Portal de Periódicos da CAPES

Outcomes-Based Pricing as a Tool to Ensure Access to Novel but Expensive Biopharmaceuticals

2016; American College of Physicians; Volume: 166; Issue: 3 Linguagem: Inglês

10.7326/m16-1847

1539-3704

Daniel M. Blumenthal, Dana P. Goldman, Anupam B. Jena,

Pharmaceutical industry and healthcare

Ideas and Opinions7 February 2017Outcomes-Based Pricing as a Tool to Ensure Access to Novel but Expensive BiopharmaceuticalsDaniel M. Blumenthal, MD, MBA, Dana P. Goldman, PhD, and Anupam B. Jena, MD, PhDDaniel M. Blumenthal, MD, MBAFrom Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, and Leonard D. Schaeffer Center for Health Policy and Economics, University of Southern California, Los Angeles, California., Dana P. Goldman, PhDFrom Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, and Leonard D. Schaeffer Center for Health Policy and Economics, University of Southern California, Los Angeles, California., and Anupam B. Jena, MD, PhDFrom Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, and Leonard D. Schaeffer Center for Health Policy and Economics, University of Southern California, Los Angeles, California.Author, Article, and Disclosure Informationhttps://doi.org/10.7326/M16-1847 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail In many areas of health care, insurers are increasingly tying reimbursement to patient outcomes to promote accountability for care. However, biopharmaceuticals have largely been divorced from these efforts, despite their growing use and high costs. This model must change for 2 reasons. First, there is a wave of new biopharmaceuticals to treat common, costly chronic diseases; second, there is uncertainty about their real-world efficacy. Without new pricing models, insurers and manufacturers will remain at odds about reimbursement, leaving physicians and patients stuck in the middle.Perhaps nowhere is this issue more salient than with proprotein convertase subtilisin/kexin type 9 (PCSK9) ...References1. Jena AB, Blumenthal DM, Stevens W, Chou JW, Ton TG, Goldman DP. Value of improved lipid control in patients at high risk for adverse cardiac events. Am J Manag Care. 2016;22:e199-207. [PMID: 27355907] MedlineGoogle Scholar2. Navarese EP, Kolodziejczak M, Schulze V, Gurbel PA, Tantry U, Lin Y, et al. Effects of proprotein convertase subtilisin/kexin type 9 antibodies in adults with hypercholesterolemia: a systematic review and meta-analysis. Ann Intern Med. 2015;163:40-51. [PMID: 25915661]. doi:10.7326/M14-2957 LinkGoogle Scholar3. Everett BM, Smith RJ, Hiatt WR. Reducing LDL with PCSK9 inhibitors—the clinical benefit of lipid drugs. N Engl J Med. 2015;373:1588-91. [PMID: 26444323] doi:10.1056/NEJMp1508120 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. Shrank W, Lotvin A, Singh S, Brennan T. In the debate about cost and efficacy, PCSK9 inhibitors may be the biggest challenge yet. Health Affairs Blog. 17 February 2015. Accessed at http://healthaffairs.org/blog/2015/02/17/in-the-debate-about-cost-and-efficacy-pcsk9-inhibitors-may-be-the-biggest-challenge-yet on 1 November 2016. Google Scholar6. Humer C, Pierson R. Express Scripts sees slow 2016 sales for new cholesterol drugs. Thomson Reuters. 12 February 2016. Accessed at www.reuters.com/article/us-express-scr-cholesteroldrugs-idUSKCN0VL2AX on 1 November 2016. Google Scholar7. Adamski J, Godman B, Ofierska-Sujkowska G, Osinska B, Herholz H, Wendykowska K, et al. Risk sharing arrangements for pharmaceuticals: potential considerations and recommendations for European payers. BMC Health Serv Res. 2010;10:153. [PMID: 20529296] doi:10.1186/1472-6963-10-153 CrossrefMedlineGoogle Scholar8. Khera AV, Won HH, Peloso GM, Lawson KS, Bartz TM, Deng X, et al. Diagnostic yield and clinical utility of sequencing familial hypercholesterolemia genes in patients with severe hypercholesterolemia. J Am Coll Cardiol. 