Healthy Skepticism Library item: 12530

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Publication type: news

Weeks C.
The battle over two drug treatments: Competing interests of price, clinical evidence and accessibility are at the centre of a contentious debate
The Globe and Mail 2008 Jan 22
http://www.theglobeandmail.com/servlet/story/RTGAM.20080122.wlmacular22/BNStory/specialScienceandHealth/home

Full text:

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.

The U.S. National Institutes of Health are conducting a study to compare Lucentis and Avastin, but results are not expected until 2010. A spokeswoman for Roche Canada said the company does not support the off-label use of Avastin for macular degeneration and is not involved in any of the clinical trials because it’s focused on cancer treatments.

The Common Drug Review, a federal body responsible for determining whether drugs merit coverage on provincial health plans, rejected Lucentis for coverage late last year.

But the application is being reconsidered at Novartis’s request, and a final decision is expected tomorrow. Although the Common Drug Review makes recommendations about which drugs should qualify for coverage, provinces still make their own decisions.

One of the questions drug review officials are facing is why government health plans should cover the cost of an expensive treatment when a seemingly suitable alternative is available at a fraction of the price.

Proponents of Lucentis say the government has a responsibility to reimburse patients for the treatment because it’s a better alternative than Avastin, which lacks sufficient clinical data.

“Right now we have a drug that is approved that could be reimbursed to people every month,” said Keith Gordon, head of research at the Canadian National Institute for the Blind.

The institute received an unrestricted grant from Novartis, which is being used in part to fund its campaign for Lucentis coverage.

Novartis said it’s important for patients to have affordable access to Lucentis because it’s the “first and only” treatment that can improve the vision and quality of life of those suffering from wet macular degeneration.

In an e-mail, the company responded to the use of Avastin to treat the eye disease by saying, “it is not approved for intraocular [in the eye] use and is not indicated for treatment of AMD [age-related macular degeneration].”

But to Mr. Cassels, an outspoken critic of the marketing practices of drug companies, the mounting pressure being placed on the government to fund expensive Lucentis treatments is a disturbing example of the industry’s push for higher profits at the expense of affordable medication.

“It would be reasonable to promote the use of the cheaper version,” he said. “This is about public health versus private interest.”

Dr. Sharma says the debate over Lucentis funding may miss an important part of the issue: Instead of focusing on Lucentis, the eye specialist said, the medical community should concentrate on compiling enough clinical evidence on Avastin so that doctors could start using Avastin much more frequently as a cheaper treatment for macular degeneration.

“Lucentis clearly is an outstanding medicine, but it’s also quite expensive,” Dr. Sharma said. “My comfort level would be higher, certainly, if we had very, very well-designed clinical trials [for Avastin].”

Macular degeneration

Primarily older adults suffer from macular degeneration, which impairs vision and can cause blindness. This occurs when the macula area of the retina thins, atrophies and, in some cases, bleeds. This is caused by yellow deposits called “drusen” forming between the membranes that support the retina.