Effect of Money-Back Guarantees on the Cost-Effectiveness of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors
Authors: Dhruv S. Kazi, Joanne Penko, Daniel A. Ollendorf, Pamela G. Coxson, Kirsten Bibbins-Domingo
Journal: Annals of Internal Medicine (2018)

Letters19 June 2018Effect of Money-Back Guarantees on the Cost-Effectiveness of Proprotein Convertase Subtilisin/Kexin Type 9 InhibitorsDhruv S. Kazi, MD, MSc, MS, Joanne Penko, MS, MPH, Daniel A. Ollendorf, PhD, Pamela G. Coxson, PhD, and Kirsten Bibbins-Domingo, PhD, MD, MASDhruv S. Kazi, MD, MSc, MSUniversity of California, San Francisco, San Francisco, California (D.S.K., J.P., P.G.C., K.B.)Search for more papers by this author, Joanne Penko, MS, MPHUniversity of California, San Francisco, San Francisco, California (D.S.K., J.P., P.G.C., K.B.)Search for more papers by this author, Daniel A. Ollendorf, PhDInstitute for Clinical and Economic Review, Boston, Massachusetts (D.A.O.)Search for more papers by this author, Pamela G. Coxson, PhDUniversity of California, San Francisco, San Francisco, California (D.S.K., J.P., P.G.C., K.B.)Search for more papers by this author, and Kirsten Bibbins-Domingo, PhD, MD, MASUniversity of California, San Francisco, San Francisco, California (D.S.K., J.P., P.G.C., K.B.)Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M17-3367 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Background: Outcomes-based pricing has been proposed as an alternative to cost-control tools, such as prior authorization and step therapy for new, high-priced drugs (1). Shared financial risk between manufacturer and payer is believed to improve access for patients who respond to therapy while discouraging uptake among nonresponders, thus improving overall cost-effectiveness. For example, the manufacturer of a high-priced therapy for multiple myeloma offers refunds for patients who do not respond to the drug, effectively lowering its price (1). Outcomes-based pricing was recently offered for proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors (2), lipid-lowering agents that reduce risk for myocardial infarction ...References1. Blumenthal DM, Goldman DP, Jena AB. Outcomes-based pricing as a tool to ensure access to novel but expensive biopharmaceuticals. Ann Intern Med. 2017;166:219-20. [PMID: 27951598]. doi:10.7326/M16-1847 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 10 June 2017. 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. Kazi DS, Moran AE, Coxson PG, Penko J, Ollendorf DA, Pearson SD, et al. Cost-effectiveness of PCSK9 inhibitor therapy in patients with heterozygous familial hypercholesterolemia or atherosclerotic cardiovascular disease. JAMA. 2016;316:743-53. [PMID: 27533159] doi:10.1001/jama.2016.11004 CrossrefMedlineGoogle Scholar5. 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 Scholar Author, Article, and Disclosure InformationAffiliations: University of California, San Francisco, San Francisco, California (D.S.K., J.P., P.G.C., K.B.)Institute for Clinical and Economic Review, Boston, Massachusetts (D.A.O.)Disclaimer: Dr. Ollendorf is an employee of the Institute for Clinical and Economic Review, an independent organization that evaluates the evidence on the value of health care interventions that is funded by grants from the Laura and John Arnold Foundation, Blue Shield of California Foundation, and the California Healthcare Foundation. The organization's annual summit is supported by dues from Aetna, America's Health Insurance Plans, Anthem, Blue Shield of California, CVS Caremark, Express Scripts, Harvard Pilgrim Health Care, OmedaRx, United Healthcare, Kaiser Permanente, Premera Blue Cross, AstraZeneca, Genentech, GlaxoSmithKline, Johnson & Johnson, Merck, National Pharmaceutical Council, Takeda, Pfizer, Novartis, Eli Lilly, and Humana. Research materials from the Framingham Heart Study cohort and Framingham Offspring Study were obtained from the National Heart, Lung, and Blood Institute Biologic Specimen and Data Repository Information Coordinating Center. This article does not necessarily reflect the opinions or views of the Framingham Heart Study cohort, Framingham Offspring Study, or National Heart, Lung, and Blood Institute.Financial Support: By the University of California, San Francisco. The funding source had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M17-3367.Reproducible Research Statement:Study protocol: Not available. Statistical code: The Cardiovascular Disease Policy Model is available to interested readers who submit a 1- to 2-page research proposal and collaboration plan to Dr. Bibbins-Domingo (e-mail, kirsten.[email protected]edu) and sign the Creative Commons agreement available at http://tiny.ucsf.edu/CVDpolicymodel, pending approval by the model team. Data set: Data for this study come from sources detailed in the Supplement (available at http://tiny.ucsf.edu/CVDpolicymodel). Data from the Framingham Heart Study are available following approval of research applications submitted at http://biolincc.nhlbi.nih.gov/studies/framcohort/?q=framingham for the Framingham Heart Study cohort and http://biolincc.nhlbi.nih.gov/studies/framoffspring/?q=framingham for the Framingham Offspring Study. Data on the health survey, vital statistics, and health care costs are publicly available from government sources described in the Supplement (available at http://tiny.ucsf.edu/CVDpolicymodel).This article was published at Annals.org on 3 April 2018. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoMoney-Back Guarantees for Expensive Drugs: Wolf's Clothing but a Sheep Underneath Sham Mailankody and Peter B. 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Bach, MDCE not improved by outcomes-based pricing 19 June 2018Volume 168, Issue 12Page: 896-898KeywordsAtherosclerotic cardiovascular diseaseDrugsHealth careHealth economicsHealth insuranceInformation storage and retrievalLongitudinal studiesMyocardial infarctionQuality adjusted life yearsStatins ePublished: 3 April 2018 Issue Published: 19 June 2018 Copyright & PermissionsCopyright © 2018 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...