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Avastin debate highlights challenges of a catastrophic drug program

Genentech Inc. Mark Nagel works on an experiment in a research laboratory at Genentech headquarters in a South San Francisco, Calif. file photo from July 10, 2006. Biotechnology company Genentech Inc. will report earnings after the close of the stock market.

Paul Sakuma/AP/Paul Sakuma/AP

To some, it's a miracle drug. To others, it's overrated and not worth the high price.

But bevacizumab, a cancer medication better known by its brand name Avastin, illustrates why a national program to cover the cost of expensive but potentially life-saving medications is needed - and the dangers that await if such a program is not executed correctly.

Avastin is widely used to treat colorectal cancer, as well as certain types of brain, breast and lung cancer. It works by preventing the growth of new blood vessels, which helps starve tumours. It was developed by Napoleone Ferrara, a scientist at the drug firm Genentech, who in 1989 isolated a key protein that drives blood vessel formation.

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Dr. Ferrara used that information to develop a new treatment and, by 2003, human clinical trials revealed that Avastin helped extend the lives of patients with colorectal cancer by a few months. Health Canada approved it as a colorectal cancer drug in 2005 after years of work and billions in research and development costs.

The time and money it took to bring Avastin to market means it doesn't come cheap - an 8½-month course of treatment costs about $30,000. The high cost, and the fact that the drug isn't a cure, led to a patchwork system of provincial coverage in the years following its approval, and a furious debate about how much a few months of life was really worth. In the rapidly changing world of medical science, where new drugs are more costly to develop, and consequently come with a steeper price tag than ever before, governments are forced to confront these uncomfortable questions.

It's a thorny issue that can't be avoided if the government hopes to maintain control over the costs of a potential catastrophic drug program, said Pamela Fralick, president and CEO of the Canadian Healthcare Association.

"It's hugely sensitive. When do you say no?" she said. "As a society, we have to make some very tough decisions."

Ontario agreed to fund the drug for colorectal cancer patients in 2008 and expanded coverage in 2009, but only after patient advocates and health groups mounted public pressure campaigns. Before that, cancer patients paid tens of thousands out of their own pockets to get Avastin in private clinics. Last year, after years of lobbying by patients, Prince Edward Island became the last province to agree to cover the treatment for colorectal cancer patients.

Britain, on the other hand, has decided not to fund Avastin, arguing that extending a patient's life by such a short time is not worth the hefty price tag.

The high cost reflects the tremendous risks drug companies take when developing treatments for disease. Wendy Zatylny, vice-president of federal affairs and communications for Canada's Research-Based Pharmaceutical Companies, an industry association representing drug companies, said it can take between 10 and 15 years to bring a single drug from discovery to market, adding that only one in every 10,000 new drug compounds discovered will eventually reach patients. The association estimates that, on average, it costs $1.3-billion to bring one drug to market.

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"The failure rate is very, very high and the risk associated with that is also high," Ms. Zatylny said.

When - or if - the federal government heeds calls for a national program to shield Canadians from high drug costs, the stakes will become even higher. Opening the door to more comprehensive coverage for expensive medications across the country could be a major benefit to patients. But experts say it may also lead to pressure on the government to cover a greater number of pricey drugs, or to cover treatment for a wider variety of diseases, both of which could cause costs to spiral out of control.

"The argument would start to be made by some people, 'Well, you know, your expensive drug qualifies you for catastrophic insurance, but my expensive drug doesn't qualify me because the province isn't going to [cover]it," said Joel Lexchin, a physician and professor in the School of Health Policy and Management at York University in Toronto.

Roche Canada, which sells Avastin in Canada, is looking to expand coverage for the drug to patients with glioblastoma multiforme, a type of brain cancer. Right now, British Columbia is the only province covering the drug for that purpose, while others are reviewing it.

Rudy Thepen, who lives outside Montreal, hopes Quebec is one province that decides to fund the drug for brain cancer. His wife, Alice, has glioblastoma multiforme and her doctors recommended she try Avastin. Ms. Thepen has been taking the drug for more than a year and her tumour has shrunk significantly, Mr. Thepan said. But because the provincial government doesn't cover it, he said they pay about $15,000 a month for the drug.

"It's sad that it's not covered," Mr. Thepen said. "What are you going to say? I don't want my wife to take it because it costs the money? You have to do it."

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Catastrophic drug coverage could also lead to a dramatic increase in the number of prescriptions. Doctors are often reluctant to prescribe drugs they know patients can't afford. "If suddenly all drugs are available and there's no perceived cost on the individual … then there will be, maybe, over-prescribing," the CHA's Ms. Fralick said.

But despite the challenges, health experts say catastrophic coverage is necessary. "We're engaged in an election, which is really a nation-building exercise. This needs to be part of that dialogue," said Aaron Levo, a spokesman for the Canadian Cancer Society. "We need some leadership on this issue and we need it fast."

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