An overview of Health Technology Assessment (HTA) practices in selected Emerging markets

1. Overview of Selected Countries
March 2010
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2. PARIOFORM
A
 Pharma markets in Emerging Markets (EMs) have been
continuously witnessing robust growth on account of:
◦ Increasing prevalence of diseases
◦ Rising healthcare spending
◦ Increasing affordability
 Political and economic transition since the 1990s has resulted in
many changes in the health sectors of these countries. Many have
adopted social health insurance (SHI) models in attempts to move
away from centrally planned and state controlled healthcare
financing and coverage.
 Healthcare reforms have been accompanied by a need for increased
spending driven by:
◦ Economic growth
◦ Ageing populations
◦ Advances in medical technology
◦ Expanding expectations on the part of national populations
 Reforms and increased spending have brought new challenges
highlighting the need for:
◦ Cost containment
◦ Improvements in quality of services
◦ Improvements in equity of access
◦ Assurance of rational and transparent spending decisions
 Increased attention is now being paid to the implementation of
measures to manage costs and obtain better value for money:
◦ Reimbursement and pricing controls – e.g. reference pricing systems
◦ Establishment of positive lists
◦ Cost sharing – e.g. co-payments
◦ Adoption of HTA in healthcare decision making
 The institutionalization of HTA had been defined as “promoting the
structures and processes suitable to produce technology
assessments that will be powerful in guiding policy and clinical
practice toward the best possible health and cost outcomes.”
 Until recently, many EMs have implemented new technologies with
little or no regard for costs or effectiveness but in many of these
countries, HTA is now in the process of becoming established and
institutionalized.
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3. PARIOFORM
A
 BIA: Budget Impact Analysis
 EE: Economic Evaluation
 CE: Cost Effectiveness
 CEA: Cost Effectiveness Analysis
 CMA: Cost Minimization Analysis
 CUA: Cost Utility Analysis
 HTA: Health Technology Assessment
 ICER: Incremental Cost Effectiveness Ratio
 KOL: Key Opinion Leader
 MA: Marketing Authorization
 MoH: Ministry of Health
 PE: Pharmacoeconomic
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4. PARIOFORM
A
HTA Background
After the 2002 financial crisis, an HTA commission was created within the regulatory
body of the Social Security (SSS) that covers 50% of the population, to evaluate
reimbursement of its mandatory package of services. However, even though Argentina
was the first country in the region to require formal health economic evidence for the
adoption of technologies into the mandatory benefit package of the social security – in
2006, HTA was abandoned as a formal requirement. Nevertheless, many private HTA
agencies exist – not centrally regulated but following international guidelines.
HTA Agency
Unidad Coordinadora de
Evaluación y Ejecución de
Tecnologías en Salud
(UCEETS) created within
the MoH October 2009.
Methodological
Guidelines
Guidelines are very new
and mostly directional
rather than mandatory.
No solid specifications on
data requirements as yet.
Selection Criteria for
Drugs to Review
HTA anticipated as a
requirement for all new
technologies applying for
reimbursement – not
mandatory as yet.
Preferred or Required
Assessment Approach
Recommendations:
−CEA primarily
−CUA secondary
Weight of Clinical vs.
Economic Evidence
Clinical benefits most
important.
Principle Outcome
Measures
Classical hard endpoints
preferred over quality
adjusted life years - but no
formal guidelines
Choice of Comparator
Current standard of care -
best if included in the
compulsory medical
package.
Decision Threshold
Not yet explicitly
established by UCEETS.
3x GDP per capita for a
QALY or DALY rule
informally used.
Cost perspective
Payer perspective
recommended - one for
each type of payer (social,
private, public) as unit
costs and resources vary.
Costs
Studies can include direct
and indirect costs - but
essentially only direct
medical costs tend to be
considered.
Budget Impact Analysis
Many HMOs request BIA.
Cost per year or per
treatment of interest.
BIA Time Horizon 1 – 5 years
Modelling
Not explicitly specified by UCEETS. Some HMOs are content with a simple incremental
cost-effectiveness indicator. More complex models are accepted but not explicitly
required. Foreign models can be adapted to the local context.
Requirements for Local
Data
Local data preferred followed by regional communicators, followed by international
data. In the absence of local data, QALYs and/or tariffs from other countries can be
extrapolated - depending on the quality of data. Local context required for costs.
