EE y Decisión. Decisión? Plano de la costo efectividad 23/03/2012. Costo Salud. Costo Salud. Costo Salud. Costo Salud. Dominado.

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1 UMBRALES Y TOMA DE DECISIONES - CAPITULO ARGENTINO ISPOR MARZO 2012 Los umbrales en Evaluaciones Económicas Aplicación Para la Toma de Decisiones Algunos ejemplos. Aplicabilidad para nuestra región? ProfFederico AugustovskiMD MScPhD Costo Salud Dominado Decisión Facil EE y Decisión V R =costo Decisión? Costo Salud V s =Efectividad Agradecimiento: Prof Andrés PichonRiviereMD MSc PhD. Panel HTAi 2011 Costo Salud Decisión? Costo Salud Dominante Decisión Facil Plano de la costo efectividad V R=costo $40,000 Decisión? V R=costo $40,000 $30,000 Mínima mejora en la efectividad $30,000 Mínima mejora en la efectividad $20,000 Gran aumento en los costos Importante mejora en la efectividad $20,000 Gran aumento en los costos Importante mejora en la efectividad $10,000 Mínimo aumento de los costos $10,000 Pendiente Mínimo aumento de los costos $10,000 V s=efectividad Años de Vida -$10,000 V s=efectividad Años de Vida -$20,000 -$20,000 -$30,000 -$30,000 1

2 V R =costo E Razón Costo-Efectividad 1 C C/E? Pendiente Diferencia en Costo = Diferencia en Efectividad V s =Efectividad 1.Cuál es la Costo/Efectividad 2. Cuál es el Umbral de Voluntad de Pagar 3. Es menor?: adoptar (si alcanza la plata) Reglas para la Decisión Es mayor?: rechazar V R=costo $40,000 $30,000 $20,000 $10,000 -$10,000 -$20,000 -$30,000 C/E $30,000 por Diferencia $20,000 en por Costo año de vida año de vida ganado= Diferencia ganado en Efectividad $10,000 por año de vida ganado V s=efectividad Años de Vida Qué Umbral Usar?? Cómo estimar el umbral? EE.UU +/ $ / QALY (díálisis) UK Libras Comisión Macroeconómica de la OMS Hasta 1 PBI per cápita: muy costo-efectivo Hasta 3 PBI per cápita: costo-efectivo Más de 3 PBI per cápita: no costo-efectivo Arbitrarios!!! Mucha investigación actual 1. Si toma decisiones en base a costoefectividad hace tiempo, evaluar empíricamente las decisiones e ICERs para estimar umbral 2. Estimarlo empíricamente en base a costos y productividad del sistema de salud. 3. Estimarlo empíricamente en base a WTP de stakeholders o en su defecto 4. Recomendación OMS Evaluación de Tecnologías Sanitarias. 2

3 CE en Brasil Mexico Aceptabilidad PBI per cápita Brasil: R$ PBI $ 0 1 PBI $ 16,000 3 PBI $ 48,000 Evaluación de Tecnologías Sanitarias. Evaluación de Tecnologías Sanitarias. País Muy C-E (<1PBI) Ejemplos C-E (h3) No C-E (>3) Hay evidencia de un umbral explícito o implícito de costo incremental por unidad de ganancia de salud? ( valor por dinero ) 100% Argentina < 6641 h >19923 Brasil < 6859 h >20577 Probabilidad de que la cobertura sea rechazada Colombia < 3729 h >11187 Perú < 3910 h >11730 Uruguay < 6956 h >20868 Banco Mundial, PBI Nominal, Datos 2007, US$ 0% Evaluación de Tecnologías Sanitarias. Costo por QALY El umbral implícito en algunos países- Canadá, USA, UK, Australiaes de aproximadamente US$50,000/QALY 3

4 VALUE-BASED PRICING UK GOES TOWARDS A VALUE BASED PRICING SCHEME IN 2014 TO ESTABLISH THE VALUE OF A NEW TECHONOLOGY, WE NEED TO ASSESS IF THE ADDED HEALTH BENEFITS EXCEED THE HEALTH BENEFITS LOST THROUGH THE DISPLACEMENT OF OTHER TREATMENTS COMPARE THE INCREMENTAL COST EFFECTIVENESS RATIO (ICER) TO THE WILLINGNESS TO PAY THRESHOLD OF THE SYSTEM CURRENT NICE THRESHOLD AROUND / QALY. Prof. Federico Augustovski VALUE BASED PRICING THE HOLY THRESHOLD Threshold Prof. Federico Augustovski 4

5 THE EMPIRICAL THRESHOLD NEW ENGLAND WHAT IS VALUE? NICE GIVES ADVICE, BUT NOT LEGALLY ENFORCED NEW SCHEME WOULD FORMALIZE THE CHOICE OF SOCIAL VALUES AND THEIR WEIGHTING 1. BURDEN OF DISEASE RELATED TO THE CONDITION (UNMET NEEDS OF TREATMENT OR SEVERITY) 2. DEGREE OF THERAPEUTIC INNOVATION 3. WIDER SOCIAL BENEFITS A NEW DRUG THAT PROVIDES VALUE, A HIGHER PRICE THRESHOLD Prof. Federico Augustovski Prof. Federico Augustovski We don't have a costeffectiveness threshold!! The frustrated Latin- American health economist Scope of the presentation Finding an appropriate threshold, can be part of the solution to our problems? In Latin America, is it possible to find an appropriate threshold? Threshold = Holy Grail If we are able to define a threshold methodologically valid, can we base our decisions on it? Even in the case that we can estimate a threshold with the most robust methods, its application in Latin American countries will face anyway many limitations. Many more limitations that its application may have today in countries like Canada, Australia or UK. 5

