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DEFINING INNOVATION WITH RESPECT TO NEW MEDICINES: A SYSTEMATIC REVIEW FROM A PAYER PERSPECTIVE

Published online by Cambridge University Press:  10 July 2018

Oriol de Solà-Morales
Affiliation:
Health Innovation Technology Transfer (HITT)osola@hittinnova.com
David Cunningham
Affiliation:
Independent Consultant
Mathias Flume
Affiliation:
Kassenärztliche Vereinigung Westfalen Lippe
Paul M. Overton
Affiliation:
Beacon Medical Communications
Natalie Shalet
Affiliation:
NAS Healthcare Solutions
Stefano Capri
Affiliation:
School of Economics and Management, LIUC University
Corresponding
E-mail address:

Abstract

Objectives:

The aim of this study was to investigate how innovation is defined with respect to new medicines.

Methods:

MEDLINE, Embase, and EconLit databases were searched for articles published between January 1, 2010 and May 25, 2016 that described a relevant definition of innovation. Identified definitions were analyzed by mapping the concepts described onto a set of ten dimensions of innovation.

Results:

In total, thirty-six articles were included, and described a total of twenty-five different definitions of innovation. The most commonly occurring dimension was therapeutic benefit, with novelty and the availability of existing treatments the second and third most common dimensions. Overall, there was little agreement in the published literature on what characteristics of new medicines constitute rewardable innovation.

Conclusions:

Alignment across countries and among regulators, health technology assessment bodies and payers would help manufacturers define research policies that can drive innovation, but may be challenging, as judgements about what aspects of innovation should be rewarded vary among stakeholders, and depend on political and societal factors.

Type
Policy
Copyright
Copyright © Cambridge University Press 2018 

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Footnotes

All authors designed the study, analyzed the results, reviewed all draft versions of the manuscript, and approved the final version for submission. Paul Overton conducted the systematic review and wrote the manuscript. The authors thank the other members of the AGORA Think Tank for helpful discussions during this work. This work was supported by Novartis Pharma AG (Basel, Switzerland) under the AGORA initiative (Advisory Group On Reimbursement and Access, a European Think Tank which aims to optimize access for patients to innovative treatments).