Sensitivity Analysis
Mostly univariate - no
formal guidelines
Discounting Rates
Not yet explicitly
established by UCEETS.
Typically 3 - 5% for both
costs and effects but no
local consensus.
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5. PARIOFORM
A
HTA Background
The government has defined the need for an HTA agency. Resources for this agency are
expected to be drawn from the universities that already have experience in this field.
This concept has the support of the Commission Reguladora de Salud (CRES) - who
currently have limited knowledge and resources for economic evaluation. The
Government suggest that the agency be housed and led by the National Health Institute.
HTA Agency
No formal agency – but
CRES (part of MoH) is a new
body under law that will
request economic analysis
(along with clinical
information)
Methodological
Guidelines
New methodological
guidelines just being
introduced.
Selection Criteria for
Drugs to Review
To be defined. Probably in
the future it will cover new
technologies that intend to
be included in the national
benefit plan.
Preferred or Required
Assessment Approach
In the future: CEA
Weight of Clinical vs.
Economic Evidence
Currently cost effectiveness
not taken into account; but
the trend is towards
increased use of CEA.
Principle Outcome
Measures
Not defined but “natural”
endpoints preferred:
mortality, incidence,
complications, etc.
Choice of Comparator
The new methodological
guidelines adopt the
standard of care.
Decision Threshold
No explicit threshold -
some researches use WHO
guidelines (per capita GDP
per life year saved) but the
guidelines suggest the use
of an efficiency frontier as
in Germany.
Cost perspective
Societal perspective
defined in guidelines –
payer perspective more
practical due to a lack of
indirect cost data.
Costs
Depends on study
perspective.
Cost data very poor with
much regional variation.
Budget Impact
Analysis
BIA requirements under
discussion. Would like to
see drug costs per capita
per year.
BIA Time Horizon Not defined.
Modelling
No specific criteria defined. All modeling very new - new guidelines propose only simple
models e.g. Markov, decision trees. Western European or US models can be adapted for
Columbia subject to validation by local experts.
Requirements for
Local Data
Foreign data is accepted because of the lack of local information. NICE guidelines and
recommendations used as reference cases. Can adapt regional data - such as Mexico -
for Columbia. Local context required for costs expressed in local currency.
Sensitivity Analysis
Not defined – simple
approach preferred.
Discounting Rates
Not defined.
Can be 0%, 3% or 5% .
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6. PARIOFORM
A
HTA Background
The pharmacoeconomic Society prepared general guidelines in 2009. The MoH accept
the need for guidelines but the Reimbursement Act is currently so prohibitive that it is
almost impossible to get these accepted as part of the decision making process.
A new draft of the Reimbursement Act will hopefully be passed before elections in May
2010. An urgent need for formalized HTA and a HTA agency as healthcare costs are
spiraling. Any future HTA agency not expected to have decision making power – only to
act as an advisory body.
HTA Agency No HTA agency.
Methodological
Guidelines
General guidelines – not
binding.
Selection Criteria for
Drugs to Review
Intended as part of the
application for coverage
under the public health
insurance.
Preferred or Required
Assessment Approach
Very simple CEA - an
optional extra as a
supporting argument for
BIA.
Weight of Clinical vs.
Economic Evidence
Clinical evidence
technically more
important – but
comparative cost
effectiveness in terms of
budget impact plays a role
in decision making.
Principle Outcome
Measures
Preference for hard
endpoints - mortality and
morbidity play a much
more important role than
patient QoL data.
Choice of Comparator
That usually used in
practice - guidelines very
weak on this.
Decision Threshold
No guidelines on
willingness to pay –
ongoing discussions at the
Pharmacoeconomics
Society involving all
stakeholders.
Cost perspective
Viewpoint of Public Health
Insurance preferred (a
State funded body).
Costs
Direct healthcare costs -
those incurred by the
health insurance funds.
Budget Impact Analysis
Required - but shortage of
relevant epidemiology and
cost sources.
BIA Time Horizon
1 - 5 years accepted - but
usually 3 years.
Modelling
It is recommended to use models already developed for other countries and adapt
them to the local context. Simple models preferred. Thorough explanation of results
more important than complexity.
Requirements for Local
Data
Foreign RCTs fully accepted - general acceptance of clinical effectiveness data from
abroad - particularly Europe. A basic requirement has just been introduced - any
pharmacoeconomic evidence presented must be re-calculated using Czech prices.
