Presentation is loading. Please wait.

Presentation is loading. Please wait.

IECS - Instituto de Efectividad Clinica y Sanitaria Institute for Clinical Effectiveness and Health Policy December 2013 La aplicación de la evaluación.

Similar presentations


Presentation on theme: "IECS - Instituto de Efectividad Clinica y Sanitaria Institute for Clinical Effectiveness and Health Policy December 2013 La aplicación de la evaluación."— Presentation transcript:

1 IECS - Instituto de Efectividad Clinica y Sanitaria Institute for Clinical Effectiveness and Health Policy December 2013 La aplicación de la evaluación de Tecnologías de Salud y las evaluaciones económicas en la definición de los Planes de Beneficios en Latinoamérica Prof Andrés Pichon-Riviere MD MSc PhD

2 A. Pichon-Riviere Institute for Clinical Effectiveness and Health Policy, Argentina (www.iecs.org.ar) HTA in LA HTA was and is formally used to shape benefit packages in several countries Clear trend reflecting the importance that LA healthcare systems pay to the concept of incorporating new technologies that are good value for money. The region needs to increase drug and technology access, but also intensify cost-conscious measures. Some LA countries have already been in this HTA process for ten or more years with institutional structures dedicated to HTA. HTA has influenced different aspects of the health system in these countries, from coverage or pricing decisions of individual health technologies to the definition of package benefits or structural decisions about the health system in general. This is particularly true in the case of Brazil, Mexico, Chile, Colombia and Uruguay.

3 Pichon-Riviere - Instituto de Efectividad Clínica y Santaria (www.iecs.org.ar) Health technology assessment Eficacy / Effectiveness Safety Costs Cost-Effectiveness / Cost-Utility Budget impact Social-ethical impact Organizational impact Impact on innovation / industrial development Impact in the health care system Values Assessment Appraisal

4 A. Pichon-Riviere Institute for Clinical Effectiveness and Health Policy, Argentina (www.iecs.org.ar) Health Economic Evaluation methodological guidelines in Latin America Countries with HEE guidelines Brazil, Colombia, Cuba and Mexico MERCOSUR: Argentina, Brazil, Paraguay and Uruguay Grupo Andino: Bolivia, Chile, Colombia, Ecuador, Peru, Venezuela

5 A. Pichon-Riviere Institute for Clinical Effectiveness and Health Policy, Argentina (www.iecs.org.ar) HEE methodological guidelines in Latin America Brazil, Colombia, Cuba and Mexico (and soon in Argentina, Uruguay, Chile, Costa Rica, Peru, Paraguay, among others) Existing HEE guidelines in the region set high methodological standards, broadly similar to guidelines from developed countries Most of them were produced or are being sponsored by the public government, suggesting their interest in going in that direction regarding decision making of new and existing technologies for reimbursement and financing purposes. Still not clear how the information provided by the EE will be used and by whom and which are the values that will be used in the decision making process. Important to achieve in the future more homogeneous requirements across countries

6 Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina (www.iecs.org.ar) Until a few years ago….. Countries have struggled to manage scarce resources and provide basic care. Rationing has been largely implicit. Newer and more expensive technologies were not even considered. They were available, at very high prices, for a small proportion of the population. LA countries were not explicitly taking into account cost- effectiveness to make decisions about purchase and coverage of health technologies. This situation created a high price tolerance for innovative drugs, which were available only for the few patients who could afford them, often at higher prices than in developed countries.

7 Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina (www.iecs.org.ar) Nowadays….. The current situation is no longer sustainable in a scenario where the region wants to move towards universal coverage, and also willing to include within its coverage access to innovative therapies, Countries in the region are already suffering this pressure. Once products are approved for marketing authorization citizens can sue for access. This right to healthcare, enforced through the courts, is currently creating a significant budget problem for health care systems at the National, state or municipal level.

