(For Audience) HTA 101 - Session 1 (02 Dec 2020) For Researchers and Academe

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Session Objectives

1. Describe the organizational


structure and functions of HTA
Philippines

2. Describe how HTA helps national and


regional health systems achieve UHC

3. Describe how different stakeholders


can participate in HTA

HTA 101: Moving Together Towards UHC


Overview of HTA
in the
Philippines
Presented by:

Anna Melissa Guerrero, MD, MPH


(HTA)
HTA Unit Head

HTA 101: Moving Together Towards UHC


Overview of HTA in the Philippines

What are health technologies?

Any healthcare intervention used to promote health, to


prevent, diagnose or treat disease or for rehabilitation or long-
term care

HTA 101: Moving Together Towards UHC


Overview of HTA in the Philippines

Health Technology Assessment


HTA refers to the systematic
evaluation of properties, effects or
impacts of health technologies
developed to address a health problem
and improve quality of lives and health
outcomes.

HTA 101: Moving Together Towards UHC


Overview of HTA in the Philippines

Key Principles: Dimensions of


HTA
Clinical Economic
Efficacy, Safety, Efficiency, Costs,
Effectiveness, Indications, Cost-effectiveness,
Populations affected Cost utility, Cost
benefit
HTA

Patient Related Organizational


Social Impact, Ethics, Diffusion, De/centralization,
Acceptability, Accessibility, Skill-Routines,
Psychological Reactions Education-training

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.

HTA 101: Moving Together Towards UHC


Overview of HTA in the Philippines

Sample Topics for Health Technology Assessment

Medicines to be listed in the Vaccines under the Health technologies/services funded


Philippine National Formulary National Immunization Program through DOH and Philhealth

HTA 101: Moving Together Towards UHC


Overview of HTA in the Philippines

Who does HTA in the


Philippines?

MARKETING APPROVAL ESSENTIAL MEDICINES LIST PURCHASING


Safety, efficacy and • Comparative effectiveness • Sustainability
quality • Costs/Cost-effectiveness • Equity
• Budget impact • Affordability
• Health service impact
• Equity/ethical/social implications

No structured and well-coordinated HTA framework for health interventions and technologies beyond drugs

HTA 101: Moving Together Towards UHC


Overview of HTA in the Philippines

Economic evaluations in the national


formulary

https://doi.org/10.1371/journal.pone.0131156 https://doi.org/10.1186/s12889-015-2046-1

HTA 101: Moving Together Towards UHC


Overview of HTA in the Philippines

Access to quality and


affordable healthcare and
health technologies

Competing public health Growing public demand for


priority concerns equitable health services

HTA 101: Moving Together Towards UHC


Overview of HTA in the Philippines

RA 11223 | Universal Healthcare Act

HTA 101: Moving Together Towards UHC


Overview of HTA in the Philippines

HTA under UHC Act


Key Stipulations
● Institutionalizing HTA as prerequisite for public financing and coverage
decisions of DOH and PhilHealth
● Creation of the Health Technology Assessment Council (HTAC) supported by
a unit with technical secretariat and policy planning and evaluation teams

HTA 101: Moving Together Towards UHC


HTA as a priority setting mechanism to guide coverage
decisions Priority Setting

Implementation Optimization
(Health Decisions
technology
management)
HTR
Monitoring Health technology
reassessment
&
Evaluation

HTA 101: Moving Together Towards UHC


Overview of HTA in the Philippines

HTA supports the health system in achieving UHC


through:

Transparency and Better resource


Priority setting Price negotiation
accountability allocation

HTA 101: Moving Together Towards UHC


Overview of HTA in the Philippines

Stakeholders – Healthcare
Multidisciplinary
providers, patients and public,
Researchers and Experts
industry

The HTA
System

Decisionmakers Technical Secretariat

HTA 101: Moving Together Towards UHC


Overview of HTA in the Philippines

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

HTA 101: Moving Together Towards UHC


Overview of HTA in the Philippines

The new implementing guidelines on HTA

HTA 101: Moving Together Towards UHC


The HTA
Administrative
Order
Presented by:

Katherine Ann Reyes, MD, MPP


HTAC Subcommittee on Preventive
& Promotive Health

HTA 101: Moving Together Towards UHC


The HTA Administrative Order

Administrative Order No. 2020-0041


Title

The New Implementing Guidelines on Health


Technology Assessment to Guide Funding Allocation
and Coverage Decisions in support of Universal
Health Care

Function

Sets HTA framework through the Process and


Methods Guides, identifies the roles and
responsibilities of stakeholders

HTA 101: Moving Together Towards UHC


The HTA Administrative Order Section V. B.