2016;67:2578-89. [PMID: 27050191] doi:10.1016/j.jacc.2016.03.520 CrossrefMedlineGoogle Scholar9. Neumann PJ, Chambers JD, Simon F, Meckley LM. Risk-sharing arrangements that link payment for drugs to health outcomes are proving hard to implement. Health Aff (Millwood). 2011;30:2329-37. [PMID: 22147861] doi:10.1377/hlthaff.2010.1147 CrossrefMedlineGoogle Scholar10. Weisman R. Harvard Pilgrim strikes "pay-for-performance" deal for cholesterol drug. The Boston Globe. 8 November 2015. Google Scholar Author, Article, and Disclosure InformationAffiliations: From Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, and Leonard D. Schaeffer Center for Health Policy and Economics, University of Southern California, Los Angeles, California.Note: Dr. Goldman is founder of, and Drs. Jena and Blumenthal are external consultants at, Precision Health Economics, a company providing consulting services to the life sciences industry. A prior study of PCSK9 inhibitors, conducted by the authors, was funded by Precision Health Economics through a grant from Amgen. No compensation was provided by the life sciences industry for the current work.Grant Support: By the Office of the Director, National Institutes of Health (NIH Early Independence Award, grant 1DP5OD017897-01; Dr. Jena), and the National Institute on Aging (grant 5P01AG033559; Dr. Goldman).Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M16-1847.Corresponding Author: Anupam B. Jena, MD, PhD, Department of Health Care Policy, Harvard Medical School, 180 Longwood Avenue, Boston, MA 02115; e-mail, [email protected]med.harvard.edu.Current Author Addresses: Dr. Blumenthal: Massachusetts General Hospital, Cardiology Division, 55 Fruit Street, Yawkey Building, Suite 5B, Boston, MA 02114.Dr. Goldman: Leonard D. Schaeffer Center for Health Policy and Economics, University of Southern California, 650 Childs Way, RGL 214, Los Angeles, CA 90089.Dr. Jena: Department of Health Care Policy, Harvard Medical School, 180 Longwood Avenue, Boston, MA 02115.Author Contributions: Conception and design: D.M. Blumenthal, D.P. Goldman, A.B. Jena.Analysis and interpretation of the data: D.M. Blumenthal, A.B. Jena.Drafting of the article: D.M. Blumenthal, D.P. Goldman, A.B. Jena.Critical revision of the article for important intellectual content: D.M. Blumenthal, D.P. Goldman, A.B. Jena.Final approval of the article: D.M. Blumenthal, D.P. Goldman, A.B. Jena.Obtaining of funding: A.B. Jena.Administrative, technical, or logistic support: A.B. Jena.Collection and assembly of data: A.B. Jena.This article was published at Annals.org on 13 December 2016. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics Cited byPredictors of PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) Inhibitor Prescriptions for Secondary Prevention of Clinical Atherosclerotic Cardiovascular DiseaseThe economics of alternative payment models for pharmaceuticalsValue-based Pricing for Rifaximin Increases Access of Patients With Irritable Bowel Syndrome With Diarrhea to TherapyEffect 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, MASInsulin Access and Affordability Working Group: Conclusions and RecommendationsWhy Are Diabetes Medications So Expensive and What Can Be Done to Control Their Cost? 7 February 2017Volume 166, Issue 3Page: 219-220KeywordsAtherosclerotic cardiovascular diseaseBiomarkersClinical trialsDrugsHealth careHealth economicsHospitalizationsHyperlipidemiaPatientsStatins ePublished: 13 December 2016 Issue Published: 7 February 2017 Copyright & PermissionsCopyright © 2016 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...