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level: Level 3

Questions and Answers List

level questions: Level 3

QuestionAnswer
provide information about the presence of a disease or other health condition. It able to discriminate between patients who have a particular disease or condition and those who do not have it.Screening and diagnostic tests
1 conducted in asymptomatic patients 2 conducted in symptomatic patients.1 Screening 2 Diagnosis
A screening or diagnostic test can have four basic types of outcomes.1 True Positive test 2 True Negative test 3 False Positive test 4 False Negative test
1 result is one that detects a marker when the disease is present. 2 result is one that does not detect the marker when the disease is absent 3 result is one that detects a marker when the disease is absent 4 result is one that does not detect a marker when the disease is present.1 true positive test 2 true negative test 3 false positive test 4 false negative test
The effectiveness of a diagnostic (or screening) technology can be determined along a chain of inquiry that leads from technical capacity of a technology to changes in patient health outcomes to cost effectiveness (where relevant to decision makers), as follows1 Technical capacity 2 Diagnostic accuracy 3 Diagnostic impact 4 Therapeutic impact 5 Patient outcome 6 Cost effectiveness
1 Does the technology perform reliably and deliver accurate information? 2 Does the technology contribute to making an accurate diagnosis?1 Technical capacity. 2 Diagnostic accuracy
1 Do the diagnostic results influence use of other diagnostic technologies, e.g., does it replace other diagnostic technologies? 2 Do the diagnostic findings influence the selection and delivery of treatment?1 Diagnostic impact 2 Therapeutic impact
1 Does use of the diagnostic technology contribute to improved health of the patient? 2 Does use of the diagnostic technology improve the cost effectiveness of health care compared to alternative interventions?1 Patient outcome 2 Cost effectiveness
Expertise for Conducting HTAHealth professionals, Managers of hospital, clinics, nursing homes, etc, Pharmacists, Laboratory technicians, Biomedical and clinical engineers, Patients and community representatives, Epidemiologists, Biostatisticians, Economists, Social scientists, Decision scientists, Ethicists, Lawyers, Computer scienticts/programmer, Librarians/information specialists
Basic HTA Framework/steps in HTA process1. Identify assessment topics 2.Specify the assessment problem or questions 3. Determine organizational locus or responsibility for assessment 4. Retrieve available relevant evidence 5. Generate or collect new evidence (as appropriate) 6. Appraise/interpret quality of the evidence 7. Integrate/synthesize evidence 8. Formulate findings and recommendations 9. Disseminate findings and recommendations 10. Monitor impact
Health technology Council:1 Core committee 2) 7 Subcommittees
HTA contributes to the achievement of UHC by:•Increasing transparency, accountability, and equity •Institutionalizing priority setting mechanism on health technology coverage •Improving efficiency in allocation of resources •Negotiating better prices of health technologies
1 In the implementation of UHC law, HTAC should prioritize the review of existing health technologies within __ (years?) upon their creation (from October 2019 to October 2021) 1 In parallel, they will also accommodate the assessment of new health technologies which are proposed by the __1 two years 2 DOH and PhilHealth.
Steps in HTA process:1. Topic nomination 2. Topic Prioritization 3. Scoping and Protocol Development 4. Assessment 5. Evidence appraisal 6. Recommendation 7. Resolution 8. Decision 9. Dissemination
FOR THE FIRST TWO YEARS of the HTA PROCESS IMPLEMENTATION; (from October 2019 to October 2021), the HTAC shall accept topic nominations from DOH and PhilHealth for the priority assessments in accordance with the UHC LawNomination
Public health emergencies: (i) bioterrorism; (ii) appearance of a novel or previously controlled or eradicated infectious agent or biological toxin; (iii) a natural disaster; (iv) a chemical attack or accidental release; (v) a nuclear attack or accident; or (vi) an attack or accidental release of radioactive materialsPrioritization
can be performed by either the internal assessment team (i.e., HTA unit) or an external assessment team that is a part of the HTA research network that will be created by the DOH and DOST (Department of Science and Technology).Assessment
(Prior to submitting topic nomination) HTAC will only consider the use of these health technologies within the approved marketing authorization of the product in the Philippines as certified by the FDADrugs and vaccines
if exempted from the current FDA process of granting marketing authorization, the technology sponsor shall submit a Certificate of Free Sale (CFS) issued by the regulatory authority from the source country or other stringent regulatory authority, which shall be validated by the Philippine FDAMedical devices
Criteria in making Recommendation:•Responsiveness to disease magnitude, severity, and equity •Safety and effectiveness •Household financial impact •Cost-effectiveness •Affordability and viability