Comparison of Healthcare Utilization by Disease Modifying Therapy Generation Among Individuals Diagnosed with Multiple Sclerosis after One Year of Initiating Therapy in the United States

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.

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

Clinical Therapeutics ◽

10.1016/j.clinthera.2013.07.330 ◽

2013 ◽

Vol 35 (10) ◽

pp. 1501-1512 ◽

Cited By ~ 17

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

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

Therapeutic Advances in Neurological Disorders ◽

10.1177/1756286420987031 ◽

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.

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