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Better decisions for better health: an

introduction to Health Technology


Assessment
Jakarta, April 2016
Francis Ruiz, NICE International

Acknowledgements: Franoise Cluzeau & Ryan


Li, NICE International & Dr Paily, Kerala
Federation of Obstetrics and Gynaecology, India
Overview

Health Technology Assessment to support priority


setting
Conducive factors for HTA development, and the use of
evidence into policy
Is it all about HTA?
HTA, clinical guidelines and improving quality
3

Priority-setting in health
The task of determining the priority to be assigned to a
service, a service development or an individual patient at a
given point in time. Prioritisation is needed because claims
(whether needs or demands) on healthcare resources
are greater than the resources available UK NHS, 2009

Decision makers are always making choices and


weighing the trade-offs between the various options,
whether implicitly or explicitly
HTA is a tool for supporting explicit priority-setting
World Health Assembly resolution on Health Intervention and
Technology Assessment in Support of UHC

Every pound can only be spent


once. If we spend it unwisely...
then we risk harming other people
whose care will be adversely
affected
It is vital that priority setting is an
evidence-informed, procedurally
fair process that defines what will
be covered through universal
health coverage.
Prof David Haslam, Chair of NICE, addressing
the 25th World Health Assembly, Geneva, 2014
What is health technology assessment
(HTA)?
HTA is a multidisciplinary field of policy analysis. It studies the medical,
social, ethical, and economic implications of development, diffusion,
and use of health technology.

Any intervention that may be used to promote health, to prevent,


diagnose or treat disease or for rehabilitation or long-term care. This
includes the pharmaceuticals, devices, procedures and organizational
systems used in health care.

Source: INAHTA/glossary http://www.inahta.net/


Using HTA to inform priority setting
Applied HTA can be considered as a process for
considering scientific evidence, economic evidence and
social values, to inform decisions as to whether to fund a
treatment / service
Includes cost-effectiveness analysis (CEA); not just clinical
effectiveness
Drawing comparisons: Compared to the status quo, what do we
gain out of the new treatment, and at what extra cost?
Not a merely technical exercise: The process and social values
are equally important
NOTE: HTA is one component to support overall quality improvement
Conducive factors for
HTA development
Collaboration of WHO Asia Pacific Observatory
(APO) and Prince Mahidol Awards Conference
Authors: HITAP, Thailand

Objective
To identify characteristics of successful HTA
agencies, conducive factors to the development of
HTA agencies in the region, barriers to their
development

Methods
Literature review
Case Studies produced by authors
from 7 settings: China, Indonesia,
Republic of Korea, Malaysia, Taiwan
(China), Thailand and Vietnam
Study team meetings, external peer
review

Source: Huntington, D. (2016); Chootipongchaivat et al. (2016)


Evidence shows 6 contextual factors that frequently
exist where HTA capacity has been developed
Local training
Good health on HTA-
information related
technology disciplines
infrastructure
Political will, Effective
leadership collaboration -
and HTA agencies
legislation & local
stakeholders
High public
expenditure, HTA Independence
Strategic
Purchasing agency from ODA

Source: Huntington, D. (2016)


4 key barriers identified to the development of HTA
agencies

Poor decision-making Strict controls on


criteria research conduct
and dissemination

Silo-based
decision HTA Undue influence of
making, weak
to no agency expert opinion
consultative
practice

Source: Huntington, D. (2016)


Policy Brief makes 5 key recommendations

1. Build human resources / national capacity


HTA research organizations
Decision-making bodies
Relevant stakeholders
2. Establish a core HTA team or agency
HTA process involves multiple actors
Essential to have an HTA focal point or agency
3. Link HTA to policy decision-making mechanisms & processes
No clear pathway, highly dependent upon local context
4. Establish legislative authority of HTA agency & processes
Participation, transparency, systematic application of HTA processes
5. Take advantage of international collaboration during formative stage of
development
Guard against substitution effect
Do you need an agency?
Institutionalising HTA emphasises the role of developing
accepted norms and rules, and effective working
relationships between relevant policymakers and
academic/research institutions
Does not necessarily mean creating new discrete HTA agencies!
Good norms and rules (based around notions of
transparency, accountability, stakeholder participation etc)
support priority-setting based on evidence, and good
governance becomes routine and more resilient to vested
interests and political change
But no one-size fits all for institutional arrangements
The importance of process
On July 31, 2008, the Constitutional Court of Colombia (the Court) handed
down a decision (T-760/2008) that ordered a dramatic restructuring of
The judicialization of health policy-
the countrys health systemthe Court does not assume it knows best what
benefits should be included under the POS/POSS, nor the precise ethical
making?
grounds for making these determinations. Rather, in keeping with recent
proposals in health ethics, the decision calls for a participatory process
that is transparent, based on relevant reasons and current
epidemiological information, subject to revision, and enforceable
(Yamin and Parra-Vera, 2009)
HITAP and the Thai health benefits package,
August 2014
National Health Security Office, responsible for UHC in Thailand,
stated their decision to include high-cost drugs was based on
evidence from HITAP
o Despite no law mandating the use of HTA to inform policy
o Example of user-pull and exchange

Illustrates the impact of


making HTA attractive
enough for decision-
makers to use it willingly
as a defence for their
decisions to the public
(HITAP on idsihealth.org/
blog, 2014)
HITAP is value for money:
Thailands UC decisions have more than paid off economic evaluation costs
Annual cost of HITAP: 37m Thai baht (0.007% of THE in 2010)

