Agency says distributor’s price too high as Ontario foots bill for treatment in U.S.
One of the world’s most costly cancer drugs will not be marketed in Canada because the distributor can’t charge the price it wants — one a federal board has found to be too high.
Bristol-Myers Squibb Canada has taken the unusual move of not launching the colorectal cancer drug Erbitux after it could not agree on a price with the Patented Medicine Prices Review Board. The drug was approved by Health Canada nine months ago.
“For the time being, we made the decision not to launch Erbitux because the value is not in line with the innovation it brings to patients,” said Marc Osborne, director of public relations for Bristol-Myers Squibb Canada, the company that licenses and distributes the product in Canada.
Mr. Osborne refused to say how much the company wants to charge for the drug, as did the Patented Medicine Prices Review Board, which regulates the price of patented medicines to ensure they are not excessive.
The Cancer Advocacy Coalition of Canada estimates the drug, used to treat advanced cases of colorectal cancer, costs about $56,000 for a standard course of therapy.
At the same time, the Ontario government is spending millions for cancer patients to receive Erbitux in U.S. hospitals, where the drug commands one of the highest prices in the world.
Ontario’s Health Ministry approved 34 of 38 cancer patients who applied to have Erbitux administered to them out of country in the 2005-06 fiscal year at a cost of $3.6-million, spokesman John Letherby said. Those figures also include costs associated with providing the drug, he said.
While Erbitux has not yet been proven to extend the lives of colorectal cancer patients, it does shrink tumours in some patients and delay tumour growth, especially when used as a combination treatment.
It is typically used on certain types of patients for whom other treatments have failed or for which they have become resistant.
“We know Erbitux can work for people who fail Avastin [another colorectal cancer drug] but the numbers of patients who benefit are small,” said Kong Khoo, a Kelowna-based medical oncologist who is on the board of directors of the Cancer Advocacy Coalition of Canada. “For these patients, however, the impact can be significant.”
One such patient, Kathy Muzzi, travels to Roswell Park Cancer Institute in Buffalo once a week from her Toronto home to receive the drug, also known as cetuximab.
She said the Ontario government pays $45,000 (U.S.) for her to receive a two-month supply of Erbitux. For her to qualify for additional treatment, she said she must prove through a CT scan that the drug is shrinking the tumour.
While the 49-year-old considers herself “very fortunate” to be able to obtain Erbitux, she said it comes at a price.
“It is very costly to me to travel to Buffalo,” Ms. Muzzi said. “I cannot drive myself due to the drugs so someone has to take the day off work weekly to drive me. The gas, food, parking and time — it all adds up.”
Brian Cohen, a Toronto-based health lawyer, said the fact patients are being sent to U.S. cancer hospitals shows Erbitux is worthwhile.
“Can there be any serious argument over whether this treatment is medically necessary?” Mr. Cohen asked. “The only argument is where OHIP [Ontario Health Insurance Plan] should fund this treatment: in an Ontario hospital or in Buffalo at three times the price.”
Mr. Cohen’s client, colorectal cancer patient Suzanne Aucoin of St. Catharines, Ont., had managed, until March, to persuade the Juravinski Cancer Centre in Hamilton to administer Erbitux to her. She paid for the drug, at $25,000 for a four-month supply, while the public health system covered the administrative cost.
When OHIP finally approved the out-of-country administration of the drug, she was told she could no longer receive it in Hamilton. So Ms. Aucoin travels once a week to Buffalo, where she receives it at a cancer hospital at a cost to the provincial government of $24,000 (U.S.) a month for both the drug and the administrative fees — something she calls “ridiculous.”
According to information obtained by Mr. Cohen under Ontario’s Freedom of Information and Protection of Privacy Act, Ontario patients requiring Erbitux are also being sent to the Memorial Sloan-Kettering Cancer Center, which has treatment facilities in New York and the surrounding area. As well, they are being sent to the Richard E. Winter Cancer Treatment Center in Ogdensburg, N.Y., for Erbitux.
According to the same documents, which were paid for by the Cancer Advocacy Coalition of Canada, doctors referring patients for Erbitux are mostly from Toronto hospitals, though cancer specialists in Hamilton, Ottawa and Barrie also have succeeded in having the drug funded for their patients in U.S. cancer centres.
The drug is not funded anywhere in Canada. In the case of Ontario, that’s because only marketed drugs can be considered for reimbursement, Cancer Care Ontario spokeswoman Fiona Taylor said.
Ralph Wong, a medical oncologist at Cancer Care Manitoba, said the situation is frustrating.
“It essentially means no access for cancer patients,” Dr. Wong said in a telephone interview from Winnipeg. “Each individual province or funding agency has to pay for that drug. Though we can access it, it is so expensive; no one will pay for it.”
This year, an estimated 20,000 people in Canada will be diagnosed with colorectal cancer. Approximately 8,500 are expected to die of the disease in 2006, according to figures from the Canadian Cancer Society.
In a telephone interview from Darmstadt, Germany, Phyllis Carter, spokeswoman for Merck KGaA, the company that licenses Erbitux in Europe, said there it sells for less than half of what it goes for in the United States.
Erbitux, she said, typically costs €4,000 a month in Western Europe. In Canadian dollars, that translates into $5,677 monthly.
Undoubtedly, that European price would have affected what Bristol-Myers Squibb Canada could charge for it here.
That’s because when a new drug is introduced, the Patented Medicine Prices Review Board scrutinizes the prices being commanded in Germany, France, Italy, Sweden, Switzerland, the United Kingdom and the United States. The Canadian price cannot be the highest of those countries; typically, it is set at the median of them.
Despite the hurdles, some patients are obtaining the drug in Canada, and paying for it themselves. Since April, 2004, Erbitux has been released 88 times through the special-access program, Health Canada spokesman Christopher Williams said. However, those figures include repeat requests.
That program allows those with serious or life-threatening conditions to obtain drugs — typically those that are unlicensed — under certain circumstances. However, the program only covers the release of the drug, not the payment for it.
As for Ms. Muzzi, she would rather obtain the drug in a Toronto hospital than go to Buffalo.
“I’m glad it’s funded, but I would prefer Ontario to approve it rather than spend $45,000 U.S. every two months [on it],” Ms. Muzzi said. “I would travel to the ends of the earth if I thought I could substantially extend my life expectancy.”