Sensitivity Analysis
According to guidelines -
appropriate to state the
influence of discounting in
the sensitivity analysis.
Discounting Rates
No rules - between 3-5%
accepted.
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7. PARIOFORM
A
HTA Background
HTA dates back to 1993. In 2004, the Transparency Secretariat (TS) and Technology
Appraisal Committee (TAC) was formed to assess the therapeutic value of drugs and to
compare them with existing therapies to prepare decisions on reimbursement
applications. Also in 2004, the National Institute for Strategic Health Research of the
MoH was established, which assists with decision making in four major areas of health
policy and financing: medical informatics and information policy, health economics,
health services research, and HTA.
HTA Agency
The National Institute for
Strategic Health Research
(ESKI) governed by the
MoH.
Methodological
Guidelines
First published in 2002 -
an update is now under
construction.
Selection Criteria for
Drugs to Review
Full HTA dossier required
for all new indications,
new actives, new
strengths.
Preferred or Required
Assessment Approach
CEA and CUA.
If there is information on
QoL then CUA more
appropriate.
Weight of Clinical vs.
Economic Evidence
Clinical evidence the basic
level of evidence - without
strong clinical evidence,
economic evidence not
even considered.
Principle Outcome
Measures
Hard endpoints preferred
- intermediate surrogate
outcomes not widely used.
Choice of Comparator
The currently accepted
standard therapy
(therapies) that the new
intervention is intended to
replace.
Decision Threshold
No formal threshold.
Informally, less than 8
million Hungarian Florins
representing 3x GDP per
capita.
Cost perspective
Payer perspective
[National Health Insurance
Fund Administration -
NHIFA].
Costs
Direct medical and direct
non-medical.
Budget Impact Analysis
BIA essential to
understand the financial
commitment required.
BIA Time Horizon 3 – 5 years.
Modelling
Simple models and presentations are fine, but more detailed descriptions of what is
being presented now required – i.e. full explanations of methods, input parameters,
time horizons, perspective, estimations, results, etc.
Presenting the model itself is “nice to have” but not obligatory.
Requirements for Local
Data
Hungarian data preferred if available – but because HTAs based on national data are
not always available, foreign HTAs are also applied – e.g. using demography,
epidemiology, standard care, healthcare utilization, unit costs, and cost-effectiveness
data from NICE analyses.
Sensitivity Analysis
Univariate generally
sufficient - but if
probalistic can be
presented this is stronger.
Discounting Rates
Current guidelines state
5% for all; new guidelines
to be published this year
state 3.7%.
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8. PARIOFORM
A
HTA Background
HTA first became a requirement around 10 years ago. Companies wishing for their
products to enter the National List of Health Services (NLHS) health basket were asked
to provide an economic evaluation - but nothing was binding. The Israeli Centre for
Technology Assessment in Health Care (ICTAHC) was established in 1998 at the Gertner
Institute for Epidemiology and Health Policy Research. The Centre is an independent
multidisciplinary research centre – although it maintains strong links with the MoH, it is
not the official HTA agency.
HTA Agency Still no formal HTA agency
Methodological
Guidelines
Updated guidelines
beginning 2010.
Selection Criteria for
Drugs to Review
Under new guidelines
-obligatory for all new
technologies with a
budget impact > 100,000
shekels (~£20K) pa.
Preferred or Required
Assessment Approach
CUA
Weight of Clinical vs.
Economic Evidence
Each technology applying
for the health basket is
ranked according to
various criteria. Weight
given to clinical evidence
is much higher than that
given to EE.
Principle Outcome
Measures
Hard endpoints preferred
- surrogate endpoints
have to be translated to
QALYs for economic
analysis.
Choice of Comparator
Standard-of-care
technologies included in
the Israeli National List of
Health Services (INLHS).
Decision Threshold
No formal threshold – but
decisions to date imply
most technologies added
have a cost effectiveness
ratio of < $50 per QALY.
Cost perspective
Payer perspective: MoH,
HMOs.
Costs
Direct medical costs for
the supplier and
consumer.
Budget Impact Analysis
To make decisions for
inclusion in the health
basket the estimated
annual cost of each new
technology based on
budget impact
estimations is required.
