| Literature DB >> 34831668 |
Julia Simões Corrêa Galendi1, Carlos Antonio Caramori2, Clarissa Lemmen1, Dirk Müller1, Stephanie Stock1.
Abstract
The implementation of health technology assessment (HTA) in emerging countries depends on the characteristics of the health care system and the needs of public health care. The objective of this survey was to investigate experts' expectations for the development of HTA in Brazil and to derive measures to strengthen the impact of HTA in Brazil on health care decisions. Based on a scoping literature review, a questionnaire was developed proposing eight theses for seven domains of HTA: (i) capacity building, (ii) public involvement, (iii) role of cost-effectiveness analysis (CEA), (iv) institutional framework, (v) scope of HTA studies, (vi) methodology of HTA, and (vii) HTA as the basis for jurisdiction. Thirty experts responded in full to the survey and agreed to five of the eight theses proposed. Experts suggested several measures to promote HTA within the scope of each domain, thus addressing capacity building related to HTA, availability, and reliability of population data, and legal endowment of the HTA system. Finally, HTA processes in Brazil should also address public health issues (e.g., appraisal of interventions directed at chronic diseases).Entities:
Keywords: Brazil; decision making; health services research; health technology assessment; redesign; surveys and questionnaires
Mesh:
Year: 2021 PMID: 34831668 PMCID: PMC8625173 DOI: 10.3390/ijerph182211912
Source DB: PubMed Journal: Int J Environ Res Public Health ISSN: 1660-4601 Impact factor: 3.390
Figure 1Basic structure of the questionnaire repeated for each domain.
Participants.
| Groups | Experts Invited ( | Total Responses ( | Complete Responses ( |
|---|---|---|---|
| NATS | 70 | 23 | 19 |
| Regulatory | 39 | 6 | 5 |
| Pharmaceutical industry | 15 | 7 | 6 |
| Total | 124 | 36 | 30 |
Abbreviations: NATS: nuclei for health technology assessment. 1 Included in final analysis.
Expectation of experts with regard to the theses and respective challenges according to the domains.
| Domain | Theses | Expectation of Experts | Challenges to the Achievement of the Thesis | |
|---|---|---|---|---|
| In 10 Years (Nr.) | Mode (%) | Mean (SD) | ||
| Capacity building | Brazil will have sufficient adequately trained personnel to understand, implement and conduct HTA studies (1) | Possible (83%) | 3.0 (0.41) |
Lack of funding (8 experts) Education is not a political priority (8 experts) Students without basic skills (i.e., evidence-based medicine, English language) to receive advanced training on HTA (7 experts) |
| Public participation | Plain public involvement will be guaranteed without compromising the technical quality of the process (2) | Possible (50%) | 2.6 (0.56) |
Patient representatives or collaborative networks exist for a few groups of diseases (6 experts). Difficulty to identify legitimate patient representatives (2 experts) Conflict of interest of patient representatives funded by the industry (8 experts) Lack of public awareness (3 experts) |
| Role of cost-effectiveness analysis (CEA) | A CEA will be required in the HTA process to obtain coverage/reimbursement of new technologies in the benefits catalog (3) | Possible (87%) | 2.9 (0.36) |
Lack of funding for research (5 experts) Need for capacity building on health economics (5 experts) Need for epidemiological and utility data (3 experts) |
| Institutional framework | A timeframe of three months to complete the HTA will be mandatory (4.a) | Possible (53%) | 2.6 (0.66) |
Lack of human resources to comply with the deadlines (9 experts) Potential impact on the quality of the reports (2 experts) |
| The HTA appraisal process for public and private institutions will be merged (4.b) | Impossible (53%) | 2.3 (0.69) |
Private and public insurances in Brazil operate from different perspectives (7 experts) | |
| Scope of HTA | The scope of HTA will be restricted to new medical technologies with high added value (e.g., biologics, biosimilars, combination products, devices, oncologic therapy, among others) and potentially high budgetary impact (5) | Possible (67%) | 3.1 (0.57) |
Difficult to foresee which technology will have a low budgetary impact (1 expert) |
| Methodology of HTA | The conduction of HTA studies will have high-quality methodology (6) | Possible (70%) | 2.9 (0.54) |
Lack of funding (5 experts) Lack of reliable epidemiological data on the Brazilian population (5 experts) Need for capacity building (3 experts) |
| HTA as basis for Jurisdiction | Judicial decisions on individual right-to-health lawsuits concerning the coverage of medical innovative technologies will use CONITEC reports as basis for jurisdiction (7) | Possible (63%) | 2.8 (0.58) |
Need for capacity building (3 experts) Mistrust between the Judiciary and technical advisors (3 experts) |
Abbreviations. HTA: health technology assessment; CONITEC: National Commission for incorporation of Technologies; NATS: nuclei for HTA; CEA: cost-effectiveness analysis; ANS: National Agency for Supplementary Healthcare; SD: standard deviation.
