The cost of multiple sclerosis drugs in the US and the pharmaceutical industry

Objective: To examine the pricing trajectories in the United States of disease-modifying therapies (DMT) for multiple sclerosis (MS) over the last 20 years and assess the influences on rising prices. Methods: We estimated the trend in annual drug costs for 9 DMTs using published drug pricing data from 1993 to 2013. We compared changes in DMT costs to general and prescription drug inflation during the same period. We also compared the cost trajectories for first-generation MS DMTs interferon (IFN)–b-1b, IFN-b-1a IM, and glatiramer acetate with contemporaneously approved biologic tumor necrosis factor (TNF) inhibitors. Results: First-generation DMTs, originally costing $8,000 to $11,000, now cost about $60,000 per year. Costs for these agents have increased annually at rates 5 to 7 times higher than prescription drug inflation. Newer DMTs commonly entered the market with a cost 25%–60% higher than existing DMTs. Significant increases in the cost trajectory of the first-generation DMTs occurred following the Food and Drug Administration approvals of IFN-b-1a SC (2002) and natalizumab (reintroduced 2006) and remained high following introduction of fingolimod (2010). Similar changes did not occur with TNF inhibitor biologics during these time intervals. DMT costs in the United States currently are 2 to 3 times higher than in other comparable countries. Conclusions: MS DMT costs have accelerated at rates well beyond inflation and substantially above rates observed for drugs in a similar biologic class. There is an urgent need for clinicians, payers, and manufacturers in the United States to confront the soaring costs of DMTs. Neurology® 2015;84:1–8 GLOSSARY AWP5 average wholesale price; DMT 5 disease-modifying therapy; FDA5 Food and Drug Administration; IFN5 interferon; MS 5 multiple sclerosis; QALY 5 quality-adjusted life-year; TNF 5 tumor necrosis factor; VA 5 Veterans Affairs; WAC 5 wholesale acquisition cost. The landscape of multiple sclerosis (MS) treatment has changed dramatically over the last decade. As of November 2014, 12 disease-modifying therapies (DMTs) for MS have been approved by the US Food and Drug Administration (FDA). Despite the availability of more treatment options, costs for all MS DMTs have increased sharply. Between 2008 and 2012, US DMTs sales doubled from $4 billion to nearly $9 billion annually. In 2004, the average annual DMT cost per person was $16,050, accounting for half of all direct medical costs for patients with MS. Currently, the average annual cost for interferon (IFN)–b-1b (Betaseron; Bayer HealthCare Pharmaceuticals, Whippany, NJ) is over $60,000. Although high drug costs are a hallmark of specialty pharmaceutical classes, such as DMTs, the unexplained escalation in costs for older, first-generation MS therapies such as IFN-b-1b, IFN-b-1a IM (Avonex; Biogen Idec, Cambridge, MA), and glatiramer acetate (Copaxone; Teva Pharmaceuticals, North Wales, PA) has caused concern in the neurology community. The objectives of this study were to (1) investigate our impression that costs for all MS DMTs have increased dramatically since 2002, (2) explore the relationship between the release of newer DMTs and the trend in costs for older DMTs, and (3) compare DMT costs in the United States From the College of Pharmacy (D.M.H., S.M.A.), Oregon State University/Oregon Health & Science University; and the Department of Neurology (D.N.B., R.H.W.), Oregon Health & Science University, Multiple Sclerosis Center of Excellence West, Veterans Affairs Medical Center, Portland. Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article. The Article Processing Charge was paid by OHSU Department of Neurology. This is an open access article distributed under the terms of the Creative Commons Attribution-Noncommercial No Derivative 3.0 License, which permits downloading and sharing the work provided it is properly cited. The work cannot be changed in any way or used commercially. © 2015 American Academy of Neurology 1 a 2015 American Academy of Neurology. Unauthorized reproduction of this article is prohibited. Published Ahead of Print on April 24, 2015 as 10.1212/WNL.0000000000001608