HTA in emerging markets

Overview of Selected Countries

March 2010

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PARIOFORMA

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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PARIOFORMA

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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PARIOFORMA

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 ComparatorCurrent 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 AnalysisMany HMOs request BIA. Cost per year or per treatment of interest.

BIA Time Horizon 1 – 5 years

ModellingNot 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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PARIOFORMA

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)


New methodological guidelines just being introduced.


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


Currently cost effectiveness not taken into account; but the trend is towards increased use of CEA.


Not defined but “natural” endpoints preferred: mortality, incidence, complications, etc.

Choice of ComparatorThe 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.

ModellingNo 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.


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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PARIOFORMA

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.


Intended as part of the application for coverage under the public health insurance.


Very simple CEA - an optional extra as a supporting argument for BIA.


Clinical evidence technically more important – but comparative cost effectiveness in terms of budget impact plays a role in decision making.


Preference for hard endpoints - mortality and morbidity play a much more important role than patient QoL data.

Choice of ComparatorThat 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 perspectiveViewpoint of Public Health Insurance preferred (a State funded body).

CostsDirect healthcare costs - those incurred by the health insurance funds.

Budget Impact AnalysisRequired - but shortage of relevant epidemiology and cost sources.

BIA Time Horizon 1 - 5 years accepted - but usually 3 years.

ModellingIt 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.


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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PARIOFORMA

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 AgencyThe National Institute for Strategic Health Research (ESKI) governed by the MoH.


First published in 2002 - an update is now under construction.


Full HTA dossier required for all new indications, new actives, new strengths.


CEA and CUA. If there is information on QoL then CUA more appropriate.


Clinical evidence the basic level of evidence - without strong clinical evidence, economic evidence not even considered.


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 perspectivePayer perspective [National Health Insurance Fund Administration - NHIFA].

Costs Direct medical and direct non-medical.

Budget Impact AnalysisBIA 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.


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 AnalysisUnivariate generally sufficient - but if probalistic can be presented this is stronger.

Discounting RatesCurrent guidelines state 5% for all; new guidelines to be published this year state 3.7%.

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PARIOFORMA

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.


Under new guidelines -obligatory for all new technologies with a budget impact > 100,000 shekels (~£20K) pa.

Preferred or Required Assessment Approach CUA


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.


Hard endpoints preferred - surrogate endpoints have to be translated to QALYs for economic analysis.

Choice of ComparatorStandard-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.


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).


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 AnalysisSensitivity analyses should be performed for both costs and benefits as needed.

Discounting Rates 3%

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PARIOFORMA

HTA BackgroundMexico 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.


Submissions should follow the guidelines released in 2009.


Mandatory for a new drugs to be included in the National Formulary.


CEA – can be supplemented by CUA but this is not obligatory.CMA – if well justified.


For innovative drugs clinical evidence is the most important criteria.


Morbidity, mortality and QoL most frequently used – but no restrictions on endpoints as long as justified in the model.

Choice of ComparatorStandard 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 AnalysisRequired in the guidelines but not perceived as obligatory.

BIA Time Horizon No specific requirements - 1-2 years sufficient.

ModellingNo 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.


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 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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PARIOFORMA

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)


A "full dossier" of relevant HTA documents required by ATOM – guidelines issued April 2009


All new active substances coming to the market seeking reimbursement.


CEACUA


Clinical and safety data represents about 80 - 85% of decision making. Economic evidence is given less weight.


Preference for hard endpoints e.g. measured in "x" years of life gained.Surrogate endpoint accepted if appropriate.

Choice of ComparatorComparator 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)

Costs2009 guidelines widened costs to include all direct and indirect costs.


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.


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.


One- or multi-way sensitivity analysis often not enough - probabilistic also recommended; best to provide CE acceptability curve.

Discounting RatesPreviously 5% - 2009 guidelines state: 5% for costs and 3.5% for effects

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PARIOFORMA

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 AgencyNo HTA agency - no "body" to feasibly take this on at the moment.

Methodological Guidelines No formal guidelines.


HTA/ EE not required – but good to have available as very simple analyses.


Expected to be CEA or CUA in the future (2-3 years).


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 AnalysisNot 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.


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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PARIOFORMA

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.


Reimbursement under DLO or EDL.


CEA and CMA where appropriate - the MoH want to see demonstrations of savings in treatment costs.


Clinical evidence is the most important factor.

Principle Outcome Measures Hard endpoints preferred

Choice of ComparatorNot specified – but local Russian comparators are important.

Decision Threshold No threshold.

Cost perspectiveNot specified – payer perspective most applicable.

CostsDirect 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.


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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PARIOFORMA

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.


Guidelines under construction – but regulations perhaps 2-4 years away.


Expected to apply to all new technologies - no distinguishes made at this stage.


No requirements – but CEA most commonly used to date. Results for CEA or CUA should be reported as ICERs.


Decisions based on clinical and safety evidence – very limited consideration of CE at present.


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.

ModellingComplex 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.


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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PARIOFORMA

HTA BackgroundCurrently 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.


First guidelines were brought in for Sep 2008.


New drugs seeking coverage by Health Insurance Companies


Can be: CMA, CEA, or CUA - depending on the clinical problem being addressed.


Clinical evidence has more weight – PE/HTA all very new.


Hard outcomes preferred - morbidity, mortality and changes in QoL. Clinically significant surrogate endpoints accepted.

Choice of ComparatorCurrently 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 perspectiveIn new guidelines, societal preferred - in 2008 it was payer perspective.

CostsDirect healthcare costs, direct non-healthcare costs and indirect costs.

Budget Impact AnalysisMandatory for all drugs - but only very basic data required.

BIA Time HorizonImpact on annual budget and the cumulative impact over 5 years.

ModellingNo 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.


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 must be performed on all uncertain data/ assumptions included in the model. Methodology not specified – univariate most common.

Discounting RatesFuture health gains and costs should be discounted at 5%.

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PARIOFORMA

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.


Very basic EE and BIA is required if applying for reimbursement status - this became law on 1st January 2009.


CEA for hospital drugs along with estimation of ICER values.


Clinical effectiveness remains the major focus - economic evaluations all very new.


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 perspectiveNo 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.

ModellingNo 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.


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 AnalysisRequired but method not specified. Univariate common.

Discounting RatesNot specified but under review for developing guidelines.

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PARIOFORMA

Parioforma Ltd. is an international business consultancy founded 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

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◦ Market research Pricing & reimbursement Environment mapping/ profiling Market modeling Trend analysis & opportunity identification

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HTA in emerging markets

Health & Medicine

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