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Health Care Resource Use and Costs of H.P. Acthar® Gel (Repository Corticotropin Injection) for Multiple Sclerosis Relapse | ||
By: PR Newswire Association LLC. - 05 Jul 2016 | Back to overview list |
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CHESTERFIELD, United Kingdom, July 5, 2016 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty biopharmaceutical company, today announced new retrospective health economic data on H.P. Acthar® Gel (repository corticotropin injection; RCI), which may be an option for the management of multiple sclerosis (MS) relapses. The manuscript, recently published in Advances in Therapy compares the health care resource use and costs of patients treated with Acthar to those treated with plasmapheresis (PMP) or intravenous immunoglobulin (IVIG). Researchers at the University of Washington conducted the analysis, which was supported by a grant from Mallinckrodt Pharmaceuticals. "This study adds to the body of data discussing Acthar," said Steve Romano, MD, Senior Vice President and Chief Scientific Officer of Mallinckrodt. "We are committed to further clinical investment in MS relapse research, a critically important aspect of managing this disease." "Managing relapses is a central concern for the overall management of MS, yet there are few studies that compare these three treatment options for multiple relapses," said Principal Investigator Ryan Hansen, Pharm.D., Ph.D., Research Assistant Professor of Pharmacy and Health Services (adjunct) at the University of Washington. "Data such as this from real-life settings can help guide decision making among health care professionals." The cohort analysis titled, "Health Care Costs and Resource Utilization in Multiple Sclerosis Relapse Patients," aimed to describe and generate hypotheses related to health care utilization, outcomes and costs among patients with MS who experienced multiple relapses. Researchers reviewed 12- and 24-month health care utilization and costs among patients who received Acthar (n=213 and n=96, respectively) compared to patients who were treated with PMP/IVIG (n=226 and n=132, respectively), in a commercially insured U.S. population. Claims data from the Truven Health Analytics MarketScan® Commercial Claims and Encounters Databases were examined between July 1, 2007, to Dec. 31, 2012, for the 12-month analyses or through Dec. 31, 2011, for the 24-month analyses. Patients in both the 12- and 24-month analyses were followed for outcomes until Dec. 31, 2013. Findings from this retrospective, observational study among MS patients include:
Limitations of the Study
The manuscript can be accessed here. About MS MS is neurologic disorder that affects the central nervous system (i.e., the brain and spinal cord).[1] Symptoms can include fatigue, balance/coordination issues, numbness or tingling, vision problems, muscle spasms, tremors and emotional changes.4 More than eight in 10 people with MS will experience a relapse, or flare-up, that brings new or worsening symptoms.[2] About MS Relapse MS is an autoimmune disorder with large annual costs.[3] On average, annual direct health care costs for MS patients have been shown to be about $24,000 higher compared to the non-MS population.[4] Relapses are one of the major drivers of increased costs,1 along with disease-modifying therapies (DMTs) designed to reduce inflammation and the risk of subsequent relapses.[5],[6] The U.S. Food and Drug Administration (FDA) approved Acthar for the treatment of MS relapse in 1978. The safety and efficacy of Acthar for MS relapse was established in a randomized, double-blind, placebo-controlled multi-centered trial with 197 patients.[7] About H.P. Acthar Gel (repository corticotropin injection)
The company is also exploring the possibility of developing other approved indications and the possibility of pursuing FDA approval of additional indications currently unapproved in the Acthar label where there is high unmet medical need. For more information about Acthar, please visit www.acthar.com. Full prescribing information may be accessed here. Important Safety Information
Please see full Prescribing Information here for additional important safety information. ABOUT MALLINCKRODT Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical and biopharmaceutical products and therapies, as well as nuclear imaging products. Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology and pulmonology; immunotherapy and neonatal respiratory critical care therapies; analgesics and hemostasis products; and central nervous system drugs. The company's core strengths include the acquisition and management of highly regulated raw materials and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing; and the Nuclear Imaging segment includes nuclear imaging agents. To learn more about Mallinckrodt, visit www.mallinckrodt.com. Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website. CONTACTS Media Meredith Fischer Investor Relations [1] Multiple Sclerosis Foundation. Symptoms of Multiple Sclerosis. Accessed April 19, 2016 at http://msfocus.org/Symptoms-of-Multiple-Sclerosis.aspx [2] National Multiple Sclerosis Society. Relapsing-remitting MS (RRMS). Accessed April 19, 2016 at http://www.nationalmssociety.org/What-is-MS/Types-of-MS/Relapsing-remitting-MS [3] Gold, L., Suh K., Schepman P. and Hansen, R. Healthcare Costs and Resource Utilization in Patients with Multiple Sclerosis Relapses Treated with H.P. Acthar Gel®. Advances in Therapy, June, 2016, p. 1. Available at http://link.springer.com/article/10.1007%2Fs12325-016-0363-0 [4] Gilden DM, Kubisiak J, Zbrozek AS. The economic burden of Medicare-eligible patients by multiple sclerosis type. Value Health. 14 (1), 61-69 (2011). [5] Owens GM, Olvey EL, Skrepnek GH, Pill MW. Perspectives for managed care organizations on the burden of multiple sclerosis and the cost-benefits of disease-modifying therapies. J Manag Care Pharm. 19 (1 Suppl A), S41-53 (2013). [6] Carroll CA, Fairman KA, Lage MJ. Updated cost-of-care estimates for commercially insured patients with multiple sclerosis: retrospective observational analysis of medical and pharmacy claims data. BMC Health Serv Res. 14 286 (2014). [7] Rose A., Kuzma J., Kurtzke J., Namerow N., Sibley W., Tourtellotte W. Neurology. May 1970. Vol. 5 – Part 2. Logo - http://photos.prnewswire.com/prnh/20150105/167103LOGO
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