommended that Orkambi should not be funded. Britain’s National Institute for Healthcare and Excellence arrived at the same conclusion.
Which places Dix in an almost impossible position. On the one hand, all of the provinces agreed to accept the committee’s advice.
If B.C. breaks ranks, everyone gets whipsawed.
As well, if Dix changes the rules for Zaharieva, he would have to do the same for the other British Columbians who have this variant. That could cost about $30 million a year.
It would also make us price-takers, not price-setters, because drug companies could charge whatever they like, and count on patients forcing politicians to go along.
On the other hand, the clinical trials of Orkambi did show that a small minority of patients gained a somewhat greater measure of benefit, at least for a time. Maybe Zaharieva is one of that group.
And this is where we start counting the circles of Hell. It’s bad enough being asked to set a price on saving someone’s life. But what about the price of prolonging someone’s life, particularly a young woman only 30 years of age?
Is it worth spending a quarter of a million dollars to buy an extra month? Or three months? Or six months? Or a year?
Worse still, we don’t know in advance which patients’ lives we might prolong, meaning we’d have to give everyone the drug. Back to square one.
Confronted with a no-win situation, Dix has done the only thing he could. He told Orkambi’s manufacturer, Vertex Pharmaceuticals, that if it has any new evidence to present, it should get hold of the Drug Expert Review Committee and ask for a rehearing.
This is a new medication, and it’s possible that with more time in the field, better outcomes might have emerged. Equally, it must be said, the downstream results could as easily be worse.
No minister should have to face such a dilemma. No patient should be placed in such a dreadful position. This is as bad as it gets.
For now, we need to make the eradication of this fell disease the aim of all humanity.