(For Audience) HTA 101 - Session 1 (02 Dec 2020) For Researchers and Academe
(For Audience) HTA 101 - Session 1 (02 Dec 2020) For Researchers and Academe
(For Audience) HTA 101 - Session 1 (02 Dec 2020) For Researchers and Academe
Reference: Bowen J.M., Patterson L.L., O'Reilly D., Hopkins R.B., Blackhouse G., Burke N., Xie F., (...), Goeree R.
Conditionally Funded Field Evaluations and Practical Trial Design Within a Health Technology Assessment Framework (2009) JACR Journal of the American College of Radiology, 6 (5) , pp. 324-331.
No structured and well-coordinated HTA framework for health interventions and technologies beyond drugs
https://doi.org/10.1371/journal.pone.0131156 https://doi.org/10.1186/s12889-015-2046-1
Implementation Optimization
(Health Decisions
technology
management)
HTR
Monitoring Health technology
reassessment
&
Evaluation
Stakeholders – Healthcare
Multidisciplinary
providers, patients and public,
Researchers and Experts
industry
The HTA
System
Future Plans
● Establishment of the HTAC and the HTA Office
● Capacity building activities for HTAC, assessors, academic partners
● Creation of PHL reference costs for economic evaluations (2020)
● Development of methodological guides for priority HTs under UHC: medical
devices, orphan drugs, cancer drugs, medical/surgical procedures
Function
HTA Institutionalization
● DOH and PhilHealth coverage depend on
positive HTAC recommendations and
approval of Secretary of Health (SOH) DOH-NHP’s
Philippine National
CPG development and
Formulary system
● Aligns HTA with the processes of DOH and service delivery
PhilHealth
DOH-NIC’s National DOH Health Facilities
Immunization Program Enhancement Program
Responsiveness to
magnitude, severity,
Interventions must address medical conditions
& equity placing the heaviest burden on the population
20 Feb 2019 10 Oct Oct 2019 Oct 2019-2021 Sept 2021 2024
2019
UHC Law UHC Law IRR HTAC Existing Tentative
(RA 11223) signed established health date to open HTA
signed thru UHC Act technologies new topic transition
rationalized nominations to DOST
1. Bioterrorism
2. Appearance of a novel or previously controlled or
eradicated infectious agent or biological toxin
Large number of deaths Large number of serious
3. A natural disaster in population injuries or long-term
disability
4. A chemical attack or its accidental release
5. A nuclear attack or accident
6. An attack or accidental release of
radioactive materials
Widespread or international Trade and travel restrictions
exposure to toxic substances
HTA Framework
● Secretary of Health
● DOH Executive Committee
● PhilHealth Board of Directors
Ma. Carmen Cornelia-Tolabing, DrPH Annabelle R. Borromeo, PhD, MHA, RN, CNS Maria Carinnes P. Alejandria, PhD
Public Health Epidemiologist Citizen’s Representative Social Anthropologist
Core Committee Vice Chair, Core Committee Core Committee
Bu C. Castro, M.D. Ll.B. FPSP Martha Bugnosen-Cayad–an, MD, MPH, CESO III Cecilia C. Maramba-Lazarte, MD, MScID, MScCT
Medico-Legal Expert Public Health Expert Clinical Trial/Research Methods Expert
Core Committee Core Committee Core Committee
Unit
As of October 2020
Jovy Veranda Jeff Madrona Jun Paculba
Admin Team Admin Team Admin Team
April Ocampo Arwin Onda, RPh Pau Panopio, RPh Mark Ramos
Yves Zuñiga,
Wincy Reyes Deinzel Uezono
FRSPH
The HTA Administrative Order Section V. B.
Subject to the same Conflict of Interest (COI) disclosure and COI management requirements as
regular HTAC members
*Reference [WHO 2016: Key enabling factors in effective and sustainable research networks]
Framework for
collaboration Research
Quality
Assurance
HTAC DOST DOH
network
Governance
HPDPB and Structure
HTAO
International
NGO Local university
universities
Deliberation
Research Quality
Institutions Assurance
Training Programs
● Plan to conduct HTA training programs
● Organize core trainers
› HTAC and International partners (HITAP, UK NICE)
● HTA website
Effective
Comms
Key Takeaways
Topic Nomination
Topic Prioritization
Assessment Topic
Proponent
Peer
Reviewer
Resolution Consultee
Decision Appellant
Dissemination Participant
Final Week
Decision
Week 50-
125
Week 48-119 Resolution
Recommendation
Week 0-8 Week 8-24 Week 24-28 Week 28-111 Week 44-115
Week 0-8 Week 1-13 Week 13-15 Week 15-16 Final Week
GENERAL HTA
PROCESS
Topic Prioritization
Evidence
Resolution Decision by SOH
Appraisal
TOPIC NOMINATION
Week 0-4
Who can nominate?
Submission of Topics
DOH Programs, PhilHealth, and other relevant stakeholders
Week 4-8
How can they nominate?
Checking for Compliance to Requirements
Accomplish documentary requirements specific to the
concerned health technology
Week 8-24
Comments on Shortlist
When can they start nominating?
September 2021
TOPIC
PRIORITIZATION
Week 8-24
How does HTAC prioritize topics?
Comments on Shortlist
HTAC screens topics based on prioritization criteria.
Week 8-9
What if the nominated topic was not prioritized?
Appeal for non-shortlisted topics
Proponents can undergo the 2-week appeals period.
