Overview of Selected Countries                                    March 2010Parioforma Ltd55 Princes GateExhibition RoadSo...
PARIOFORMA   Pharma markets in Emerging Markets (EMs) have been    continuously witnessing robust growth on account of:  ...
PARIOFORMA   BIA: Budget Impact Analysis   EE: Economic Evaluation   CE: Cost Effectiveness   CEA: Cost Effectiveness ...
PARIOFORMA                          After the 2002 financial crisis, an HTA commission was created within the regulatory  ...
PARIOFORMA                         The government has defined the need for an HTA agency. Resources for this agency are   ...
PARIOFORMA                          The pharmacoeconomic Society prepared general guidelines in 2009. The MoH accept      ...
PARIOFORMA                          HTA dates back to 1993. In 2004, the Transparency Secretariat (TS) and Technology     ...
PARIOFORMA                          HTA first became a requirement around 10 years ago. Companies wishing for their       ...
PARIOFORMA                          Mexico is just in the first steps of using pharmacoeconomics in decision making – but ...
PARIOFORMA                          The Agency for Health Technology Assessment in Poland (AHTAPol) was established as    ...
PARIOFORMA                          In 2001 the National Health Insurance House (NHIH) was involved in a project funded   ...
PARIOFORMA                          Russia has no HTA Agency or formal department assigned to review economic             ...
PARIOFORMA                          HTA just starting in the Kingdom. Health technology registration process control has  ...
PARIOFORMA                          Currently PE/ HTA has a very limited role in decision-making. Committee for           ...
PARIOFORMA                          No independent HTA body to assess the findings of such work or to evaluate it against ...
PARIOFORMA   Parioforma Ltd. is an international business consultancy founded    headquartered in London, UK.   We deliv...
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HTA in emerging markets


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HTA in emerging markets

  1. 1. Overview of Selected Countries March 2010Parioforma Ltd55 Princes GateExhibition RoadSouth KensingtonLondon SW7 2PNUnited Kingdomwww.parioforma.com
  2. 2. 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. 2
  3. 3. 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 3
  4. 4. PARIOFORMA 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 HTA Background 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. Unidad Coordinadora de Guidelines are very new Evaluación y Ejecución de and mostly directional Methodological rather than mandatory. HTA Agency Tecnologías en Salud (UCEETS) created within Guidelines No solid specifications on the MoH October 2009. data requirements as yet. HTA anticipated as a requirement for all new Recommendations: Selection Criteria for Preferred or Required −CEA primarily technologies applying for Drugs to Review reimbursement – not Assessment Approach −CUA secondary mandatory as yet. Classical hard endpoints Weight of Clinical vs. Clinical benefits most Principle Outcome preferred over quality Economic Evidence important. Measures adjusted life years - but no formal guidelines Not yet explicitly Current standard of care - established by UCEETS. best if included in theChoice of Comparator compulsory medical Decision Threshold 3x GDP per capita for a package. QALY or DALY rule informally used. Payer perspective Studies can include direct recommended - one for and indirect costs - but Cost perspective each type of payer (social, Costs essentially only direct private, public) as unit medical costs tend to be costs and resources vary. considered. Many HMOs request BIA.Budget Impact Analysis Cost per year or per BIA Time Horizon 1 – 5 years treatment of interest. Not explicitly specified by UCEETS. Some HMOs are content with a simple incremental Modelling cost-effectiveness indicator. More complex models are accepted but not explicitly required. Foreign models can be adapted to the local context. Local data preferred followed by regional communicators, followed by internationalRequirements for Local data. In the absence of local data, QALYs and/or tariffs from other countries can be Data extrapolated - depending on the quality of data. Local context required for costs. Not yet explicitly established by UCEETS. Mostly univariate - no Sensitivity Analysis formal guidelines Discounting Rates Typically 3 - 5% for both costs and effects but no local consensus. 4
