Unit 1: Introduction to Health Technology Assessment

economics

It is the study of scarcity, the study of how people use resources and respond to incentives, or the study of decision making.

economics

It can find ways of reconciling unlimited wants with limited resources.

economic efficiency

It is defines as "Producing at a point at which average product is maximized and average variable cost is minimized."

scarcity

The quest for economic efficiency stems from the fact that there are never enough resources to provide all the goods and services desire by a society.

costs

The economic concept of ___stems from the notion that resources have alternative uses (i.e., Money spent in a rehabilitation program for drug addicts is not available to be spent on prenatal care for indigent women.)

opportunity cost

is defines as the potential benefit that could have been received if the resources have been used in their next-best alternative.

economic efficiency

Adopting the concept of ___ implies that choices should be made in a way that maximizes the total benefit from the available resources.

economic optimization

When more than 1 alternative is available, the optimal choice produces an outcome that is most consistent with the decision maker's stated objectives.

constrained optimization

takes into consideration the cost and availability of resources (i.e., with an increase in patient volumes, should physicians in a small group practice hire an office manager, an additional nurse, or both?)

The Law of Demand

There is an inverse relationship between the amount of a commodity that a person will purchase and he sacrifice that must be made to obtain it.

The Law of Demand

when the price of an item is high, your purchases less, and when the price is lower, more is purchased. As long as the circumstances of the consumer don’t change materially, the inverse relationship holds

substituion effect

If the price of a branded drug goes up, an alternative drug or even a generic can substitute. This is referred as the __

demand goes up

when the price of a commodity goes down,__

higher demand

An increase in population size affects demand, too. More consumers result in a__for all goods or services

the law of supply

there is a direct relationship between the amount of a commodity that a producer will make available and the reward that is received.

the law of supply

Higher prices increase the availability of an item. At lower prices, less will be available.

supply and demand equilibrium

is the market price that exists when the quantity demanded equal the quantity supplied.

pharmacoeconomics

It is the description and analysis of the costs of drug therapy to health care systems and society.

pharmacoeconomics

It identifies, measures and compares the costs and consequences of pharmaceutical products and services.

costs

Represents the inputs used to obtain and use the pharmaceutical product or services.

Rx

represents the drug product or service being assessed

outcome

represents the health-related outcomes produced by the pharmaceutical product or service.

costs, Rx, outcome

basic pharmacoeconomic equation

cost- minimization analysis

only the costs of the intervention are compared because the outcomes are assumed to be equivalent

cost- minimization analysis

Cannot be used when outcomes of interventions are different

cost- minimization analysis

Example: comparing two generic medications that are rated as equivalent by the FDA

cost- effectiveness analysis

Measures outcomes in natural units (e.g., mmHg, cholesterol levels, symptom-free days [SFDs], years of life saved)

cost- effectiveness analysis

Outcomes are routinely collected in clinical trials and in clinical practice

cost- effectiveness analysis

Programs with different types of outcomes cannot be compared.

cost- utility analysis

Measures outcomes based in years of life that are adjusted by "utility" weights, which range from 1.0 for "perfect health" to 0.0 for יל "dead". Utility weighs incorporate patient or society preferences for specific health states.

cost- utility analysis

o consensus on how to measure these utility weights, and they are more of a "rough estimate" that a precise measure.

Can determine whether the benefit of a program or intervention exceed the costs of implementation & can compare multiple programs or interventions with similar or unrelated outcomes.

Not only are cost valued in monetary terms, but also the benefits

universal health coverage

defined by the WHO, ___ means that all people have access to the health services they need, when and there they need them, without financial hardships. It includes the full range of essential health services, from health promotion to prevention, treatment, rehabilitation and palliative care.

Kalusugang Pangkalahatan

universal health cure, also known as__ is the ‘provision to every Filipino of the highest possible quality of health care that is accessible, efficient, equitably distributed, adequately funded, fairly financed, and appropriately used by an informed and empowered public".