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

PhilHealth Benefit Package


Development

HTA 101: Moving Together Towards UHC


HTA Methods Guide

Criteria guiding HTAC


recommendations

Responsiveness to
magnitude, severity,
Interventions must address medical conditions
& equity placing the heaviest burden on the population

HTA 101: Moving Together Towards UHC


HTA Methods Guide

Criteria guiding HTAC


recommendations

Safety Best available evidence must show intervention to


and Effectiveness be safe and effective

HTA 101: Moving Together Towards UHC


HTA Methods Guide

Criteria guiding HTAC


recommendations

The intervention must be affordable and costs Affordability


must be viable to funding agents and Viability

HTA 101: Moving Together Towards UHC


HTA Methods Guide

Criteria guiding HTAC


recommendations

The intervention must provide overall gain to Cost


the health system and outweigh opportunity Effectiveness
costs

HTA 101: Moving Together Towards UHC


HTA Methods Guide

Criteria guiding HTAC


recommendations

The intervention must have economic Household


studies; Financial Impact
reduce out-of-pocket expenses

HTA 101: Moving Together Towards UHC


The HTA Administrative Order Section V. C.-D.,
M.

As new evidence arises, reviews and periodic


evaluations shall ensure that health
technologies funded by the DOH and PhilHealth
continue to add value to the health system.

HTA 101: Moving Together Towards UHC


The HTA Administrative Order Section V.
C-.D.

HTA Process and Methods Principles

Ethical Soundness Inclusiveness Scientific Defensibility Transparency

Efficiency Enforceability Due Process

HTA 101: Moving Together Towards UHC


The HTA Administrative Order Section V. N.-Q.

HTA implementation During Public Health Emergencies


The HTA Council may do expedited HTA
timeline upon the receipt of a written letter from
the Secretary of Health.

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

HTA 101: Moving Together Towards UHC


The HTA Administrative Order PHEs Defined in RA 11223 (UHC Act)

Public Health Poses a high probability of any of the


following:
Emergency
Common causes:

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 101: Moving Together Towards UHC


The HTA Administrative Order

Decision-makers 3. FINAL DECISION

HTA Framework
● Secretary of Health
● DOH Executive Committee
● PhilHealth Board of Directors

HTA Council 2. RECOMMENDATION


Core
Committee

Clinical Medical and Preventive and


Traditional Other Health
Drugs Vaccines Equipment and Surgical Promotive
Medicine Technologies
Devices Procedures Health

Regular resource persons: 1. EVIDENCE GENERATION


FDA, PhilHealth, patient groups, HTA Unit
clinical experts ● Evidence generation
HTA Research Network
● Policy and planning
By-invitation resource
● Technical secretariat support
persons:
Reps from private sector and
HCPs

HTA 101: Moving Together Towards UHC


The HTA Administrative Order HTAC Core Committee

HTA Council Composition

Marita V. Tolentino Reyes, MD


Chair, Core Committee

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

Aleli D. Kraft, PhD Jacinto Blas V. Mantaring III, MD, MSc


Health Economist Clinical Epidemiologist/Evidence-based Medicine Expert
Core Committee Core Committee

HTA 101: Moving Together Towards UHC


The HTA Administrative Order HTAC Subcommittees

HTAC Subcommittees Preventive and Promotive Health

Limuel Anthony Abrogena, MD, FPAFP


Katherine Ann Reyes, MD, MPP
Luz Barbara Dones, MPH, RN

Drugs Clinical Equipment & Devices

Agnette Peralta, MSc Traditional Medicine


Noel Juban, MD, MSc
Lizette Kristine Lopez, MD Catherine Manuela Ramos, MSc
Marc James delos Santos, MD Isidro Sia, MD, PhD
Imelda G. Peña, RPh, DrPH
Gemiliano Aligui, MD, MPH, PhD
Martin Camara, DC

