The Impact of Disease-Modifying Therapy Access Barriers on People With Multiple Sclerosis: Mixed-Methods Study.

Stefan Varga,Kristen Johnson,Debbie Moreton,John J Ko,Kristina F Simacek,Bozena J Katic

doi:10.2196/11168

Abstract

BackgroundIn the United States, people with relapsing-remitting multiple sclerosis (RRMS) can face difficulty accessing disease-modifying therapies (DMTs) because of insurance, pharmacy, or provider policies. These barriers have been associated with poor adherence and negative health outcomes.ObjectiveThe goals of this study were to describe the overall occurrence of difficulties and delays associated with gaining access to DMTs among people with RRMS, to assess DMT adherence during periods of reduced access, and to contextualize the patients’ journey from receipt of a prescription for DMT to obtaining and taking their medication when faced with access barriers.MethodsWe recruited US-based adults self-reporting RRMS from a Web-based health data-sharing social network, PatientsLikeMe. Individuals were invited to complete a Web-based survey if they reported a diagnosis of RRMS and were prescribed a DMT for MS. Follow-up phone interviews were conducted with 10 respondents who reported experiencing an MS-related relapse during the time they had experienced challenges accessing DMTs.ResultsAmong 507 survey completers, nearly half were either currently experiencing an issue related to DMT assess or had difficulty accessing a DMT in the past (233/507, 46.0%). The most frequently reported reasons for access difficulty were authorization requirements by insurance companies (past issues: 78/182, 42.9%; current issues: 9/42, 21%) and high out-of-pocket costs (past issues: 54/182, 29.7%; current issues: 13/42, 31%). About half (20/39, 51%) of participants with current access issues and over a third (68/165, 41.2%) of those with past issues went without their medication until they could access their prescribed DMT. Relapses were reported during periods of reduced DMT access for almost half (56/118, 47.5%) of those with past issues and nearly half (22/45, 49%) of those with current issues. Resolving access issues involved multiple stakeholder agents often coordinated in a patient-led effort. Among those who had resolved issues, about half (57/119, 47.9%) reported that doctors or office staff were involved, under half (48/119, 40.3%) were involved themselves, and about a third (39/119, 32.8%) reported the drug manufacturer was involved in resolving the issue. Follow-up interviews revealed that the financial burden associated with obtaining a prescribed DMT led to nonadherence. Additionally, participants felt that DMT treatment delays and stress associated with obtaining the DMT triggered relapses or worsened their MS.ConclusionsThis study expands current research by using a patient-centered, mixed-methods approach to describe barriers to MS treatment, the process to resolve barriers, and the perceived impact of treatment barriers on outcomes. Issues related to DMT access occur frequently, with individuals often serving as their own agents when navigating access difficulties to obtain their medication(s). Support for resolution of DMT access is needed to prevent undue stress and nonadherence.

Highlights

Multiple sclerosis (MS) is a chronic autoimmune disease of the central nervous system affecting an estimated 450,000-550,000 people in the United States [1,2]
Issues related to disease-modifying therapy (DMT) access occur frequently, with individuals often serving as their own agents when navigating access difficulties to obtain their medication(s)
Median Patient-Determined Disease Steps (PDDS) score was 4, indicating some gait disability. Of those in the validated sample, 60.4% (233/386) had experienced difficulty accessing a DMT in the past (188/386, 48.7%) or were currently experiencing an issue related to DMTs access (45/386, 11.7%)

Summary

Introduction

Multiple sclerosis (MS) is a chronic autoimmune disease of the central nervous system affecting an estimated 450,000-550,000 people in the United States [1,2]. Responding to rising costs of DMTs [10,11], insurers have adopted strategies to optimize the utilization of specialty medications through management, including requiring prior authorization, step therapy (where a patient must fail a preferred medication first), or tiered formularies that increase cost sharing for patients [12,13]. For people with MS, high out-of-pocket costs for DMTs have been associated with lower adherence and inappropriate disease management, which leaves patients at increased risk of relapse and payers vulnerable to increased associated resource use [16,17]. In the United States, people with relapsing-remitting multiple sclerosis (RRMS) can face difficulty accessing disease-modifying therapies (DMTs) because of insurance, pharmacy, or provider policies. These barriers have been associated with poor adherence and negative health outcomes

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