References

1.London School of Economics. Tender loving care? Purchasing medicines for continuing therapeutic improvement and better health outcomes. 2016. http://eprints.lse.ac.uk/67824/ (accessed November 16, 2016).Google Scholar
2.Schnipper, LE, Bastian, A. New frameworks to assess value of cancer care: Strengths and limitations. Oncologist. 2016;21:654658.CrossRefGoogle ScholarPubMed
3.Schnipper, LE, Davidson, NE, Wollins, DS, et al. American Society of Clinical Oncology Statement: A conceptual framework to assess the value of cancer treatment options. J Clin Oncol. 2015;33:25632577.CrossRefGoogle ScholarPubMed
4.Cherny, NI, Sullivan, R, Dafni, U, et al. A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: The European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). Ann Oncol. 2015;26:15471573.CrossRefGoogle Scholar
5.Cox, C, Kamal, R, Jankiewicz, A, et al. Recent trends in prescription drug costs. JAMA. 2016;315:1326.CrossRefGoogle Scholar
6.Penington, R, Stubbings, JA. Evaluation of specialty drug price trends using data from retrospective pharmacy sales transactions. J Manag Care Spec Pharm. 2016;22:10101017.Google ScholarPubMed
7.Aronson, JK, Ferner, RE, Hughes, DA. Defining rewardable innovation in drug therapy. Nat Rev Drug Discov. 2012;11:253255.CrossRefGoogle ScholarPubMed
8.Claxton, K, Martin, S, Soares, M, et al. Methods for the estimation of the National Institute for Health and Care Excellence cost-effectiveness threshold. Health Technol Assess. 2015;19:1503.CrossRefGoogle ScholarPubMed
9.McCabe, C, Bergmann, L, Bosanquet, N, et al. Market and patient access to new oncology products in Europe: A current, multidisciplinary perspective. Ann Oncol. 2009;20:403412.CrossRefGoogle ScholarPubMed
10.Buxton, MJ, Chambers, JD. What values do the public want their health care systems to use in evaluating technologies? Eur J Health Econ. 2011;12:285288.CrossRefGoogle ScholarPubMed
11.Kesselheim, AS, Wang, B, Avorn, J. Defining innovativeness in drug development: A systematic review. Clin Pharmacol Ther. 2013;94:336348.CrossRefGoogle ScholarPubMed
12.Andria, B, Auriemma, L, Attanasio, C, et al. The impact of innovation for biotech drugs: An Italian analysis of products licensed in Europe between 2004 and 2011. Eur J Hosp Pharm. 2013;20:328335.CrossRefGoogle Scholar
13.Mol, PGM, Arnardottir, AH, Motola, D, et al. Post-approval safety issues with innovative drugs: A European cohort study. Drug Safety. 2013;36:11051115.CrossRefGoogle ScholarPubMed
14.Motola, D, De Ponti, F, Rossi, P, et al. Therapeutic innovation in the European Union: Analysis of the drugs approved by the EMEA between 1995 and 2003. Br J Clin Pharmacol. 2005;59:475478.CrossRefGoogle ScholarPubMed
15.Motola, D, De Ponti, F, Poluzzi, E, et al. An update on the first decade of the European centralized procedure: How many innovative drugs? Br J Clin Pharmacol. 2006;62:610616.CrossRefGoogle ScholarPubMed
16.Bryan, S, Lee, H, Mitton, C. ‘Innovation’ in health care coverage decisions: All talk and no substance? J Health Serv Res Policy. 2013;18:5760.CrossRefGoogle ScholarPubMed
17.Green, C. Considering the value associated with innovation in health technology appraisal decisions (deliberations): A NICE thing to do? Appl Health Econ Health Policy. 2010;8:15.CrossRefGoogle ScholarPubMed
18.Ferner, RE, Hughes, DA, Aronson, JK. NICE and new: Appraising innovation. BMJ. 2010;340:b5493.CrossRefGoogle ScholarPubMed
19.Linley, WG, Hughes, DA. Societal views on NICE, cancer drugs fund and value-based pricing criteria for prioritising medicines: A cross-sectional survey of 4118 adults in Great Britain. Health Econ. 2013;22:948964.CrossRefGoogle ScholarPubMed
20.Rawlins, M, Barnett, D, Stevens, A. Pharmacoeconomics: NICE's approach to decision-making. Br J Clin Pharmacol. 2010;70:346349.CrossRefGoogle ScholarPubMed
21.Heible, C. Pharmacologic-technical progress and the economics of growth. Pharm Policy Law. 2013;15:103125.Google Scholar
22.Sorescu, AB, Chandy, RK, Prabhu, JC. Sources and financial consequences of radical innovation: Insights from pharmaceuticals. J Mark. 2003;67:82102.CrossRefGoogle Scholar
23.Sternitzke, C. Knowledge sources, patent protection, and commercialization of pharmaceutical innovations. Res Policy. 2010;39:810821.CrossRefGoogle Scholar
24.Adami, S, Ciampalini, S, Dell'Aera, M, et al. Defining innovations of therapeutic interventions: A position paper by the Italian Society of Hospital Pharmacists. Int J Clin Pharm. 2012;34:259262.CrossRefGoogle ScholarPubMed
25.Alexander, GC, O'Connor, AB, Stafford, RS. Enhancing prescription drug innovation and adoption. Ann Intern Med. 2011;154:833837.CrossRefGoogle ScholarPubMed
26.Barbui, C, Cipriani, A, Lintas, C, et al. CNS drugs approved by the centralised European procedure: True innovation or dangerous stagnation? Psychopharmacology (Berl). 2007;190:265268.CrossRefGoogle ScholarPubMed
27.Caprino, L, Russo, P. Developing a paradigm of drug innovation: An evaluation algorithm. Drug Discov Today. 2006;11:9991006.CrossRefGoogle Scholar
