A breakthrough drug that can successfully reverse the most common form of blindness in the elderly could hit Canadian pharmacy shelves as early as next year.
But breakthroughs don't come cheaply, and this one could very well drive the already mounting cost of health care even higher.
In the United States, where Genentech's Lucentis is already approved for use, it costs about $2,000 a dose and is required once a month for the rest of a patient's life.
Physicians in Canada -- eagerly awaiting Lucentis's arrival because it not only prevents vision loss caused by age-related macular degeneration, but in most cases also reverses damage done with very few adverse effects -- are concerned that it will be just as expensive here.
That means it may be out of reach for the thousands of Canadians who could benefit from it.
"Lucentis appears to be a huge, quantum leap better than anything else on the market, so it's a big deal," said Alan Berger, chief ophthalmologist at St. Michael's Hospital in Toronto.
A major study published in today's issue of The New England Journal of Medicine echoes these sentiments, confirming that Lucentis can reverse the deterioration of the retina that is caused by macular degeneration.(There are two types of macular degeneration -- wet and dry.
The new drug treats the "wet" type, which is characterized by faulty, leaky blood vessels and affects everyday tasks such as reading, driving and recognizing faces.)
"But $24,000 a year, that's also a lot of money that a lot of people don't have."
While waiting for Lucentis to be approved by Health Canada, physicians such as Dr. Berger have been scrambling to find ways of salvaging their patients' quickly diminishing eyesight.
More than two million Canadians suffer from varying degrees of the macular degeneration but that number is expected to balloon rapidly as the oldest baby boomers turn 60.
They've found that using a cheaper alternative, already on the market in Canada, appears to do just as good a job as Lucentis when injected into the eye.
But that drug, Avastin, is approved to treat only colorectal cancer and is designed to prevent the growth of new blood vessels that feed tumours.
Incidentally, both drugs are manufactured by Genentech and have surprisingly similar molecular makeups.
"Basically, two Lucentises make one Avastin," said David Wong, an assistant professor of ophthalmology at the University of Toronto, who has been prescribing the cancer drug off-label to his patients with the debilitating eye disease since last fall.
Many of his patients have been able to read three more lines on an eye chart after receiving a few doses of Avastin. (Off-label means that doctors can prescribe any approved medication for other purposes.)
"From what I've seen, [Avastin]works just as well as Lucentis, and is a fraction of the cost."
A dose of Avastin for colorectal cancer can be bought for roughly $900 in Canada. Special pharmacies can divide it into as many as 20 parts.
After taking into account sterilization and packaging costs, the smaller dose of Avastin that can be injected into the eye could cost as little as $150 for the patient.
That is roughly 10 times cheaper than the expected cost for the same dosage of Lucentis.
The controversy highlights the struggle of pharmaceutical companies to achieve what they see as two equally essential priorities: making medical advances and turning a profit.
Although both drugs block blood-vessel growth, Lucentis, unlike Avastin, has been tested in randomly controlled clinical trials for use in the eye, said Dawn Kalmar, a spokeswoman for San Francisco-based Genentech.
"So to do a price comparison between the two is not really appropriate because they can't be compared in terms of the studies they've been through," she said.
"Lucentis went through nearly a decade of clinical study and we believe that patients deserve a treatment that's been studied rigorously and been through the FDA-approval process."
But all that may mean nothing to Canadians, according to Dr. Berger, if Lucentis isn't covered by provincial health-care programs.
"My first thing is to give my patients the best possible known, scientifically proven treatment. Lucentis has years' worth of clinical trials, whereas Avastin, there are a lot of things we don't know about it -- safety issues, complications -- because we're basically going on smaller studies and clinical experience," he said.
"But there's a big difference between the two in terms of cost, a lot of money."
In Ontario, for instance, the monthly injections could cost the province $600-million for the roughly 25,000 people in the province who could benefit from it.
"Do you think the Ministry of Health will just come up with [that money]" he asked.
Chances are it won't, according to Dr. Wong, because it hasn't done so for another macular degeneration medication that just came out last year, Macugen.
Even now, Canadian patients are paying for Avastin out of their own pockets because it hasn't been approved for use in the eye.
Although the Patented Medicine Prices Review Board sets prices for drugs sold in Canada, the price of Lucentis is expected to be the same around the world (so far it is available only in the United States and Switzerland), according to Philip Rosenfeld, a professor at the University of Miami's Bascom Palmer Eye Institute. He's the one who pioneered the use of Avastin in eye patients and has been pushing for a head-to-head comparison of the two drugs.
"So the question that everyone's asking is do both drugs work the same? No one knows, but we'll have to find out, because, guess what, Avastin is not going away."
Dr. Rosenfeld said cost is a huge determining factor for many of his patients, who come from South and Central America and the Caribbean. He said they all choose the cheaper alternative because it also has promising results.
"So we're interested in this to protect medicare and its rising costs, we're interested in this as a public-safety question, and just from the scientific standpoint -- is there a difference?"
Those keeping an eye on developments may eventually find out.
Just this week, the U.S. government-funded National Eye Institute approved a trial in principle (depending on how the study will be funded) that would pit the two drugs against each to finally determine which is better.Report Typo/Error
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