Price of ‘blue baby' drug soars

LISA PRIEST

From Saturday's Globe and Mail

A life-saving drug used to treat “blue baby syndrome” has gone up in price as much as tenfold, an increase so steep that children's hospitals in Canada say they don't know how they are going to afford it.

The price was increased after Health Canada licensed INO Therapeutics to market nitric oxide, a gas used to treat hundreds of babies every year with infant pulmonary hypertension. With that condition, an inadequate amount of blood flows through the lungs and not enough oxygen is absorbed, causing some babies to turn blue.

Up until one week ago, all 16 Canadian pediatric hospitals were able to purchase less expensive nitric oxide from two other companies under Health Canada's special access program, said Elaine Orrbine, chief executive officer of the Canadian Association of Paediatric Health Centres.

However, those two companies, Viasys Healthcare and Pulmonox Medical Inc., no longer sell the gas, due largely to a legal settlement with INO Therapeutics over a patent lawsuit, Jim Cosman, president of Summit Technologies Inc., its distributor, confirmed yesterday.

Consequently, Canada's pediatric hospitals have no choice but to buy nitric oxide from INO Therapeutics, now the only company that sells it.

“What has been created is a monopoly and there is no choice in Canada but this one supplier right now,” said Ms. Orrbine, who described the new price as exorbitant. “ . . . Every children's hospital is truly alarmed by this.”

The use of nitric oxide for newborn pulmonary hypertension was pioneered in Canada, some of it through research grants from what was then called the Medical Research Council of Canada.

At Toronto's Hospital for Sick Children, the price increase means the cost per patient will rise to $2,300 a day from $300 a day, said Peter Cox, clinical director of the critical care unit, where about 170 infants and children are treated with nitric oxide each year.

If Dr. Cox used the same amount of nitric oxide this year as last, his unit's costs would increase to about $1-million to $1.5-million from about $150,000, depending on how long it is used. Typically, babies are on nitric oxide for several days.

Another 60 babies and children are treated with nitric oxide each year for such things as congenital heart disease and some lung defects, meaning Sick Kids' overall costs could be as much as $2-million annually.

“Children in Canada currently have pretty free access to nitric oxide,” Dr. Cox said. “With this enormous charge, it's going to make you wonder whether you should use it.”

Estimates on the price vary somewhat because INO Therapeutics charges for the gas, sold under the trade name INOmax, by the hour, whereas the other two companies sold it by the cylinder. Not all patients require the same amount of the gas.

Mr. Cosman, president of Summit Technologies Inc., estimated the cost to hospitals would be three to five times higher. But using the company's calculations of $95 an hour, Dr. Cox said the price increase was far more than that and potentially as much as tenfold higher.

Whatever the case, Ms. Orrbine of the Canadian Association of Paediatric Health Centres said it will mean millions more in costs to children's hospitals during a time of fiscal restraint.

Jared Rhines, senior director of global development of INO Therapeutics, said the price for nitric oxide is likely to run about $95 to $100 an hour, up from the discounted $55 an hour, where it was sold under Health Canada's special access program, which provides unlicensed drugs to patients with serious or life-threatening conditions.

“I'm not sure how anybody can make comparisons of prices here,” said Mr. Rhines, adding that with the other companies, hospitals had to buy not only the tank of gas but also the delivery system.

“They charged on a per cylinder basis,” he said of the gas that is to be marketed in Canada within 60 days. “We charge on a time basis. . . . One price includes everything you need including service.”

Who can sell nitric oxide, and for what price, has also been an issue in Europe.

Last year, the European Patent Office ruled that the patent there for the use of nitric oxide to treat respiratory failure was invalid.

The decision meant that any company in Europe could deliver nitric oxide to hospitals, provided that they meet quality and safety standards.

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