BIA Time Horizon 3 years.
Modelling
No specific guidelines. Starting from 2009, models presented to the MoH are passed to
the Gertner Institute for evaluation who require the model itself (Excel file).
Requirements for Local
Data
Economic evaluations conducted abroad should be adapted to Israeli settings - mostly
by adapting to local costs (clinical data normally accepted but a KoL opinion may be
needed). Both evaluations should be included. Any major Western market acceptable.
Sensitivity Analysis
Sensitivity analyses should
be performed for both
costs and benefits as
needed.
Discounting Rates 3%
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9. PARIOFORM
A
HTA Background
Mexico is just in the first steps of using pharmacoeconomics in decision making – but
cost effectiveness data has been a requirement since 2004. With regards to cost
effectiveness, current regulation states that the applicant must submit with the request
for submission all pharmacoeconomic tests.
HTA Agency
No HTA agency for
pharmaceuticals so the
Consejo de Salubridad
General (CSG) review the
PE evidence. A second
review is carried out at
Institutional level.
Methodological
Guidelines
Submissions should follow
the guidelines released in
2009.
Selection Criteria for
Drugs to Review
Mandatory for a new
drugs to be included in the
National Formulary.
Preferred or Required
Assessment Approach
CEA – can be
supplemented by CUA but
this is not obligatory.
CMA – if well justified.
Weight of Clinical vs.
Economic Evidence
For innovative drugs
clinical evidence is the
most important criteria.
Principle Outcome
Measures
Morbidity, mortality and
QoL most frequently used
– but no restrictions on
endpoints as long as
justified in the model.
Choice of Comparator
Standard of care available
in the National and
Institutional formularies.
Decision Threshold
No formal threshold.
A very informal cost
effectiveness threshold of
~50,000 pesos per patient.
Cost perspective
Societal or payer
perspective – but indirect
costs are very difficult to
obtain. Payer perspective
(Institutions: i.e. IMSS,
ISSSTE, PEMEX) preferred.
Costs
Direct costs the most
important consideration.
Budget Impact Analysis
Required in the guidelines
but not perceived as
obligatory.
BIA Time Horizon
No specific requirements -
1-2 years sufficient.
Modelling
No need to present the actual model. Complexity not required – just asking for a clear,
model with full explanation of inputs and outputs supported by local research or
literature research, and a local expert.
Requirements for Local
Data
Acceptable to use foreign data on efficacy/ effectiveness - UK, EU or US data
acceptable. Models created for other countries can be that adapted with Mexican costs
and epidemiology.
Sensitivity Analysis
Sensitivity analysis of
relevant variables
affecting the model.
All methods acceptable if
applicable to the model,
Discounting Rates
Guidelines have set a 5%
discount for costs and
benefits. Recommended
to explore ranges 3% - 7%
for costs and 0% - 7% for
benefits in the sensitivity
analysis.
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10. PARIOFORM
A
HTA Background
The Agency for Health Technology Assessment in Poland (AHTAPol) was established as
a state financed institute in Sep 2005. But in Jan 2009, it was granted a more formal
responsibility as the government HTA Agency. AHTAPol now has influence at the
highest level of the MoH – however, its role is advisory only and its decisions are not
binding on the MoH.
HTA Agency
AHTAPol (Polish acronym:
AOTM)
Methodological
Guidelines
A "full dossier" of relevant
HTA documents required
by ATOM – guidelines
issued April 2009
Selection Criteria for
Drugs to Review
All new active substances
coming to the market
seeking reimbursement.
Preferred or Required
Assessment Approach
CEA
CUA
Weight of Clinical vs.
Economic Evidence
Clinical and safety data
represents about 80 - 85%
of decision making.
Economic evidence is
given less weight.
Principle Outcome
Measures
Preference for hard
endpoints e.g. measured
in "x" years of life gained.
Surrogate endpoint
accepted if appropriate.
Choice of Comparator
Comparator must be one
used in normal Polish
practice.
Decision Threshold
WHO threshold: 3x GDP
per capita
Cost perspective
Societal perspective very
rare.
Most analyses assessed
from National Health Fund
(NFZ) point of view (payer
perspective)
Costs
2009 guidelines widened
costs to include all direct
and indirect costs.
Budget Impact Analysis
BIA obligatory.