  5. 5. PARIOFORMA 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. HTA Background 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. No formal agency – but CRES (part of MoH) is a new New methodological body under law that will Methodological HTA Agency guidelines just being request economic analysis Guidelines introduced. (along with clinical information) To be defined. Probably in the future it will cover newSelection Criteria for Preferred or Required technologies that intend to In the future: CEA Drugs to Review be included in the national Assessment Approach benefit plan. Currently cost effectiveness Not defined but “natural”Weight of Clinical vs. not taken into account; but Principle Outcome endpoints preferred:Economic Evidence the trend is towards Measures mortality, incidence, increased use of CEA. complications, etc. No explicit threshold - some researches use WHO The new methodological guidelines (per capita GDPChoice of Comparator guidelines adopt the Decision Threshold per life year saved) but the standard of care. guidelines suggest the use of an efficiency frontier as in Germany. Societal perspective Depends on study defined in guidelines – perspective. Cost perspective payer perspective more Costs practical due to a lack of Cost data very poor with indirect cost data. much regional variation. BIA requirements under Budget Impact discussion. Would like to BIA Time Horizon Not defined. Analysis see drug costs per capita per year. No specific criteria defined. All modeling very new - new guidelines propose only simple Modelling 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 Requirements for recommendations used as reference cases. Can adapt regional data - such as Mexico - Local Data for Columbia. Local context required for costs expressed in local currency. Not defined – simple Not defined. Sensitivity Analysis approach preferred. Discounting Rates Can be 0%, 3% or 5% . 5
  6. 6. PARIOFORMA 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. HTA Background 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. Methodological General guidelines – not HTA Agency No HTA agency. binding. Guidelines Intended as part of the Very simple CEA - an Selection Criteria for application for coverage Preferred or Required optional extra as a Drugs to Review under the public health Assessment Approach supporting argument for insurance. BIA. Clinical evidence technically more Preference for hard important – but endpoints - mortality and Weight of Clinical vs. Principle Outcome comparative cost morbidity play a much Economic Evidence effectiveness in terms of Measures more important role than budget impact plays a role patient QoL data. in decision making. No guidelines on willingness to pay – That usually used in ongoing discussions at theChoice of Comparator practice - guidelines very Decision Threshold Pharmacoeconomics weak on this. Society involving all stakeholders. Viewpoint of Public Health Direct healthcare costs - Cost perspective Insurance preferred (a Costs those incurred by the State funded body). health insurance funds. Required - but shortage of 1 - 5 years accepted - butBudget Impact Analysis relevant epidemiology and BIA Time Horizon cost sources. usually 3 years. It is recommended to use models already developed for other countries and adapt Modelling 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 fromRequirements for Local abroad - particularly Europe. A basic requirement has just been introduced - any Data pharmacoeconomic evidence presented must be re-calculated using Czech prices. According to guidelines - appropriate to state the No rules - between 3-5% Sensitivity Analysis Discounting Rates influence of discounting in accepted. the sensitivity analysis. 6
  7. 7. PARIOFORMA 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 HTA Background 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. The National Institute for First published in 2002 - Strategic Health Research Methodological HTA Agency an update is now under (ESKI) governed by the Guidelines construction. MoH. Full HTA dossier required CEA and CUA. Selection Criteria for for all new indications, Preferred or Required If there is information on Drugs to Review new actives, new Assessment Approach QoL then CUA more strengths. appropriate. Clinical evidence the basic level of evidence - without Hard endpoints preferred Weight of Clinical vs. Principle Outcome strong clinical evidence, - intermediate surrogate Economic Evidence economic evidence not Measures outcomes not widely used. even considered. The currently accepted No formal threshold. standard therapy Informally, less than 8Choice of Comparator (therapies) that the new Decision Threshold million Hungarian Florins intervention is intended to representing 3x GDP per replace. capita. Payer perspective [National Health Insurance Direct medical and direct Cost perspective Fund Administration - Costs non-medical. NHIFA]. BIA essential toBudget Impact Analysis understand the financial BIA Time Horizon 3 – 5 years. commitment required. 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, Modelling 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 areRequirements for Local not always available, foreign HTAs are also applied – e.g. using demography, Data epidemiology, standard care, healthcare utilization, unit costs, and cost-effectiveness data from NICE analyses. Univariate generally Current guidelines state sufficient - but if 5% for all; new guidelines Sensitivity Analysis probalistic can be Discounting Rates to be published this year presented this is stronger. state 3.7%. 7