Elicited measures to promote HTA in the Brazilian health care system according to the domains.
| Domain | Measures to Promote HTA in Brazil according to the Domain [Mean Value (SD)] |
|---|---|
| Capacity building |
Project-based training [3.7 (0.47)], permanent university-based graduate [3.2 (0.91)] and post-graduation programs [3.9 (0.34)]; Courses offered by private universities [3.3 (0.51)], public universities [3.8 (0.42)], international collaborations [3.7 (0.44)] or public–private partnerships [3.7 (0.54)]; In-class traditional courses [3.3 (0.57)], online courses [3.0 (0.75)] or combination of in-class and online courses [3.6 (0.67)]. |
| Public participation |
Standardized advertising to the public to stimulate participation in public consultations [3.4 (0.72)]; Mandatory voting seat for patients’ representatives in the Plenaries of CONITEC [2.9 (0.87)]; Education for patients’ representatives on HTA to support participation in public consultations [3.4 (0.75)]. |
| Role of cost-effectiveness analysis (CEA) |
Mandatory CEAs for inclusion in the benefits catalog (reinforced by law) [2.9 (0.81)]; Self-binding from the pharmaceutical industry on producing CEAs [3.1 (0.70)]; Responsibility of conduction of CEA by Independent public universities staff [3.6 (0.50)], independent private universities staff [3.2 (0.64)], or an internal capacitated commission of CONITEC [3.1 (0.65)]; CET as reference for the interpretation of the results of the CEA [3.0 (0.80)]; CET as a standard value to be developed by Brazilian researchers, based on the budget available for health in Brazil (or willingness to pay) [3.2 (0.90)]; CET applied as one criterion among others (including ethical, evidence of medical benefit, health care priority, practicability, etc.) [3.6 (0.48)]; Co-financing by the proponent (third parties) and the government would be appropriate and sustainable for encouraging cost-effectiveness studies.a |
| Institutional framework |
Reform of the specific legislation to ensure timeliness of reports (3 months) [3.0 (0.75)]; Expansion of the capacity of the NATS [3.4 (0.76)] and of the CONITEC [3.5 (0.67)]; Increase of participation of the ANS in the plenaries of CONITEC [3.0 (0.77)]; Health professionals other than physicians should be represented in decision-making bodies a; Regional representation with regard to ethnical characteristics a; To finance full-time researchers to work at the NATS a. |
| Scope of HTA |
Simplified appraisal procedure to medical technologies with low budget impact (e.g., over-the-counter drugs, organizational and informational protocols, among others) [3.2 (0.78)]; Alternative criteria to prioritize the scope of HTA:
Public health needs [3.6 (0.70)], frequent right to health lawsuits concerning a specific technology [3.2 (0.70)], unmet medical needs [3.3 (0.70)], technologies not previously evaluated by other countries [3.0 (0.80)], high therapeutic value of the technology [3.3 (0.77)]. Prioritize technologies for primary health care a. |
| Methodology of HTA |
Expansion of the capacity and training of the CONITEC [3.5 (0.62)] and of the NATS [3.6 (0.55)]; Revision and periodical update of the methodological guidelines [3.6 (0.48)]; Provision of financial support to independent researchers that dedicate themselves to either from public universities HTA [3.5 (0.62)] or from private universities [3.1 (0.70)]; Expansion of the capacity of data collection [3.7 (0.47)] and amelioration of the accessibility of “DATASUS” [3.7 (0.62)]; Implementation of mandatory integrated electronic databases in the main hospitals [3.5 (0.62)] and in centers of the “Family Health Program” [3.5 (0.67)]. |
| HTA as basis for Jurisdiction |
Establishment of expert groups to advise the law courts regarding HTA [3.6 (0.66)]; Implementation of early awareness system (or horizon scanning) to identify innovative medical technologies with the potential to become a target of lawsuits [3.4 (0.55)]; Mandatory HTA appraisal by CONITEC after authorization to enter the market is granted by ANVISA, to ensure timely reports [3.2 (0.78)]; Invest in the expansion of the NATS JUS a. |
a Measures suggested as free text, therefore not appraised by the group. Abbreviations: HTA: health technology assessment; CONITEC: National Commission for incorporation of Technologies; NATS: nuclei for HTA; CEA: cost-effectiveness analysis; CET: cost-effectiveness Threshold; ANS: National Agency for Supplementary Healthcare; ANVISA: National Health Surveillance Agency; DATASUS: Information Technology Department of the National Healthcare system; NATS JUS: NATS dedicated entirely to assisting the judiciary with regard to technical issues on HTA; SD: standard deviation.