Bari Talente,1 Lisbet T Finseth,1 Natalie Blake,2 Kathleen Costello,3 Hollie Schmidt,4 Joe Vandigo,5 Elisabeth M Oehrlein5
1National Multiple Sclerosis Society, Washington, DC, USA; 2Multiple Sclerosis Foundation, Fort Lauderdale, FL, USA; 3Can Do Multiple Sclerosis, Avon, CO, USA; 4Accelerated Cure Project for Multiple Sclerosis, Waltham, MA, USA; 5Applied Patient Experience, Washington, DC, USA
Correspondence: Joe Vandigo, Applied Patient Experience, Washington, DC, USA, Email [email protected] Bari Talente, National Multiple Sclerosis Society, Washington, DC, USA, Email [email protected]
Purpose: Disease-modifying therapies (DMTs) are vital for managing multiple sclerosis (MS), but research using administrative data often excludes patient preferences and factors clinicians consider in treatment decisions. Patient experience data are crucial to understand and improve MS treatment initiation, adherence, and outcomes.
Methods: A cross-sectional survey of US adults with MS or clinically isolated syndrome was conducted online from December 2022 to January 2023 by the MS Coalition. A mixed methods analysis was conducted: logistic regression for quantitative data and thematic analysis of qualitative data.
Results: Among 1,323 participants (median age 55; 78% female), 80% expressed concerns about loss of independence, 65% about financial impacts, 64% about emotional impacts, 57% about relationships, and 42% about careers. Emotional tolls included identity loss, stress from navigating healthcare, and financial strain on families. Concerns varied by age, sex, and disability status. Nearly all participants (97%) reported DMT experience, with 73% having used two or more DMTs. Key factors in initiating DMT included slowing disease progression (92%), preventing relapses (89%), and following medical advice (89%). Financial barriers, such as high out-of-pocket costs, led to treatment delays or discontinuation in 19%. Barriers varied by demographic factors and included stress from medication costs, insurance denials, and fear of losing health coverage. Financial assistance was crucial for many. Half of participants had stopped a DMT due to doctor recommendations, side effects, or insurance issues.
Conclusion: The survey highlights the emotional and financial burdens of living with MS, including concerns about independence and relationships. The findings underscore the need for comprehensive care and provide actionable recommendations for managed care, research, and healthcare providers.
Keywords: multiple sclerosis, disease-modifying therapy, patient experience data survey, treatment initiation, adherence
Background
Multiple sclerosis (MS) is broadly categorized into two subtypes based on disease progression: relapsing forms and progressive forms. Relapsing forms of MS are characterized by episodes of new or worsening symptoms, called relapses, followed by periods of recovery (remissions), during which symptoms may improve or disappear. Progressive forms of MS involve a gradual increase in disability with or without distinct relapses.1
Disease-modifying therapies (DMTs) are integral to MS management. They are intended to reduce relapses and delay disease progression, although they do not directly alleviate symptoms, which are treated separately.2 DMTs are classified as “moderate efficacy” (eg, interferon-beta [IFNβ], glatiramer acetate, dimethyl fumarate, teriflunomide) and “high efficacy” (eg, alemtuzumab, cladribine, fingolimod, natalizumab, ocrelizumab, siponimod, ozanimod, ofatumumab, ublituximab).3–7 Given the progressive, lifelong nature of MS, therapy switching is common.8,9 Failure to tailor treatment to disease activity may result in worsened clinical outcomes and increased disability.6
Clinical practice guidelines direct healthcare providers to consider patient preferences related to safety, route of administration, lifestyle, efficacy, common adverse effects, and tolerability when discussing DMTs during shared decision-making with patients.2,10 In addition, providers and patients must consider treatment sequencing (ie, initiating one therapy can affect the safety and efficacy of subsequent therapies), rapidly evolving evidence regarding effectiveness, heterogeneity of treatment effect, and a rapidly expanding treatment armamentarium.7,11,12 Insurance coverage and out-of-pocket costs further impact the selection of therapies, as providers and patients seek to balance high-quality care with affordability.13–15
Studies indicate that a substantial proportion of people with MS in the United States experience financial hardships due to high out-of-pocket costs associated with their treatment regimens despite having insurance.16,17 Health insurance policies often require patients to pay copayments, a fixed amount per prescription, or co-insurance, which ties patient payments to a percentage of the medication’s list price before discounts or rebates.18,19
A 2019 market research study among people with MS showed that high out-of-pocket costs and the complex insurance approval process are linked to worsened symptoms and increased emotional distress.20 A Medicare claims analysis, which examines data from the US federal health insurance program primarily covering people aged 65 and older or with certain disabilities, found that beneficiaries not subject to traditional cost-sharing are likelier to initiate a DMT following diagnosis.21 This is important as evidence supports that early initiation, especially of high-efficacy therapies, allows for people with MS to receive the maximum possible benefit from their DMT.5,22 Across conditions, evidence demonstrates that utilization management is associated with worse medication adherence and clinical outcomes.19,23–25 People with MS who are adherent to their DMT have a longer time to their first relapse, a lower annualized relapse rate, and a longer period before needing a cane, walker, or wheelchair.26
People with MS not only face financial difficulties due to utilization management strategies but also experience higher levels of absenteeism and productivity losses compared to people without MS.16,27–29 Additional factors such as early retirement and the need for informal care contribute to substantial indirect costs.30
Research on treatment patterns and adherence often uses administrative data, which provides information about patient touchpoints within the health system.31,32 These data are helpful in identifying population-level trends but lack detailed information on many factors clinicians and patients must consider in shared decision making. While out-of-pocket and non-medical costs are known barriers to care, these data are often missing from administrative datasets. Thus, context regarding why patients delay treatment or do not adhere to care plans is often absent.33,34
Other types of quantitative research could also benefit from additional qualitative information directly from people with MS. For example, a systematic review of stated preference studies in people with MS highlighted that most attributes were based on prior research or clinicians. The authors highlighted the importance of qualitative methods to guide attribute and level selection in future studies since people’s experiences with MS are diverse, and without engaging people with MS, key factors in decision-making are likely to be omitted.34
This study collected patient experience data that are not routinely collected in real-world datasets but are critical for understanding and improving patients’ experiences, adherence, and outcomes with DMTs. These include the impacts of MS on daily living, emotional health, and financial well-being; the experiences and topics important to patients when deciding among DMTs during shared decision-making; factors associated with high-efficacy treatment initiation; as well as financial and non-financial barriers and side effects impacting adherence.
Methods
Study Design — Click here to continue reading
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