World’s most expensive drug — which costs up to $700,000 per year — too expensive, Canada says
Canada’s drug-price regulator has taken the rare step of calling a hearing into what is considered the world’s most expensive prescription medicine, accusing its manufacturer of exceeding the permissible price cap.
The yearly cost per patient of as much as $700,000 is even more than the manufacturer, Alexion Pharmaceutical, charges in the United States, which typically has the steepest prices globally, says the Patented Medicines Price Review Board (PMPRB).
Soliris is a breakthrough, potentially lifesaving treatment for two rare blood diseases, affecting about 180 patients in Canada.
The board, which has not held an excessive-price hearing since 2012, said it had demanded the U.S.-based firm lower the price and pay back revenue it made above the cap. It refused both requests, according to formal allegations issued by board staff.
“Alexion continues to sell Soliris to Canadians at the highest international price among the comparator countries,” says the staff document.
If a board adjudication panel finds the price is excessive at a hearing to be held no later than March 6, it could order a cost reduction and the repaying of surplus income.
Soliris has caused waves throughout the world in recent years with its eyebrow-raising price tag, but this may be the first attempt by a regulator anywhere to force a rollback.
The company, though, denies that it has broken Canadian rules, while some experts say the regulatory process itself ignores a key fact – that provincial drug plans have already negotiated secret discounts on Soliris for many of the patients they cover.
“Alexion refutes all of the allegations in their entirety and will vigorously challenge the PMPRB’s proposed order,” it said in an emailed statement Monday. “The … allegations that Alexion charged an ‘excessive price’ for Soliris in Canada are simply wrong, and not based on sound reasoning.”
The company says it has not raised the price since Soliris first came on the market in 2009, and if the cost is lower in other countries, it’s only because of changes in the exchange rate.
Soliris and its formidable price have made Alexion something of a darling on Wall Street, generating $650-million in profit last year on sales of $2.2-billion.
All provincial drug plans now cover the cost of Soliris for the 90 or so patients in Canada with paroxysmal nocturnal hemoglobinuria (PNH), a rare disorder that destroys red blood cells, threatening organ damage, heart attacks, stroke and blood clots.
The list price is more than $500,000 annually in Canada — and treatment life-long — but the provinces banded together to negotiate a lower figure, a process since applied to several other drugs.
Soliris has also been approved to treat atypical hemolytic uremic syndrome (aHUS), a genetic disorder believed to affect 60-90 Canadians, causing dangerous blood clots. The annual treatment cost is $700,000, according to the PMPRB. Quebec is the only province to pick up the cost for those without private coverage.
The group representing aHUS patients says it does not have a position on the price, but notes it has been a stumbling block to provincial coverage for a lifesaving medication.
“We have been waiting for two years since Soliris was approved by Health Canada and while we wait, patients’ lives continue to be at risk,” said Michael Eygenraam of aHUS Canada.
Soliris is the most striking example of a recent, controversial trend toward highly priced medications, often to treat relatively rare conditions.
The University of British Columbia’s health-policy centre has a conference on the topic planned for next month — called “Sticker Shock.”
Does it still make sense, though, for the PMPRB to regulate drug costs by comparing the published list prices in different nations? Experts say the system is relevant to workplace and other private drug plans, and to people paying out of pocket for prescription medicines, who tend to be stuck with the list price.
But it means little for provincial plans that — similar to counterparts in other countries — are negotiating lower costs behind closed doors, said Michael Law, a health-policy professor at the University of British Columbia.
“It’s like comparing the sticker price in one car dealership to the sticker price in another car dealership,” he said. “When we don’t know what the underlying bargained prices are, then we don’t know if we’re higher or lower.”
That said, the process has some value in protecting Canadians against paying more than other, similar jurisdictions, said Steve Morgan, another pharmaceutical policy expert at UBC.
“The PMPRB’s system is flawed, but it’s at least an absolute minimum safety net,” he said. “And if we’re hitting that safety net, there probably is an issue to be taken up.”
National Post
Canada’s drug-price regulator has taken the rare step of calling a hearing into what is considered the world’s most expensive prescription medicine, accusing its manufacturer of exceeding the permissible price cap.