6 X X X X X X X X X X X All health technologies (programs, drugs, devices..) X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X How to best allocate our limited funds? It is important to know which interventions or technologies are important (with a highest priority for the society, those that we can not fail to provide). Secure resources to guarantee that these interventions will be available for the entire population. What services/technologies are less important? Those that if we fail to provide will not greatly affect health or social outcomes. But defining what is important, what is a priority, is not easy. All health technologies (programs, drugs, devices..) Health Economic Evaluation (Cost-Utility) Cost-saving Very low cost per Other values (e.g. Social value) Cost-saving Very low cost per Intermediate cost /DALY Intermediate cost /DALY High cost per High cost per Very high cost per Very high cost per 6

7 Cost-saving Other values (e.g. Social value) Very low cost per Viagra (male sexual disfunction) Intermediate cost /DALY Cancer drugs High cost per Very high cost per Budget impact p x q Budget impact p x q U$D 5,000 U$D 14,000 U$D 25,000 U$D 32,000 Threshold 7

8 Canada, UK, Australia Health Economic Evaluation (Cost-Utility) Latin America Health Economic Evaluation (Cost-Utility) Not-Covered (outside the benefic package) Threshold Not-Covered (outside the benefic package) Threshold 2-3 GDP More transparent decision-making processes History of HTA & HEE (many health technologies evaluated) Inefficiencies & Corruption & Inequities under control Inefficiencies - Inequities Obsolete technologies Corruption Lack of transparency in decision-making processes No HTA & HEE history (a few health technologies evaluated so far) 1 GDP (in U$D nominal values) 9,000-11,000 Argentina, Brasil, Chile, México and Uruguay 5,000-7,000 Colombia, Panamá o Perú. Beyond the validity of any threshold, its application in Latin American (or developing) countries faces many limitations. These limitations are less related to the threshold in itself but to the characteristics of health systems : Inefficiencies Inequities Obsolete technologies Lack of transparency in decision-making processes. Dead due to all causes no recurrence distant recurrence Dead due to brest cancer Epidemiological adjustment only for overall mortality Epidemiological adjustment for transition probabilities (not adjusted for the effect oftrastuzumab) locoregional recurrence Cost-effectiveness of trastuzumab in early breast cancer in six Latin-American countries Funding: Global Health Research Initiative (International Development Agency CIDA-, Canadian Institutes of Health Research CIHR-, Health Canada and the International Development Research Centre IDRC-). Incremental cost-effectiveness Cost-Effectivenness ratio (cost - USD) ratio (cost U$D) Brasil Argentina Chile Peru Bolvia Uruguay 66,854 56,327 46,500 40,973 39,277 65,301 41,553 37,237 26,576 27,753 21,875 40,321 Epidemiological adjustment for transition probabilities (also adjusting for effect of trastuzumab) 85,803 69,716 63,862 50,037 54,599 83,529 8

9 Latin America Erlotinib for Lung Cancer Sunitinib for kidney cancer Etanercept in AR Capecitabinein breast c Rituximab for lymphoma Dalfampridine (Ampyra) in Multiple Sclerosis Acrylic Vertebroplasty PET Scan Da Vinci Robot Deep Brain Stimulation for Parkinson s Disease. Not-Covered (outside the benefic package) Trastuzumab? Health Economic Evaluation (Cost-Utility) Trastuzumab Threshold 2-3 GDP Final remarks (1) Do not be paralyzed by the lack of a perfect threshold (we have bigger problems than that!) Thresholds based on GDP or other methods arising in each country can always helpful as a reference (not to wait for perfect data to estimate a threshold). Threshold are a tool not a rule It is important to move forward and produce more and more studies of cost-effectiveness and cost-utility in the region Inefficiencies - Inequities Obsolete technologies Corruption Lack of transparency in decision-making processes No HTA & HEE history (a few health technologies evaluated so far) Start applying explicitly the economic evidence in the decision-making process Wait until conditions are ideal can take years. Meanwhile take into account the limitations imposed by the context Final remarks (2) Final remarks (3) May be countries that are beginning to apply Cost-Effectiveness (CE) evidence to inform coverage decisions should initially: 1. Analyze the CE of various interventions in the context of defined health problems (e.g. cancer). And make decisions only when we have relatively complete information. 2. Focus the analysis on the best and worst. Promote the use of interventions with a very favorable CE and identify interventions with ridiculously high CE ratios to prevent them entering the public coverage. 3. Produce more information in the region. We need to expand our knowledge base about the cost-effectiveness of interventions in Latin America. Challenge: to decide where we should invest our analysis efforts and resources. Does it makes sense to focus all our analysis efforts on just a few high-cost technologies? Develop a transparent decision making process and attack the inefficiencies of the health system as a whole. HTA of new technologies is not a substitute for the reform of the health care systems. In developing countries HTA of individual technologies probably represents only a very small contribution to a big problem. It is important to find the way in which the HTA methods can be apply to develop better health care systems as a whole. 9

10 Gracias!! Federico Augustovski MD MSc PhD 10