Health gains from multiple sclerosis drugs come at a high price, study finds

The study -- which appears in the journal Neurology -- 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. The study found that while MS patients using disease- modifying drugs experience modest health gains, the cost associated with using these drugs is more than 8 times higher than what is considered "reasonable" from a health economics cost-effectiveness perspective.

"While it is clear that disease-modifying drugs are beneficial to some MS patients, those gains come at a tremendous economic cost," said Katia Noyes, Ph.D., M.P.H., 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 disease of the central nervous system and is the most common cause of neurological disability in young adults. The disease causes muscle weakness, numbness or tingling in arms and legs, difficulty with coordination, balance and walking, blurred vision, and slurred speech. Early in the course of the disease the symptoms manifest themselves in cycles of acute symptoms followed by periods of remission and recovery. Over time these symptoms tend to become more permanent and debilitating.

In the 1990's several new drugs were introduced that modified the course of the disease, as opposed to traditional therapies that primarily treat the symptoms of MS. These drugs -- which include interferons and glatiramer acetate -- have been shown in large clinical studies to slow the progression of the disease and reduce relapses. However, these drugs are associated with side effects and are very expensive, costing as much as $30,000 per 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, it 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. Health care 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.

Noyes and her colleagues employed a method called quality-adjusted life years (QALY) to evaluate the health effects of the drugs. QALY is a standard tool used to evaluate disease burden by estimating the improved quality of life gained over time by taking a particular medication or course of therapy. A general rule of thumb among health policy experts is that for an intervention to be judged "cost-effective" it should cost $100,000 or less to produce an extra QALY. According to the study, disease-modifying drugs for MS cost more than $800,000 per QALY.

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 2 quality-adjusted months over 10 years compared to those who did not take disease modifying drugs. Patients taking interferon beta-1b had an average of 6 out of 10 free of relapses compared to 5 years for those not taking the drugs. The authors also found that the benefit to patients was greater if they began taking the drugs early during the onset of the disease.

The study's authors point out that in countries such as Britain, Canada, and Germany the cost of these drugs is 67 percent lower than the U.S. "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," said Noyes.

The study's co-authors include Robert Holloway, M.D., M.P.H., Steven Schwid, M.D. (deceased), and Alina Bajorska, M.S. with URMC, Lahar Mehta M.D. with Evergreen Neuroscience Institute, Bianca Weinstock-Guttman, M.D. with the University at Buffalo, and Andrew Dick, Ph.D. with the Rand Corporation. The study was funding with support from the National Center for Research Resources and the National Multiple Sclerosis Society.