1. Progressively realize universal health care in the country through a systemic approach and clear delineation of roles of key agencies and stakeholders towards better performance in the health system

2. Ensure that all Filipinos are guaranteed equitable access to quality and affordable health care goods and services, and protected against financial risk.

what are the two RA 11223 Universal Health Care Act objectives

health technology

is the application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures and systems developed to solve a health problem and improves quality of lives.

RA 11223, Health Technology Assessment (HTA)

refers to the systematic evaluation of properties, effects or impact of health-related technologies, devices, medicines, vaccines, procedures and all other health0related systems developed to solves a health problem and improves quality of lives and health outcomes, utilizing a multidisciplinary process to evaluate the social, economic, organizational, and ethical issues a health intervention or health technology.

WHO, Health Technology Assessment (HTA)

refers to the systematic evaluation of properties, effects, and/or impacts of health technology. It is a multidisciplinary process to evaluate the social, economic, organizational and ethical issues of a health intervention or health technology. The main purpose of conducting an assessment is to inform a policy decision making.

Health Technology Assessment (HTA)

covers both the direct, intended consequences of technologies and interventions and their indirect, unintended consequences.

Health Technology Assessment (HTA) approach

used to inform policy and decision-making in healthcare, especially on how best to allocate limited funds to health interventions and technologies.

explicit analytical frameworks, drawing on clinical, epidemiological, health economic and other information and methodologies

the assessment is conducted by interdisciplinary groups, using__

HTA Council (HTAC)

an independent advisory body created under the RA 11223 recommends which health technologies the DOH and the Philippine Health Insurance Corporation (PHIC) may fund

ethics, public health, medical law and health economy, sociology, evidence-based medicine, vaccines, devices, procedures, and other health technologies.

The members of the council include practitioners of

• medicines

• vaccines

• clinical equipment and devices

• medical and surgical procedures

• preventive and promotive interventions

• traditional medicines

• other health technologies

HTAC subcommitees

core committee

It is responsible for the development and submission of final recommendations to policyand decision-makers, based on the evidence appraisal of the different subcommittees.

9 voting members

core committee composed of how many voting members?

core committee

The committee approves the agenda of the HTAC meetings in consultations with the HTA office Director and the HTA Technical Secretariat; and ensures that the equality of the evaluations submitted by the Assessment Teams to the HTAC adheres to the agreed methodological standards.

subcommittees

they support the HTA Core Committee in achieving a timely, effective, efficient and responsive technology appraisal process by performing the initial review of HTA reports and submissions of the industry, Assessment Teams and other actors which submit, evidence to the HTA Council for purposes of technology appraisal.

minimum of 1 and maximum 3 non-voting members

All subcommittees shall have a minimum of and maximum of non-voting members for each subcommittee.

technical secretariat team

They shall provide the HTAC w/ the necessary information and resources for discharging its duties under the UHC Law including the conduct of needed orientation and training programs fornewly appointed members of the HTAС

Policy Planning & Evaluation Team

Responsible for the overall management of the health technology assessment and appraisal program including internal assessments especially when immediate policy advice is needed, the development of normative guidelines and engagement with stakeholders at all stages of the appraisal

• Food and Drug Administration

• Department of Health

• Philippine Health Insurance Corporation

• Philippines Institute of Traditional and Alternative Healthcare

• Price Negotiation Board

• Assessment teams

• Academe

Other Participants in the HTA Process

Department of Health

Leads health sector in the institutionalization of the HTA process as a fair and transparent priority setting mechanism that shall be recommendatory to the DOH and PhilHealth for the development of a range of entitlements such as drugs, medicines, pharmaceutical products and other devices.

Philippine Health Insurance Corporation

Designs national health insurance benefit package and finance packages based on the positives recommendations of HТАС

Food and Drug Administration

Provides/shares relevant clinical evidence with the HTAC on the safety and efficacy of medical products under its jurisdiction including premarketing and post-marketing regulatory assessments

Philippines Institute of Traditional and Alternative Healthcare

provides/shares relevant traditional medicines health outcomes, costing and data collected from researches/studies/documentation funded or conducted.