28.Gonzalez, SS, Hofer, JM. FDA's “Breakthrough” drug therapy designation: A real regulatory breakthrough for innovations? Part 1. Pharm Ind. 2015;77:801808.Google Scholar
29.Gridchyna, I, Aulois-Griot, M, Maurain, C, Bégaud, B. How innovative are pharmaceutical innovations? The case of medicines financed through add-on payments outside of the French DRG-based hospital payment system. Health Policy. 2012;104:69–75.CrossRefGoogle ScholarPubMed
30.Erice statement on drug innovation. Br J Clin Pharmacol. 2008;65:440441.CrossRefGoogle Scholar
31.Joppi, R, Bertele, V, Garattini, S. Disappointing biotech. BMJ. 2005;331:895897.CrossRefGoogle ScholarPubMed
32.Kwong, WJ, Norton, EC. The effect of advertising on pharmaceutical innovation. Rev Ind Organ. 2007;31:221236.CrossRefGoogle Scholar
33.Lexchin, J. International comparison of assessments of pharmaceutical innovation. Health Policy. 2012;105:221225.CrossRefGoogle ScholarPubMed
34.Morgan, S, Lopert, R, Greyson, D. Toward a definition of pharmaceutical innovation. Open Med. 2008;2:e4-e7.Google Scholar
35.O'Connor, DJ, McDonald, K, Lam, SP. A regulator's guide to the UK early access to medicines scheme. Regul Rapp. 2016;13:1013.Google Scholar
36.Petrini, C. Innovative therapies: General aspects and ethical criteria for evaluating protocols. Clin Ter. 2013;164:e53-e61.Google ScholarPubMed
37.Puntmann, I, Schmacke, N, Melander, A, et al. EVITA: A tool for the early evaluation of pharmaceutical innovations with regard to therapeutic advantage. BMC Clin Pharmacol. 2010;10:5.CrossRefGoogle ScholarPubMed
38.Raymond, AS. EMA initiatives for innovation. Pharm Policy Law. 2010;12:1518.Google Scholar
39.Salter, B, Zhou, Y, Datta, S. Hegemony in the marketplace of biomedical innovation: Consumer demand and stem cell science. Soc Sci Med. 2015;131:156163.CrossRefGoogle ScholarPubMed
40.Soleimani, F, Zenios, S. Disrupting incrementalism in health care innovation. Ann Surg. 2011;254:203208.CrossRefGoogle ScholarPubMed
41.Wardell, WM, DiRaddo, J. The measurement of pharmaceutical innovation. J Clin Pharmacol. 1980;20:19.CrossRefGoogle ScholarPubMed
42.Nelson, AL, Cohen, JT, Greenberg, D, Kent, DM. Much cheaper, almost as good: Decrementally cost-effective medical innovation. Ann Intern Med. 2009;151:662667.CrossRefGoogle ScholarPubMed
43.Cadranel, J, Créquit, P, Vieira, T, et al. How to provide an equal access to innovative therapies? Rev Mal Respir Actualites. 2015;7:462475.Google Scholar
44.Gonçalves, A, Maraninchi, D, Marino, P. Anticancer drugs: Which prices for therapeutic innovations? Bull Cancer. 2016;103:361367.CrossRefGoogle ScholarPubMed
45.Autret-Leca, E. Most innovative drugs labelled during the last years in paediatrics: Does the paediatrician have the tools for their identification? Arch Pediatr. 2010;17:12371242.CrossRefGoogle ScholarPubMed
46.Agenzia Italiana del Farmaco. Criteria for ranking therapeutic innovation of new drugs. 2007. http://www.agenziafarmaco.gov.it/allegati/integral_document.pdf (accessed August 19, 2016).Google Scholar
47.National Institute of Health and Care Excellence. Guide to the methods of technology appraisal. 2013. https://www.nice.org.uk/process/pmg9/resources/guide-to-the-methods-of-technology-appraisal-2013-pdf-2007975843781 (accessed August 19 2016).Google Scholar
48.National Institute of Health and Care Excellence. Single technology appraisal: User guide for company evidence submission template. 2015. https://www.nice.org.uk/process/pmg24/resources/single-technology-appraisal-user-guide-for-company-evidence-submission-template-pdf-72286715419333 (accessed August 19, 2016).Google Scholar
49.Haute Autorité de Santé. Methods for health economic evaluation. 2012. http://www.has-sante.fr/portail/jcms/c_2035665/en/methods-for-health-economic-evaluation (accessed August 19, 2016).Google Scholar
50.Tandvårds- och läkemedelsförmånsverket. Health Economics evaluations of medical devices 2015. http://www.tlv.se/Upload/Medicinteknik/Slutrapport_medicinteknik_151221.pdf (accessed August 19, 2016).Google Scholar
51.Scottish Medicines Consortium. What we do now and how could we accommodate innovation concepts? 2012. https://www.ispor.org/congresses/Berlin1112/presentations/Ailsa-Brown-Galbraith-Wight.pdf (accessed August 19, 2016).Google Scholar
54.Berwick, DM. Disseminating innovations in health care. JAMA. 2003;289:19691975.CrossRefGoogle ScholarPubMed
55.Schlander, M, Garattini, S, Kolominsky-Rabas, P, et al. Determining the value of medical technologies to treat ultra-rare disorders: A consensus statement. J Mark Access Health Policy. 2016. doi:10.3402/jmahp.v4.33039.CrossRefGoogle ScholarPubMed
56.Toumi, M, Jadot, G. Economic impact of new active substance status on EU payers’ budgets: Example of dimethyl fumarate (Tecfidera®) for multiple sclerosis. J Mark Access Health Policy. 2014. doi:10.3402/jmahp.v2.23932.CrossRefGoogle ScholarPubMed

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