Health Teachnology Assessment • Developed to address a health problem such

as Covid-19
• Improves the quality of lives and health
---- January 29, 2022 -----
outcomes, example the vaccines, evaluate
Moving Together Towards Universal Health and assed if it does work and the intention of
Care why it made it in the first place (which is
made to prevent the severity of the disease
Session Objectives
and minimize the hospitalization)
• Describe the organizational structure and
• Hospital should be the last line of defense,
functional of HTA Philippines
so we must go into the prevention way first
• Describe how HTA helps national and regional (prevention such as health care protocols,
health system achieve UHC social distancing, wearing mask and
vaccinated)
• Describe how different stakeholder can
participate in HTA • Researchers of HTA must assessed the
vaccine first before distribute it to the
Stakeholders: (public health offices, healthcare
public. They must report it first to the
professional and any related industries; patients,
government officials that this vaccine is
public and government)
worked and can minimize the severity of
Overview of HTA Philippines disease and hospitalization)
What are health technologies? • And if it works, they must also see to it if
kaya ba sa budget and benefits must be
➢ Any healthcare intervention used to promote
bigger than the risk.
health to prevent, diagnose or treat disease or
for rehabilitation or long-term care Dimension of HTA
• Intervention can be devices, certain • Clinical
healthcare services, software or certain
• Economic
program, medicines, etc
• Patient Related
• Because of the pandemic, the function of
HTA was recognized more that’s why they • Organizational
assessed the vaccine (basically they assessed
• Above mentioned are the aspects that the HTA
the vaccine if it is worth it for the
will assessed. They also do systematic related
government to fund it for us)
review of literature. They also do meta analysis.
Health Technology Assessment They are looking of existing and current
evidences of whatever health technology so that
➢ HTA refers to the systematic evaluation of
they can assess if it work.
properties, effects or impacts of health
technologies developed to address a health • Vaccine in Europe, USA, South America,
problem and improve quality of lives and health Southeast Asia and other part of Asia, how’s
outcomes. their effectivity, real world data, was it positive
for them, was it negative for them. Its like
• Evaluating the intervention (mentioned
comparisons, if it worked for them that’s why
above)

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 they find it its worth to spend certain kind of So FDA is marketing approval. And also they’re
health technology. the one who does test for safety ang efficacy.
• HTA look for the existing literature and going to • HTA – looking for the existing evidences and do
look for data such as for: economic analysis (cost-effective analysis) so
that they can make recommendation whether or
• Clinical
not the “product”/health technology is good to
• Efficacy, Safety, Effectiveness, Indications, fund the government)
Populations affected
• Economic • DOH – Pharmaceutical Development
• Efficiency, Costs, Cost-effectiveness, Cost
o Essential Medicine List
utility, Cost benefit
o Purpose
• Patient Related
▪ Comparative effectiveness
• Social Impact, Ethics, Acceptability,
Psychological Reactions ▪ Costs/Cost-effectiveness
• Organizational ▪ Budget impact
• Diffusion, De/centralization, Accessibility, ▪ Health service impact
Skill-Routines, Education-training
▪ Equity/ethical/social implications

• (Patient-Related: Acceptability) HTA looking • During lockdown, a lot of business was closed.
for data that the public will be open minded and
Some jobs are loss due to certain position and
accept the vaccine. Because the Government
jobs are not consider as essentials. The analysis
don’t want to buy a vaccine that will not utilized
of HTA with the help of other sectors such as
the private and public stakeholder, if they invest
the vaccine which is given to everyone for free
Who does HTA in the Philippines?
will the country get the returned of investment
No structured and well-coordinated HTA framework na if we increase the vaccine uptake, more
for health interventions and technologies beyond people will then be employed, more business
drugs reopened or they are new business recognized
that they can profit in the good way from this
• FDA
pandemic. Also, small and medium business and
o Marketing Approval big enterprises will be open as the vaccination
uptake will goes up. And HTA looking this kind
o Purpose:
of effect. HTA seeing budget given for this
▪ Safety, efficacy and quality vaccines and what’s going on with our revenue.
They’re looking at that
• registering the product, provide a certificate for
EUA (emergency use authorization) so that it
can be used to the Filipino public (nothing
should be used without the knowledge of FDA).

