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What Happens When MS Patients Stop Treatment?

SEATTLE — Multiple sclerosis (MS) patients who stopped oral treatment for more than 60 days experienced more relapses, used more healthcare resources, and incurred higher costs than patients without treatment lapses, a retrospective analysis of U.S. insurance claims data showed.

Non-adherence was linked to nearly 28% more relapses, 25% more emergency department (ED) visits, and 40% more hospitalizations among MS patients who used once- or twice-daily oral disease-modifying therapy (DMT), reported Jacqueline Nicholas, MD, MPH, of the OhioHealth Multiple Sclerosis Center in Columbus, in a poster presentation at Consortium of Multiple Sclerosis Centers annual meeting.

“When we look at all the differences between patients who are continuously on oral DMTs versus patients who have lapsed for more than 60 days, we see an increase in healthcare costs across the spectrum,” Nicholas told MedPage Today. “It’s an incredible economic burden not only for society and insurance companies, but also for these individuals.”

“As a physician, I know it’s important to educate my patients to be on therapy, but this research shows it’s important to continue to advocate and push not just for the clinical outcomes, but for the financial outcomes as well,” she added.

Research has pointed to several variables that may trigger lapses in medication adherence. An exploratory study suggested avoidance coping — downplaying the seriousness of MS or not wanting to be reminded of it — plays a role, as well as drug side effects and cost of treatment. Out-of-pocket costs for MS drugs have risen sharply in recent years, with private-insurance MS patients paying 20 times more for drugs in 2016 than they did in 2004.

In this analysis, Nicholas and colleagues looked at clinical and economic outcomes of patients who had a lapse of >60 days in oral DMT treatment with dimethyl fumarate (Tecfidera), fingolimod (Gilenya), and teriflunomide (Aubagio).

They assessed IQVIA real-world adjudicated claims data of U.S. patients (ages 18 to 63) who had two or more MS diagnosis claims from January 2011 through June 2015 and more than one claim for a once- or twice-daily oral DMT in that period (index date). Eligible patients also had continuous commercial insurance 6 months before and 18 months after the index date. Lapses in treatment were defined as the number of days between ending a supply of one prescription and filling the next prescription of either the same or another DMT.

A total of 8,779 patients met the eligibility criteria. Over the 18-month follow-up period, 1,326 (15.1%) had a lapse in their treatment of >60 days and 7,453 (84.9%) did not.

After propensity score matching, the researchers looked at 1,316 patients who had a lapse of >60 days and 1,316 people who did not. About 75% of each group was female and the average baseline age was 44. Among people who stopped DMTs for >60 days, the mean lapse was 143.3 days. Among the matched cohort, the mean treatment lapse was 17.6 days.

Compared with the matched cohort, patients who stopped treatment for >60 days had:

  • 27.6% more relapses (mean 1.16 vs 0.84, P<0.0001)
  • 40.0% more hospitalizations (mean 0.20 v 0.12, P=0.0003)
  • 24.6% more ED visits (mean 0.61 vs 0.46, P=0.0098)
  • 22.4% more outpatient visits (mean 6.24 vs 4.84, P<0.0001)
  • 24.5% greater costs in hospitalizations, ED visits, outpatient visits, tests, and procedures (mean $16,012 vs $12,092, P=0.0006)

The findings indicate further research is needed, Nicholas noted. “I don’t think I would have suspected such a great range in costs and such an incredibly increased use of [ED] visits and hospitalizations,” she said.

The analysis has several limitations, she added. It did not include information about disease type or severity, or reasons why patients lapsed. Matching factors were determined by a literature review, but other variables may result in residual confounding. The data also may not representative of people without employer-paid commercial health insurance.

The study was supported by EMD Serono/Merck KGaA.

Nicholas disclosed support from EMD Serono.