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HEALTH TECHNOLOGY PERFORMANCE ASSESSMENT: REAL-WORLD EVIDENCE FOR PUBLIC HEALTHCARE SUSTAINABILITY

Published online by Cambridge University Press:  23 June 2017

Augusto Afonso Guerra-Júnior
Affiliation:
SUS Collaborating Centre for Technology Assessment and Excellence in Health, Universidade Federal de Minas Gerais Department of Social Pharmacy, School of Pharmacy, Universidade Federal de Minas Gerais
Lívia Lovato Pires de Lemos
Affiliation:
SUS Collaborating Centre for Technology Assessment and Excellence in Health, Universidade Federal de Minas Gerais Post-Graduation Program in Public Health, School of Medicine, Universidade Federal de Minas Geraislilolemos@gmail.com
Brian Godman
Affiliation:
Strathclyde Institute of Pharmacy and Biomedical Sciences, Strathclyde University Division of Clinical Pharmacology, Karolinska University Hospital Huddinge, Karolinska Institutet
Marion Bennie
Affiliation:
Strathclyde Institute of Pharmacy and Biomedical Sciences, Strathclyde University
Cláudia Garcia Serpa Osorio-de-Castro
Affiliation:
Sergio Arouca National School of Public Health, Fundação Oswaldo Cruz
Juliana Alvares
Affiliation:
SUS Collaborating Centre for Technology Assessment and Excellence in Health, Universidade Federal de Minas Gerais Department of Social Pharmacy, School of Pharmacy, Universidade Federal de Minas Gerais
Aine Heaney
Affiliation:
National Prescribing Service Medicinewise
Carlos Alberto Vassallo
Affiliation:
Facultad de Ciencias Médicas, Universidad Nacional del Litoral
Björn Wettermark
Affiliation:
Public Healthcare Services Committee, Department of Healthcare Development, Stockholm County Council Department of Medicine Solna, Clinical Epidemiology/Clinical pharmacology, Karolinska Institutet and Karolinska University Hospital
Gaizka Benguria-Arrate
Affiliation:
Osteba, Basque Office for HTA Ministry for Health, Basque Government
Iñaki Gutierrez-Ibarluzea
Affiliation:
Osteba, Basque Office for HTA Ministry for Health, Basque Government
Vania Cristina Canuto Santos
Affiliation:
Department of Management and Incorporation of Technologies, Brazilian Ministry of Health
Clarice Alegre Petramale
Affiliation:
Department of Management and Incorporation of Technologies, Brazilian Ministry of Health
Fransciso de Assis Acurcio
Affiliation:
SUS Collaborating Centre for Technology Assessment and Excellence in Health, Universidade Federal de Minas Gerais Department of Social Pharmacy, School of Pharmacy, Universidade Federal de Minas Gerais For the CCATES team

Abstract

Objectives: Health technology financing is often based on randomized controlled trials (RCTs), which are often the same ones used for licensing. Because they are designed to show the best possible results, typically Phase III studies are conducted under ideal and highly controlled conditions. Consequently, it is not surprising that technologies do not always perform in real life in the same way as controlled conditions. Because financing (and price paid) decisions can be made with overestimated results, health authorities need to ask whether health systems achieve the results they expect when they choose to pay for a technology. The optimal way to answer this question is to assess the performance of financed technologies in real-world settings. Health technology performance assessment (HTpA) refers to the systematic evaluation of the properties, effects, and/or impact of a health intervention or health technology in the real world to provide information for investment/disinvestment decisions and clinical guideline updates. The objective is to describe the development and principal aspects of the Guideline for HTpA commissioned by the Brazilian Ministry of Health.

Methods: Our methods used include extensive literature review, refinement with experts across countries, and public consultation.

Results: A comprehensive guideline was developed, which has been adopted by the Brazilian government.

Conclusion: We believe the guideline, with its particular focus on disinvestment, along with the creation of a specific program for HTpA, will allow the institutionalization and continuous improvement of the scientific methods to use real-world evidence to optimize available resources not only in Brazil but across countries.