8 A. Pichon-Riviere Institute for Clinical Effectiveness and Health Policy, Argentina (www.iecs.org.ar) Brasil (desde el año 2011)

9 URUGUAY - Decreto del P. E. de 2010 Los medicamentos que se prevea brindar bajo la cobertura financiera del FNR sólo podrán ingresar al Formulario Terapéutico de Medicamentos si previamente cuentan con: a)informe Comisión Técnica Asesora que establezca evidencia científica suficiente e indicaciones b) informe de evaluación económica que establezca adecuada relación costo/efectividad c) informe de impacto presupuestal que acredite sustentabilidad financiera del protocolo de cobertura d) informe favorable de la Comisión Asesora del FTM Los laboratorios que presenten nuevos medicamentos en vistas a su incorporación al FTM deberán presentar evaluaciones económicas realizadas de acuerdo a las guías fármaco-económicas más aceptadas.

10 A. Pichon-Riviere Institute for Clinical Effectiveness and Health Policy, Argentina (www.iecs.org.ar) CHILE

11 A. Pichon-Riviere Institute for Clinical Effectiveness and Health Policy, Argentina (www.iecs.org.ar) Type of EE presented by the sponsor of the technology “Acceptability” criteria Cost-minimizationNew technology should be cost saving Cost-effectiveness & Cost-utilityNew technology should be dominant (more effective & less costly) OR The ICER should be below one GDP per capita per life year gained OR The ICER should be below one GDP per capita per QALY gained Costo-benefitThe internal rate of return should be at least two percentage points higher than the internal rate of return of the CETES (Federal Treasury certificates) MEXICO 2011 New Guideline and “acceptability” criteria for inclusion of new drugs

12 Willingness to pay for a QALY (Quality Adjusted Life Year) Mexican Cost per QALY threshold = one GDPpc per QALY (GDPpc: Gross Domestic Product per capita) (other countries in LA accept the WHO reference of 1 to 3 GDP per DALY) What can be the effect of applying these thresholds in the Latin America? In the past, new and expensive technologies were not routinely covered by public health systems. In this context governments, with few exceptions, did not care for the price of new technologies (these new technologies were available at a high cost only for those few who could afford them). But as the region moves towards universal coverage the price of new technologies will be increasingly important.

13 Suecia PIBpc U$ USA = 0,8 PIBpc UK PIBpc U$ USA = 1,2 PIBpc España PIBpc U$ USA = 1,5 PIBpc Francia PIBpc U$ USA = 1,1 PIBpc Australia PIBpc U$ USA = 1,1 PIBpc Canada PIBpc U$ USA = 1,0 PIBpc Rango PIBpc (respecto a USA) Europa–USA–Canada–Australia: 0,8 a 1,5 0,8 1,5

14 Suecia PIBpc U$ USA = 0,8 PIBpc UK PIBpc U$ USA = 1,2 PIBpc Argentina PIBpc U$ USA = 4,4 PIBpc Peru PIBpc U$ USA = 8,0 PIBpc España PIBpc U$ USA = 1,5 PIBpc Francia PIBpc U$ USA = 1,1 PIBpc Australia PIBpc U$ USA = 1,1 PIBpc Canada PIBpc U$ USA = 1,0 PIBpc Ecuador PIBpc U$ USA = 10,7 PIBpc Chile PIBpc U$ USA = 3,3 PIBpc Mexico PIBpc U$ USA = 4,8 PIBpc Brasil PIBpc U$ 12,594 USA = 3,8 PIBpc Bolivia PIBpc U$ USA = 20,3 PIBpc Colombia PIBpc U$ USA = 6,8 PIBpc Rango PIBpc (respecto a USA) Latino América: 3,3 a 20,3 Europa–USA–Canada–Australia: 0,8 a 1,5 3,3 20,3 0,8 1,5

15 A. Pichon-Riviere Institute for Clinical Effectiveness and Health Policy, Argentina (www.iecs.org.ar) COST EFFECTIVENESS AND COST UTILITY OF TRASTUZUMAB IN THE ADJUVANT TREATMENT OF EARLY HER2-POSITIVE BREAST CANCER IN SEVEN LATIN AMERICAN COUNTRIES: IMPLICATIONS FOR PATIENT ACCESS. Andres Pichon-Riviere (1); O. Ulises Garay (1); Federico Augustovski (1); Carlos Vallejos (2); Leandro Huayanay (3); Maria del Pilar Navia Bueno (4); Alarico Rodriguez (5); Cidley de Oliveira Guioti (6).