Vaccines Medical & Surgical Procedures


Other Health Technologies

Mediadora Saniel, MD, MBA-H Maria Minerva Calimag, MD, PhD


Iris Thiele Isip Tan, MD, MSc,
Jose Enrico Lazaro, PhD Joan Cristine Lareza, MD, FPOGS,
FPCP, FPSEDM
Mary Anne Roldan-Castor, MD, FPSUOG, FPSMS
Raymond Francis Sarmiento, MD
FPPS, FPSAAI Maria Isabelita Rogado, RN, MAN
Josefina Tuazon, RN, MN, DrPH

HTA 101: Moving Together Towards UHC


Health
Technology
Melissa Guerrero, MD,
Assessment MPH (HTA)
Head

Unit
As of October 2020
Jovy Veranda Jeff Madrona Jun Paculba
Admin Team Admin Team Admin Team

Sheena Samonte Yen Genuino-Marfori,


Lead for Tech Sec RPh, MSc
Team Lead for PPE Team

Norie Cagasan, Sab Aguinaldo, Maan Bermudez, Patty Encarnacion,


Raz Cabus, RND CJ Peradilla Marv Fajardo, MD
RND RPh MD RPh

Mica Policarpio, Nathan Solibaga, Sarah Obmaña,


Mico Ramos Bright Judan Lara Liban, RPh Ally Mondala, RPh
RPh RCh RPh

April Ocampo Arwin Onda, RPh Pau Panopio, RPh Mark Ramos

Yves Zuñiga,
Wincy Reyes Deinzel Uezono
FRSPH
The HTA Administrative Order Section V. B.

Technical resource persons

01 Non-voting relevant experts, stakeholders and


representatives

Regular resource persons from DOH, PhilHealth, FDA, PITAHC,


02 patient groups and clinical medicine experts

03 By-invitation from the private sector and health care


providers

Subject to the same Conflict of Interest (COI) disclosure and COI management requirements as
regular HTAC members

HTA 101: Moving Together Towards UHC


The HTA Administrative Order Section VI.
D.

HTA Research Network


A network of research partners shall be formed jointly by DOH and DOST to support
the activities of the HTA Unit.

The network aims


to:
01 Implement a research agenda related to HTA

Conduct trainings, workshops, and other activities to


02 build capacity in conducting assessments.

HTA 101: Moving Together Towards UHC


The HTA Administrative Order

Roles and Responsibilities of


Offices

HTA 101: Moving Together Towards UHC


The HTA Administrative Order Section VII. | Roles &
Responsibilities

Decision Makers Partners

Office of the Secretary of Department of Science and Technology


Health

PhilHealth Board of Directors DOH - Health Regulation Team

HTA 101: Moving Together Towards UHC


The HTA Administrative Order Roles & Responsibilities

DOH Offices and Attached


Agencies
Input Data Process Planning

Epidemiology Bureau (EB)


Disease Prevention and Control
Legal Service (LS) Health Policy
Bureau (DPCB)
Food and Drug Administration (FDA) Development and
Price Negotiation Planning Bureau
Health Facilities Enhancement
Philippine Institute of Traditional and Board (PNB) (HPDPB)
Program (HFEP)
Alternative Health Care (PITAHC)

HTA 101: Moving Together Towards UHC


HTA Research
Networks
Presented by:
Jaime C. Montoya, MD, MSc, PhD, CESO
II Executive Director, Philippine Council for
Health Research and Development
Department of Science and Technology

HTA 101: Moving Together Towards UHC


HTA Research Network

Enabling Factors for Effective & Sustainable HTA


Network*

Shared Goals within the Clear governance Effective


structures Sustained resources communications support
Network

*Reference [WHO 2016: Key enabling factors in effective and sustainable research networks]

HTA 101: Moving Together Towards UHC


HTA Research Network Enabling Factors

DOST-PCHRD & HTA Philippines:


Partnership Objectives Shared
Goals

● Conduct capacity and platform-building


for regular HTA activities
● Develop a mechanism for implementing
health technology assessments efficiently

