| Literature DB >> 29751764 |
Tania Yuka Yuba1, Hillegonda Maria Dutilh Novaes2, Patrícia Coelho de Soárez1.
Abstract
BACKGROUND: The quality of the evidence used in health technology assessment (HTA) agency reports has been considered essential for decision-making processes and their legitimacy. In Brazil, CONITEC is the agency responsible for defining data mandatory for the submission of proposals for the incorporation of new technologies. The objective of this study was to analyse CONITEC recommendation reports, the type of scientific evidence used in them and their compliance with operational procedures.Entities:
Keywords: evidence-based decisions; evidence-based policy; health policy; health technology assessment
Mesh:
Year: 2018 PMID: 29751764 PMCID: PMC5948855 DOI: 10.1186/s12961-018-0319-8
Source DB: PubMed Journal: Health Res Policy Syst ISSN: 1478-4505
Classification of studies used as evidence in HTA reports according to selected criteriaa
| Study category | Criteria | |||||||
|---|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | |
| Description of the characteristics and current uses of the technology | Evaluation of safety and effectiveness | Cost-effectiveness analysis | Information on costs and financial impact | Organisational considerations | Systematic or systematised review | Critical evaluation of the quality of the evidence | Ethical, social and legal considerations | |
| Full HTA | Always | Always | Always | Always | Optional | Always | Optional | Optional |
| Mini-HTA | Always | Always | Not performed | Always | Optional | Always | Optional | Optional |
| Rapid review | Always | Always | Not performed | Optional | Optional | Always | Optional | Optional |
| Other | Always | Optional | Not performed | Optional | Optional | Optional | Optional | Optional |
HTA health technology assessment
aBased on the classification system devised by Merlin et al. [7]
Fig. 1CONITEC reports according to type of recommendation, 2012–2016 (n = 199). CONITEC: (Brazilian) Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde (CONITEC, National Committee for Health Technology Incorporation); Other: reports recommending broader use or exclusion of the technologies
CONITEC reports, by type of technology and type of demand, 2012–2016 (n = 199)
| Variable | 2012 | 2013 | 2014 | 2015 | 2016 | Total | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
| % |
| % |
| % |
| % |
| % |
| % | |
| Type of technology | ||||||||||||
| Drugs | 22 | 75.9 | 39 | 72.2 | 18 | 43.9 | 33 | 75.0 | 24 | 77.4 | 136 | 68.3 |
| Procedures | 4 | 13.8 | 7 | 13.0 | 14 | 34.1 | 9 | 20.5 | 6 | 19.4 | 40 | 20.1 |
| Devices | 1 | 3.4 | 4 | 7.4 | 7 | 17.1 | 2 | 4.5 | 0 | – | 14 | 7.0 |
| Dietary supplements | 1 | 3.4 | – | – | 2 | 4.9 | – | – | 1 | 3.2 | 4 | 2.0 |
| Vaccines | 1 | 3.4 | 4 | 7.4 | – | – | – | – | 0 | – | 5 | 2.5 |
| Type of demand | ||||||||||||
| Internal | 14 | 48.3 | 25 | 46.3 | 34 | 82.9 | 30 | 68.2 | 14 | 45.2 | 117 | 58.8 |
| Public health sector | 13 | 44.8 | 23 | 42.6 | 32 | 78.0 | 29 | 65.9 | 13 | 41.9 | 110 | 55.3 |
| Judiciary and public ministry | 1 | 3.4 | 2 | 3.7 | 2 | 4.9 | 1 | 2.3 | 1 | 3.2 | 7 | 3.5 |
| External | 11 | 37.9 | 28 | 51.9 | 7 | 17.1 | 13 | 29.5 | 16 | 51.6 | 75 | 37.7 |
| Pharmaceutical industry | 11 | 37.9 | 28 | 51.9 | 4 | 9.8 | 12 | 27.3 | 9 | 29 | 64 | 32.2 |
| Civil society | – | – | – | – | 2 | 4.9 | – | – | 4 | 12.9 | 6 | 3.0 |
| Medical device companies | – | – | – | – | – | – | 1 | 2.3 | 2 | 6.4 | 3 | 1.5 |
| Food industry | – | – | – | – | 1 | 2.4 | – | – | 1 | 3.2 | 2 | 1.0 |
| Mixed | 4 | 13.8 | 1 | 1.9 | – | – | 1 | 2.3 | 1 | 3.2 | 7 | 3.5 |
| Public health sector/the pharmaceutical industry or civil society | 4 | 13.8 | 1 | 1.9 | – | – | 1 | 2.3 | 1 | 3.2 | 7 | 3.5 |
| TOTAL | 29 | 100.0 | 54 | 100.0 | 41 | 100.0 | 44 | 100.0 | 31 | 100.0 | 199 | 100.0 |
CONITEC Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde (National Commission for the Incorporation of Technologies into the Unified Healthcare System)
CONITEC reports, by ICD-10 chapters and use of health economic evaluation, 2012–2016 (n = 199)
