Money-Back Guarantees for Expensive Drugs: Wolf's Clothing but a Sheep Underneath
Authors: Sham Mailankody, Peter B. Bach
Journal: Annals of Internal Medicine (2018)

Editorials19 June 2018Money-Back Guarantees for Expensive Drugs: Wolf's Clothing but a Sheep UnderneathSham Mailankody, MBBS and Peter B. Bach, MDSham Mailankody, MBBSMemorial Sloan Kettering Cancer Center, New York, New York (S.M., P.B.B.)Search for more papers by this author and Peter B. Bach, MDMemorial Sloan Kettering Cancer Center, New York, New York (S.M., P.B.B.)Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M18-0539 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Prices of branded specialty drugs are often far higher than they would be if they were based on their benefits. The pharmaceutical industry thus has a plan called outcomes-based contracting that involves refunds when a patient does not experience the intended therapeutic benefit. Kazi and colleagues' (1) rigorous analysis shows that, at least in the case of Amgen's money-back guarantee for its lipid-lowering drug evolocumab, this approach really does not solve much (2).Kazi and colleagues compare the incremental cost-effectiveness ratio for baseline statin therapy with that for baseline therapy plus ezetimibe or evolocumab in adults with atherosclerotic cardiovascular disease. ...References1. Kazi DS, Penko J, Ollendorf DA, Coxson PG, Bibbins-Domingo K. Effect of money-back guarantees on the cost-effectiveness of proprotein convertase subtilisin/kexin type 9 inhibitors. Ann Intern Med. 2018;168:896-8. doi:10.7326/M17-2441 LinkGoogle Scholar2. Amgen and Harvard Pilgrim agree to first cardiovascular outcomes-based refund contract for Repatha (evolocumab) [press release]. Thousand Oaks, CA: Amgen; 2 May 2017. Accessed at www.amgen.com/media/news-releases/2017/05/amgen-and-harvard-pilgrim-agree-to-first-cardiovascular-outcomesbased-refund-contract-for-repatha-evolocumab on 19 March 2018. Google Scholar3. Kazi DS, Penko J, Coxson PG, Moran AE, Ollendorf DA, Tice JA, et al. Updated cost-effectiveness analysis of PCSK9 inhibitors based on the results of the FOURIER trial. JAMA. 2017;318:748-50. [PMID: 28829863] doi:10.1001/jama.2017.9924 CrossrefMedlineGoogle Scholar4. Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, et al; FOURIER Steering Committee and Investigators. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017;376:1713-22. [PMID: 28304224] doi:10.1056/NEJMoa1615664 CrossrefMedlineGoogle Scholar5. Kaltenboeck A, Bach P. Outcomes-based drug contracts do not move us closer to value. Morning Consult. 21 June 2017. Accessed at https://morningconsult.com/opinions/outcomes-based-drug-contracts-not-move-us-closer-value on 19 March 2018. Google Scholar6. Bach PB, Giralt SA, Saltz LB. FDA approval of tisagenlecleucel: promise and complexities of a $475 000 cancer drug. JAMA. 2017;318:1861-2. [PMID: 28975266] doi:10.1001/jama.2017.15218 CrossrefMedlineGoogle Scholar7. Fox J, Watrous M. Overcoming challenges of outcomes-based contracting for pharmaceuticals: early lessons from the Genentech–Priority Health pilot. Health Affairs Blog. 3 April 2017. Accessed at www.healthaffairs.org/do/10.1377/hblog20170403.059442/full on 19 March 2018. Google Scholar8. Williamson S. Patient access schemes for high-cost cancer medicines [Letter]. Lancet Oncol. 2010;11:111-2. [PMID: 20152762] doi:10.1016/S1470-2045(09)70402-4 CrossrefMedlineGoogle Scholar9. Boggild M, Palace J, Barton P, Ben-Shlomo Y, Bregenzer T, Dobson C, et al. Multiple sclerosis risk sharing scheme: two year results of clinical cohort study with historical comparator. BMJ. 2009;339:b4677. [PMID: 19955128] doi:10.1136/bmj.b4677 CrossrefMedlineGoogle Scholar10. Blumenthal D, Linthicum M, Kamal-Bahl S. Strategies to address the challenges of outcomes-based pricing agreements for pharmaceuticals. Health Affairs Blog. 3 April 2017. Accessed at www.healthaffairs.org/do/10.1377/hblog20170403.059449/full on 19 March 2018. Google Scholar Author, Article, and Disclosure InformationAffiliations: Memorial Sloan Kettering Cancer Center, New York, New York (S.M., P.B.B.)Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M18-0539.Corresponding Author: Peter B. Bach, MD, Center for Health Policy and Outcomes and Department of Medicine, Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, New York, NY 10017; e-mail, [email protected]org.Current Author Addresses: Dr. Bach: Center for Health Policy and Outcomes and Department of Medicine, Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, New York, NY 10017.Dr. Mailankody: Department of Medicine, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY 10065.This article was published at Annals.org on 3 April 2018. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoEffect of Money-Back Guarantees on the Cost-Effectiveness of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors Dhruv S. Kazi , Joanne Penko , Daniel A. Ollendorf , Pamela G. Coxson , and Kirsten Bibbins-Domingo Metrics Cited byBarriers and Opportunities for Implementation of Outcome-Based Spread Payments for High-Cost, One-Shot Curative TherapiesPricing methods in outcome-based contracting: δ1: cost effectiveness analysis and cost-utility analysis-based pricingPaying For Value From Costly Medical Technologies: A Framework For Applying Value-Based Payment ReformsThe Effect of Money-Back Guarantee and Customer Value on Dual-Channel Supply ChainWhat Can Cost-Effectiveness Analysis Tell Us About Chimeric Antigen Receptor T-Cell Therapy for Relapsed Acute Lymphoblastic Leukemia?CE not improved by outcomes-based pricing 19 June 2018Volume 168, Issue 12Page: 888-889KeywordsCardiovascular therapyDisclosureDrug marketingDrug pricesDrugsMyocardial infarctionNon small cell lung cancerPrecursor cellsStatinsT cell receptors ePublished: 3 April 2018 Issue Published: 19 June 2018 Copyright & PermissionsCopyright © 2018 by American College of Physicians. 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