HTA 101: Moving Together Towards UHC


HTA Research Network Enabling Factors

Expected role of research network members


Shared
Goals
● As institutions
○ Identify faculty and staff with HTA expertise
○ Oversee HTA studies being conducted by
constituents
○ Participate in periodic M&E activities
○ Develop short courses, post-graduate trainings
for HTA related disciplines

HTA 101: Moving Together Towards UHC


HTA Research Network Enabling Factors

Expected role of research network members


Shared
Goals
● As individuals
○ Conduct studies pertinent to HTA
○ Participate in peer review
○ Submit reports on time

HTA 101: Moving Together Towards UHC


HTA Research Network Enabling Factors

Stakeholder Roles and


Responsibilities Shared
Goals
Research Coordination and Evidence Generation
Technical Support

Health Technology Assessment Office Local and International Universities

Health Policy Development and Non-government research organizations


Planning Bureau (HPDPB)

DOST PCHRD Health Professional Societies

HTA 101: Moving Together Towards UHC


HTA Research Network Enabling Factors

Framework for
collaboration Research
Quality
Assurance
HTAC DOST DOH
network

Governance
HPDPB and Structure
HTAO

International
NGO Local university
universities

Deliberation

HTA 101: Moving Together Towards UHC


HTA Research Network Enabling Factors

How to be part of the HTA Research Network


Need to define:
● Minimum expertise of research groups
● Minimum standard methodology Governance
● Improvement of HTA methodology Structure

● Review process during monitoring and


evaluation
● Available resources for training programs
● Research dissemination platforms
● Affiliated in a research institution
with administrative and financial
support

HTA 101: Moving Together Towards UHC


HTA Research Network Enabling Factors

How to be part of the HTA Research Network


What are the mechanisms on engaging public and private
institutions in the research network?
● Directed Call (COVID-19 Topics) Governance
Structure
● Pre-selected institutions will be contacted for research
● Open Call
● Publish list of available topics for research,
capable institutions will contact HTA
● Letter of Intent to be part of the cluster or consortium

HTA 101: Moving Together Towards UHC


HTA Research Network Enabling Factors

COVID-19 Topics: Commissioning Process


List of topics Directed call
Research
HTAC AHEAD-HPSR DOH
Institutions

Research Quality
Institutions Assurance

Research HPDPB and


Sustained
Institutions HTAO
Resources
STA: 2 weeks
Complex: 2
months
Deliberation

HTA 101: Moving Together Towards UHC


HTA Research Network Enabling Factors

Training Programs
● Plan to conduct HTA training programs
● Organize core trainers
› HTAC and International partners (HITAP, UK NICE)

● Plan to develop postgraduate training for HTA related disciplines


Sustained
Resources

HTA 101: Moving Together Towards UHC


HTA Research Network Enabling Factors

Research Dissemination Plans


● Online HTA research repository
● Accessible to the public

● HTA website

Effective
Comms

HTA 101: Moving Together Towards UHC


HTA Research Network Enabling Factors

COVID-19 research timeline and key


activities
Dec 2020 Jan 2021 Q1 2021 Mar 2021 Q2 2021

Submission of LOI Awarding of


Launching activity Target completion
Orientation activity Development of contracts and
& call for dates
TOR implementation
partners
STA: 2 weeks
Complex: 2
months

HTA 101: Moving Together Towards UHC


HTA Research Network

The significance of being an institutional


member of the HTA Research Network
● Expansion of the institutional faculty development program
● Broadening of the institutional research portfolio
● Recognition as a significant contributor to the attainment of universal
health care nationally and regionally
● Better appreciation of institutional relevance in national development

HTA 101: Moving Together Towards UHC


HTA Research Network

Best practices in organizing research


networks
Common interest and priority agenda Information sharing platforms

Aligned thrusts of the institutions Capacity building


activities

Established oversight mechanism Recognition for performing institutions

HTA 101: Moving Together Towards UHC


HTA Research Network

Common challenges in organizing research


networks
● Institutional commitment
● Individual commitment to promote network
● Lack of a common results framework
● Lack of joint activities among members
● Lack of alignment between funding and network
cycles
● Lack of donor’s interest to fund infrastructure

HTA 101: Moving Together Towards UHC


HTA Research Network

Key Takeaways

Collaboration strengthens the science


01 behind and practice of local HTA

Building an HTA research networks will help


02 multidisciplinary experts to work together and share
perspectives

Especially during PHEs, research networks will allow us to


03 quickly collect and share more data

HTA 101: Moving Together Towards UHC


The HTA Process
Guide
Presented by:
Limuel Anthony Abrogena, MD, FPAFP
Chair, HTAC Subcommittee on Preventive &
Promotive Health

HTA 101: Moving Together Towards UHC


HTA Process Guide Process Guide
Overview

What is the Process Guide?


