scholarly journals Health economics of disease-modifying therapy for multiple sclerosis in the United States

2021 ◽  
Vol 14 ◽  
pp. 175628642098703
Author(s):  
Daniel M. Hartung
Keyword(s):  
United States ◽  
Multiple Sclerosis ◽  
Financial Burden ◽  
Economic Value ◽  
The United States ◽  
Insurance Companies ◽  
Disease Modifying Therapy ◽  
Price Increases ◽  
Significant Disability ◽  
Disease Modifying

Multiple sclerosis (MS) is chronic neuroinflammatory condition associated with significant disability. The economic burden of MS is substantial, and high and rising disease-modifying therapy (DMT) prices are the single largest drivers of healthcare expenditures. Over much of the last decade, price increases for most DMTs have surpassed 10% annually. Currently, many MS DMTs exceed US$90,000 a year and their economic value is widely debated. In addition to creating a financial burden for the healthcare system, high DMT costs negatively impact patients through unaffordable out-of-pocket costs and excessive restrictions by insurance companies. The objective of this narrative review is to summarize economic issues related to MS DMTs, including trends in pricing, relative value, and effects on patient care in the United States.

scholarly journals Development of Glatopa® (Glatiramer Acetate): The First FDA-Approved Generic Disease-Modifying Therapy for Relapsing Forms of Multiple Sclerosis

2017 ◽  
Vol 31 (5) ◽  
pp. 481-488 ◽  
Author(s):  
Christine Bell ◽  
James Anderson ◽  
Tanmoy Ganguly ◽  
James Prescott ◽  
Ishan Capila ◽  
...  
Keyword(s):  
United States ◽  
Multiple Sclerosis ◽  
Glatiramer Acetate ◽  
Treatment Options ◽  
Functional Characterization ◽  
The United States ◽  
Complex Nature ◽  
Disease Modifying Therapy ◽  
The Us ◽  
Disease Modifying

The multiple sclerosis (MS) treatment landscape in the United States has changed dramatically over the past decade. While many disease-modifying therapies (DMTs) have been approved by the US Food and Drug Administration (FDA) for the treatment of relapsing forms of MS, DMT costs continue to rise. The availability of generics and biosimilars in the MS-treatment landscape is unlikely to have a major impact on clinical benefit. However, their availability will provide alternative treatment options and potentially lower costs through competition, thus increasing the affordability of and access to these drugs. In April 2015, the first generic version of the complex drug glatiramer acetate (Glatopa® 20 mg/mL) injection was approved in the United States as a fully substitutable generic for all approved indications of the 20 mg/mL branded glatiramer acetate (Copaxone®) dosage form. Despite glatiramer acetate’s complex nature—being a chemically synthesized (ie, nonbiologic) mixture of peptides—the approval occurred without conducting any clinical trials. Rather, extensive structural and functional characterization was performed to demonstrate therapeutic equivalence to the innovator drug. The approval of Glatopa signifies an important milestone in the US MS-treatment landscape, with the hope that the introduction of generic DMTs and eventually biosimilar DMTs will lead to future improvements in the affordability and access of these much-needed treatments for MS.

Treatment Patterns in Disease-Modifying Therapy for Patients With Multiple Sclerosis in the United States

2013 ◽  
Vol 35 (10) ◽  
pp. 1501-1512 ◽  
Author(s):  
Machaon M. Bonafede ◽  
Barbara H Johnson ◽  
Madé Wenten ◽  
Crystal Watson
Keyword(s):  
United States ◽  
Multiple Sclerosis ◽  
The United States ◽  
Treatment Patterns ◽  
Disease Modifying Therapy ◽  
Disease Modifying

scholarly journals The Impact of Disease-Modifying Therapy Access Barriers on People With Multiple Sclerosis: Mixed-Methods Study (Preprint)

2018 ◽  
Author(s):  
Kristina F Simacek ◽  
John J Ko ◽  
Debbie Moreton ◽  
Stefan Varga ◽  
Kristen Johnson ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Mixed Methods ◽  
Financial Burden ◽  
The United States ◽  
Insurance Companies ◽  
Access Barriers ◽  
Web Based ◽  
Disease Modifying ◽  
The Impact

BACKGROUND 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. OBJECTIVE The 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. METHODS We 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. RESULTS Among 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. CONCLUSIONS This 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.

Medication costs harm patients with multiple sclerosis

2020 ◽  
pp. 10.1212/CPJ.0000000000000927
Author(s):  
Marc R. Nuwer ◽  
Kevin Patel
Keyword(s):  
Multiple Sclerosis ◽  
Cost Burden ◽  
Part D ◽  
Pharmaceutical Price ◽  
Patient Cost ◽  
Coverage Gap ◽  
Disease Modifying Therapy ◽  
Price Increases ◽  
Medication Costs ◽  
Disease Modifying

Governmental policies aimed to reduce costs to patients of multiple sclerosis (MS) disease modifying therapy (DMT). Closing the Part D coverage gap intended just that—to reduce patient cost burden. Hartung et al.1 found this policy ineffective. Simultaneous pharmaceutical price increases offset reductions in patients' personal costs.

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