Word document version

advertisement
HTA Principles Survey Questionnaire
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 115, first indicate by highlighting 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, highlight the appropriate box (yes, no or
unsure)
5. Please send the completed survey (saved word doc.) to asiaconsortium@ispor.org.
HTA Principles Survey Questionnaire
III. Responder Information
1. Your Country or Region:
2. Your Organization name:
3. How would you classify your organization? (Highlight appropriate box)
□ 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: (Highlight appropriate box)
□ 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)
E-mail:
Phone:
Address:
2
HTA Principles Survey Questionnaire
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
□ Extremely Relevant
□ Fairly Relevant
□ Somewhat Relevant
□ Barely Relevant
□ Not Relevant
1.1
Comments:
Is the remit of the HTA organization clearly defined?
□ Yes
□ No
□ Unsure
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?
□ Yes
□ No
□ Unsure
2. HTA should be an unbiased and transparent exercise.
Please indicate the relevance of Principle # 2 to your country’s HTA processes
□ Extremely Relevant
□ Fairly Relevant
□ Somewhat Relevant
□ Barely Relevant
□ Not Relevant
2.1
Comments:
Is the HTA assessment agency independent of the body making the reimbursement or coverage
decision?
□ Yes
□ No
□ Unsure
Comments:
3
HTA Principles Survey Questionnaire
2.2 Are the recommendations of the HTA organization made by an independent expert advisory committee?
□ Yes
□ No
□ Unsure
Comments:
2.3 Are any conflicts of interest of committee members documented and made public?
□ Yes
□ No
□ Unsure
Comments:
2.4 Are the meetings of the committee held in public?
□ Yes
□ No
□ Unsure
Comments:
2.5 Is the supporting information and the basis of the recommendations made publicly available?
□ Yes
□ No
□ Unsure
Comments:
2.6 Does the organization normally commission outside groups to undertake the health technology
assessment?
□ Yes
□ No
□ Unsure
Comments:
2.7 Are the reports produced subjected to independent peer-review prior to final determination?
□ Yes
□ No
□ Unsure
Comments:
2.8 Are the draft conclusions subject to review by stakeholders and the public, with rationale underlying
final determinations of contentious issues?
□ Yes
□ No
□ Unsure
Comments:
4
HTA Principles Survey Questionnaire
3. HTA should include all relevant technologies.
Please indicate the relevance of Principle # 3 to your country’s HTA processes
□ Extremely Relevant
□ Fairly Relevant
□ Somewhat Relevant
□ Barely Relevant
□ Not Relevant
Comments
3.1 Are all types of technologies (e.g. drugs, devices, diagnostics, procedures, behavioral modification)
considered?
□ Yes
□ No
□ Unsure
Comments:
3.2 Within each category, are both new and existing technologies considered?
□ Yes
□ No
□ Unsure
Comments:
3.3 In assessments of new technologies, are all relevant alternatives considered?
□ Yes
□ No
□ Unsure
Comments:
4. A clear system for setting priorities for HTA should exist.
Please indicate the relevance of Principle # 4 to your country’s HTA processes
□ Extremely Relevant
□ Fairly Relevant
□ Somewhat Relevant
□ Barely Relevant
□ Not Relevant
Comments
5
HTA Principles Survey Questionnaire
4.1 Does a formal system for prioritizing and selecting topics exist?
□ Yes
□ No
□ Unsure
Comments:
4.2 Is the priority-setting approach clear and transparent?
□ Yes
□ No
□ Unsure
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
□ Extremely Relevant
□ Fairly Relevant
□ Somewhat Relevant
□ Barely Relevant
□ Not Relevant
Comments
5.1 Does the HTA organization consider costs as well as benefits and harms?
□ Yes
□ No
□ Unsure
5.2 Does the HTA organization have published methods guidelines for assessing the benefits, harms and
costs of health technologies?