● Reference document detailing:
○ HTA Governance Framework
○ General and Expedited HTA Process,
timelines
○ Important Forms and Templates

● Should be interpreted together with


the Methods Guide

HTA 101: Moving Together Towards UHC


HTA Process Guide

The HTA Process


Major Applications

Existing Health Technologies


● Currently financed by DOH and PhilHealth
General ● RA 11223 Sec 41(g) Transitory Provision
HTA Process
New Health Technologies
● Considered to be financed by DOH and PhilHealth
● RA 11223 Sec 6 Service Coverage

HTA 101: Moving Together Towards UHC


HTA Process Guide

The HTA Process


Major Applications

Expedited For all HTs considered for funding to address


HTA Process Public Health Emergencies (PHEs)

HTA 101: Moving Together Towards UHC


HTA Process Guide

The HTA Process


Major Applications

New HTs; not PHE but DOH and PhilHealth


priorities (4 Topics may be Urgent HTA Process
accepted per quarter) (for non-PHEs)

HTA 101: Moving Together Towards UHC


HTA Process Guide

The HTA Process


Major Applications Minor Application

Scope of Minor Inclusions


● Additional strength
● Additional packaging Minor Application
● Additional pack size/volume

HTA 101: Moving Together Towards UHC


HTA Process Guide Stakeholder role in the HTA process
flow

HTA Steps General Public Patients HCPs Policymakers Industry Researchers

Topic Nomination

Topic Prioritization

Scoping and Protocol Development


Legend

Assessment Topic
Proponent

Peer
Reviewer

Evidence Appraisal Assessor as part


of research
Recommendation network

Resolution Consultee

Decision Appellant

Dissemination Participant

HTA 101: Moving Together Towards UHC


HTA Process Guide Overview of HTA Processes

Final Week

General HTA Process Dissemi


nation
Week 57-128

Decision
Week 50-
125
Week 48-119 Resolution

Recommendation

Week 0-8 Week 8-24 Week 24-28 Week 28-111 Week 44-115

Topic Topic Scoping & Topic Evidence


Nomination Prioritization Protocol Assessment Appraisal
Development

Week 0-8 Week 1-13 Week 13-15 Week 15-16 Final Week

Topic Nomination Topic Evidence Appraisal Decision Dissemination


& Prioritization Assessment & Recommendation Expedited HTA Process

HTA 101: Moving Together Towards UHC


HTA Process Guide General HTA Process |
Algorithm

GENERAL HTA
PROCESS

HTAU Technical Scoping and


Topic Topic
Secretariat calls for Protocol
Nomination Assessment
topic nomination Development

Topic Prioritization

Evidence
Resolution Decision by SOH
Appraisal

Initial Recommendation Dissemination

HTA 101: Moving Together Towards UHC


HTA Process Guide General HTA Process | Step
1

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

HTA 101: Moving Together Towards UHC


HTA Process Guide General HTA Process | Step
2

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.

What happens to topics that fail to meet these criteria? Week 24


Clarificatory meeting
Applications shall no longer proceed with the assessment and
will need to reapply as new topics.