AOTM look closely at the
impact on Polish
Healthcare Budget - high
priority. Particularly
interested in ICERs.
BIA Time Horizon
2009 guidelines state 2
years – previously 5 years.
Modelling
If required, the structure of the model should be as simple as possible – situations
requiring modelling defined in guidelines. Model structure should be presented.
Assumptions of the model should be clear, well justified and tested in a sensitivity
analysis. If data in model extrapolated over a time horizon of the primary trials, the
following scenarios should be analysed: optimistic, pessimistic and neutral.
Requirements for Local
Data
Foreign data from US and European markets acceptable – but strongly recommend the
use of clinical data "transferable" to the Polish situation. Need to consider local
treatment protocols and practices as well as costs.
Sensitivity Analysis
One- or multi-way
sensitivity analysis often
not enough - probabilistic
also recommended; best
to provide CE acceptability
curve.
Discounting Rates
Previously 5% - 2009
guidelines state: 5% for
costs and 3.5% for effects
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11. PARIOFORM
A
HTA Background
In 2001 the National Health Insurance House (NHIH) was involved in a project funded
by the European Commission to build Institutional capacity of the national health
system in Romania - a small component focused on evidence-based practices. This was
the first time this topic had ever been considered in project form in Romania - the
project ran for about 3 years. Unfortunately after the project ended there was no
Institution that took on the responsibility to follow-up and to build further on any of
the methods that had been identified during the project.
HTA Agency
No HTA agency - no
"body" to feasibly take
this on at the moment.
Methodological
Guidelines
No formal guidelines.
Selection Criteria for
Drugs to Review
HTA/ EE not required –
but good to have available
as very simple analyses.
Preferred or Required
Assessment Approach
Expected to be CEA or
CUA in the future (2-3
years).
Weight of Clinical vs.
Economic Evidence
Efficacy and safety are the
criteria for access to
reimbursement list - some
negotiations on price, but
no formal consideration of
CE/ HTA.
Principle Outcome
Measures
Hard endpoints preferred.
Choice of Comparator
If applicable it would be
standard of care.
Decision Threshold
No formal threshold – but
for expensive drugs
expensive drugs the NHIH
often place restrictions on
prescribing.
Cost perspective
Payer perspective
expected in future.
Societal perspective would
be very difficult – in terms
of collecting relevant data.
Costs
No requirements – but
direct medical costs are
easier to access than
indirect medical costs.
Access to cost data still
problematic.
Budget Impact Analysis
Not a requirement. The
NHIH perform their own
budget impact simulation.
BIA Time Horizon Not a requirement.
Modelling
Data provided must only show the results and basic approach. It should be noted that
there is no “body” or “function” assigned or trained to evaluate economic evidence.
Requirements for Local
Data
European medical guidelines accepted. No formal requirements for local data - but
informally there is the consensus that it is good to have Romanian data. Treatment
settings are often different - i.e. out-patient treatments in other countries are most
often an in-patient treatments in Romania - e.g. chemotherapy, dialysis, etc.
Sensitivity Analysis N/A Discounting Rates N/A
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12. PARIOFORM
A
HTA Background
Russia has no HTA Agency or formal department assigned to review economic
submissions. In 2002, the Russian chapter of ISPOR (RSPOR) created methodological
guidelines - which were approved by the MoH. However, although not rescinded, they
are not used or adhered to by the MoH. PE data is required for drug applications for
inclusion in the DLO (supplementary drug list for certain social groups – mainly elderly,
disabled, veterans or long-term sick) or the EDL (Essential Drug List). Decentralization of
funding means that data has to be submitted at both national and regional levels - but
regional evaluations are even less sophisticated.
HTA Agency No HTA agency.
Methodological
Guidelines
Guidelines not adhered to
– MoH requests PE data
with no specifications on
what is required.
Selection Criteria for
Drugs to Review
Reimbursement under
DLO or EDL.
Preferred or Required
Assessment Approach
CEA and CMA where
appropriate - the MoH
want to see
demonstrations of savings
in treatment costs.
Weight of Clinical vs.
Economic Evidence
Clinical evidence is the
most important factor.
Principle Outcome
Measures
Hard endpoints preferred
Choice of Comparator
Not specified – but local
Russian comparators are
important.
Decision Threshold No threshold.
Cost perspective
Not specified – payer
perspective most
applicable.