16 A. Pichon-Riviere Institute for Clinical Effectiveness and Health Policy, Argentina (www.iecs.org.ar)

17 NOTES: Gross Domestic Product per capita (GDP pc) come from World Bank FIGURE 3 - Cost effectiveness acceptability curves. Cost per QALY thresholds expressed as number of GDPs per capita

18 A. Pichon-Riviere Institute for Clinical Effectiveness and Health Policy, Argentina (www.iecs.org.ar) PERU Current cost of one 440 mg vial of trastuzumab: USD 1,981 At this price, the cost-efectivenness of trastuzumab is 10.3 GDP per capita per QALY. If Peru sets a willingness to pay per QALY threshold similar to that of Mexico (1 GDP per capita), trastuzumab should cost USD 350 instead of USD 1,981 to be considered cost effective.

19 Budget constrained health care system New technologies -Benefits gained -Additional Cost Displaced services -Benefits forgone -Resources released Is the benefit gain from the new treatment greater than the benefit foregone through displacement? Cost-Effectiveness Thresholds in Latin America? Adaptado de Drummond M. Seminario Internacional de Evaluaciones Económicas. Buenos Aires, 2012 Opportunity cost

20 Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina (www.iecs.org.ar) Health benefit package (basket of services) of an imaginary country where the Ministry of Health (many years ago) defined a cost- effectiveness threshold of U$D 10,000 per QALY in order to consider a technology as cost- effective and allow its incorporation to the benefit package. This limit is imposed by the constrained health care budget Nueva Tecnología Sanitaria Costo-efectividad U$D 5,000/QALY Technologies that will be displaced offered less “value for money”. The benefit gain from the new treatment is greater than the benefit forgone New health technology with a cost- effectiveness ratio of U$D 25,000/QALY Is the benefit gain from the new treatment greater than the benefit foregone through displacement? No. Displaced technologies offered better “value for money” (the healthcare system loosed “health” and loosed efficiency( Cost-saving (e.g. polio- sabin vaccination) Very cost-effective (e.g. U$D 1,000 per QAL) Relatively good cost- effectiveness (e.g. U$D 5,000 per QALY) Cost-effective (e.g. U$D 7,500 per QALY) Cost-effective (but in the limit, e.g. U$D 8,000 or 10,000 per QALY)

21 Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina (www.iecs.org.ar) Conclusions 1 Until recently, LA countries were not explicitly taking into account cost-effectiveness. This situation created a high price tolerance for innovative drugs, which were available only for the few. The role of cost-effectiveness information in LA is becoming more important to support price negotiations and to decide whether or not to incorporate health technologies into health benefit packages. It is expected that many countries in the region will begin to consider a threshold between one and three GDP per capita per QALY or Life Year (as recommended by the WHO and similar to those explicitly or implicitly used in developed countries).

22 Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina (www.iecs.org.ar) Conclusions 2 Under this scenario, if global pricing policies continue to set similar prices internationally, it will be very unlikely for innovative drugs to be cost-effective in LA This inevitably entails similar or higher ICERs in current dollars, and much higher ICERs and less cost-effective results in terms of GDPPC. Therefore LA countries may not incorporate these new pharmaceuticals, unless they adopt significantly higher cost- effectiveness thresholds, such as 5 or 10 or more GDPPC per QALY, which does not sound reasonable or sustainable.

23 Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina (www.iecs.org.ar) Conclusions 3 Therefore LA will need to negotiate prices more related to countries’ income. One way out of this impasse would be to apply differential pricing, based on local assessments of value for money. The implication is that rich countries would pay higher prices than poorer ones. To improve the affordability of key drugs and health technologies while maintaining incentives for innovation is a challenge for rich and poor countries alike. Meeting this challenge is a joint responsibility of pharmaceutical companies, in applying differential pricing and governments, that would need to resist from international reference pricing and parallel trade of pharmaceuticals.

24 Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina (www.iecs.org.ar) Thank you! Andres Pichon-Riviere MD MSc PhD


Download ppt "IECS - Instituto de Efectividad Clinica y Sanitaria Institute for Clinical Effectiveness and Health Policy December 2013 La aplicación de la evaluación."

Similar presentations


Ads by Google