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Older Drugs With Limited Trial Evidence: Are They Worth the Expense? The Case of Repository Corticotropin Marketed as H.P. Acthar Gel

2019; American College of Physicians; Volume: 170; Issue: 11 Linguagem: Inglês

10.7326/m18-3513

1539-3704

Alí Duarte‐García, Eric L. Matteson, Nilay D. Shah,

Health Systems, Economic Evaluations, Quality of Life

Ideas and Opinions4 June 2019Older Drugs With Limited Trial Evidence: Are They Worth the Expense? The Case of Repository Corticotropin Marketed as H.P. Acthar GelAli Duarte-García, MD, Eric L. Matteson, MD, MPH, and Nilay D. Shah, PhDAli Duarte-García, MDMayo Clinic College of Medicine and Science, Rochester, Minnesota (A.D., E.L.M., N.D.S.)Search for more papers by this author, Eric L. Matteson, MD, MPHMayo Clinic College of Medicine and Science, Rochester, Minnesota (A.D., E.L.M., N.D.S.)Search for more papers by this author, and Nilay D. Shah, PhDMayo Clinic College of Medicine and Science, Rochester, Minnesota (A.D., E.L.M., N.D.S.)Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M18-3513 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Over the past decade, substantial increases in the prices of older drugs, such as insulin, penicillamine, pyrimethamine, and repository corticotropin (rACTH), have generated controversy. However, compared with the others, rACTH—better known by its brand name, H.P. Acthar gel—has little evidence supporting its use, and the availability of cheaper alternatives, such as prednisone, makes its case worth reviewing.Repository corticotropin was developed as a byproduct of the meatpacking industry by Armour & Company in the late 1940s. It was approved by the U.S. Food and Drug Administration (FDA) in 1952 for treating inflammatory conditions after Hench and other researchers at the ...References1. Hench PS, Kendall EC, Slocumb CH, Polley HF. Effects of cortisone acetate and pituitary ACTH on rheumatoid arthritis, rheumatic fever and certain other conditions. Arch Intern Med (Chic). 1950;85:545-666. [PMID: 15411248] CrossrefMedlineGoogle Scholar2. U.S. Food and Drug Administration. Drug Approval Package. H.P. Acthar Gel (repository corticotropin) Injection. Silver Spring, MD: U.S. Food and Drug Administration; 2011. Accessed at www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022432_hp_acthar_gel_toc.cfm on 14 March 2019. Google Scholar3. Burnham TC, Huang S, Lo AW. Pricing for survival in the biopharma industry: a case study of Acthar gel and Questcor Pharmaceuticals. Journal of Investment Management. 2017;15:69-91. Google Scholar4. Pollack A. Questcor Finds Profits, at $28,000 a Vial. The New York Times. 29 December 2012. Accessed at www.nytimes.com/2012/12/30/business/questcor-finds-profit-for-acthar-drug-at-28000-a-vial.html on 15 March 2019. Google Scholar5. Questcor. Oppenheimer Healthcare Conference. 11 December 2013. Accessed at www.sec.gov/Archives/edgar/data/891288/000119312513469101/d640390dex991.htm on 14 March 2019. Google Scholar6. Hartung DM, Johnston K, Van Leuven S, Deodhar A, Cohen DM, Bourdette DN. Trends and characteristics of US Medicare spending on repository corticotropin. JAMA Intern Med. 2017;177:1680-2. [PMID: 28892525] doi:10.1001/jamainternmed.2017.3631 CrossrefMedlineGoogle Scholar7. U.S. Food and Drug Administration. Kefauver-Harris Amendments Revolutionized Drug Development. Silver Spring, MD: U.S. Food and Drug Administration; 2018. Accessed at www.fda.gov/ForConsumers/ConsumerUpdates/ucm322856.htm on 14 March 2019. Google Scholar8. Office of Enterprise Data and Analytics. Medicare Part D Drugs. CMS Dashboard. Baltimore: Centers for Medicare & Medicaid Services. Accessed at https://portal.cms.gov/wps/portal/unauthportal/unauthmicrostrategyreportslink?evt=2048001&src=mstrWeb.2048001&documentID=203D830811E7EBD800000080EF356F31&visMode=0¤tViewMedia=1&Server=E48V126P&Project=OIPDA-BI_Prod&Port=0&connmode=8&ru=1&share=1&hiddensections=header,path,dockTop,dockLeft,footer on 14 March 2019. Google Scholar9. Ornstein C. The Obscure Drug With a Growing Medicare Tab. ProPublica. 4 August 2014. Accessed at www.propublica.org/article/the-obscure-drug-with-a-growing-medicare-tab on 15 March 2019. Google Scholar10. Mallinckrodt Pharmaceuticals. Facts About Acthar Gel®. Staines-Upon-Thames, United Kingdom: Mallinckrodt Pharmaceuticals; 2019. Accessed at www.mallinckrodt.com/about/acthar on 14 March 2019. Google Scholar Author, Article, and Disclosure InformationAffiliations: Mayo Clinic College of Medicine and Science, Rochester, Minnesota (A.D., E.L.M., N.D.S.)Financial Support: Dr. Duarte-García is supported by the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, which receives no industry funding.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M18-3513.Corresponding Author: Ali Duarte-García, MD, Division of Rheumatology, Mayo Clinic, 200 First Street SW, Rochester, MN 55905; e-mail, duarte.[email protected]edu.Current Author Addresses: Drs. Duarte-García and Matteson: Division of Rheumatology, Mayo Clinic, 200 First Street SW, Rochester, MN 55905.Dr. Shah: Division of Health Care Policy and Research, Mayo Clinic, 200 First Street SW, Rochester, MN 55905.Author Contributions: Conception and design: A. Duarte-García, E.L. Matteson.Analysis and interpretation of the data: E.L. Matteson, N.D. Shah.Drafting of the article: A. Duarte-García, E.L. Matteson.Critical revision of the article for important intellectual content: A. Duarte-García, E.L. Matteson, N.D. Shah.Final approval of the article: A. Duarte-García, E.L. Matteson, N.D. Shah.Administrative, technical, or logistic support: N.D. Shah.This article was published at Annals.org on 7 May 2019. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoOlder Drugs With Limited Trial Evidence: Are They Worth the Expense? Daniel M. Hartung , David M. Cohen , Atul Deodhar , and Dennis N. Bourdette Older Drugs With Limited Trial Evidence: Are They Worth the Expense? Maarten Boers Older Drugs With Limited Trial Evidence: Are They Worth the Expense? Ali Duarte-García , Eric L. Matteson , and Nilay D. 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Bourdette, MD 4 June 2019Volume 170, Issue 11Page: 791-792KeywordsAdrenocorticotropic hormoneDrug safetyDrugsLupus erythematosusMedicarePsoriatic arthritisRheumatoid arthritisRheumatologySafety ePublished: 28 May 2019 Issue Published: 4 June 2019 Copyright & PermissionsCopyright © 2019 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...