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 • PhilHealth Some challenges of HTA

o Purchasing • Competing public health priority concerns
o Purpose: • Access to quality and affordable healthcare and
health technologies
▪ Sustainability
o An example of it is the antigen test kits
▪ Equity
and RT-PCR
▪ Affordability • Growing public demand for equitable health
services

Economic Evaluation in the national formulary Some laws that aligned to UHC and priority to HTA
• HTA check what’s on the formulary. Checked • Rare disease Act – R.A 10747
the evidences, the literature, economic impact • Mental health Law – R.A 11036
and these medicine in the formulary has.
• Cancer control Act
• It is important what’s in the formulary is being
utilized and that we’re getting our money worth • Kalusugan at Nutrisyon ng Magnanay Act (First
on it 1000 days) – R.A 11148

R.A 11223 – Universal Healthcare Act (UHC)

Key Stipulations
• Institutionalizing HTA as prerequisite for public
financing and coverage decisions of DOH and
PhilHealth
• If UHC wasn’t sign, HTA couldn’t take action
yet
• Creation of the Health Technology Assessment
Council (HTAC) supported by a unit with
technical secretariat and policy planning and
evaluation teams
• To do the evaluation they have to create a
council (HTAC)

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 HTA as a priority setting mechanism to guide HTA supports the health system in achieving
coverage decisions UHC through:
• Market approval • Priority setting
o Regulatory review for product quality, • Transparency and accountability
efficacy and safety • Better resource allocation
• Priority setting • Price negotiation
o HTA
The HTA System
▪ CPG development
Who are involved:
o Which can be included?
• Multidisciplinary Researchers and Experts
▪ PhilHealth benefit packages • Stakeholders – Healthcare providers, patients
▪ DOH Public Health Programs and public, industry

▪ National Immunization Program • Decision maker

▪ Health Facilitates and • Technical Secretariat

Enlargement Program
Future Plans
▪ Phil national formulary • Establishment of the HTAC and the HTA Office
o At how much?
• Capacity building activities for HTAC,
▪ Price Negotiation Board / assessors, academic partners
bidding • Creation of PHL reference costs for economic
evaluations (2020)
• Implementation (Health technology • Development of methodological guides for
management) priority HTs under UHC: medical devices,
orphan drugs, cancer drugs, medical/surgical
o Monitoring and evaluation
procedures, traditional medicine
• Optimization Decisions • During this Covid, vaccine and other test
• HTR (Health technology reassessment) (antigen and RT-PCR) are the priority in the
HTA

The new implementing guidelines on HTA\

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 HTA Administrative Order • Cost Effectiveness

• Administrative Order No. 2020 – 0041 o The intervention must provide overall
gain to the health system and outweigh
• Title: The New Implementing Guidelines on
opportunity costs
Health Technology Assessment to Guide
Funding Allocation and Coverage Decisions in • Household Financial Impact
support of Universal Health Care
o The intervention must have economic
• Function: Sets HTA framework through the studies; reduce out-of-pocket expenses
Process and Methods Guides, identifies the roles • As new evidence arises, reviews and
and responsibilities of stakeholders
periodic evaluations shall ensure that health
• Identifies who’s in the HTA, what’s their technologies funded by the DOH and
position, what’s their duties and responsibilities PhilHealth continue to add value to the
health system.
HTA Institutionalization
o There are certain technologies help
• DOH and PhilHealth coverage depend on
improve the diagnoses part of healthcare
positive HTAC recommendations and approval
process, or prevention, treatment,
of Secretary of Health (SOH)
mitigation part of healthcare system.
• Aligns HTA with the processes of DOH and Does this health technology help the
PhilHealth burden certain roles from the healthcare
professional?
Criteria guiding HTAC recommendations
HTA Process and Methods Principles
• Responsiveness to magnitude, severity, &
equity • Ethical Soundness
o Interventions must address medical • Inclusiveness (for the masses)
conditions placing the heaviest burden • Scientific Defensibility
on the population
• Transparency
• Safety and Effectiveness
• Efficiency
o Best available evidence must show
intervention to be safe and effective • Enforceability
o Ex. The vaccine, HTA must look for the • Due Process
best profile, safety profile
HTA implementation timeline
• Affordability and Viability • Feb 20, 2019
o The intervention must be affordable and
o UHC Law (RA 11223) signed
costs must be viable to funding agents
• Oct 10, 2019
o Looking for the cost utility, cost
effectiveness and budget impact o UHC Law IRR signed

o Implementation Rules and

Regulations (IRR)