  8. 8. PARIOFORMA 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 HTA Background 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. Methodological Updated guidelines HTA Agency Still no formal HTA agency Guidelines beginning 2010. Under new guidelines -obligatory for all new Selection Criteria for Preferred or Required technologies with a CUA Drugs to Review budget impact > 100,000 Assessment Approach shekels (~£20K) pa. Each technology applying for the health basket is Hard endpoints preferred ranked according to - surrogate endpoints Weight of Clinical vs. Principle Outcome various criteria. Weight have to be translated to Economic Evidence given to clinical evidence Measures QALYs for economic is much higher than that analysis. given to EE. No formal threshold – but Standard-of-care decisions to date imply technologies included inChoice of Comparator the Israeli National List of Decision Threshold most technologies added have a cost effectiveness Health Services (INLHS). ratio of < $50 per QALY. Direct medical costs for Payer perspective: MoH, Cost perspective HMOs. Costs the supplier and consumer. To make decisions for inclusion in the health basket the estimatedBudget Impact Analysis annual cost of each new BIA Time Horizon 3 years. technology based on budget impact estimations is required. No specific guidelines. Starting from 2009, models presented to the MoH are passed to Modelling the Gertner Institute for evaluation who require the model itself (Excel file). Economic evaluations conducted abroad should be adapted to Israeli settings - mostlyRequirements for Local by adapting to local costs (clinical data normally accepted but a KoL opinion may be Data needed). Both evaluations should be included. Any major Western market acceptable. Sensitivity analyses should be performed for both Sensitivity Analysis costs and benefits as Discounting Rates 3% needed. 8
  9. 9. PARIOFORMA 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 HTA Background effectiveness, current regulation states that the applicant must submit with the request for submission all pharmacoeconomic tests. No HTA agency for pharmaceuticals so the Consejo de Salubridad Submissions should follow Methodological HTA Agency General (CSG) review the the guidelines released in PE evidence. A second Guidelines 2009. review is carried out at Institutional level. CEA – can be Mandatory for a new Selection Criteria for Preferred or Required supplemented by CUA but drugs to be included in the this is not obligatory. Drugs to Review National Formulary. Assessment Approach CMA – if well justified. Morbidity, mortality and For innovative drugs QoL most frequently used Weight of Clinical vs. Principle Outcome clinical evidence is the – but no restrictions on Economic Evidence most important criteria. Measures endpoints as long as justified in the model. No formal threshold. Standard of care available A very informal costChoice of Comparator in the National and Decision Threshold Institutional formularies. effectiveness threshold of ~50,000 pesos per patient. Societal or payer perspective – but indirect costs are very difficult to Direct costs the most Cost perspective obtain. Payer perspective Costs important consideration. (Institutions: i.e. IMSS, ISSSTE, PEMEX) preferred. Required in the guidelines No specific requirements -Budget Impact Analysis but not perceived as BIA Time Horizon obligatory. 1-2 years sufficient. No need to present the actual model. Complexity not required – just asking for a clear, Modelling 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 dataRequirements for Local acceptable. Models created for other countries can be that adapted with Mexican costs Data and epidemiology. Guidelines have set a 5% Sensitivity analysis of discount for costs and relevant variables benefits. Recommended Sensitivity Analysis affecting the model. Discounting Rates to explore ranges 3% - 7% All methods acceptable if for costs and 0% - 7% for applicable to the model, benefits in the sensitivity analysis. 9
  10. 10. PARIOFORMA 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 HTA Background 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. A "full dossier" of relevant AHTAPol (Polish acronym: Methodological HTA documents required HTA Agency AOTM) Guidelines by ATOM – guidelines issued April 2009 All new active substances Selection Criteria for Preferred or Required CEA coming to the market Drugs to Review seeking reimbursement. Assessment Approach CUA Clinical and safety data Preference for hard represents about 80 - 85% endpoints e.g. measured Weight of Clinical vs. Principle Outcome in "x" years of life gained. of decision making. Economic Evidence Economic evidence is Measures Surrogate endpoint given less weight. accepted if appropriate. Comparator must be one WHO threshold: 3x GDPChoice of Comparator used in normal Polish Decision Threshold per capita practice. Societal perspective very rare. 2009 guidelines widened Most analyses assessed Cost perspective Costs costs to include