Health technology performance assessment: Real-world evidence for public healthcare sustainability

International Journal of Technology Assessment in Health Care

Volumn 33, Issue 2, 2017, Pages 279-287

  Guerra Júnior, Augusto Afonso ^a   Pires De Lemos, Lívia Lovato ^a   Godman, Brian ^b,c   Bennie, Marion ^b   Osorio De Castro, Cláudia Garcia Serpa ^d   Alvares, Juliana ^a   Heaney, Aine ^e   Vassallo, Carlos Alberto ^f   Wettermark, Björn ^c,g   Benguria Arrate, Gaizka ^h   Gutierrez Ibarluzea, Iñaki ^h   Santos, Vania Cristina Canuto ⁱ   Petramale, Clarice Alegre ⁱ   Acurcio, Fransciso De Assis ^a  

^a FEDERAL UNIVERSITY OF MINAS GERAIS   (Brazil)

^b UNIVERSITY OF STRATHCLYDE   (United Kingdom)

^c KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^d INSTITUTO OSWALDO CRUZ   (Brazil)

^e National Prescribing Service Medicinewise   (Brazil)

^f Universidad Nacional del Litoral   (Brazil)

^g STOCKHOLM COUNTY COUNCIL   (Sweden)

^h Basque Office for HTA Ministry for Health   (Sweden)

ⁱ MINISTÉRIO DA SAÚDE   (Brazil)

Author keywords

Biomedical; Health information systems; Health policy; Observational studies; Technology assessment

Indexed keywords

INVESTMENTS;

BIOMEDICAL; HEALTH INFORMATION SYSTEMS; HEALTH POLICY; OBSERVATIONAL STUDY; TECHNOLOGY ASSESSMENTS;

HEALTH;

BRAZIL; CONSENSUS DEVELOPMENT; CONSULTATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; GOVERNMENT; HEALTH CARE POLICY; HUMAN; INSTITUTIONALIZATION; INVESTMENT; MEDICAL INFORMATION SYSTEM; OBSERVATIONAL STUDY; PHASE 3 CLINICAL TRIAL; BIOMEDICAL TECHNOLOGY ASSESSMENT; MEDICAL TECHNOLOGY; PRACTICE GUIDELINE; RANDOMIZED CONTROLLED TRIAL (TOPIC);

BIOMEDICAL TECHNOLOGY; BRAZIL; GUIDELINES AS TOPIC; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TECHNOLOGY ASSESSMENT, BIOMEDICAL;

EID: 85021092893     PISSN: 02664623     EISSN: 14716348     Source Type: Journal    
DOI: 10.1017/S0266462317000423     Document Type: Article

References (29)

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).
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.
3. Tugwell P, Knottnerus JA. Is the 'Evidence-Pyramid' now dead? J Clin Epidemiol. 2015;68:1247-1250.
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.
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.
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.
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.
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.
9. Svensson S, Menkes DB, Lexchin J. Surrogate outcomes in clinical trials: A cautionary tale. JAMA Intern Med. 2013;173:611-612.
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.
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.
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.
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.
14. Gafni A, Birch S. Incremental cost-effectiveness ratios (ICERs): The silence of the lambda. Soc Sci Med. 2006;62:2091-2100.
15. McCabe C, Claxton K, Culyer AJ. The NICE cost-effectiveness threshold: What it is and what that means. Pharmacoeconomics. 2008;26:733-744.
16. Howard DH, Bach P, Berndt ER, Conti RM. Pricing in the market for anticancer drugs. J Econ Perspect. 2015;29:139-162.
17. Simoens S, Picavet E, Dooms M, Cassiman D, Morel T. Costeffectiveness assessment of orphan drugs: A scientific and political conundrum. Appl Health Econ Health Policy. 2013;11:1-3.
18. Raftery JP. NICE's cost-effectiveness range: Should it be lowered? Pharmacoeconomics. 2014;32:613-615.
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).
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.
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.
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.
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.
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.
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.
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.
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.
28. Parkinson B, Sermet C, Clement F, et al. Disinvestment and valuebased purchasing strategies for pharmaceuticals: An international review. Pharmacoeconomics. 2015;33:905-924.
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