| ICD-10 chapter | Without HEE | With HEE | Total | Percent |
|---|---|---|---|---|
| I Certain infectious and parasitic diseases | 25 | 5 | 30 | 15.1% |
| II Neoplasms | 14 | 16 | 30 | 15.1% |
| X Diseases of the respiratory system | 9 | 12 | 21 | 10.6% |
| XIII Diseases of the musculoskeletal system and connective tissue | 11 | 9 | 20 | 10.1% |
| IX Diseases of the circulatory system | 2 | 10 | 12 | 6.0% |
| IV Endocrine, nutritional and metabolic diseases | 9 | 2 | 11 | 5.5% |
| XI Diseases of the digestive system | 8 | 3 | 11 | 5.5% |
| III Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism | 8 | 2 | 10 | 5.0% |
| XIV Diseases of the genitourinary system | 5 | 5 | 10 | 5.0% |
| XXI Factors influencing health status and contact with health services | 7 | 2 | 9 | 4.5% |
| V Mental and behavioural disorders | 6 | 2 | 8 | 4.0% |
| VI Diseases of the nervous system | 3 | 4 | 7 | 3.5% |
| XII Diseases of the skin and subcutaneous tissue | 5 | 1 | 6 | 3.0% |
| VII Diseases of the eye and adnexa | 2 | 2 | 4 | 2.0% |
| XVII Congenital malformations, deformations and chromosomal abnormalities | 2 | 1 | 3 | 1.5% |
| VIII Diseases of the ear and mastoid process | 2 | 2 | 1.0% | |
| XVI Certain conditions originating in the perinatal period | 1 | 1 | 2 | 1.0% |
| XIX Injury, poisoning and certain other consequences of external causes | 1 | 1 | 2 | 1.0% |
| XV Pregnancy, childbirth and the puerperium | 1 | 1 | 0.5% | |
| Total | 121 | 78 | 199 | 100.0% |
CONITEC Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde (National Committee for Health Technology Incorporation), ICD-10 International Statistical Classification of Diseases and Related Health Problems 10th Revision, HEE health economic evaluation
CONITEC reports, by type of recommendation, type of study, type of demand and type of health economic evaluation, 2012–2016 (n = 199)
| Recommendation, by type of study | Internal request | External request | Mixed request | Total | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Full HEEa | CA/CD | BIA | No HEE | Full HEEa | CA/CD | BIA | No HEE | Full HEEa | BIA | No HEE | ||
| Incorporate, | 83 (70.9) | 13 (17.3) | 5 (71.4) | 101 (50.8) | ||||||||
| Full HTA | 8 | – | – | – | 10 | – | – | – | 2 | – | – | 20 |
| Mini-HTA | – | 2 | 9 | – | – | – | 1 | – | – | – | – | 12 |
| Rapid review | – | – | – | 2 | – | – | – | – | – | – | – | 2 |
| Other | – | – | 44 | 18 | – | 1 | 1 | – | – | 2 | 1 | 67 |
| Do not incorporate, | 17 (14.5) | 62 (82.7) | 2 (28.6) | 81 (40.7) | ||||||||
| Full HTA | 2 | – | – | – | 55 | – | – | – | 1 | – | – | 58 |
| Mini-HTA | – | 1 | 9 | – | – | 2 | 3 | – | – | – | – | 15 |
| Rapid review | – | – | – | 5 | – | – | – | 1 | – | – | – | 6 |
| Other | – | – | – | – | – | – | – | 1 | – | – | 1 | 2 |
| Maintain/expand/exclude, | 17 (14.5) | – | – | 17 (8.5) | ||||||||
| Mini-HTA | – | – | 1 | – | – | – | – | – | – | – | – | 1 |
| Rapid review | – | – | – | 3 | – | – | – | – | – | – | – | 3 |
| Other | – | – | 1 | 12 | – | – | – | – | – | – | – | 13 |
| Total, | 117 (100.0) | 75 (100.0) | 7 (100.0) | 199 (100.0) | ||||||||
CONITEC Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde (National Committee for Health Technology Incorporation), EE economic evaluation (cost-effectiveness analysis, cost-utility analysis, cost-benefit analysis or cost-minimisation analysis), CA cost analysis, CD cost description, BIA budget impact analysis
aIncludes a BIA
Fig. 2Incremental cost-effectiveness ratios, in 2016 Brazilian reals (R$), for the technologies that gained a CONITEC recommendation for incorporation, 2012–2016 (n = 13). CONITEC Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde (National Commission for the Incorporation of Technologies into the Unified Healthcare System), CHE Centre for Health Economics (University of York), CET cost-effectiveness threshold, WHO World Health Organization, GDP gross domestic product, PET-CT positron emission tomography-computed tomography, HPV human papillomavirus. *R$ 17,106.18. †R$ 27,229.00. ‡R$ 81,687.00