The Burrill Report


The price of drugs such as Biogen Idec’s Avonex and Bayer Healthcare Pharma’s Betaseron, aimed at reducing the frequency of relapses in multiple sclerosis patients, is eight times higher than what is generally considered cost-effective by health economists, according to a new study by researchers at the University of Rochester.

The study, published in the journal Neurology, looked at a group of disease-modifying therapies to treat MS, which first became available in the 1990s. Among the drugs the study examined were EMD Serono’s Rebif and Teva Pharmaceutical’s Copaxone.

“While evidence suggests that these drugs slow MS progression and reduce the frequency of relapses, these therapies are characterized by significant side effects and high costs, representing great economic burden to patients, as well as public and private payers,” the researchers write.

The study analyzed data from 844 individuals with early stage MS and projected health care costs, including the cost of the drugs, and lost productivity over a 10 year period. It found that while MS patients using disease-modifying drugs experience modest health gains, the cost associated with using these drugs was near or exceeded $1 million per quality adjusted life year or QALY. QALY is used by health economists as a measure of years of perfect health provided by the use of a therapy. Though there is no standard for the value of a QALY, $100,000 or less per QALY is commonly used as a measure of cost-effectiveness.

“While it is clear that disease-modifying drugs are beneficial to some MS patients, those gains come at a tremendous economic cost,” says Katia Noyes, associate professor in the Department of Community and Preventive Medicine at the University of Rochester Medical Center and lead author of the study. “These results point to the need to continually evaluate the cost-effectiveness of new treatments in the interest of controlling health care costs.”

MS is a neurodegenerative disease where the body attacks the protective sheath of nerves. The disease causes muscle weakness, numbness or tingling in arms and legs, difficulty with coordination, balance and walking, blurred vision, and slurred speech. Like other autoimmune diseases, the symptoms often come in flares followed by periods of remission and recovery. Over time these symptoms tend to become more permanent and debilitating.

Drugs, which include interferon or, in the case of Capoxone, glatiramer acetate, were introduced in the 1990s and changed the treatment of MS. Until then, treatments had centered on the symptoms of the disease. But these new therapies sought to slow progression of the disease and reduce relapses. While the researchers say they have been shown in large clinical studies to do that, their benefits are limited. For instance, individuals taking disease-modifying drugs experienced a modest improvement in health according to the study. For example, MS patients taking interferon beta-1a gained about two quality-adjusted months over 10 years compared to those who did not take disease-modifying drugs. But these drugs are associated with side effects and cost as much as $30,000 a year.

The authors used data from an ongoing survey of MS patients funded by the National Multiple Sclerosis Society. Using this and several other sets of data, they projected the health care costs – medications, hospital admissions, out-patient visits, diagnostic testing, and home and long term care – over a 10 year period associated with individuals taking disease-modifying drugs and those who instead underwent other basic treatments to control their symptoms. Healthcare costs were generated using Medicaid and Medicare reimbursement rates. The study also calculated lost productivity – interruptions in work or schooling – and estimated these costs using Bureau of Labor Statistics data.

“MS is a lifelong disease, and the analysis looked at only four years of data,” said Bayer in a written statement in response to the report. “As such, the results should be interpreted cautiously.” Other companies mentioned in the study did not respond to a request for comment at the time of publication.

Teva Pharmaceuticals also criticized the short timeframe of the study and said "when longer timelines that are consistent with the disease are used, the cost per QALY is similar to those in other high burden illnesses."

The authors note that in countries such as Britain, Canada, and Germany the cost of these drugs is 67 percent lower than in the United States. “If we could bring the cost of these drugs in line with what pharmaceutical companies are paid in other industrialized countries, we could significantly improve the cost-benefit ratio,” says Noyes.

The study notes that the therapies were more cost-effective in patients who started therapy at the first sign of symptoms. However, they say the high cost of the drugs could cause patients to delay the start of therapy when it would do them the most good.

In an editorial accompanying the study, Kathleen Smyth, a researcher at the Case Western Reserve University School of Medicine and Neurological Outcomes Center, says many people feel that such studies should have no effect on clinical practice because a physician’s primary goal should be the well-being of individual patients, rather than maximizing benefit for all patients or controlling costs. The reality is that doctors face increasing pressure from payers to manage these therapies through the use of formularies and utilization management programs and cost-effectiveness studies will “no doubt inform these approaches,” she writes. “Rather than ignoring or discounting [cost-effectiveness] studies, clinicians may enhance the care they provide by taking an active interest in their design, interpretation, and application.”



July 22, 2011
http://www.burrillreport.com/article-study_finds_disease_modifying_ms_drug_too_costly.html