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 • Oct 2019 • Trade and travel restrictions

o HTAC established thru UHC Act HTA Framework
o Health Technology Assessment
Council
• Oct 2019 – 2021
o Existing health technologies
rationalized
• Sept 2021
o Tentative date to open new topic 1. Evidence Generation
nominations • Regular resource persons: FDA,
• 2024 PhilHealth, patient groups, clinical
experts By-invitation
o HTA transition to DOST
• Resource persons: Reps from private
➢ During Public Health Emergencies The HTA
sector and HCPs
Council may do expedited HTA upon the receipt
of a written letter from the Secretary of Health. • HTA Unit <-> HTA Research Network
o Evidence generation

Public Health Emergency o Policy and planning

Common causes: o Technical secretariat support

1. Bioterrorism 2. Recommendation

2. Appearance of a novel or previously • HTA Council : Core Committee

controlled or eradicated infectious agent or o Drugs
biological toxin
o Vaccines
3. A natural disaster
o Clinical Equipment and
4. A chemical attack or its accidental release
Devices
5. A nuclear attack or accident o Medical and Surgical
6. An attack or accidental release of Procedures
radioactive materials o Preventive and Promotive
Poses a high probability of any of the following: Health
• Large number of deaths in population o Traditional Medicine

• Large number of serious injuries or long- o Other Health Technologies

term disability (Long term Covid-19)
3. Final Decision
• Widespread or international exposure to • Decision-makers
toxic substances

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 o Secretary of Health o Mary Anne Roldan-Castor, MD, FPPS,

FPSAAI
o DOH Executive Committee
• Clinical Equipment & Devices
o PhilHealth Board of Directors
o Agnette Peralta, MSc
HTA Council Composition
o Catherine Manuela Ramos, MSc
• Marita V. Tolentino Reyes, MD Chair, Core
Committee o Marc James delos Santos, MD
• Ma. Carmen Cornelia-Tolabing, DrPH Public • Preventive and Promotive Health
Health Epidemiologist Core Committee
o Limuel Anthony Abrogena, MD, FPAFP
• Annabelle R. Borromeo, PhD, MHA, RN, CNS
o Katherine Ann Reyes, MD, MPP
Citizen’s Representative Vice Chair, Core
Committee o Luz Barbara Dones, MPH, RN
• Maria Carinnes P. Alejandria, PhD Social • Traditional Medicine
Anthropologist Core Committee
o Isidro Sia, MD, PhD
• Bu C. Castro, M.D. Ll.B. FPSP Medico-Legal
o Gemiliano Aligui, MD, MPH, PhD
Expert Core Committee
o Martin Camara, DC
• Martha Bugnosen-Cayad–an, MD, MPH, CESO
III Public Health Expert Core Committee • Other Health Technologies
• Cecilia C. Maramba-Lazarte, MD, MScID, o Iris Thiele Isip Tan, MD, MSc, FPCP,
MScCT Clinical Trial/Research Methods Expert FPSEDM
Core Committee
o Raymond Francis Sarmiento, MD
• Aleli D. Kraft, PhD Health Economist Core
o Josefina Tuazon, RN, MN, DrP
Committee
Health Technology Assessment Unit
• Jacinto Blas V. Mantaring III, MD, MSc Clinical
Epidemiologist/Evidence-based Medicine
Expert Core Committee

