Nearly every person with a chronic health condition likely has the same voicemail recording on their phone... “Hello Mr. Smith, it’s your local pharmacy. Your 3-month prescription refill is now ready for pick-up.”
Like so many medications meant to address chronic diseases, disease-modifying therapies (DMTs) for multiple sclerosis (MS) are often doled out in batches, with patients often receiving 30-day or 3-month refills in close succession.
Convenient? Sure. But we also know that patients struggle with medication compliance and persistence, particularly in the face of tolerability issues.
With nearly 2 dozen approved MS DMTs now available, switching drugs – whether due to patient preference, side effects, cost, efficacy, or otherwise—happens often. But what happens to that 6-month supply of an injectable DMT that’s sitting in Mr. Smith’s hall closet? It stays there. Or worse, it gets tossed out with the rest of the household trash.
The problem may be far greater than most clinicians realize.
“The magnitude of unused DMTs from people with MS has never been quantified and the impact of such therapies in the context of the overall economic burden of care in MS remains poorly understood,” Darin T. Okuda, MD, professor of neurology and director of Neuroinnovation and the Multiple Sclerosis & Neuroimmunology Imaging Program at The University of Texas Southwestern Medical Center at Dallas, and colleagues wrote. “Despite wide-spread concern about the costs of DMTs in MS, the true prevalence of the problem of wasted medication remains.”
Watching the phenomenon first-hand, investigators led by Okuda set out to quantify just how much DMT waste was occurring and why. What they weren’t prepared for was to fill an exam room of an MS clinic with millions of dollars' worth of unused, life-altering drugs in a matter of months.
The findings suggest a much more pervasive problem than what is visible at the surface, implying that a one-size-fits-all approach to treatment counseling and patient education may not be sufficient, especially in underserved populations and those at greater risk for more aggressive disease based on race or ethnicity.
“This not only represents a mechanism for reducing medical waste, but also emphasizes the necessity for enhanced education and mindful communication with patients to ensure proper management and long-term care,” Okuda and colleagues wrote.
To better understand the problem, Okuda and colleagues launched a single-center study that included new and existing patients seen in the clinic from January 1, 2018 to December 31, 2018, during which patients voluntarily disposed of their FDA-approved DMTs within the clinic. Participants could complete an optional survey about treatment experience and therapy transition, with discontinuation data captured via comprehensive questionnaire. In addition, Okuda and colleagues conducted a 1-month prospective study between November 1, 2018, and December 1, 2018, during which a more pronounced push to collect unused DMTs occurred, with all participating patients required to complete a comprehensive survey that included information on past clinical history and reasoning for treatment transitions.
Ultimately, 422 patients were enrolled in the study, of which 73.2% were female and 86.3% were white, with a mean age at disease onset of 32.9 years, mean disease duration of 12.8 years, and mean treatment duration of 2.86 years. The majority of patients were covered by commercial insurance (79.9%) or Medicare (19%).
Notably, nearly 60% of patients switched DMTs for non-medical reasons, 54% for medical reasons, and 41% for reasons related to medication tolerability. Men were less likely than women to switch DMTs due to injection fatigue or wanting an oral medication (HR 55%; 95% CI, 0.26-0.78; P =.01). Black or African American patients with MS were 91% more likely to want to switch to an oral medication due to injection fatigue and 221% more likely to switch based on perceived lack of efficacy relative to white patients with MS (95% CI, 1.07-3.42; P =.03; 95% CI, 1.04-4.70; P =.04). Patients taking injectable DMTs had a 396% greater risk of switching based on perceived efficacy compared with those on monoclonal antibody treatments, with a similar trend observed among those taking oral DMTs compared with those receiving infusion-based therapies.
A lower risk of switching due to medical reasons was observed in patients on oral or injectable DMTs versus those taking infused or monoclonal antibody treatments (P<.0001 for both). Black or African American patients were 50% less likely to switch treatments due to side effects compared with whites, with a general trend showing that a history of exposure to a greater number of prior DMTs resulted in decreased risk of switching due to side effects (P =.01).
In terms of status of the unused medications, nearly 29% reported continued use of previously prescribed DMTs before starting new treatment, 22.7% reported discarding them, 22.4% reported storing the unused treatments in their home, 15.4% returned them to the clinic, 7.8% returned them to their local pharmacy or fire department, and nearly 3% reported giving their unused DMTs to other patients with MS.
Over the course of the 1-year study, the commercial value of the retrieved unused DMTs amounted to $5,152,632.02 based on average wholesale price (2018), with projected cost increases of approximately 10% adjusted for 2021 values. Among those enrolled in the 1-month prospective study (n=49), acquired unused DMTs amounted to an average wholesale price of more than $1 million based on 2018 costs, translating to roughly $21,600.00 per patient.
The staggering degree of waste observed, both in healthcare costs and unused drugs, “emphasizes the need for treatment strategies aimed at more than just factors related to therapeutic efficacy,” Okuda and colleagues wrote.
“In order to truly guide our patients toward the best outcomes we need to understand the barriers—some of which we may ourselves be blind to—and we hope these data about unused DMTs provide insights that shed light on reasons for lack of compliance and discontinuation and inspire clinicians to look at the implicit biases in our system and our practices that disrupt medication adherence so that we may provide more individualized counseling and culturally competent care,” Okuda told NeurologyLive®.
Given active and ongoing discussions surrounding costs of specialty therapies, and the likelihood that DMT discontinuation will only continue to increase over time given the aging MS population, new treatments slated to hit the market, and an increasing number of people diagnosed with MS due to advances in diagnostics and disease treatment strategies, identifying a solution to this problem is paramount and would ultimately benefit the healthcare system, Okuda and colleagues concluded.
“If there is no immediate solution to effectively addressing escalating prices, reducing US health care cost may be as simple as only paying for treatments that are actually used by consumers,” they wrote.