This document discusses health technology assessment (HTA) in India. It provides an outline of HTA and its potential applications. HTA is defined as a multidisciplinary process that systematically evaluates the medical, social, economic and ethical issues related to a health technology. The document discusses the need for HTA in India given rising healthcare costs and limited resources. It outlines the HTA process, including defining the research question, criteria for study inclusion/exclusion, literature searches, and steps like systematic reviews and economic evaluations. Key applications of HTA mentioned are assessing new technologies for investment/disinvestment and informing priority setting and coverage decisions.

1. Health Technology Assessment
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DAY-5-IIHMR
Dr S.B.Sinha
President Biomedical Engineering Society of India

2. Outline
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 Health financing in India
 Need for application of HTA
 Process
 Potential Applications

3. Level and Pattern of Health Financing in India

4. How Much is Actually Required?
Cost of Universal Health Care in India
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Prinja S et al (2012). PLoS One.

5. Conclusion
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 Resource scarcity !
 Rising health care costs
– Demographic-Demographics is defined as statistical
data about the characteristics of a population,
such as the age, gender and income of the people
within the population
– Epidemiologic-Epidemiology is the study of how often
diseases occur in different groups of people and
why
– Social-New drugs, devices and technologies

6. Policy Context
•Allocation decisions CAN’T BE AVOIDED
- Limited resources
- Unlimited “wants”
- CHOICES need to be made between alternative
uses of resources
Choose between which
‘wants’ we can ‘afford’
given our resource
budget constraint
Value for money

7. 1.
Three
Dimension
s
2.
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3.

8. Changing Paradigms in Health Care Financing
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 Increase in Public Financing
– Need for decisions on setting priority for services
 Purchaser-provider split
– Need for decisions on setting priority for services and models
of care delivery
 Newer forms of provider payments

9. Opportunity Cost
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 Value of benefits foregone for not investing in the next
best alternative- the opportunity cost is measured as
the health lost as a result of the displacement of
activities to fund the selected intervention
 Cost of every decision on how resources are allocated
 Need for rational priority setting

10. Just as health care systems vary worldwide, the payer
assessment process differs from country to country
Market Access around the world

11. Health Technology Assessment (HTA)
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A 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 improve quality
of lives.
HTA is a Multidisciplinary process that summarizes information
about the medical, social, economic and ethical issues related to
the use of a health technology in a systematic, transparent,
unbiased, robust manner.
Its aim is to inform the formulation of safe, effective, health policies
that are patient/population focused and cost-effective solutions
European network for Health Technology Assessment. Common Questions. What is Health Technology Assessment (HTA). Accessed Aug. 1, 2013
at: http://www.eunethta.eu/about-us/faq#t287n73

12. What does word Health Technology
mean?
Drugs
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Medical devices & Implants
Diagnostics Health interventions & programs

13. Scope of HTA: Synergy with UHC
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 Health Maximization
 Reduce OOP-Out-of-pocket payments are
expenditures borne directly by a patient
 Equity-health equality means everyone receives the
same standard of healthcare facilities

14. HTA’s Perspective
Investment decisions
 Whether to Invest in Newer
Technologies
 Whether to Scale up Newer
Technologies
Dis-investment decisions
Discontinue the existing
health
technology/intervention
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 Re-allocate/ reduce allocation
to health technology/
intervention
Courtesy: Dr Yot

15. Regardless of the technology assessed,
HTAs include similar elements

16. TEA BREAK 11.00 AM
WE WILL MEET AT 11.30 AM

17. Steps in HTA
1. Systematic Review.- Qualitative and Quantitative
reviews by literature search or by original research. A
systematic review answers a defined research
question by collecting and summarizing all empirical
evidence that fits pre-specified eligibility criteria.
2. Meta Analysis.- A meta-analysis is the use of
statistical methods to summarize the results of these
studies
3. Economic Evaluation- Best Value for money- Clinical
Effectiveness and Cost Effectiveness for alternative
therapies.

