Article Published on the Cost Effectiveness for Treating MS
Overview: Much attention has been focused on an article appearing in the July 26 issue of Neurology (vol. 77, pages 355-363) titled, “Cost-effectiveness of disease-modifying therapies for multiple sclerosis.” This article presents the results of a study that looks at several factors in an effort to estimate the overall 10-year expense versus benefit associated with the long-term treatments for MS, in combination with other costs and lost wages.
Previous cost-effectiveness studies in MS have yielded a wide range of results. The purpose of this study was to gain a more accurate understanding of the costs of disease-modifying therapies (DMTs) for MS in conjunction with their impact on quality of life. This study was co-funded by the National MS Society, the National Institutes of Health, and the University of Rochester
Study Details: The study, conducted by Dr. Katia Noyes from the University of Rochester in New York and colleagues, required the collection and extensive analysis of intricate data derived from surveys, simulations, statistical models, and government agencies. The team looked at data specifically relating to individuals with relapsing-remitting MS (RRMS) and secondary-progressive MS (SPMS) living in the United States, along with estimated costs for their healthcare, DMTs, and lost wages. Collecting all data from within one country is important when computing cost effectiveness, since the price of DMTs and other expenses vary greatly between different countries.
These two types of MS (RRMS and SPMS) were selected because these are the most common “relapsing” forms of MS that may be treated by the four types of DMTs used in this analysis. The DMTs that were included to evaluate specific cost and effectiveness included interferon beta-1a (Avonex® and Rebif®), interferon beta-1b (Betaseron®), glatiramer acetate (Copaxone®), and natalizumab (Tysabri®).
The primary source used for this study was the 2000 to 2005 Sonya Slifka Longitudinal Multiple Sclerosis study, which surveyed more than 2,000 people in the United States with MS. Dr. Noyes and colleagues created models through an immense amount of data collection that included demographic factors such as gender, race, age, location, education, marital status, and degree of disability. The researchers performed a type of simulation to estimate disease activity for individual patients over the course of 10 years.
Projected health outcomes with each DMT over the course of 10 years were estimated and compared to individuals on supportive care only (not taking a DMT). Related medical costs (hospital and emergency room costs, doctor and therapy appointments, home-health care, blood tests, and MRI), financial losses due to changes in productivity, and total costs with and without DMT, were all calculated.
Results: To summarize, the authors of this study concluded that the cost for an individual with MS on DMT is high in comparison to individuals treated for other chronic diseases and for MS patients in other countries. The benefit in terms of healthy years gained was considered “modest.” The authors use a measurement known as “quality-adjusted life-year” (QALY), which looks at the number of quality years added to a patient’s life when using the drug, the quality of life during those years, and the associated cost. Please note that QALY outcomes are not used by the FDA for drug approval.
Readers should note that this study used available data to make projections and did not involve actual patients in a clinical trial setting. The effects of DMTs on relapse rates, MRI damage, long-term disease progression, and disability were not factored into the analysis. Until a cure is found, reducing relapse rates, reducing MRI damage, slowing disease progression and delaying the potential for significant disability are the primary goals of DMTs.
The authors point out that a reduction in the cost of DMTs would bring the cost effectiveness of MS treatments to a level similar to other diseases. As an example, they specify the reduction in price of one of the drugs by 67 percent – a significant price reduction – would make its cost effectiveness comparable to treatments for similar diseases.
However, the authors also note that starting DMT early improves the cost effectiveness of MS treatments. This is because clinical trials have shown that early therapy can delay the onset of MS and reduce the number of flare-ups, while potentially slowing disease progression. Through early treatment, an individual with MS may be able to work longer and incur fewer medical expenses.
Commentary:
MSAA Chief Medical Officer Dr. Jack Burks states, “From MSAA’s viewpoint, this article should not discourage appropriate patients from starting or continuing DMTs. This study uses data from a large survey that was conducted with more than 2,000 individuals with MS over the course of roughly four years. The 10-year models and simulations were not based on actual patient histories, but rather highly developed expectations for each individual’s disease activity and associated expenses.
“In addition, MS is a difficult disease to predict. One person may experience less disease activity, while another may progress more quickly. The FDA-approved DMTs have been shown in clinical trials to reduce disease activity, reduce the frequency and severity of exacerbations, and slow disease progression. With this in mind, MSAA supports the recommendation of the American Academy of Neurology that DMT should be used for those for whom it is appropriate,”
While the authors also note that a reduction in the cost of DMTs would bring the cost effectiveness of MS treatments to a level similar to other diseases, this may not be possible anytime soon. Taking a new drug from development to approval, including several years of clinical trials, is estimated to cost up to one billion dollars.
Dr. Burks continues, “Cost-effectiveness studies may be used by insurance providers to create formulas for coverage. When the cost effectiveness of a treatment is considered too high, insurance providers could possibly put new limits on coverage. This is a controversial issue for MS-treatment coverage, as no one can put a price on one’s health, mobility, independence, and quality of life – and we know that these drugs work for many individuals with RRMS and SPMS.
“Other studies have shown DMTs for MS to be ‘cost effective.’ This study emphasizes the need for more data before establishing any additional health-policy decisions.
“Additionally, recent data suggest that individuals who participated in the early interferon trials (before any treatments were available) and were on the active treatment, are outliving those who were in the placebo (non-treated) group. These data along with positive clinical trial results continue to reinforce the value of the DMTs.”
Particularly for individuals who do not have adequate drug coverage and do not receive their medications through any patient-assistance program, a price reduction would be of great help. MSAA advocates for these individuals who recognize the value of the DMTs but are unable to afford them.
Individuals looking for more information on the DMTs and patient assistance programs may view a listing of these services on our website or call MSAA’s Helpline at (800) 532-7667 to speak with a client services consultant for assistance. For general information on DMTs for the treatment of MS, please refer to this listing on MSAA’s website as well.
Written by Susan Wells Courtney, MSAA Senior Writer & Creative Director
Reviewed by Dr. Jack Burks, MSAA Chief Medical Officer