HTAC Subcommittee
• Drugs
o Noel Juban, MD, MSc
o Lizette Kristine Lopez, MD
They do this work
o Imelda G. Peña, RPh, DrPH
• HTA Unit <-> HTA Research Network
• Vaccines
o Evidence generation
o Mediadora Saniel, MD, MBA-H
o Policy and planning
o Jose Enrico Lazaro, PhD
o Technical secretariat support

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 Technical resource persons • Data

• Non-voting relevant experts, o Epidemiology Bureau (EB)
stakeholders and representatives
o Food and Drug Administration
• Regular resource persons from DOH, (FDA)
PhilHealth, FDA, PITAHC, patient
o Philippine Institute of Traditional
groups and clinical medicine experts
and Alternative Health Care
• By-invitation from the private sector and (PITAHC)
health care providers • Process
HTA Research Network
o Legal Service (LS)
• A network of research partners shall be formed
o Price Negotiation Board (PNB)
jointly by DOH and DOST to support the
activities of the HTA Unit • Planninng
• The network aims: o Health Policy Development and
Planning Bureau (HPDPB)
o Implement a research agenda related to
HTA The HTA Process Guide
o Conduct trainings, workshops, and other What is the Process Guide?
activities to build capacity in conducting • Reference document detailing:
assessments.
o HTA Governance Framework
Roles and Responsibilities of Offices
o General and Expedited HTA Process,
• Decisions makers
timelines
o Office of the Secretary of Health
o Important Forms and Templates
o PhilHealth Board of Directors
• Should be interpreted together with the Methods
• Partners Guide
o Department of Science and The HTA Process
Technology • General HTA Process
o DOH - Health Regulation Team
o Existing Health Technologies

▪ Currently financed by DOH and

DOH Offices and Attached Agencies PhilHealth
• Input ▪ RA 11223 Sec 41(g) Transitory
Provision
o Disease Prevention and Control
Bureau (DPCB) o New Health Technologies

o Health Facilities Enhancement ▪ Considered to be financed by

Program (HFEP) DOH and PhilHealth

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 ▪ RA 11223 Sec 6 Service o Evidence Appraisal & Recommendation

Coverage • Week 15-16
• Expedited HTA Process
o Evidence Appraisal & Recommendation
o For all HTs considered for funding to
• Week 15-16
address Public Health Emergencies
(PHEs) o Decision
• Urgent HTA Process (for non-PHEs) • Final week
o New HTs; not PHE but DOH and o Dissemination
PhilHealth priorities (4 Topics may be
General HTA Process
accepted per quarter)
• Week 24-28
o Non-PHEs – Non-Public Health
Emergency o Scoping & Protocol Development
• Minor Application • Week 41-111
o Scope of Minor Inclusions o Topic Assessment

▪ Additional strength • Topic Assessment

▪ Additional packaging o Evidence Appraisal

▪ Additional pack size/volume • Week 48-119

o Recommendation
• Week 50-125
o Resolution
• Week 57-128
o Decision
• Final week
Expedited HTA Process o Dissemination
• Week 0-8
o Topic Nomination
GENERAL HTA PROCESS
o Topic Nomination & Prioritization
1. HTAU Technical Secretariat calls for topic
• Week 1-13 nomination

o Topic assessment 2. Topic Nomination

• Week 8-24 3. Topic Prioritization

o Topic Prioritization 4. Scoping and Protocol Development

• Week 13-15 5. Topic Assessment

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 6. Evidence Appraisal • What happens to topics that fail to meet

these criteria?
7. Initial Recommendation
o Applications shall no longer proceed
8. Resolution
with the assessment and will need to
9. Decision by SOH reapply as new topics.