all direct from National Health Fund and indirect costs. (NFZ) point of view (payer perspective) BIA obligatory. AOTM look closely at the impact on Polish 2009 guidelines state 2Budget Impact Analysis BIA Time Horizon Healthcare Budget - high years – previously 5 years. priority. Particularly interested in ICERs. If required, the structure of the model should be as simple as possible – situations requiring modelling defined in guidelines. Model structure should be presented. Modelling 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 theRequirements for Local use of clinical data "transferable" to the Polish situation. Need to consider local Data treatment protocols and practices as well as costs. One- or multi-way sensitivity analysis often Previously 5% - 2009 not enough - probabilistic Sensitivity Analysis also recommended; best Discounting Rates guidelines state: 5% for to provide CE acceptability costs and 3.5% for effects curve. 10
  11. 11. PARIOFORMA 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 HTA Background 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. No HTA agency - no Methodological HTA Agency "body" to feasibly take No formal guidelines. this on at the moment. Guidelines HTA/ EE not required – Expected to be CEA or Selection Criteria for Preferred or Required but good to have available CUA in the future (2-3 Drugs to Review as very simple analyses. Assessment Approach years). Efficacy and safety are the criteria for access to Weight of Clinical vs. reimbursement list - some Principle Outcome Hard endpoints preferred. Economic Evidence negotiations on price, but Measures no formal consideration of CE/ HTA. No formal threshold – but for expensive drugs If applicable it would beChoice of Comparator standard of care. Decision Threshold expensive drugs the NHIH often place restrictions on prescribing. No requirements – but Payer perspective direct medical costs are expected in future. easier to access than Cost perspective Societal perspective would Costs indirect medical costs. be very difficult – in terms Access to cost data still of collecting relevant data. problematic. Not a requirement. TheBudget Impact Analysis NHIH perform their own BIA Time Horizon Not a requirement. budget impact simulation. Data provided must only show the results and basic approach. It should be noted that Modelling there is no “body” or “function” assigned or trained to evaluate economic evidence. European medical guidelines accepted. No formal requirements for local data - butRequirements for Local informally there is the consensus that it is good to have Romanian data. Treatment Data 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 11
  12. 12. PARIOFORMA 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 HTA Background 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. Guidelines not adhered to Methodological – MoH requests PE data HTA Agency No HTA agency. Guidelines with no specifications on what is required. CEA and CMA where appropriate - the MoH Selection Criteria for Reimbursement under Preferred or Required want to see Drugs to Review DLO or EDL. Assessment Approach demonstrations of savings in treatment costs. Weight of Clinical vs. Clinical evidence is the Principle Outcome Hard endpoints preferred Economic Evidence most important factor. Measures Not specified – but localChoice of Comparator Russian comparators are Decision Threshold No threshold. important. Direct medical and Not specified – payer indirect medical costs. Cost perspective perspective most Costs Cost data difficult to applicable. obtain.Budget Impact Analysis No formal requirement. BIA Time Horizon N/A 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 Modelling 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 toRequirements for Local those used in Western Europe or the US – hence the emphasis on local comparators. Data 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 12
  13. 13. PARIOFORMA 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 HTA Background 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. Guidelines under SFDA hope to be the Methodological construction – but HTA Agency appointed HTA agency. Guidelines regulations perhaps 2-4 years away. No requirements – but Expected to apply to all CEA most commonly used Selection Criteria for new technologies - no Preferred or Required to date. Results for CEA or Drugs to Review distinguishes made at this Assessment Approach CUA should be reported as stage. ICERs. Decisions based on clinical Hard endpoints required - Weight of Clinical vs. and safety evidence – very Principle Outcome morbidity, mortality, QoL - Economic Evidence limited consideration of Measures intermediate endpoints CE at present. not accepted. No threshold defined yet - Not specified - choice of but a threshold value must comparator should relate be set to understand theChoice of Comparator to the study population, Decision Threshold level of cost effectiveness and the local context or that deserves premium practice. pricing. Not specified - societal No requirements - preferred but the lack of depends on the study local data on costs makes perspective. Costs Cost perspective this difficult. Next best is Costs excluded from the analysis MoH perspective as this is and their impact must be the largest provider. clearly specified.Budget Impact Analysis Not looking at BIA yet. BIA Time Horizon Not required. Complex models not required. All endpoint data and all the sources of input data need Modelling 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 otherRequirements for Local countries acceptable - but when international data is presented, its applicability to the Data local situation needs to be justified. Required to define the differences and explore their effects when extrapolating international data to the local population. Required but method not Sensitivity Analysis Discounting Rates Not specified. specified. 13
  14. 14. PARIOFORMA Currently PE/ HTA has a very limited role in decision-making. Committee for Pharmacoeconomics and Clinical Outcomes of Slovak Ministry of Health was founded HTA Background 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. No HTA agency - Committee for Pharmaco- economics and Clinical Methodological First guidelines were HTA Agency Outcomes responsible for Guidelines brought in for Sep 2008. evaluating economic analyses. New drugs seeking Can be: CMA, CEA, or CUA Selection Criteria for Preferred or Required coverage by Health - depending on the clinical Drugs to Review Insurance Companies Assessment Approach problem being addressed. Hard outcomes preferred - Clinical evidence has more morbidity, mortality and Weight of Clinical vs. Principle Outcome weight – PE/HTA all very changes in QoL. Clinically Economic Evidence new. Measures significant surrogate endpoints accepted. Level 1: €18,000, Level 2: Currently accepted €26,500. An official standard therapy that the threshold - but no drugChoice of Comparator new intervention is Decision Threshold has been refused on this intended to replace. basis (measured in cost per QALY). In new guidelines, societal Direct healthcare costs, Cost perspective preferred - in 2008 it was Costs direct non-healthcare payer perspective. costs and indirect costs. Mandatory for all drugs - Impact on annual budgetBudget Impact Analysis but only very basic data BIA Time Horizon and the cumulative impact required. over 5 years. No preferences on modeling – but complexity not required. Results are most important Modelling - 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.Requirements for Local Base-case analysis is needed to present direct adaptation of resource use data from a Data 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/ Future health gains and Sensitivity Analysis assumptions included in Discounting Rates costs should be the model. Methodology discounted at 5%. not specified – univariate most common. 14
  15. 15. PARIOFORMA 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 HTA Background 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. No HTA agency. No indication that a "single" Methodological HTA Agency national agency will be No guidelines. adopted at this point - a Guidelines HTA network is proposed. Very basic EE and BIA is required if applying for CEA for hospital drugs along Selection Criteria for Preferred or Required reimbursement status - with estimation of ICER Drugs to Review this became law on 1st Assessment Approach values. January 2009. Clinical effectiveness Everything is acceptable - Weight of Clinical vs. remains the major focus - Principle Outcome but "hard" endpoints carry Economic Evidence economic evaluations all Measures more weight. very new. Drugs ranked by ICER – but this is not the only ranking criteria. ICER > €45000 per QALY considered cost Standard of care inChoice of Comparator Slovenia Decision Threshold ineffective. ICERs €30000 - €45000 considered moderately cost effective; ICERs < €30000 considered cost effective. No actual preference - payer perspective normal. Depends on study Cost perspective But a desire for societal in Costs perspective. future.Budget Impact Analysis Basic BIA only. BIA Time Horizon No guidelines yet. No specifications for modelling – no capabilities for anything complex. No requirement Modelling 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 toRequirements for Local provide an estimation of how the information could be applied in Slovenia – often by Data adapting with local data. New HTA network expected to use EUnetHTA tools to adapt foreign data for Slovenia. Required but method not Not specified but under Sensitivity Analysis specified. Univariate Discounting Rates review for developing common. guidelines. 15
  16. 16. 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  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 OFFICESContact: Charles Rowlands Intrix Corp, Darien USAcharles.rowlands@parioforma.com Connecticut Eastern Vanguard, Moscow55 Prince’s Gate EuropeExhibition RoadLondon SW7 2PN Brazil Intrix Corp, São PauloUnited KingdomTel: +44 (0) 7803 907577 Japan TRN, Tokyowww.parioforma.com 16