HTA Principles Survey Questionnaire

Transcription

1 I. Introduction This survey aims to inform health care decision makers in their rational and efficacious applications of health technology assessment (HTA) in Asia, while adhering to key established benchmarks. These benchmarks may be referred to as the 15 key principles of HTA [1, 2, 3]. The principles strive to outline the best practices for HTA application, following the organizational structure, methodology, process of implementation, and the use of information in health care decision making. Through this survey, it is hoped that data may be captured to accurately reflect the current HTA situation across Asia and ultimately generate evidence for better-informed health care decisions. II. Questionnaire Instructions 1. This questionnaire is designed to evaluate the HTA system at the level of your country/jurisdiction. HTA processes may include (1) HTA organization (such as the department who manage the health insurance coverage decision process within the Ministry of Health or Health Insurance Scheme, or an independent organization assigned by the government; (2) HTA appraisal committee; or (3) agencies who conduct HTA assessment and generate the report. 2. There are 15 key principles of HTA, with corresponding questions. For each principle 1-15, first indicate the relevance (usefulness) of the principle to your particular country s context, rating from Extremely relevant to Not Relevant. 3. After rating the relevancy, please include any specific comments pertaining to the principle s relevancy in your country. 4. For each principle s corresponding question, mark the appropriate box (yes, no or unsure) with a check mark. 5. Please send the completed survey (saved PDF) to asiaconsortium@ispor.org.

2 III. Responder Information HTA Principles Survey Questionnaire 1. Your Country or Region: 2. Your Organization name: 3. How would you classify your organization? a. Central/Federal Government b. Local/Provincial/State Government c. Professional (e.g. medical-related society) d. Pharmaceutical/Medical Device Industry e. Academic/Not for profit Research Institution f. Hospital g. Private insurer/managed care h. Other (Please state in the text field provided) 4. Does your organization do any of the following: a. Coordinate HTA activities (in the country concerned) b. Make reimbursement decisions, or issue guidance based on HTAs c. Assess HTAs (e.g. Industry submissions) d. Undertake HTAs e. None of the above 5. Your Name (optional) 6. Your Contact Information (optional) Phone: Address: 2

3 IV. Questionnaire Structure of HTA 1. The goal and scope of the HTA should be explicit and relevant to its use. Please indicate the relevance of Principle # 1 to your country s HTA processes t Relevant 1.1 Is the remit of the HTA organization clearly defined? 1.2 Is a scoping document drawn up prior to an HTA, containing information on the specific decision problem to be addressed, the relevant patient populations to be considered, the intervention of interest, the relevant alternatives (comparators), and the outcomes (PICOs) to be assessed? 2. HTA should be an unbiased and transparent exercise. Please indicate the relevance of Principle # 2 to your country s HTA processes t Relevant 2.1 Is the HTA assessment agency independent of the body making the reimbursement or coverage decision? 3

4 2.2 Are the recommendations of the HTA organization made by an independent expert advisory committee? 2.3 Are any conflicts of interest of committee members documented and made public? 2.4 Are the meetings of the committee held in public? 2.5 Is the supporting information and the basis of the recommendations made publicly available? 2.6 Does the organization normally commission outside groups to undertake the health technology assessment? 2.7 Are the reports produced subjected to independent peer-review prior to final determination? 2.8 Are the draft conclusions subject to review by stakeholders and the public, with rationale underlying final determinations of contentious issues? 4

5 3. HTA should include all relevant technologies. HTA Principles Survey Questionnaire Please indicate the relevance of Principle # 3 to your country s HTA processes t Relevant 3.1 Are all types of technologies (e.g. drugs, devices, diagnostics, procedures, behavioral modification) considered? 3.2 Within each category, are both new and existing technologies considered? 3.3 In assessments of new technologies, are all relevant alternatives considered? 4. A clear system for setting priorities for HTA should exist. Please indicate the relevance of Principle # 4 to your country s HTA processes t Relevant 5

6 4.1 Does a formal system for prioritizing and selecting topics exist? 4.2 Is the priority-setting approach clear and transparent? Methods of HTA 5. HTA should incorporate appropriate methods for assessing costs and benefits. Please indicate the relevance of Principle # 5 to your country s HTA processes t Relevant 5.1 Does the HTA organization consider costs as well as benefits and harms? 5.2 Does the HTA organization have published methods guidelines for assessing the benefits, harms and costs of health technologies? 6

7 5.3 Is a full systematic review of clinical evidence required as a basis for economic modeling? 5.4 Does the team undertaking HTA assessments on behalf of the organization include individuals with skills in epidemiology/biostatistics, health services research and economics? 6. HTAs should consider a wide range of evidence and outcomes. Please indicate the relevance of Principle # 6 to your country s HTA processes t Relevant 6.1 Does the relevant clinical evidence include observational and non-randomized studies, as well as RCTs? 6.2 Does the HTA consider impacts on quality of life and other patient-reported outcomes, as well as clinical events? 6.3 Does the HTA consider relevant sub-groups of the patient population (e.g. by baseline risk)? 7

