MONTREAL — Some Montreal hospitals are paying up to 100 times more for an essential cancer medication because of a sudden shortage of the drug, raising concerns some patients might ultimately be turned away for treatment if the shortage persists.
The drug is called paclitaxel, an injectable chemotherapy medication used to treat breast, lung and ovarian cancer. It usually sells for $42 to $50 a vial, but some hospitals are now paying up to $4,000 a vial.
The drug shortage occurred after Health Canada inspectors suspended the operations of Biolyse Pharma Corp., of St. Catharines, Ont., on April 11. Health Canada cited the generic drug maker with six violations in the production of paclitaxel.
Since then, a number of Montreal hospitals, including the Jewish General and Maisonneuve-Rosemont, have turned to another drug supplier, Hospira, for paclitaxel. Normally, hospitals buy medications in groups, negotiating the lowest prices possible.
But the drug shortage has meant that some hospitals are buying the medication “off-contract,” paying exorbitant prices.
An April 29 invoice from Hospira to Maisonneuve-Rosemont shows the hospital purchased 30 vials for paclitaxel for $118,327. The east-end hospital would normally pay $1,285 for the same supply.
On Monday, the Montreal Health and Social Services Agency informed hospitals that it’s aware of the problem and urged doctors to “maintain access to care for the patients concerned.”
Dr. Gerald Batist, director of the Segal Cancer Centre at the Jewish General, confirmed that the paclitaxel shortage has put the hospital in a financial squeeze.
“Yes, there was this sudden drop in access to this essential drug, and the Hospira replacement was meant to cost multiple times more,” Batist wrote in an email to The Gazette.
“We were able to get by until now with the Biolyse drug that was not recalled, but we had to put a variety of backup plans in place. This was two weeks ago.
“Given the fragility and challenges to hospital budgets these days, anything like this puts our efforts at saving (money) at risk,” Batist added. “One point is certain: we will under no circumstances compromise patient care for the sake for the budget.”
But Brigitte Kiecken, president of Biolyse Pharma, told The Gazette some Montreal hospitals did express concern to her that some patients might be turned away.
“This is a crisis,” Kiecken said. “Each day it’s getting worse and worse.”
Biolyse Pharma had been manufacturing paclitaxel for the past five years. Although Health Canada barred the company from shipping out finished batches of the drug, it did not recall any medication already in hospitals.
Kiecken said her company has addressed all of Health Canada’s cited violations, but she added that the regulatory agency wants the results of further testing before allowing Biolyse to resume production. In the meantime, hospitals like Maisonneuve-Rosemont that had been purchasing from Biolyse under contract are billing the company the difference between what they are now paying Hospira for paclitaxel and what they used to pay Biolyse.
“It could be costing the company $1 million a day and they might not be around to pay all the bills, in which case it’ll be the provinces that pick up the tab,” said John Fulton, an Ontario biotech consultant who is familiar with Biolyse.
Batist said he understands Health Canada’s role to monitor drug safety, but there is also the question of drug access.
“I think Health Canada is stuck,” Batist added. “On the one hand, they must ensure drug quality, and on the other ensure drug availability. They can’t regulate price, so if a company takes advantage — or maybe it costs that much more to make it on short notice, I don’t know — Health Canada has to consider how stringent its regulations should be applied so as not to cut off access.”
Health Canada officials were not available for comment Monday, but in a May 9 advisory the agency denied there was a supply disruption of paclitaxel and said it was continuing “to work with the staff at Biolyse Pharma to resolve the issues identified during the inspection as quickly as possible.”
In an email to The Gazette, a public affairs official with Hospira denied the Illinois-based company was engaging in price gouging, and said negotiations over pricing were still underway with hospitals.
“When Hospira learned about the paclitaxel supply disruption several weeks ago, we made it our top priority to step in and help address the shortage, as we understand the critical significance of this product to patients and health care providers,” said Dan Rosenberg.
“We took quick action, and are currently supplying the entire Canadian market, up from 30 per cent before the supply disruption.
“It is expensive and complicated from a logistical standpoint to meet this huge and sudden increase in demand, especially for an important product like paclitaxel, which we supply to customers around the world,” he added.
Rosenberg noted that “the price Biolyse charged for paclitaxel was extremely low, representing a 99-per-cent discount from the price before 2005, when the product went generic.”