HTA 101: Moving Together Towards UHC


HTA Process Guide General HTA Process | Step
3

SCOPING & PROTOCOL DEVELOPMENT, TOPIC ASSESSMENT,


EVIDENCE APPRAISAL, INITIAL RECOMMENDATION

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

HTA 101: Moving Together Towards UHC


HTA Process Guide General HTA Process | Step
7

RESOLUTION FROM HTAC &


DECISION OF THE SOH

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

HTA 101: Moving Together Towards UHC


HTA Process Guide General HTA Process | Final
Step

DISSEMINATION

Facebook hta.doh.gov.ph Webinars

HTA 101: Moving Together Towards UHC


HTA Process Guide Overview of HTA Processes

Week 0-8 Week 1-13 Week 13-15 Week 15-16 Final Week

Topic Nomination Topic Evidence Appraisal Decision Dissemination


Expedited HTA Process
& Prioritization Assessment & Recommendation

Week 0-8 Week 8-24 Week 24-28 Week 28-111 Week 44-115

Topic Topic Scoping & Topic Evidence


Nomination Prioritization Protocol Assessment Appraisal
Development
Week 48-119

Recommendatio Week 50-125


n
Resolutio
Week 57-128
n
Decision

Final Week
General HTA Process
Dissemination

HTA 101: Moving Together Towards UHC


HTA Process Guide Expedited HTA Process |
Algorithm

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

Weeks 1-13 Weeks 13-15 Weeks 15-16

HTA 101: Moving Together Towards UHC


HTA Process Guide Expedited HTA Process | Rapid
Reviews

Rapid Reviews for COVID-19 HTs Guidance documents for the


implementers and users of
the health technology on the
minimum specifications

Rapid reviews serve as


● Rapid antigen test (15 Oct 2020) evidentiary basis for HTAC
recommendation

● Rapid antibody tests (31 July 2020)


● RT-PCR for COVID-19 diagnosis (18 May 2020)
● Extracorporeal membrane oxygenation (10 Sept 2020)
● Investigational drugs for COVID-19 (Apr 2020)
● AI-assisted diagnosis for COVID-19 (Mar, Apr 2020)

Access our COVID Rapid Reviews


hta.doh.gov.ph/assessments
Evidence summaries
present HTAC
recommendation on
specific HTs and how they
considered evidence

HTA 101: Moving Together Towards UHC


HTA Process Guide

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

● Existing HTs (since October 2019) from DOH and PhilHealth


2 Current Annual HTA Process ● Expedited HTA Process (since March 2020, COVID-19)
● New HTs considered as DOH and PhilHealth priorities

3 HTA Processes in the works ● New HTA Processes (September 2021)

HTA 101: Moving Together Towards UHC


The HTA Methods
Guide
Jacinto Blas Mantaring III, MD, MSc
Clinical Epidemiologist/Evidence-based
Medicine Expert, Core Committee

Aleli Kraft, PhD


Health Economist, Core Committee

Maria Carinnes Alejandria, PhD


Sociologist/Anthropologist, Core
Committee HTA 101: Moving Together Towards UHC
The HTA Methods Guide:
Overview and Clinical
Assessment
Presented by:

Jacinto Blas Mantaring III, MD, MSc


Clinical Epidemiologist/Evidence-based
Medicine Expert, HTAC Core Committee

HTA 101: Moving Together Towards UHC


HTA Methods Guide Methods Guide
Overview

What is the HTA Methods Guide?


● Guides researchers in conducting HTA
● Reports generated inform how DOH and
PhilHealth allocate public funding and
resources

HTA 101: Moving Together Towards UHC


HTA Methods Guide General HTA Process | Recap of Topic Assessment

TOPIC
ASSESSMENT

Key Participants

● HTA Research Network


● HTA Unit Assessment Team
Week 28-111
Assessment of dossier and formulation of analyses
Option 1: Critical Appraisal of a submitted HTA by
the proponent
Option 2: Conduct of HTA (either by HTAU or commissioned
through the HTA research network)

HTA 101: Moving Together Towards UHC


Basic Methodological Initial PICOT
Framework of Topic
Assessment
Scoping

Final PICOT

Protocol
Development

Clinical
Assessment

Superior Non-inferior Inferior

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

Final PICOT O Outcome/s

T Timeframe
Protocol
Development

Clinical
Assessment

Superior Non-inferior Inferior

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

Superior Non-inferior Inferior

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

Superior Non-inferior Inferior

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

Superior Non-inferior Inferior

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

HTA 101: Moving Together Towards UHC


HTA Methods Guide General HTA Process | Types of Economic
Evaluation

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

Cost expressed as Philippine Peso

Additional
Benefit expressed as Natural units Natural units Philippine peso
quantity/quality of life

