Thousands of Canadians will be diagnosed this year with macular degeneration, a debilitating eye disease that primarily strikes older adults and can rob them of their vision and independence.
But an argument over whether the government should pay for an expensive treatment when a cheaper alternative is available is bringing a contentious debate over the competing interests of price, clinical evidence and accessibility into the spotlight.
In Canada, two treatments are available that seem to fight the progression of wet macular degeneration, a severe form of the disease that has traditionally been challenging to treat.
One, called Lucentis, has shown remarkable success in clinical trials, but can cost patients tens of thousands of dollars a year. The other, Avastin, is available at a fraction of the price but the drug, developed to fight colorectal cancer, hasn't been approved by Health Canada to treat the eye disease.
Now, federal officials are facing increasing pressure from Novartis Pharmaceuticals Canada Inc., which sells Lucentis in Canada, and interest groups to provide public coverage for the pricier treatment despite widespread use of the cheaper option, prompting questions about the company's actions and the competing priorities of price and clinical evidence.
"What is in the public interest here conflicts with what is in the private interest," said Alan Cassels, a drug policy researcher at the University of Victoria. "It puts the medical system into an ethical dilemma."
Macular degeneration is the leading cause of severe vision loss in Canada, particularly among seniors.
It occurs when the macula, a highly sensitive part of the retina responsible for detailed central vision, becomes diseased and diminishes the ability to see objects clearly.
The disease can take two forms, known as "dry" and "wet." The dry kind is less severe and much more common than wet macular degeneration, which occurs when blood vessels leak and scar the macula, causing rapid vision loss.
While some laser treatments and other medication have been shown to fight the effects of wet macular degeneration, Lucentis is considered a blockbuster drug because it seems to offer the most promising results and can reverse the disease's effects in some people. Health Canada fast-tracked the approval process for this drug, and it came on the Canadian market last September.
A Lucentis treatment costs $1,575 plus the pharmacy dispensing fee and wholesaler markups. Novartis says patients receive best results when injections are given every month for an indefinite period.
But since Lucentis wasn't available in Canada until recently, retina specialists across the country have been using Avastin in an off-label capacity to treat patients - and many have reported successful results.
"It kind of spread like wildfire, [Avastin's] off-label use," said Sanjay Sharma, retina specialist and ophthalmology professor at Queen's University in Kingston. "There was no real alternative."
The drug is also attractive to many patients because a treatment usually costs only a few hundred dollars.
Physicians are allowed to prescribe any medication to patients, even if it hasn't been approved to treat a specific ailment, a practice that's referred to as off-label treatment. Health Canada doesn't monitor the off-label use of drugs in Canada, but a spokesman said the department would intervene if there were serious safety concerns.
Lucentis and Avastin were developed by the same company, Genentech, have a similar composition, and are administered through an injection to the eye to treat macular degeneration.
But Avastin, sold by Roche Canada, was designed to treat colorectal cancer. At this point, no major studies of its effectiveness for treating macular degeneration have been done, and these are necessary for the drug to be eligible for coverage under provincial or federal health plans.