18. 1. Define research question
2. Develop study inclusion/exclusion criteria
Patients
Intervention(s)
Comparator(s)
Outcomes
Study type
3. Develop literature search strategy
Typically conducted across multiple databases
Search strategies should be broad enough to capture all relevant publications,
but narrow enough to avoid excessive irrelevant information
4. Screen studies for inclusion and collect relevant data
Systematic review: process
PICOS

19. 1. Define research question- Which BP Machine needs to be
used for measuring BP- Digital OR Aneroid type
Problem Definition- With the phasing out of Mercury BP
Machines which was till now considered Gold standard we
need to evaluate which type of BP Machine to use for the
patient.
D
Example –Selection of Aneroid Vs Digital BP
Machine

20. 1. Define research question
2. Develop study inclusion/exclusion criteria
Patients
Example –Selection of Aneroid Vs Digital BP
Machine
Age?Adult or
pediatric
Diagnostic criteria?
Self or HCP
Comorbidities?
Whether
Diabetics
Disease
severity?
Routine or
Severe
Ethnicity?
Include all

21. 1. Define research question
2. Develop study inclusion/exclusion criteria
Patients
Intervention(s)
Example –Selection of Aneroid Vs Digital BP
Machine
Definition of
Blood Pressure?
Frequency?
Purpose-
Screening/
Classification as
Hypertension?

22. 1. Define research question
2. Develop study inclusion/exclusion criteria
Patients
Intervention
Comparator(s)
Example –Selection of Aneroid Vs Digital BP
Machine
Mercury Type BP?
Placebo?
Other BP
Measuring
techniques?
Simulators?
Young
normal
Adult?

23. 1. Define research question
2. Develop study inclusion/exclusion criteria
Patients
Intervention(s)
Comparator(s)
Outcomes
Example –Selection of Aneroid Vs Digital BP
Machine
Accurate BP
Measurement?
Ease of use?
Hypertension?
Screening?
Adverse events?
Easy to
maintain ?

24. 1. Define research question
2. Develop study inclusion/exclusion criteria
Patients
Intervention(s)
Comparator(s)
Outcomes
Study type
Example –Selection of Aneroid Vs Digital BP
Machine
RCTs?
Non-RCTs?
Quasi-
randomized?
Economic
evaluations?
Real-world
evidence?

25. Sensitivity and Specificity
Test sensitivity is the ability of a test to correctly
identify those with the disease (true positive rate),
A highly sensitive test means that there are few
false negative results, and thus fewer cases of
disease are missed.
Sensitivity = true positive / (true positive + false
negative)
= Probability of being test positive when disease
present.
90% sensitivity = 90% of people who have the target
disease will test positive

26. Example
We tested 10 Samples for True Diabetics patients. 9
Samples confirmed Diabetes while one sample showed
negative results. Calculate the Sensitivity
Sensitivity= True Positive/ (True Positive + False Negative)
= 9/(9+1)= 0.9 OR 90%
Thus Sensitivity is 90% and it means that it will predict 90% of
the results as Diabetes and will miss one diabetes patient.
Thus if we are carrying the tests on a population of 100 and if 70
patients are shown positive this means we have missed 7
diabetes patients and there are actually 77 Diabetes pat

27. Sensitivity and Specificity
Test specificity is the ability of the test to correctly
identify those without the disease (true negative
rate).
Specificity (negative in health)
The ability of a test to correctly classify an individual
as disease- free is called the test′s specificity.
Specificity = true negative/ (true negative + false
positive)
= Probability of being test negative when disease absent.

28. Example- Specificity
In a given patient population we have 58 persons who
are not having Hypertension. However in the testing it
identifies 12 persons as having the disease.
Thus we have True Negative as 58 but False positives as
12
Specificity= True Negative/(True Negatives +False
Positives)=58/70=0.82
Thus we have Specificity= 82 %
The test will correctly identify 82% who do not have
the disease, but it will also identify 18% of people
as having the disease when they do not.