The yearly cost per patient of as much as $700,000 is even more than the manufacturer, Alexion Pharmaceutical, charges in the United States, which typically has the steepest prices globally, says the Patented Medicines Price Review Board (PMPRB).
Soliris is a breakthrough, potentially lifesaving treatment for two rare blood diseases, affecting about 180 patients in Canada.
The board, which has not held an excessive-price hearing since 2012, said it had demanded the U.S.-based firm lower the price and pay back revenue it made above the cap. It refused both requests, according to formal allegations issued by board staff.
Alexion continues to sell Soliris to Canadians at the highest international price among the comparator countries
Federal rules require that drug prices be no more than the median – mid-point – of seven other industrialized nations.
“Alexion continues to sell Soliris to Canadians at the highest international price among the comparator countries,” says the staff document.
If a board adjudication panel finds the price is excessive at a hearing to be held no later than March 6, it could order a cost reduction and the repaying of surplus income.
Soliris has caused waves throughout the world in recent years with its eyebrow-raising price tag, but this may be the first attempt by a regulator anywhere to force a rollback.
The company, though, denies that it has broken Canadian rules, while some experts say the regulatory process itself ignores a key fact – that provincial drug plans have already negotiated secret discounts on Soliris for many of the patients they cover.
“Alexion refutes all of the allegations in their entirety and will vigorously challenge the PMPRB’s proposed order,” it said in an emailed statement Monday. “The … allegations that Alexion charged an ‘excessive price’ for Soliris in Canada are simply wrong, and not based on sound reasoning.”
The company says it has not raised the price since Soliris first came on the market in 2009, and if the cost is lower in other countries, it’s only because of changes in the exchange rate.
Soliris and its formidable price have made Alexion something of a darling on Wall Street, generating $650-million in profit last year on sales of $2.2-billion.
All provincial drug plans now cover the cost of Soliris for the 90 or so patients in Canada with paroxysmal nocturnal hemoglobinuria (PNH), a rare disorder that destroys red blood cells, threatening organ damage, heart attacks, stroke and blood clots.
The list price is more than $500,000 annually in Canada — and treatment life-long — but the provinces banded together to negotiate a lower figure, a process since applied to several other drugs.
Allegations that Alexion charged an ‘excessive price’ for Soliris in Canada are simply wrong, and not based on sound reasoning
The discounted price, though, is kept secret at the company’s request.
Soliris has also been approved to treat atypical hemolytic uremic syndrome (aHUS), a genetic disorder believed to affect 60-90 Canadians, causing dangerous blood clots. The annual treatment cost is $700,000, according to the PMPRB. Quebec is the only province to pick up the cost for those without private coverage.
The group representing aHUS patients says it does not have a position on the price, but notes it has been a stumbling block to provincial coverage for a lifesaving medication.
“We have been waiting for two years since Soliris was approved by Health Canada and while we wait, patients’ lives continue to be at risk,” said Michael Eygenraam of aHUS Canada.
Soliris is the most striking example of a recent, controversial trend toward highly priced medications, often to treat relatively rare conditions.
The University of British Columbia’s health-policy centre has a conference on the topic planned for next month — called “Sticker Shock.”
Does it still make sense, though, for the PMPRB to regulate drug costs by comparing the published list prices in different nations? Experts say the system is relevant to workplace and other private drug plans, and to people paying out of pocket for prescription medicines, who tend to be stuck with the list price.
But it means little for provincial plans that — similar to counterparts in other countries — are negotiating lower costs behind closed doors, said Michael Law, a health-policy professor at the University of British Columbia.
“It’s like comparing the sticker price in one car dealership to the sticker price in another car dealership,” he said. “When we don’t know what the underlying bargained prices are, then we don’t know if we’re higher or lower.”
That said, the process has some value in protecting Canadians against paying more than other, similar jurisdictions, said Steve Morgan, another pharmaceutical policy expert at UBC.
“The PMPRB’s system is flawed, but it’s at least an absolute minimum safety net,” he said. “And if we’re hitting that safety net, there probably is an issue to be taken up.”
National Post