Type
Policies
Copyright
Copyright © Cambridge University Press 2017 

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References

REFERENCES

1. Paris, V, Belloni, A. Value in pharmaceutical pricing: OECD Health Working Papers, No. 63: OECD Publishing; 2013. https://doi.org/10.1787/5k43jc9v6knx-en (accessed October 15, 2015).CrossRefGoogle Scholar
2. Barnieh, L, Manns, B, Harris, A, et al. A synthesis of drug reimbursement decision-making processes in organisation for economic co-operation and development countries. Value Health. 2014;17:98-108.CrossRefGoogle ScholarPubMed
3. Tugwell, P, Knottnerus, JA. Is the ‘Evidence-Pyramid’ now dead? J Clin Epidemiol. 2015;68:1247-1250.CrossRefGoogle ScholarPubMed
4. Malmstrom, RE, Godman, BB, Diogene, E, et al. Dabigatran - A case history demonstrating the need for comprehensive approaches to optimize the use of new drugs. Front Pharmacol. 2013;4:39.Google Scholar
5. Gold, R, Kappos, L, Arnold, DL, et al. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N Engl J Med. 2012;367:1098-1107.Google Scholar
6. Joppi, R, Cinconze, E, Mezzalira, L, et al. Hospitalized patients with atrial fibrillation compared to those included in recent trials on novel oral anticoagulants: A population-based study. Eur J Intern Med. 2013;24:318-323.Google Scholar
7. Divittorio, G, Jackson, KL, Chindalore, VL, Welker, W, Walker, JB. Examining the relationship between bone mineral density and fracture risk reduction during pharmacologic treatment of osteoporosis. Pharmacotherapy. 2006;26:104-114.Google Scholar
8. Prasad, V, Kim, C, Burotto, M, Vandross, A. The strength of association between surrogate end points and survival in oncology: A systematic review of trial-level meta-analyses. JAMA Intern Med. 2015;175:1389-1398.Google Scholar
9. Svensson, S, Menkes, DB, Lexchin, J. Surrogate outcomes in clinical trials: A cautionary tale. JAMA Intern Med. 2013;173:611-612.Google Scholar
10. Henshall, C, Sansom, L, Eichler, H-G, et al. Understanding the role and evidence expectations of health technology assessment and coverage/payer bodies: What are they looking for, and how and why does this differ from what regulators require? Ther Innov Regul Sci. 2014;48:341-346.Google Scholar
11. Downing, NS, Aminawung, JA, Shah, ND, Krumholz, HM, Ross, JS. Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005–2012. JAMA. 2014;311:368-377.Google Scholar
12. Avorn, J, Kesselheim, AS. The 21st Century Cures Act–Will it take us back in time? N Engl J Med. 2015;372:2473-2475.Google Scholar
13. Anderson, ML, Chiswell, K, Peterson, ED, Tasneem, A, Topping, J, Califf, RM. Compliance with results reporting at ClinicalTrials.gov. N Engl J Med. 2015;372:1031-1039.CrossRefGoogle ScholarPubMed
14. Gafni, A, Birch, S. Incremental cost-effectiveness ratios (ICERs): The silence of the lambda. Soc Sci Med. 2006;62:2091-2100.Google Scholar
15. McCabe, C, Claxton, K, Culyer, AJ. The NICE cost-effectiveness threshold: What it is and what that means. Pharmacoeconomics. 2008;26:733-744.Google Scholar
16. Howard, DH, Bach, P, Berndt, ER, Conti, RM. Pricing in the market for anticancer drugs. J Econ Perspect. 2015;29:139-162.Google Scholar
17. Simoens, S, Picavet, E, Dooms, M, Cassiman, D, Morel, T. Cost-effectiveness assessment of orphan drugs: A scientific and political conundrum. Appl Health Econ Health Policy. 2013;11:1-3.Google Scholar
18. Raftery, JP. NICE's cost-effectiveness range: Should it be lowered? Pharmacoeconomics. 2014;32:613-615.Google Scholar
19. Ferrario, A, Kanavos, P. Managed entry agreements for pharmaceuticals: The European experience. London School of Economics and Political Science. 2013;154. http://eprints.lse.ac.uk/50513/ (accessed November 1, 2016).Google Scholar
20. Caires de Souza, AL, de Assis Acurcio, F, Guerra Junior, AA, Rezende Macedo do Nascimento, RC, Godman, B, Diniz, LM. Insulin glargine in a Brazilian state: Should the government disinvest? An assessment based on a systematic review. Appl Health Econ Health Policy. 2014;12: 19-32.Google Scholar
21. Gomes, RM, Guerra Júnior, AA, Lemos, LL, et al. Tenyear kidney transplant survival of cyclosporine- or tacrolimus-treated patients in Brazil. Expert Rev Clin Pharmacol. 2016;9:991-999.CrossRefGoogle ScholarPubMed
22. Raaschou, P, Simard, JF, Holmqvist, M, Askling, J, Group, AS. Rheumatoid arthritis, antitumour necrosis factor therapy, and risk of malignant melanoma: Nationwide population based prospective cohort study from Sweden. BMJ. 2013;346:f1939.Google Scholar
23. de Oliveira Costa, J, Almeida-Brasil, CC, Godman, B, et al. Implementation of clinical guidelines in Brazil: Should academic detailing be used? JPHSR. 2016;7:105-115.Google Scholar
24. Daniels, T, Williams, I, Robinson, S, Spence, K. Tackling disinvestment in health care services. The views of resource allocators in the English NHS. J Health Organ Manag. 2013;27:762-780.CrossRefGoogle ScholarPubMed
25. Frønsdal, KB, Facey, K, Klemp, M, Norderhaug, IN, Mørland, B, Røttingen, JA. Health technology assessment to optimize health technology utilization: Using implementation initiatives and monitoring processes. Int J Technol Assess Health Care. 2010;26:309-316.Google Scholar
26. Elshaug, AG, Moss, JR, Littlejohns, P, Karnon, J, Merlin, TL, Hiller, JE. Identifying existing health care services that do not provide value for money. Med J Aust. 2009;190:269-273.Google Scholar
27. Husereau, D, Boucher, M, Noorani, H. Priority setting for health technology assessment at CADTH. Int J Technol Assess Health Care. 2010;26:341-347.Google Scholar
28. Parkinson, B, Sermet, C, Clement, F, et al. Disinvestment and value-based purchasing strategies for pharmaceuticals: An international review. Pharmacoeconomics. 2015;33:905-924.Google Scholar
29. Ford, I, Murray, H, McCowan, C, Packard, CJ. Long-term safety and efficacy of lowering low-density lipoprotein cholesterol with statin therapy: 20-year follow-up of West of Scotland Coronary Prevention Study. Circulation. 2016;133:1073-1080 Google Scholar