29. LUNCH BREAK 1 PM
WE WILL MEET AT 2.00 PM

30. Key economic concepts
Concept 1: OPPORTUNUTY COST
The cost of an alternative use of
resources that must be forgone in
order to pursue a certain action. Put
another way, the benefits you could
have received by taking an alternative
action.

31. Opportunity cost
Within a fixed budget
constraint, if the healthcare
system spends more on one
thing, it has to do less of
something else
You can only spend £1 once
The “opportunity cost” is the
value of the best alternative
use of resources
Source: Peter Littlejohns, The Challenge of Health Care in Europe: “value for money”

32. Key economic concepts
Concept 2: EFFICIENCY
The use of resources so as to maximise the
production of goods and services. In healthcare,
the decision maker’s objective is to ensure that a
particular healthcare programme represents an
efficient use of resources:
Choose programmes which maximise total health
benefits subject to the budget constraint (resource
constraints

33. So far…
•Economics is the science of scarcity which
aims at obtaining maximum value for
money
•Achieving value for money requires
services to be evaluated for cost-
effectiveness
•Associated concepts are efficiency (how
well resources are used) and opportunity
cost (makes clear the explicit trade-off that
underline resource use in health care)

34. Economic Evaluation
•What is Economic Evaluation and
cost-effectiveness
•Steps required to conduct a
cost-effectiveness analysis
•Critical appraisal of
cost-effectiveness

35. Economic Evaluation
Definition of economic evaluation:
“the comparative analysis of alternative courses of action in
terms of both their costs and their consequences”

36. Steps required for an EE
1. Define the economic question and the perspective of the study
2. Define the alternative treatments to be evaluated
3. Determine the study design
4. Identify, measure and value the costs of the treatment and the
alternative treatments
5. Identify, measure and value the benefits of the treatment and the
alternative treatments
6. Adjust costs and benefits for differential timing
7. Measure the differential costs and benefits of the treatments
8. Analyse the incremental estimates
9. Test the sensitivity of the results
10. Assess the generalisability and limitations of the study

37. Perspective
•Different perspectives:
– Government or NHM
– Healthcare institutions, e.g. hospital
– Third party payers (insurance company)
– Patient and family
– Societal
•The perspective will determine which costs and
consequences to identify, measure and value

38. MORBIDITY AND MORTALITY
Morbidity is any condition that isn't healthy.
Mortality refers to death.
A person with high morbidity may not live as
long as someone who is healthy. However,
morbidity doesn't always mean you are in
danger of dying right away. If an illness gets
worse over time, it could raise your risk of
mortality.

39. Quality-adjusted life years (QALYs)
Combines gains from reduced morbidity (quality) and mortality (quantity) into a single
measure
Health-related
quality of life
(weights)
Perfect health 1.0
0.0
Dead
Death A Death B
Time (years)
Treatment A
Treatment B
QALYs gained

40. QALY weights (utilities)
• Preference elicitation
– Visual analogue scale
– Time trade off
– Standard gamble
• Mapping into health state measures for which
preferences are known e.g. EQ-5D
– Mobility
– Self care
– Usual Activity
– Pain and discomfort
– Anxiety and depression

41. Preference Elicitation
A tool used to help a person rate the intensity of certain sensations and
feelings, such as pain. The visual analog scale for pain is a straight line with
one end meaning no pain and the other end meaning the worst pain imaginable
The time trade-off (TTO) is a choice-based method of eliciting health state
utility, which reflects the length of remaining life expectancy that a person may
be prepared to trade-off in order to avoid remaining in a sub-perfect health
state.
The standard gamble, which determines the risk of a bad outcome, such as
death, that a patient would be willing to take to avoid the outcome for which the
utility is being assessed (e.g., stroke with severe long-term neurological
sequelae) and the time tradeoff, which involves giving up future years of life in a
less than perfect state of health in exchange for a shorter life expectancy in a
good state of health, are difficult to use for the assessment of temporary health
states