Price Negotiation Board

Coordinates with the HTAC in determining the clinical and economic value of new health technologies as one of the bases of prices negotiation arrangement with the industry

Assessment teams

perform assessment of health technologies following the methodological standards set the DOH/HTAC. They may be internal or external teams

Academe

provides scientific advice to the HTA office and HTAC on appropriate methodological standards that could applied in the assessment and appraisal of health technologies; serve as peer reviewer or coinvestigator for internal evaluation

AO 2020-0041

The New Implementing Guidelines on Health technology Assessment to Guide Funding Allocation and Coverage Decisions in support Universal Health Care

this order aims to define the overall institutionalization and implementation framework for HTA through the Process and Methods Guides, as a priority setting mechanism that shall be recommendatory to DOH and PHIC in their coverage and funding allocation for UHC.

general objective of AO 2020-0041

HTA Process Guides

It refers to the document that provides the detailed processes involved in the implementation of the HTA which are embedded with mechanisms to incorporate the НТА process principles as outlined in the UHC Act. It also covers the operational procedures and governance of the HTАС

HTA Methods Guide

It refers to the document that provides standard methods of conducting HTA to generate evidence which will become that basis of HTAС recommendations to the decision-makers.

1. Topic nomination

2. Topic prioritization

3. Scoping and Protocol Development

4. Topic Assessment

5. Evidence appraisal

6. Initial recommendation

7. Resolution

8. Decision by Secretary of Health

9. Dissemination

10. Topic Nomination and Prioritization

11. Development and Assessment

12. Evidence Appraisal

HTA Process

topic nomination

It is the process of referring topics to HTAC for which technology appraisals may be produced and disseminated for the guidance for policymakers in healthcare coverage decisions and to health providers and patients in the optimal and appropriate use of health technologies.

topic nomination

New and potentially innovative health technologies which responds to unmet or priority health care needs in the local Philippine content may also be submitted for HTAC appraisal by relevant industries with the required clinical, social and economic evidence.

topic nomination

For existing health technologies, a reassessment may be triggered by the emergence of new clinical evidence that may have an impact in the previous recommendation of HTAC.

(1) Certificate of Product Registration for drugs and vaccines

(2) Certificate of Free Sale for medical devices

The following document shall be required prior to the acceptance of the application.

Topic prioritization

Refers to the selection of topics through a standard set of criteria by HTAC to ensure that the appraisal process responds to the priority health care needs of the country and that the topics address conditions that are important to patients, health care providers, Philhealth and DOH program managers, hospitals and local health systems administrators.

a. budget impact to DOH and PhilHealth

b. total users of technology

c. cost- effectiveness

d. severity of disease

e. equity, ethical and social implications

Criteria for prioritization (for existing health technologies)

a) Total users of health technology

b) severity of disease

c) estimated household financial impact

d) equity, ethical and social implications

e) national health services needs

Criteria for prioritization (for new health technologies)

scoping and development

refers to the process of defining the overall scope of the technology assessment in terms of at least 6 major components:

a) Population of patients who will benefit from the intervention

b) Health technology or intervention of interest

c) Appropriate comparators relevant to the local practice of context

d) Clinically meaningful outcomes

e) Study design

f) Any other consideration that will likely impact the results of the assessment such as appropriate perspective, equity/legal/social issues, time horizon for the analysis, among others.

scoping and protocol development 6 major components

topic assessment

It refers to the application of formal scientific methods of evidence synthesis to assess the clinical, economic, health, system, ethical, legal and other social impact of covering or disinvesting a particular health technology in the local Philippines context.

appraisal (evidence appraisal)

refers to the process by which the HTAC evaluates and makes a judgment on the value of a health technology in the Philippine context using its established criteria based in the evidence presented by the Subcommittees supported by the HTA output of the Assessment Teams

evidence appraisal

a face to face public consultation shall be conducted. once the output of the Assessment Team is approved, they shall developed an evidence summary to be presented to the HTA Core committee for final deliberation and recommendation

a) Background

b) Description of the new health technology and comparator

c) Clinical effectiveness and safety

d) Economic evaluation

e) Health system implications

f) Legal, ethical, social issues if any.

he evidence of the summary must include:

The Chair of the Subcommittee or another designated Committee

initial recommendation; ____member with the support of the Assessment Team shall present to the HTA Core Committee the evidence summary for the assessed health technology, highlighting the important pieces of evidence considered as well as the Subcommittee conclusions on whether the said health technology warrants a positive or negative recommendation.