10. Dissemination • Week 8-24

o Comments on Shortlist

TOPIC NOMINATION • Week 8-9

• Who can nominate? o Appeal for non-shortlisted topics

o DOH Programs, PhilHealth, and • Week 24

other relevant stakeholders
o Clarificatory meeting
• How can they nominate?
SCOPING & PROTOCOL DEVELOPMENT,
o Accomplish documentary TOPIC ASSESSMENT, EVIDENCE
requirements specific to the APPRAISAL, INITIAL RECOMMENDATION
concerned health technology • Key Participants Invited experts (e.g.,
• When can they start nominating? Healthcare providers, Program Managers,
Patients)
o September 2021
• *The HTA Unit defines the overall scope of
• Week 0-4
technology assessment (PICO)
o Submission of Topics
• Week 4-8
• Week 24-28
o Checking for Compliance to
o Feedback to HTA Unit
Requirements
• Week 28-111
• Week 8-24
o Assessment of dossier and formulation
o Comments on Shortlist
of analyses
TOPIC PRIORITIZATION
• Week 44-115
• How does HTAC prioritize topics?
o Peer review of Preliminary Assessment
o HTAC screens topics based on
o Public Consultation on acceptability and
prioritization criteria.
other social values
• What if the nominated topic was not
o Quality assurance of output and
prioritized?
appraisal of result
o Proponents can undergo the 2-week
appeals period.

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 RESOLUTION FROM HTAC & DECISION OF • Week 15-16

THE SOH
o Evidence Appraisal & Recommendation
• Key Participants • Week 15-16
o General Public, Patients, Healthcare
o Decision
providers, Hospitals Policymakers,
Industry, Researchers • Final week
o *Stakeholders submit appeals to o Dissemination
reconsider negative HTA Council
EXPEDITED HTA PROCESS
recommendation
Point: Public health emergency or priority of DOH
• Week 48 – 119
and PhilHealth
o Recommendation making
1. Secretary of Health declares Public Health
• Week 50-152 Emergency
o Receipt of appeals 2. DOH National Health Program Director
submits documents to HTAU
• Week 52-125
3. HTAU Technical Secretariat receives
o Screening and consideration of appeals
documents

4. Assessment proceeds if HTA Council

DISSEMINATION approves
• HTA will disseminate once there will be positive 5. Topic Nomination & Prioritization
decision and uploaded their respective
6. Topic Assessment
government websites and the summery of the
recommendations 7. Evidence Appraisal and Recommendation

8. Decision by SOH

Expedited HTA Process 9. Dissemination

• Week 0-8
o Topic Nomination Rapid Reviews for COVID-19 HTs
o Topic Nomination & Prioritization • Rapid antigen test (15 Oct 2020)
• Week 1-13 • Rapid antibody tests (31 July 2020)
o Topic assessment • RT-PCR for COVID-19 diagnosis (18 May
2020)
• Week 8-24
• Extracorporeal membrane oxygenation (10 Sept
o Topic Prioritization
2020)
• Week 13-15 • Investigational drugs for COVID-19 (Apr 2020)
o Evidence Appraisal & Recommendation

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 Investigational drug – drugs that don’t have yet • Guides researchers in conducting HTA
registration or certificate to the FDA but being • Reports generated inform how DOH and
given to the public due to public emergency
PhilHealth allocate public funding and
• AI-assisted diagnosis for COVID-19 (Mar, Apr resource
2020)

TOPIC ASSESSMENT Weeks 41-111

Key Takeaways • The HTA Assessment Team synthesizes
1. HTA Process Guide evidence to assess the clinical, economic,
health system, ethical, legal and social
o HTA involves collective effort across
impacts of technologies; overseen by the
sectors
HTAC Subcommittees
o PG ensures inclusiveness, transparency
• Key Participants
and accountability
o HTA Research Network
o HTA processes transform topics into
action o HTA Unit Assessment

o Evidence-based recommendations move

PH closer to UHC • Team 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
2. Current Annual HTA Process
network)
o Existing HTs (since October 2019) from
DOH and PhilHealth
• Week 44-111
o Expedited HTA Process (since March
2020, COVID-19) o Assessment of dossier and
formulation of analyses
o New HTs considered as DOH and
PhilHealth priorities • Week 28-111

3. HTA Processes in the works o Assessment of dossier and

formulation of analyse
o New HTA Processes (September 2021)

The HTA Methods Guide

The HTA Methods Guide: Overview and Clinical

Assessment

What is the HTA Methods Guide?

