Expensive colorectal cancer drug to go on sale

LISA PRIEST

From Monday's Globe and Mail

A pharmaceutical company that refused to market one of the world's most expensive cancer drugs due to a cost dispute will sell its medicine to Canadians after all – at a price lower than it had wanted.

Marc Osborne, spokesman for Bristol-Myers Squibb Canada, confirmed that cetuximab will be marketed some time this year at a price agreed to by the Patented Medicine Prices Review Board.

But he said the decision to launch had largely to do with studies showing the drug can prolong the lives of metastatic colorectal cancer patients, in addition to patients with certain head and neck cancers.

“The price issue is behind us,” Mr. Osborne said in a telephone interview from Montreal. “We're going to work at making sure it's available to Canadians beyond the special access program.”

Bristol-Myers Squibb Canada took the unusual move about two years ago of deciding not to launch the drug because the price it wanted to charge was found to be too high by the federal board that regulates the cost of patented medicines to ensure they are not excessive.

The move was seen as contentious, with E. Richard Gold, director of the Centre for Intellectual Property Policy at McGill University, likening it to holding colorectal cancer patients hostage.

“While we seemingly obtained a good result in this case, both the Commissioner of Patents and the Competition Bureau should be prepared to step in to prevent such abusive behaviour in the future,” said Dr. Gold, adding that the commissioner has the power to issue a compulsory licence to another drug company, that in turn could make and sell the same medicine.

Now that the drug will be marketed, the next question will be whether provincial governments will fund it. The Cancer Advocacy Coalition of Canada estimates it costs about $56,000 for a standard course of therapy.

For many patients, obtaining the drug often meant paying out of pocket after first applying through Health Canada's special access program, where those with serious or life-threatening conditions can obtain drugs – typically those that are unlicenced under certain circumstances. Since 2005, cetuximab, known by the trade name Erbitux, has been released 495 times under that program, according to Health Canada spokesman Alastair Sinclair. Currently, some Quebec hospitals fund cetuximab on a case-by-case basis. The BC Cancer Agency has funded the drug since January, 2008, for patients with locally advanced squamous cell carcinoma of the head and neck, with a course of treatment running about $10,000.

Ontario has provided the broadest coverage for colorectal cancer patients, having sent those eligible to receive it to United States cancer hospitals for the past three years. Specifically, it spent $24.3-million for 328 patients to have the infusions in the United States from fiscal 2005-2006 to April 15, 2008, according to figures provided by Ontario Health Ministry spokesman John Yoannou.

One of those patients, John Colacci, an infrastructure engineer at a bank, travelled each week to Amherst, N.Y., for nine months, where he received the infusion as an outpatient until mid-April. He said the Ontario government spent $208,125 (U.S.) on his treatment.

“I'm so pleased because I got fabulous results from it,” Mr. Colacci, 43, said in a telephone interview from Toronto. “It literally melted it away.”

Now that the father of three's cancer has returned, he has been prescribed a different drug, Avastin, which he must pay for out of pocket as it is not funded in Ontario.

Colorectal cancer is the second leading cause of cancer death in Canada, with 8,900 people projected to die of the disease this year. About 21,500 people in Canada will be diagnosed with colorectal cancer in 2008, according to Canadian Cancer Society figures.

Barry Stein, president of the Colorectal Cancer Association of Canada, said he hopes the decision to market the drug means broader coverage across the country, adding that “we want every opportunity for patients to have timely access to effective medications that improve outcomes.”

Cetuximab is used on certain types of colorectal cancer patients for whom other treatments have failed or for which they have become resistant.

Derek Jonker, a medical oncologist in Ottawa who specializes in colorectal cancer, said the drug improves overall survival by about six weeks.

Specifically, a study published in the New England Journal of Medicine in November, 2007, reported the median survival for metastatic colorectal cancer was 6.1 months for patients treated with cetuximab plus the best supportive care, compared to 4.6 months for patients on best supportive care alone, defined as any and all therapies that improve quality of life and control symptoms. The survival data are seen as modest by oncologists.

“Once we narrow this down to the ideal patient population, this drug will be highly important and moved into earlier and earlier stages of treatment,” Dr. Jonker said in a interview from Ottawa.

As for the price issue, patented drugs in Canada cannot simply be sold at a price that the market will bear – such as the case in the United States.

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.

Sylvie Dupont, board secretary of the Patented Medicine Prices Review Board, said she could not reveal the cost of cetuximab as it is confidential. However, a report from that federal board, shows the median price of the drug charged in seven countries in 2005 was $324 per two-milligram/millilitre dose. By comparison, the U.S. price was more than double that at $673 per two-2 milligram/millilitre dose.

Mr. Osborne, director of public affairs and government relations for Bristol-Myers Squibb Canada, the company that licenses and distributes the drug in Canada, said he could not provide the price, citing competitive reasons.

He said he did not know what month the drug would be marketed this year, adding that supplementary information still needs to be filed with Health Canada. As well, the company is seeking a new indication to use the drug on patients with head and neck cancer.

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