□ Yes
□ No
□ Unsure
6
HTA Principles Survey Questionnaire
5.3 Is a full systematic review of clinical evidence required as a basis for economic modeling?
□ Yes
□ No
□ Unsure
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?
□ Yes
□ No
□ Unsure
6. HTAs should consider a wide range of evidence and outcomes.
Please indicate the relevance of Principle # 6 to your country’s HTA processes
□ Extremely Relevant
□ Fairly Relevant
□ Somewhat Relevant
□ Barely Relevant
□ Not Relevant
Comments
6.1 Does the relevant clinical evidence include observational and non-randomized studies, as well as RCTs?
□ Yes
□ No
□ Unsure
6.2 Does the HTA consider impacts on quality of life and other patient-reported outcomes, as well as clinical
events?
□ Yes
□ No
□ Unsure
6.3 Does the HTA consider relevant sub-groups of the patient population (e.g. by baseline risk)?
□ Yes
□ No
□ Unsure
7
HTA Principles Survey Questionnaire
7. A full societal perspective should be considered when undertaking HTAs.
Please indicate the relevance of Principle # 7 to your country’s assessment process
□ Extremely Relevant
□ Fairly Relevant
□ Somewhat Relevant
□ Barely Relevant
□ Not Relevant
Comments
7.1 Does the HTA only consider the impact on a specific budget, for example for drugs?
□ Yes
□ No
□ Unsure
Comments:
7.2. Does the HTA consider all health care costs?
□ Yes
□ No
□ Unsure
Comments:
7.3. Can other costs be included as extra information?
□ Yes
□ No
□ Unsure
Comments:
7.4. Are productivity gains and losses (i.e., indirect costs and benefits) considered when relevant?
□ Yes
□ No
□ Unsure
7.5. Are costs for informal care included when relevant?
□ Yes
□ No
□ Unsure
8
HTA Principles Survey Questionnaire
7.6. Are costs in added years of life included in the cost-effectiveness ratio?
□ Yes
□ No
□ Unsure
8. HTAs should explicitly characterize uncertainty surrounding estimates.
Please indicate the relevance of Principle # 8 to your country’s assessment process
□ Extremely Relevant
□ Fairly Relevant
□ Somewhat Relevant
□ Barely Relevant
□ Not Relevant
Comments
8.1. Does the HTA include a sensitivity analysis?
□ Yes
□ No
□ Unsure
8.2. Are confidence intervals presented for key estimates?
□ Yes
□ No
□ Unsure
8.3. Have the key deficiencies in available data been identified and discussed?
□ Yes
□ No
□ Unsure
8.4. Is an agenda for key future research proposed?
□ Yes
□ No
□ Unsure
9
HTA Principles Survey Questionnaire
9. HTAs should consider and address issues of generalizability and transferability.
Please indicate the relevance of Principle # 9 to your country’s HTA processes
□ Extremely Relevant
□ Fairly Relevant
□ Somewhat Relevant
□ Barely Relevant
□ Not Relevant
Comments
9.1. Does the HTA organization have methods guidance for dealing with transferability issues when using data or
analyses from other jurisdictions?
□ Yes
□ No
□ Unsure
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?
□ Yes
□ No
□ Unsure
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
□ Extremely Relevant
□ Fairly Relevant
□ Somewhat Relevant
□ Barely Relevant
□ Not Relevant
Comments
10
HTA Principles Survey Questionnaire
10.1. Is the HTA organization formally required to engage stakeholders in its activities?
□ Yes
□ No
□ Unsure
10.2. Does the HTA organization involve stakeholders in the scoping of HTAs?
□ Yes
□ No
□ Unsure
10.3. Does the HTA organization have a mechanism for identifying the relevant stakeholders?
□ Yes
□ No
□ Unsure
10.4. Does the HTA organization encourage or require submissions of evidence from stakeholders?
□ Yes
□ No
□ Unsure
10.5. Does the HTA organization allow stakeholders to comment on HTA assessment reports at the draft stage?
□ Yes
□ No
□ Unsure
10.6. Does the HTA organization allow stakeholders to appeal against recommendations/ decisions?
□ Yes
□ No
□ Unsure
11
HTA Principles Survey Questionnaire
10.7. Do the HTA organization’s appraisal committees include stakeholder representation (e.g. patient groups,
technology manufacturers, clinical specialists)?