Week 24-28
Key Participants Feedback to HTA Unit
Invited experts (e.g., Healthcare providers, Program
Managers, Patients)
Week 28-111
Assessment of dossier and formulation of analyses
*The HTA Unit defines the overall scope of technology
assessment (PICO) Week 44-115
- Peer review of Preliminary Assessment
- Public Consultation on acceptability and other social values
- Quality assurance of output and appraisal of result
Week 48-119
Key Participants Recommendation making
General Public, Patients, Healthcare providers, Hospitals
Policymakers, Industry, Researchers
Week 50-152
Receipt of appeals
*Stakeholders submit appeals to reconsider negative HTA
Council recommendation
Week 52-125
Screening and consideration of appeals
DISSEMINATION
Week 0-8 Week 1-13 Week 13-15 Week 15-16 Final Week
Week 0-8 Week 8-24 Week 24-28 Week 28-111 Week 44-115
Final Week
General HTA Process
Dissemination
EXPEDITED HTA
PROCESS Weeks 0-1
DOH National
Assessment
Secretary of Health Health Program HTAU Technical Topic
proceeds if
declares Public Director submits Secretariat receives Nomination
HTA Council
Health Emergency documents to documents &
approves
HTAU Prioritization
Topic
Assessment Decision by SOH
Dissemination
Evidence Appraisal and
Recommendation
Key Takeaways
● HTA involves collective effort across sectors
● PG ensures inclusiveness, transparency and accountability
1 HTA Process Guide ● HTA processes transform topics into action
● Evidence-based recommendations move PH closer to UHC
TOPIC
ASSESSMENT
Key Participants
Final PICOT
Protocol
Development
Clinical
Assessment
Economic Assessment Ethical, Legal, Social, Economic Assessment Ethical, Legal, Social, Health Technology will
(Cost-effectiveness/Utility
and Health System (Cost-minimization Analysis + and Health System not be recommended
Analysis +
Budget Impact Analysis) Implications Analysis Budget Impact Analysis) Implications Analysis by HTAC
Basic Methodological Initial PICOT P Population
Framework of Topic
Assessment I Intervention
Scoping
C Comparator
T Timeframe
Protocol
Development
Clinical
Assessment
Economic Assessment Ethical, Legal, Social, Economic Assessment Ethical, Legal, Social, Health Technology will
(Cost-effectiveness/Utility
and Health System (Cost-minimization Analysis + and Health System not be recommended
Analysis +
Budget Impact Analysis) Implications Analysis Budget Impact Analysis) Implications Analysis by HTAC
Basic Methodological Initial PICOT
Framework of Topic
Assessment
Scoping
Final PICOT
Protocol
Development
Clinical
Assessment
Economic Assessment Ethical, Legal, Social, Economic Assessment Ethical, Legal, Social, Health Technology will
(Cost-effectiveness/Utility
Analysis +
and Health System (Cost-minimization Analysis + and Health System not be recommended
Implications Analysis Budget Impact Analysis) Implications Analysis by HTAC
Budget Impact Analysis)
Basic Methodological Initial PICOT
Framework of Topic
Assessment
Scoping
Final PICOT
Protocol
Development
Clinical
Assessment
Economic Assessment Ethical, Legal, Social, Economic Assessment Ethical, Legal, Social, Health Technology will
(Cost-effectiveness/Utility
Analysis +
and Health System (Cost-minimization Analysis + and Health System not be recommended
Implications Analysis Budget Impact Analysis) Implications Analysis by HTAC
Budget Impact Analysis)
Basic Methodological Initial PICOT
Framework of Topic
Assessment
Scoping
Final PICOT
Protocol
Development
Clinical
Assessment
Economic Assessment Ethical, Legal, Social, Economic Assessment Ethical, Legal, Social, Health Technology will
(Cost-effectiveness/Utility
Analysis +
and Health System (Cost-minimization Analysis + and Health System not be recommended
Implications Analysis Budget Impact Analysis) Implications Analysis by HTAC
Budget Impact Analysis)
The HTA Methods Guide:
Economic Assessment
Presented by:
Aleli Kraft, PhD
Health Economist, HTAC Core Committee
Cost Minimization Cost Effectiveness Cost Utility Analysis Cost Benefit Analysis
Analysis Analysis
Comparing costs to Measuring added cost Comparing costs per Comparing health and
determine least costly per extra unit of extra unit of health non-health benefits in
Refers to health technology health outcome benefit measured in terms money terms to cost
achieved of “utilities” or
quantity/quality of life
Equivalent or
Applied when clinical effect of
non-inferior to the Superior to the comparator
proposed technology is...
comparator
Additional
Benefit expressed as Natural units Natural units Philippine peso
quantity/quality of life
None currently in place; ICER thresholds from Responsiveness to magnitude, severity and
WHO often considered as guides equity; effectiveness and safety; household
financial impact; and, affordability and
viability
Equity
Considerations
● Everyone receives fair opportunity to attain their full health
potential;
● No one disadvantaged from achieving said potential
● PROGRESS-Plus
Equity
Considerations
● Everyone receives fair opportunity to attain their full health
potential;
● No one disadvantaged from achieving said potential
● Place of residence
● Race/ethnicity/ culture/language
● PROGRESS-Plus ● Occupation
● Gender/sex
● Religion
● Education
● Socioeconomic status
● Social capital
● Plus other factor possible
factors such as disease status or
disability
Legal
Implications
● Consider relevant local and international laws on:
○ Health technology regulation (patent, market entry, off-label use, data protection,
product liability, etc)
○ Patient rights
○ Disease-specific laws and policies of relevant health sector agencies
Topic Nomination
AO 2020-0041
In the event of a public health
emergency (as defined in the
Topic Assessment UHC Act-IRR), the HTAC may do
an expedited process of HTA.
RAPID REVIEWS
Follow systematic review
process (8-12 months) but
Decision by SOH
simplify its components;
1-3 months
Key Takeaways