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Basic Methodological • Health Technology will not be

recommended by HTAC
Framework of Topic Assessment
b. Non-inferior
• Economic Assessment (Cost-
minimization Analysis + Budget
Impact Analysis)
• Ethical, Legal, Social, and Health
System Implications Analysis

c. Superior
• Economic Assessment (Cost-
effectiveness/Utility Analysis +
Budget Impact Analysis)
• Ethical, Legal, Social, and Health
System Implications Analysis

1. Initial PICOT Cost Minimalization Analysis

• P Population • Ex. There is same medicine with same
• I Intervention classification and MOA but the other
medicine is cheaper than the other. So the
• C Comparator HTA will choose the cheaper one
• O Outcome/s Budget Impact Analysis
• T Timeframe • Used to estimate how health interventions may
• the practice of formulary, once pharmaceutical impact funding over time
endorse certain antibiotic. The hospital will • Aims to increase awareness among DOH &
compare the current antibiotic they have vs the PhilHealth policymakers, and aid in budget or
antibiotic that the medrep endorse service planning
2. Scoping • Perspective: public payer
3. Final PICOT

4. Protocol Development

5. Clinical Assessment

a. Inferior

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 Philippine Reference Case for Health Economic • Discounting

Evaluation
o Annual base case discount rate of 7%
• Decision Problem (Ramsey Formula)
o Rationale of the study and the policy o Decrease discount rate as time period
question (PICO, setting, among others) increases for time horizon greater than
30 years
• Perspective
o Perform sensitivity analysis at 3 and
o Preferably publicly-funded healthcare
10%
payer
o Apply same rate to costs and benefits at
• Comparator
a time
o Current standard of care or most widely
• Uncertainty
used intervention or no comparator
o Explore and quantify uncertainties
• Time Horizon
through appropriate sensitivity analyses
o Lifetime horizon
o Deterministic Sensitivity Analysis
o Time horizon shorter than patient’s
o Probabilistic Sensitivity Analysis (PSA)
lifetime
• Heterogeneity
When are HTs considered “cost-effective” in the
o Effects and costs of HTs on sub-
Philippines?
populations
• Threshold for Cost or Non-Cost Effectiveness
o Relevant subgroups a priority
o None currently in place; ICER
• Measure of Health Outcomes
thresholds from WHO often considered
o Preferably expressed as utilities; quality- as guides
adjusted life years (QALY): • Other Decision Criteria
o QALY = Preferences for a health state X
o Responsiveness to magnitude, severity
Time in that state (Years)
and equity; effectiveness and safety;
o Disability adjusted life years (DALYs) household financial impact; and,
may also be acceptable if QALY is affordability and viability
unavailable
The HTA Methods Guide: Ethical, Legal, Social
• Measure of Costs and Health Systems Impact Assessments
o CEA/CUA: direct healthcare costs Equity Considerations
o HFI: direct and non-healthcare costs • Everyone receives fair opportunity to attain
their full health potential;
• No one disadvantaged from achieving said
potential

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 • PROGRESS-Plus surveys) with DOH program managers,

HCPs, LGUs, other relevant stakeholders
o Place of residence
Topic Assessment
o Race/ethnicity/ culture/language
• AO 2020-0041 In the event of a public
o Occupation
health emergency (as defined in the UHC
o Gender/sex Act-IRR), the HTAC may do an expedited
process of HTA.
o Religion
• RAPID REVIEWS Follows systematic
o Education
review process (8-12 months) but simplify
o Socioeconomic status its components; 1-3 months
o Social capital Key Takeaways
o Plus other factor possible factors • HTA Methods Guide sets methodological
such as disease status or disability standards that inform the HTAC’s
recommendations and decisions
Legal Implications
• Like the PG (Process Guide), the MG
• Consider relevant local and international
(Method Guide) hinges upon inclusivity,
laws on:
transparency, accountability
o Health technology regulation (patent,
• Sound recommendations rely on
market entry, off-label use, data
stakeholders with different fields of
protection, product liability, etc)
expertise, such as clinical, economic, social
o Patient rights
•
o 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

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

- HTA will look up for the impact whether it is

positive or not
• Conduct other qualitative methods (in-depth
interviews, focus group discussions,

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