42. Preferences: Key assumptions
1) Constant proportional trade-off
e.g. 10 years in a health state with a utility of 0.4 (10*0.4 =
4 QALYs) is equivalent to 5 years in a health state with a
utility of 0.8 (5*0.8 = 4 QALYs)
2) Additive independence in preferences
e.g. 5 years in health state A followed by 8 years in health
state B (5*0.4+8*0.8=8.4 QUALY)is better than 8 years in
A followed by 5 years in B (8*0.4+5*0.8=7.2 QUALY)
3) Equity: In aggregating, a QALY’s worth of health
represents the same value whoever receives it

43. THRESHOLDS
Thresholds are established by the Govt of the Country and
determines the willingness of a Govt. to implement a particular
health program if the 1 QUALY cost is below the threshold.
WHO recommends threshold to be set as 1 to 3 times the Per
Capita GDP.
Some of the countries Threshold Levels are as below:
UK- $ 22,000; USA- $ 24,000; Norway- $ 43,000, Malawi- $ 3
These thresholds are increased based on rarity of diseases.
India is yet to determine the Threshold Levels

44. ICER
• Was an INCREMTNAL ANALYSIS of COSTS and
CONSEQUENCES of alternatives performed?
 Assess the extra benefits incurred for any extra cost
 Results of CEA expressed in terms od the
INCREMENTAL COST-EFFECTIVENESS RATIO (ICER)
 Decision rules:
The league table rule: Select programmes in ascending order of the
ICER until resources are exhausted
The threshold ICER rule: Select programmes with ICER ≤ 

45. 0
Health care expenditures
Health
benefit
per
$1,000
How Does CEA guide HTAPolicy?
Budget
Net health gain from
using HITA

46. Economic analysis: “willingness to pay”
threshold
Cost difference (+)
Cost difference (−)
Effect
difference (+)
Effect
difference (−)
Reject
Accept
WTP threshold
SC
Some countries/health care systems use an official or unofficial threshold of acceptable
ICERs for new technology assessments

47. Process matters! The “ideal situation”…?
Principles Putting them into practice…
Independence “Arm’s length” from government, payers, industry and
professional groups; strong and enforced conflict of interest
policies
Transparency Meetings open to the public; material placed on the web;
decision criteria and rationale for individual decisions made
public
Inclusiveness Wide and genuine consultation with stakeholders; willingness
to change decision in light of new evidence
Scientific basis Strong, scientific methods and reliance on critically appraised
evidence and information
Timeliness Decisions produced in reasonable timeframe; minimise
delays in publishing decisions
Consistency Same technical and process rules applied to all cases
Legal framework Reference in country’s legal framework; institutional role in
informing coverage and payment decisions
Regular review Regular updating of decisions and of methods

48. IIHMR 21st Dec 2021
Stakeholder engagement…
Review
Assessment
“Appraisal”
“Decision”
“Scoping” Submission
Consultation

49. Who are stakeholders?
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 Those responsible for delivering the care (professionals, managed
care programmes).
 Those receiving it (consumers or patients and their caregivers).
 those financing it (governments, health insurers, the public, and
employers).
 those managing care (policy makers, public health services).
 those monitoring care
 Employers
 Pharmaceutical/device industry

50. Why involve stakeholders?
NHSRC-14TH NOV 2018
Evidence is imperfect
– Varying quality
– Complex to interpret
– May not address appropriate outcomes
HTA based decisions/recommendations are
constructed through a deliberative process
– Evidence rarely translates directly into recommendations
– Process includes consideration of evidence quality, weighing
harms & benefits
– Also includes preferences, values, judgments
– A process that should be inclusive…

51. RESOURCES
1. Health Technology Assessments handbook- www.dacehta.dk- Danish Centre for
Health Technology Assessments.
2. Fellowship program in Health Technology Assessments- NHSRC/DHR- One week
residential Workshop.
3. International HTA networks.
4. WHO Collaborating Centres HTA Network
5. Iinternational Network of Agencies for HTA- INAHTA.
6. NICE- UK- National Institute of Health and Care Excellence

52. Thanks!!!
NHSRC-14TH NOV 2018
Email
sbsinha@hotmail.com
MOB- 9210473793