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09/13/05

Expensive cancer drugs get approval


Two colorectal cancer drugs received Health Canada approval yesterday, opening the door for provincial governments to fund the costly medications.

Avastin, a first-line treatment for incurable colorectal cancer, and Erbitux, which shrinks tumours in some patients, were approved for use against the second-biggest cause of cancer death in Canada, Health Canada spokeswoman Jirina Vlk confirmed yesterday.

Dr. Carol Sawka, provincial vice-president of clinical programs of Cancer Care Ontario, said it is "great news for cancer patients that new drugs are becoming available," but cautioned "it does not mean it is available for use the next day."

Indeed, all provinces and their prospective drug review panels, after perusing the scientific evidence, will ultimately determine whether the new intravenous cancer medications will be funded and for which patients, a process that typically takes several months.

Typical of cancer drugs, the cost is steep: Though the price has not been set, Avastin costs the average patient $53,000 (U.S.) for a year’s supply, though with price controls it would likely cost less in Canada. Erbitux can run up to $100,000 a year, but it, too, is expected to be less expensive.

Colorectal cancer is a common disease and an estimated 19,600 Canadians will be diagnosed with it this year and 8,400 will die of it, according to Canadian Cancer Society figures.

Malcolm Moore, chairman of the National Cancer Institute of Canada’s gastrointestinal cancer group, said many of those 8,400 would be potentially eligible for Avastin, if it is funded by provincial governments.

"In all honesty, if the drug cost $100 a month, there’s no question it would be used almost for everybody," said Dr. Moore, an oncologist at Princess Margaret Hospital in Toronto who specializes in colorectal cancer. "But it’s not going to cost $100 a month. It’s going to be a decision based on cost-effectiveness and how you pay for this versus something else."

Also known as bevacizumab, Avastin is one of a number of new, revolutionary cancer therapies that, while not a cure, prevents the growth of new blood vessels, helping to starve tumours and making it harder for cancers to grow.

Canada is the 26th country to approve Avastin, which was approved in the United States 18 months ago for first-line use in treating colorectal cancer that has metastasized or spread.

Clinical trial results showed that patients with incurable cancer who received chemotherapy and Avastin lived almost five months longer, compared with those who received only chemotherapy. Patients treated with Avastin and chemotherapy survived a median of 20.3 months, compared with the 15.6-month median survival time of those who received chemotherapy alone.

Avastin is being studied in patients with curable colorectal cancer, with an eye to seeing whether recurrences can be prevented and, if so, whether that spells increased survival or saved lives.

"The good news is they really do work and they really do improve survival and are part of an exciting new wave," Dr. Moore said of Avastin and Erbitux. But he quickly added that funding of the drugs could be a challenge.

"Hard decisions are going to have to be made," he said. "No one likes to say no to things that are helpful, it’s just a very difficult decision."

The problem is global. By next year, worldwide spending on cancer medications will total $31.7-billion (U.S.), up from $22.3-billion in 2004, making it the fastest-growing drug category in the world, according to projections by the market research firm Bain & Co.

Barry Stein, president of the Montreal-based Colorectal Cancer Association of Canada, called the Health Canada approvals a "fantastic opportunity for patients to take these drugs, shrink the tumour and where they didn’t qualify for surgery before, they will now qualify."

But for some patients, like Gisella Bonanno of Montreal, news of Avastin’s approval comes too late. She has been travelling to a cancer hospital in Burlington, Vt., every two weeks to get the drug to treat a second recurrence of colorectal cancer, treatment she expects to complete in November.

Since treatment with Avastin is accompanied by chemotherapy, she must pay for that too, bringing her total annual treatment bill to about $200,000, which she hopes will be funded by the Quebec government and private insurance.

Still, she is delighted that Erbitux has been approved.

"If Avastin doesn’t work, Erbitux would be my next first course," Ms. Bonanno said yesterday. "I have a safety net, it feels good to have options. I hope I don’t need it, but if I should, it’s there."

While Erbitux, also known as cetuximab, has not been proved to extend patients’ lives yet, it was shown to shrink tumours in some patients and delay tumour growth, especially when used as a combination treatment. Typically, it is used on certain types of patients for whom other treatments have failed.

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