Costs
Direct medical and
indirect medical costs.
Cost data difficult to
obtain.
Budget Impact Analysis No formal requirement. BIA Time Horizon N/A
Modelling
No specifications or guidance on modelling requirements. It should be noted that there
is no “body” or “function” assigned or trained to look at models submitted. The MoH
want to see simple data only: cost of drug + cost of complications + cost of
administration/ management. Summed all together this gives an illustration of the
economic value of the drug.
Requirements for Local
Data
Foreign data on efficacy and effectiveness often used – but a preference for adaptation
to the local situation. Treatment standards and practices are often very different to
those used in Western Europe or the US – hence the emphasis on local comparators.
Costs all very different – e.g. a long hospitalization will often be 10x cheaper than giving
the patient an expensive drug. Also standard Western out-patient treatments are in-
patient in Russia.
Sensitivity Analysis Not specified Discounting Rates Not specified
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13. PARIOFORM
A
HTA Background
HTA just starting in the Kingdom. Health technology registration process control has
been moved from the MoH to the Saudi Food and Drug Authority [SFDA] - the SFDA are
now trying to introduce the concept of economic evaluations. HTA submission
guidelines are currently being drawn up by the SFDA in conjunction with leading
academic experts.
HTA Agency
SFDA hope to be the
appointed HTA agency.
Methodological
Guidelines
Guidelines under
construction – but
regulations perhaps 2-4
years away.
Selection Criteria for
Drugs to Review
Expected to apply to all
new technologies - no
distinguishes made at this
stage.
Preferred or Required
Assessment Approach
No requirements – but
CEA most commonly used
to date. Results for CEA or
CUA should be reported as
ICERs.
Weight of Clinical vs.
Economic Evidence
Decisions based on clinical
and safety evidence – very
limited consideration of
CE at present.
Principle Outcome
Measures
Hard endpoints required -
morbidity, mortality, QoL -
intermediate endpoints
not accepted.
Choice of Comparator
Not specified - choice of
comparator should relate
to the study population,
and the local context or
practice.
Decision Threshold
No threshold defined yet -
but a threshold value must
be set to understand the
level of cost effectiveness
that deserves premium
pricing.
Cost perspective
Not specified - societal
preferred but the lack of
local data on costs makes
this difficult. Next best is
MoH perspective as this is
the largest provider.
Costs
No requirements -
depends on the study
perspective. Costs
excluded from the analysis
and their impact must be
clearly specified.
Budget Impact Analysis Not looking at BIA yet. BIA Time Horizon Not required.
Modelling
Complex models not required. All endpoint data and all the sources of input data need
to be explained clearly. Model structure should be included. Presentation and results of
the model should be clear and tested by sensitivity analysis.
Requirements for Local
Data
No specific requirements for local data. Efficacy/effectiveness data from other
countries acceptable - but when international data is presented, its applicability to the
local situation needs to be justified. Required to define the differences and explore
their effects when extrapolating international data to the local population.
Sensitivity Analysis
Required but method not
specified.
Discounting Rates Not specified.
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14. PARIOFORM
A
HTA Background
Currently PE/ HTA has a very limited role in decision-making. Committee for
Pharmacoeconomics and Clinical Outcomes of Slovak Ministry of Health was founded
late 2007 – this is an advisory body to Reimbursement Committee. PE/ HTA practices
expected to align closer with standard European practice over the next 2 years.
HTA Agency
No HTA agency -
Committee for Pharmaco-
economics and Clinical
Outcomes responsible for
evaluating economic
analyses.
Methodological
Guidelines
First guidelines were
brought in for Sep 2008.
Selection Criteria for
Drugs to Review
New drugs seeking
coverage by Health
Insurance Companies
Preferred or Required
Assessment Approach
Can be: CMA, CEA, or CUA
- depending on the clinical
problem being addressed.
Weight of Clinical vs.
Economic Evidence
Clinical evidence has more
weight – PE/HTA all very
new.
Principle Outcome
Measures
Hard outcomes preferred -
morbidity, mortality and
changes in QoL. Clinically
significant surrogate
endpoints accepted.
Choice of Comparator
Currently accepted
standard therapy that the
new intervention is
intended to replace.
Decision Threshold
Level 1: €18,000, Level 2:
€26,500. An official
threshold - but no drug
has been refused on this
basis (measured in cost
per QALY).