HTA 101: Moving Together Towards UHC


HTA Methods Guide General HTA Process | Economic
Evaluation

Budget Impact Analysis


● Used to estimate how health interventions may impact funding over time
● Aims to increase awareness among DOH & PhilHealth policymakers, and aid
in budget or service planning
● Perspective: public payer

HTA 101: Moving Together Towards UHC


HTA Methods Guide

Philippine Reference Case for Health Economic


Evaluation
Decision Problem Perspective Comparator

Rationale of the study and Current standard of care or


Preferably publicly-funded
the policy question (PICO, most widely used
healthcare payer
setting, among others) intervention or no
comparator

Time Horizon Heterogeneity

● Lifetime horizon ● Effects and costs of HTs on


● Time horizon shorter than sub-populations
patient’s lifetime ● Relevant subgroups a priori

HTA 101: Moving Together Towards UHC


HTA Methods Guide

Philippine Reference Case for Health Economic


Evaluation
Measure of Health Outcomes Measure of Costs

Preferably expressed as utilities; quality-adjusted


life years (QALY):
● CEA/CUA: direct healthcare costs
QALY = Preferences for a health state X Time
in that state (Years) ● HFI: direct and non-healthcare costs

Disability adjusted life years (DALYs) may also be


acceptable if QALY is unavailable

HTA 101: Moving Together Towards UHC


HTA Methods Guide

Philippine Reference Case for Health Economic


Evaluation
Discounting Uncertainty

● Annual base case discount rate of 7%


(Ramsey Formula) ● Explore and quantify uncertainties through
● Decrease discount rate as time period increases appropriate sensitivity analyses
for time horizon greater than 30 years ● Deterministic Sensitivity Analysis
● Perform sensitivity analysis at 3 and 10% ● Probabilistic Sensitivity Analysis (PSA)
● Apply same rate to costs and benefits at a time

HTA 101: Moving Together Towards UHC


HTA Methods Guide General HTA Process | Economic
Evaluation

When are HTs considered “cost-effective” in the


Philippines?
01 02

Threshold for Cost or Non-Cost Effectiveness Other Decision Criteria

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

HTA 101: Moving Together Towards UHC


The HTA Methods Guide:
Ethical, Legal, Social and
Health Systems Impact
Assessments
Presented by:
Maria Carinnes Alejandria, PhD
Social Anthropologist,
HTAC Core Committee

HTA 101: Moving Together Towards UHC


HTA Methods Guide General HTA Process |
ELSHSI

Equity
Considerations
● Everyone receives fair opportunity to attain their full health
potential;
● No one disadvantaged from achieving said potential
● PROGRESS-Plus

HTA 101: Moving Together Towards UHC


HTA Methods Guide General HTA Process |
ELSHSI

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

HTA 101: Moving Together Towards UHC


HTA Methods Guide General HTA Process |
ELSHSI

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

● Consider using EUnetHTA ELSI checklist in assessing and reporting


ethical, legal, and social issues surrounding a proposed health technology

HTA 101: Moving Together Towards UHC


HTA Methods Guide General HTA Process |
ELSHSI

Health Systems Impact


● Consider availability, feasibility or and capacity of human resources, service
capacity or facilities, and the potential to impact other roles of existing
divisions or organizations
● Conduct other qualitative methods (in-depth interviews, focus group
discussions, surveys) with DOH program managers, HCPs, LGUs, other
relevant stakeholders

HTA 101: Moving Together Towards UHC


HTA Methods Guide Expedited HTA Process | Recap of Topic Assessment

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.

Evidence Appraisal & Recommendation

RAPID REVIEWS
Follow systematic review
process (8-12 months) but
Decision by SOH
simplify its components;
1-3 months

Dissemination Khangura, 2012 (as cited in Dobbins, 2017)

HTA 101: Moving Together Towards UHC


HTA Methods Guide

Key Takeaways

HTA Methods Guide sets methodological standards that inform


01 the HTAC’s recommendations and decisions

Like the PG, the MG hinges upon inclusivity, transparency,


02 accountability

Sound recommendations rely on stakeholders with different fields


03 of expertise, such as clinical, economic, social

HTA 101: Moving Together Towards UHC


Have questions, concerns, or suggestions?
Contact us via email at [email protected]
or visit our website at hta.doh.gov.ph.

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