HTA Core Committee

shall deliberate on the evidence presented arriving at a judgement and recommendation on the public funding and use of the health technology in the health system.

a) Responsiveness to disease magnitude, severity and equity

b) Safety and effectiveness

c) Household Financial Impact

d) Cost-effectives

e) Affordability and viability

Criteria in developing recommendations:

resolution; 10 days; 15 days

An appeal may be submitted to the HTA Technical Secretariat within ___working days from posting of the HTAC Core Committee recommendation, if there is new data that was not part of the initial submission and may impact the recommendation of the HTAC. The appeal shall be decided within __working days from receipt of the documents.

resolution

For certain changes, the study shall be revised accordingly and assessed by the HTAC Subcommittee on the same basis as stated above. The revised technical report incorporating the new studies shall be presented to the Subcommittee for further assessment and appraisal prior to presentation to the HTA Core Committee.

Decision by Secretary of Health

The Chair of the HTA Core Committee through the Secretariat shall transmit the recommendation of the Committee to the Secretary of Health for interventions which fall under the remit of the specific health programs at the DOH and PhilHealth Board of Directors for health interventions that are part of the benefit packages of PhilHealth for final decision-making.

Philippine National Formulary.

Drugs and vaccines that are approved by the Secretary of Health and/or PhilHealth Board of Directors shall be listed in the

Dissemination

The HTA Unit shall develop and publish the communication materials, policy briefs and evidence summaries for healthcare professionals, patients and policy makers on the appropriate use of the health technologies based on the appraisal and recommendations of the HTA core committee.

Dissemination

The HTAC shall review and finalize the content of the communication materials before public dissemination.

Topic Nomination & Prioritization

The request for an expedited process must emanate from the Secretary of Health, following the declaration of a public health emergency.

• Accomplished proposal form

• FDA marketing authorization or WHO certification of prequalification for drugs and medicines

• Other relevant documents

Directors of the DOH national health programs shall submit the following documents to facilitate the review process as verified and endorsed by the Secretary of Health.

within 7 days

The decision to use the expedited process is the responsibility of the HTAC which shall act on the request/petition of the SOH ___ of receiving the request for an expedited review of a health technology.

Development & Assessment ; within 2-12 weeks

The HTA office shall extend all assistance to HTAC through fast track evidence assessment supported by internal or external assessment teams which shall conduct a rapid review hat should be completed ____of the request/petition for an expedited review process.

• The health technology has been approved for marketing and use by the Philippines FDA, when applicable

• There is no other better or existing health intervention that can address the particular condition/situation

• The health intervention shall be used for a current public health emergency or imminent health threat that could affect a sizeable population as defined in the UHC Act.

Evidence Appraisal; The HTAC shall evaluate the health technology and recommended its use based on the following criteria:

All healthcare technologies

General HTA process; initiation and scope

Healthcare technologies for public health emergencies

Expedited HTA process; initiation and scope

Comprehensive Assessments take 12-48 weeks

General HTA process; timelines

rapid assessments take 2- 12 weeks

Expedited HTA process; timelines

Broad criteria (cost-effectiveness, equity, and public health impact)

General HTA process; Criteria for Assessment

Technologies approved by FDA or WHO

Expedited HTA process; Criteria for Assessment

Extensive consultations

General HTA process; Stakeholder Engagement

Fewer consultations (time constraints as it is a public emergency)

Expedited HTA process; Stakeholder Engagement

Long-term health inclusion

General HTA process; outcome