Hiding in plain sight: The magnitude of unused disease modifying therapies in multiple sclerosis and strategies for reducing the economic burden of care.

BACKGROUND

The rising costs associated with multiple sclerosis (MS) disease modifying therapies (DMTs) creates challenges for patients and the healthcare system in the United States (U.S.). Within a specialty medicine waste project, we quantified the magnitude of unused medications and corresponding value, the primary factors driving treatment switches, and explored reasons for discontinuations by race and ethnicity.

METHODS

Over one calendar year, MS DMTs were recovered from new and existing patients from a single neuroimmunologist within a tertiary MS care center. Baseline demographic and clinical information, including reasons for medication discontinuation or transitions were captured. Patients were stratified into three treatment transition categories: (i) non-medical, (ii) medical, or (iii) tolerability reasons. Cause-specific Cox proportional hazard functions were fit for possible causes for treatment changes.

RESULTS

A total of 422 patients (female: 73.2%, median age at diagnosis: 32.9 years (y)) comprised of 86.3% Whites, 11.6% Black or African Americans, 1.4% Asians, and 0.7% Native Americans were included, representing 23% of patients evaluated within 2018, with a mean disease duration of 12.8 years (y) (standard deviation (SD): 8.2) and treatment duration of 2.9y (3.4). Women were more likely to switch due to injection fatigue or desire for an oral DMT when compared to men (95% CI [0.26, 0.78], p = 0.01). Being Black or African American people with MS increased the hazard of switching treatment due to injection fatigue and desire for an oral medication relative to White patients with MS by 91% (95% CI [1.07, 3.42], p = 0.03) and switching to a new DMT based on the subjective report of a perceived lack of efficacy was 221% greater (95% CI [1.04, 4.70], p = 0.04), but not in relation to side effects, being 50% less likely to switch (95% CI [0.28, 0.90], p = 0.02). In the passive recruitment phase over a single calendar year, DMTs with a retail value of $5.2 million (Average Wholesale Price (AWP)) were recovered. In the 1-month active recruitment phase within the same year involving 49 people with MS, unused MS DMTs of $1.1 million (AWP) were acquired. Of the 471 patients studied, 56.2% reported transitions in DMTs for reasons other than adequate disease control and tolerability at one point in their treatment history, underscoring the need for individualized therapy selections that enhance persistence and increase the likelihood of reducing further neurological disability.

CONCLUSION

The magnitude of unused and wasted MS DMTs is staggering and these findings allude to a larger, more pervasive problem within the healthcare system with financial resources being applied to therapies that go unused.