Clinical trials and treatment in multiple sclerosis (MS) place an unwelcome economic burden upon countries with MS prevalence. With rising costs and a growing interest in MS clinical trials from emerging countries, new studies are needed to evaluate the significance of these factors.
Clinical trials and treatment in multiple sclerosis (MS) place an unwelcome economic burden upon countries with MS prevalence. With rising costs and a growing interest in MS clinical trials from emerging countries, new studies are needed to evaluate the significance of these factors. Such studies were revealed at a poster session during the 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Posters in this series outlined the economic impact of MS treatment and clinical trials in specific countries, and discussed ways of reducing this economic burden. In the first poster discussed here, Cathryn Carroll, PhD, Health Economic and Outcomes Research, Teva Pharmaceuticals, Inc, Kansas City MO, offers an updated study on the current state of medical and pharmacy costs for US patients with MS in 2011. In the second, Lynne Hughes, vice president and therapeutic strategy head, Neurology, Global Project Management, Quintiles, Reading, UK, looks at emerging countries in MS research, and attributes the economic burden of MS to their absence from global clinical trials.
In the first poster, Dr Carroll et al evaluate the influence of disease-modifying drugs (DMD) and comorbidities on healthcare costs for patients with multiple sclerosis (PwMS). To execute their study, Carroll and her team pulled data from the i3 Invision Data Mart medical and pharmacy claims database. For the years 2006 and 2011, continuously enrolled insured patients with at least one medical claim of MS diagnosis were sampled. This sample group was then divided into a primary group and 2 subgroups according to course of treatment for MS. The primary group consisted of PwMS who received any MS treatment in 2006 and 2011; the first subgroup was made up of those patients marked by any DMD use such as [INF]β-1a or natalizumab; and the second subgroup saw patients receiving DMD monotherapy exclusively. The mean charges (in US dollars) for these treatments were then evaluated, followed by mean charges for treatment for patients with comorbidities.
Results showed that from 2006 to 2011, mean charges for MS treatment, after adjusted for inflation, increased by 60%, with mean total annual healthcare charges being $26,520 per patient in 2011. Treatment for patients using single DMDs accounted for 75% of these charges in 2011, though proportionately, these costs were similar to those reported in 2004. Carroll points to comorbidities as the main cause of this spike in healthcare costs with disorders like optic neuritis, ataxia, abnormality of gait, and spasms requiring costly treatments. She also notes the remarketing of natalizumab in 2006 as a potential contributing factor to increased MS pharmacy and medical service charges.
In the second poster, Hughes et al address declining trial recruitment rates in countries with high MS prevalence, and call for an expansion of the MS clinical trial network to include emerging countries who currently bear an economic burden due to MS treatment and study. Using their own proprietary database, Hughes and her team reported on 10 years of global relapsing-remitting multiple sclerosis (RRMS) trials in Brazil, Russia, Africa, Middle East, and Turkey, abbreviated in the poster as “BRAMET” countries. Some of the characteristics assessed include reimbursement of DMDs, recruitment rates, MRI accessibility, catchment area and access to patients, and timeliness for start-up compared to other neurology trials.
Among the most notable results of this study was the determination that the BRAMET countries possess an effective centralized referral system with large catchment areas covering approximately 945 million people, which allows for large pools of patients available per site. Another meaningful result was the difference in recruitment rates in BRAMET countries when compared to the US and Western Europe (US/WE). The range of average recruitment rates in BRAMET were 0.19 (South Africa) to 0.89 (Russia) versus 0.3 for US/WE. It is also important to note that the imaging equipment used in BRAMET countries was comparable to that used in US/WE, indicating a readiness to seriously take part in MS clinical trials and research.
According to Hughes, these results show that emerging countries are eager to perform in MS clinical trials, and that through effective pre-screening measures between sites and sponsors/CROs, this outcome is possible. Further, their participation in global clinical trials will alleviate economic burden and offer effective therapeutic options to patients.