8 7. A full societal perspective should be considered when undertaking HTAs. Please indicate the relevance of Principle # 7 to your country s assessment process t Relevant 7.1 Does the HTA only consider the impact on a specific budget, for example for drugs? 7.2. Does the HTA consider all health care costs? 7.3. Can other costs be included as extra information? 7.4. Are productivity gains and losses (i.e., indirect costs and benefits) considered when relevant? 7.5. Are costs for informal care included when relevant? 8

9 7.6. Are costs in added years of life included in the cost-effectiveness ratio? 8. HTAs should explicitly characterize uncertainty surrounding estimates. Please indicate the relevance of Principle # 8 to your country s assessment process t Relevant 8.1. Does the HTA include a sensitivity analysis? 8.2. Are confidence intervals presented for key estimates? 8.3. Have the key deficiencies in available data been identified and discussed? 8.4. Is an agenda for key future research proposed? 9

10 9. HTAs should consider and address issues of generalizability and transferability. Please indicate the relevance of Principle # 9 to your country s HTA processes t Relevant 9.1. Does the HTA organization have methods guidance for dealing with transferability issues when using data or analyses from other jurisdictions? 9.2. Does the HTA organization consider the generalizability of the results of its studies to other patient populations, health care delivery systems or practice settings that are relevant for its jurisdiction? Processes for Conducting HTA 10. Those conducting HTAs should actively engage all key stakeholder groups. Please indicate the relevance of Principle # 10 to your country s HTA processes t Relevant 10

11 10.1. Is the HTA organization formally required to engage stakeholders in its activities? Does the HTA organization involve stakeholders in the scoping of HTAs? Does the HTA organization have a mechanism for identifying the relevant stakeholders? Does the HTA organization encourage or require submissions of evidence from stakeholders? Does the HTA organization allow stakeholders to comment on HTA assessment reports at the draft stage? Does the HTA organization allow stakeholders to appeal against recommendations/ decisions? 11

12 10.7. Do the HTA organization s appraisal committees include stakeholder representation (e.g. patient groups, technology manufacturers, clinical specialists)? 11. Those undertaking HTAs should actively seek all available data Please indicate the relevance of Principle # 11 to your country s HTA processes t Relevant Does the systematic review of clinical evidence include the gray literature and unpublished data? Does the HTA organization have processes for handling confidential data from manufacturers? 12. The implementation of HTA findings needs to be monitored. Please indicate the relevance of Principle # 12 to your country s HTA processes t Relevant 12

13 12.1. Does the HTA organization develop an implementation plan for its HTAs? Does the HTA organization monitor the impact of its recommendations? Use of HTA in Decision Making 13. HTA should be timely. Please indicate the relevance of Principle # 13 to your country s HTA processes t Relevant Does the HTA organization have a defined time period for conducting HTAs/producing recommendations? Does the HTA organization adhere to the agreed timelines? Does the organization have a mechanism to update its HTAs/recommendations within a given time period? 13

14 14. HTA findings need to be communicated appropriately to different decision makers. Please indicate the relevance of Principle # 14 to your country s HTA processes t Relevant Does the HTA organization develop a communications plan for its recommendations and decisions? Are separate versions of reports produced for different audiences (e.g. health professionals, decision makers, general public)? Is the effectiveness of communication monitored and evaluated? 15. The link between health technology assessment and decision-making processes needs to be transparent and clearly defined. Please indicate the relevance of Principle # 15 to your country s HTA processes t Relevant 14

15 15.1. Does the organization distinguish between the scientific assessment of the evidence and the appraisal decision? Does the organization have an explicit decision rule for acceptance/non-acceptance of health technologies? Does the organization have a transparent approach for weighing various considerations (e.g. comparative effectiveness, cost-effectiveness, budget impact, equity)? Does the organization recommend, or operate, conditional reimbursement/coverage-with-evidencedevelopment schemes? Does the organization distinguish between identifiable sub-groups of the patient population when making decisions? 15

16 V. References This survey is compiled by Dr. Yen-Huei (Tony) Tarn on behalf of HTAnetAsia of ISPOR Asia Consortium based on the following articles with the permissions from the authors: [1] Drummond M, Schwartz JS, Jonsson B, et al. Key principles for the improved conduct of health technology assessments for resource allocation decisions. International Journal of Technology Assessment in Health Care 2008; 24: [2] Neumann P, Drummond M, Jonsson B, et al. Are Key Principles for improved health technology assessment supported and used by health technology assessment organizations? International Journal of Technology Assessment in Health Care 2010; 26: [3] Drummond M, Neumann P, Jonsson B, et al. Can We Reliably Benchmark Health Technology Assessment organizations? International Journal of Technology Assessment in Health Care 2012; 28:2,