□ Yes
□ No
□ Unsure
11. Those undertaking HTAs should actively seek all available data
Please indicate the relevance of Principle # 11 to your country’s HTA processes
□ Extremely Relevant
□ Fairly Relevant
□ Somewhat Relevant
□ Barely Relevant
□ Not Relevant
Comments
11.1. Does the systematic review of clinical evidence include the gray literature and unpublished data?
□ Yes
□ No
□ Unsure
11.2. Does the HTA organization have processes for handling confidential data from manufacturers?
□ Yes
□ No
□ Unsure
12. The implementation of HTA findings needs to be monitored.
Please indicate the relevance of Principle # 12 to your country’s HTA processes
□ Extremely Relevant
□ Fairly Relevant
□ Somewhat Relevant
□ Barely Relevant
□ Not Relevant
Comments
12
HTA Principles Survey Questionnaire
12.1. Does the HTA organization develop an implementation plan for its HTAs?
□ Yes
□ No
□ Unsure
12.2. Does the HTA organization monitor the impact of its recommendations?
□ Yes
□ No
□ Unsure
Use of HTA in Decision Making
13. HTA should be timely.
Please indicate the relevance of Principle # 13 to your country’s HTA processes
□ Extremely Relevant
□ Fairly Relevant
□ Somewhat Relevant
□ Barely Relevant
□ Not Relevant
Comments
13.1. Does the HTA organization have a defined time period for conducting HTAs/producing recommendations?
□ Yes
□ No
□ Unsure
Comments:
13.2. Does the HTA organization adhere to the agreed timelines?
□ Yes
□ No
□ Unsure
13.3. Does the organization have a mechanism to update its HTAs/recommendations within a given time period?
□ Yes
□ No
□ Unsure
Comments:
13
HTA Principles Survey Questionnaire
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
□ Extremely Relevant
□ Fairly Relevant
□ Somewhat Relevant
□ Barely Relevant
□ Not Relevant
Comments
14.1. Does the HTA organization develop a communications plan for its recommendations and decisions?
□ Yes
□ No
□ Unsure
14.2. Are separate versions of reports produced for different audiences (e.g. health professionals, decision makers,
general public)?
□ Yes
□ No
□ Unsure
Comments:
14.3. Is the effectiveness of communication monitored and evaluated?
□ Yes
□ No
□ Unsure
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
□ Extremely Relevant
□ Fairly Relevant
□ Somewhat Relevant
□ Barely Relevant
□ Not Relevant
Comments
14
HTA Principles Survey Questionnaire
15.1. Does the organization distinguish between the scientific assessment of the evidence and the appraisal
decision?
□ Yes
□ No
□ Unsure
Comments:
15.2. Does the organization have an explicit decision rule for acceptance/non-acceptance of health technologies?
□ Yes
□ No
□ Unsure
Comments:
15.3. Does the organization have a transparent approach for weighing various considerations (e.g. comparative
effectiveness, cost-effectiveness, budget impact, equity)?
□ Yes
□ No
□ Unsure
Comments:
15.4. Does the organization recommend, or operate, conditional reimbursement/coverage-with-evidencedevelopment schemes?
□ Yes
□ No
□ Unsure
Comments:
15.5. Does the organization distinguish between identifiable sub-groups of the patient population when making
decisions?
□ Yes
□ No
□ Unsure
15
HTA Principles Survey Questionnaire
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; 24:3 244–258.
[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; 26:1 71–78.
[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, 159–165.
16
Download