Cost perspective
In new guidelines, societal
preferred - in 2008 it was
payer perspective.
Costs
Direct healthcare costs,
direct non-healthcare
costs and indirect costs.
Budget Impact Analysis
Mandatory for all drugs -
but only very basic data
required.
BIA Time Horizon
Impact on annual budget
and the cumulative impact
over 5 years.
Modelling
No preferences on modeling – but complexity not required. Results are most important
- these need to be fully explained and presented transparently to assist decision
making. Common for international models to be adapted using local cost data.
Requirements for Local
Data
Foreign data accepted - preferably from Hungary, Poland and Czech Rep. if available.
Base-case analysis is needed to present direct adaptation of resource use data from a
foreign study. If comparison shows clinical practice is different then base-case should
be supplemented with an analysis that tries to adjust for practice differences.
Sensitivity Analysis
Sensitivity analysis must
be performed on all
uncertain data/
assumptions included in
the model. Methodology
not specified – univariate
most common.
Discounting Rates
Future health gains and
costs should be
discounted at 5%.
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15. PARIOFORM
A
HTA Background
No independent HTA body to assess the findings of such work or to evaluate it against
internationally accepted standards. The MoH called for the establishment of an
HTA commission in April 2008. HTA evidence is not mandatory at this stage to support
new drug submissions. However, in the next year, HTA will be formally recognized
under the law - in terms of both organization and application. The new HTA
commission will prepare the guidelines and discuss the future development and
implementation of HTA in Slovenia.
HTA Agency
No HTA agency. No
indication that a "single"
national agency will be
adopted at this point - a
HTA network is proposed.
Methodological
Guidelines
No guidelines.
Selection Criteria for
Drugs to Review
Very basic EE and BIA is
required if applying for
reimbursement status -
this became law on 1st
January 2009.
Preferred or Required
Assessment Approach
CEA for hospital drugs along
with estimation of ICER
values.
Weight of Clinical vs.
Economic Evidence
Clinical effectiveness
remains the major focus -
economic evaluations all
very new.
Principle Outcome
Measures
Everything is acceptable -
but "hard" endpoints carry
more weight.
Choice of Comparator
Standard of care in
Slovenia
Decision Threshold
Drugs ranked by ICER – but
this is not the only ranking
criteria. ICER > €45000 per
QALY considered cost
ineffective. ICERs €30000 -
€45000 considered
moderately cost effective;
ICERs < €30000 considered
cost effective.
Cost perspective
No actual preference -
payer perspective normal.
But a desire for societal in
future.
Costs
Depends on study
perspective.
Budget Impact Analysis Basic BIA only. BIA Time Horizon No guidelines yet.
Modelling
No specifications for modelling – no capabilities for anything complex. No requirement
to present the actual model - just a scheme of how it performs and a full explanation of
the results.
Requirements for Local
Data
EE analyses from other countries can be presented but companies are required to
provide an estimation of how the information could be applied in Slovenia – often by
adapting with local data. New HTA network expected to use EUnetHTA tools to adapt
foreign data for Slovenia.
Sensitivity Analysis
Required but method not
specified. Univariate
common.
Discounting Rates
Not specified but under
review for developing
guidelines.
15

16. PARIOFORM
A
 Parioforma Ltd. is an international business consultancy founded
in 2005 and headquartered in London, UK.
 We deliver market access intelligence based on primary research
to help our customers formulate market access strategies.
 Specific activities include:
◦ Payer, provider and/ or prescriber research
 Profiling/ mapping
 Surveys
 Testing attitudes
 Switching criteria
 Unmet needs
 Evidence requirements
◦ Market research
 Pricing & reimbursement
 Environment mapping/ profiling
 Market modeling
 Trend analysis & opportunity identification
◦ Parioforma designs and delivers strategic workshops to help
our clients understand and internalize information for tool
development.
LONDON OFFICE ASSOCIATE OFFICES
Contact: Charles Rowlands
charles.rowlands@parioforma.com
55 Prince’s Gate
Exhibition Road
London SW7 2PN
United Kingdom
Tel: +44 (0) 7803 907577
www.parioforma.com
USA Intrix Corp, Darien
Connecticut
Eastern
Europe
Vanguard, Moscow
Brazil Intrix Corp, São Paulo
Japan TRN, Tokyo
16