Description Impact

Assessed possibility of universal Health gains: 1500 averted


Prevention of coverage of the HPV vaccine using new cases and 750 female
cervical cancer deaths per year Cost savings
cost-effectiveness analysis
(2007) from the
Compared multiple scenarios to
cervical
conclude that the most cost-effective Cost savings: 6 million
international dollars, cancer
strategy would be improving
approximating 0.02% of the screening
screening accessibility rather than
total health expenditure budget assessment
universal vaccination
in 2007 alone more
than covered
Assessed value-for-money of HITAPs
New drug Health gains: 101 paediatric
three-ARV regimen vs. current operating
regimen in HIV infections averted annually
AZT monotherapy and single dose costs (0.01%
PMTCT of HIV of nevirapine of THE budget
(2010) Cost savings: 2.6 million USD
Solved social debate regarding in 2007)
over a lifetime
feasibility and value for money of
a new drug regimen in PMCT of
HIV
Source: First Step Program Evaluation Report 2010; Praditsitthikorn N et al. 2011; HITAP Case Study 12March2011 (unpublished);
PMTCT in Asia Manuscript 2011 (Unpublished)
Going beyond HTA (1)
HTA traditionally applied to single interventions but many
LMICs concerned with new infrastructure (or platform)
Key insight is that introduction of new infrastructure (or abandonment
of old infrastructure) may affect costs (and possibly benefits) of
numerous interventions
Such structural reforms can usually be implemented only
occasionally
Their implementation may introduce big non-incremental shifts in the
optimal package of health services (and the associated C-E threshold)
Examples
Augmentation of existing network of local health centres with a
network of community nurses focusing on home visits for routine care
Consolidation of local health centres into district hospitals
Introduction of point-of-care diagnostic services into the functions of
health centres (previously provided by remote specialist services)
Source: Smith, P. (2016)
Going beyond HTA (2):
improving quality and frontline practice
Medical education
and professional
training
Performance
management
Budget management
Clinical Provider payment
Clinical Trials mechanisms incl.
Guidelines
and Quality case-based payment
and Health Communication of
Evidence Standards
Technology entitlement to
Reviews patients and their
Assessment
families
Clinical audit and
provider
benchmarking
Provider regulation
and accreditation

17
What are quality standards?

Quality standards (QS) are a concise set of


evidence-informed statements, designed to drive
and measure priority quality improvements, within
a particular area of care (e.g. acute management
of stroke).
QS part of a stepwise process to turn
Evidence evidence into policy
The starting point is the
evidence base (clinical
trials etc.)
HTA/Clinical
guidelines
Evidence is distilled to
produce HTAs/clinical
guidelines
Quality
standards

Quality standards are


Quality derived from evidence-
measures based clinical guidelines

QS indicators and measures


can inform quality initiatives and
financial incentives, HBPs,
Incentives other levers (regulation etc)
Example: NICE guidance on atrial
fibrillation
NICE guideline on AF Updated guideline Quality standard
(June 2006) (June 2014) (July 2015)

Covers Incorporates Quality statement 1


management of technology
patients with AF appraisal Adults with
recommendations non-valvular atrial
New drugs for and provides clinical fibrillation and
anticoagulation context (e.g. stroke a CHA2DS2-
Separate NICE & bleeding risk) VASC stroke risk
health technology score of 2 or above
assessments for Anticoagulation are offered
apixaban (Feb may be with anticoagulation.
2013); dabigatran apixaban,
etexilate (March dabigatran
2012); rivaroxaban etexilate,
(May 2012) rivaroxaban or a
vitamin K
antagonist.

Guideline review:
September 2016

Clinical and cost


effectiveness; on positive list
Example: Kerala obstetric QS
Made use of data from Confidential Review of
Maternal Deaths
Using WHO, NICE, KFOG and RCOG
guideline recommendations as evidence
base
10 statements with measurable indicators:
1. Active Management of Third Stage of Labour
2. PPH Prevention 4th Stage Management
3. Management of Post-Partum Haemorrhage with Blood and Blood Products
4. Obstetric Intensive Care
5. Placenta Praevia Accreta
6. Pre-eclampsia
7. Anti-hypertensive Treatment
8. Severe Hypertension in pregnancy and in Immediate Postpartum Period
9. HELLP
10. Eclampsia
Example of a quality statement:
Management of third stage of labour*

WHO recommendations
Quality statement Oxytocin (10 IU, IV/IM) is the
recommended uterotonic drug for
Women who have given birth the prevention of post partum
either vaginally or by caesarean haemorrhage.
are offered a bolus dose of (Strong recommendation,
oxytocin or ergometrine at the moderate-quality evidence)
time of delivery of the shoulder
or within 1 minute of the delivery KOFG recommendations
of foetus to prevent post partum Administer uterotonic agent
haemorrhage and to assist within 1 min. of delivery of baby.
delivery of the placenta (Oxytocin or syntometrine or
ergometrine)

*Third stage of labour: From delivery of the fetus to the complete delivery of the placenta
Quality measure
Measures of process
No. of women giving birth vaginally
Quality measure receiving oxytocin or ergometrine
Proportion of women giving during third stage of labour in the
birth vaginally who receive = hospital (numerator)
oxytocin or ergometrine during
third stage of labour All women giving birth vaginally in
the hospital (denominator)

Implementation

Outcome
Proportion of women who experience estimated
blood loss 500ml following a vaginal delivery
Learning from other countries
Experience with the QS for
maternal care in Kerala
Experience from Vietnam (in
stroke care)

Case country examples


contained in Principles for
developing Quality Standards in
low & Middle Income countries

http://www.idsihealth.org/knowledge_base/principles-
for-developing-clinical-quality-standards-in-lmics/

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