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Mesa Redonda: Nuevas Estrategias de Financiación de la Innovación Sanitaria Madrid, 28 de Noviembre 2012 Jaime Espín, PhD Profesor1 Agenda • El concepto de innovación: sus distintos elementos y sus distintas interpretaciones • La innovación como criterio para la fijación del precio y reembolso de medicamentos • Innovación en políticas farmacéuticas • Nuevas propuestas para recompensar la innovación 2 1 3 4 2 5 Concepto Innovación 6 3 TRES DIMENSIONES Valor Terapéutico / Clinico Calidad de Vida Socio- Económico Fuente: Value of Innovation. Pharmaceutical Forum. European Commission 7 8 4 9 10 5 Convergencia de Precios - UE 25 (1994-2005) Fuente Commission staff working document, accompanying the communication from the commission. "Economic reforms and competitiveness. Key messages from the European Competitiveness Report 2006" (com (2006) 697 final) 11 Formal Price Referencing Today 12 Source: WHO/WTO report of the workshop on differential pricing and financing of essential drugs, available http://www.wto.org/english/tratop_e/trips_e/tn_hosbjor_e.htm. 6 13 La innovación en la Ley de Garantías (I) 14 7 La innovación en la Ley de Garantías (II) 15 La innovación en la Ley de Garantías (III) 16 8 Fuente: Sabine Vogler, Jaime Espin and Claudia Habl. Pharmaceutical Pricing and Reimbursement Information (PPRI) – New PPRI analysis including Spain. Pharmaceutical Policy and Law. Volumen: 11 Pages – 213- 234. 2009 17 18 Fuente: PPRI Report 2008 9 Source: European Commission. DG Competition 19 Pharmaceutical Sector Inquiry, Preliminary Report. (DG Competition Staff Working Paper), 28 November 2008 Source: Eurostat 0,01000 0,00900 0,00800 cty mlist forma 0,00700 AUSTRIA RETAIL - CAPECITABINE - TAB BELGIUM RETAIL - CAPECITABINE - TAB 0,00600 FINLAND RETAIL - CAPECITABINE - TAB FRANCE RETAIL - CAPECITABINE - TAB 0,00500 GERMANY PHMSCOPE - CAPECITABINE - TAB GREECE RETAIL - CAPECITABINE - TAB IRELAND HOSPITAL - CAPECITABINE - TAB 0,00400 ITALY RETAIL - CAPECITABINE - TAB LUXEMBOURG RETAI - CAPECITABINE - TAB 0,00300 NETHERLNDS XPONE - CAPECITABINE - TAB SPAIN RETAIL - CAPECITABINE - TAB 0,00200 0,00100 qtr_12_2010 qtr_06_2010 qtr_12_2009 qtr_06_2009 qtr_12_2008 qtr_06_2008 qtr_12_2007 qtr_06_2007 qtr_12_2006 qtr_06_2006 qtr_12_2005 qtr_06_2005 qtr_12_2004 qtr_06_2004 qtr_12_2003 qtr_06_2003 qtr_12_2002 qtr_06_2002 qtr_12_2001 qtr_06_2001 qtr_12_2000 qtr_06_2000 qtr_12_1999 qtr_06_1999 0,00000 Datos Source: Own analysis with IMS – Data. Do not cite. Draft 20 10 0,00600 0,00500 cty mlist forma AUSTRIA RETAIL - ALISKIREN - TAB 0,00400 BELGIUM RETAIL - ALISKIREN - TAB FINLAND RETAIL - ALISKIREN - TAB FRANCE RETAIL - ALISKIREN - TAB GERMANY PHMSCOPE - ALISKIREN - TAB 0,00300 GREECE RETAIL - ALISKIREN - TAB IRELAND HOSPITAL - ALISKIREN - TAB ITALY RETAIL - ALISKIREN - TAB LUXEMBOURG RETAI - ALISKIREN - TAB 0,00200 NETHERLNDS XPONE - ALISKIREN - TAB PORTUGAL RETAIL - ALISKIREN - TAB SPAIN RETAIL - ALISKIREN - TAB 0,00100 qtr_12_2010 qtr_06_2010 qtr_12_2009 qtr_06_2009 qtr_12_2008 qtr_06_2008 qtr_12_2007 qtr_06_2007 qtr_12_2006 qtr_06_2006 qtr_12_2005 qtr_06_2005 qtr_12_2004 qtr_06_2004 qtr_12_2003 qtr_06_2003 qtr_12_2002 qtr_06_2002 qtr_12_2001 qtr_06_2001 qtr_12_2000 qtr_06_2000 qtr_12_1999 qtr_06_1999 0,00000 Datos Source: Own analysis with IMS – Data. Do not cite. Draft 21 22 11 Acuerdos basados en resultados entre financiadores e industria Acuerdos basados en resulta dos financieros A nivel de población P articipación en el mercado Acuerdos basados en resultados clínicos o de salud A nivel de paci ente Precio V olume n Limite de utilizac ión Ree mbolso vincula do a resulta dos Cobe rtura Condi cional Cobertura bajo la búsqueda de e videncia Continuac ión del tratamiento Condic ionada Garantía de resultados E squema o proc eso del cuidado Industria financia el inicio del tratamie nto E studios Experimentales Sola mente en inve stigación Resultados clínicos finales Re sultados intermedios Fuente: Espín, et al. Esquemas innovadores de mejora del acceso al mercado de nuevas tecnologías: los acuerdos de riesgo compartido. Gac Sanit. 2010;24:491-7. - vol.24 núm 06 23 Janssen-Cilag Paciente Tratamiento Velcade Responde en 4 ciclos No responde en 4 ciclos Continua con Velcade Abandona tratamiento Velcade sufragado por el NHS Se solicita reembolso Suministro de los primeros cuatros ciclos para cada paciente al coste del NHS Reembolso Posible auditoria ante “inusuales” reembolsos 24 12 MEDICINE INDICATION A NICE Technology Appraisal Payment of a fixed sum for a patient commencing on a regimen irrespective of actual costs incurred Gefitinib (IressaR) 1st line locally advanced or metastatic non small lung cancer NICE Approved drug B Sunitinib (SutentR) 1st line advanced/metastatic RCC NICE Approved drug Reimbursement of initial phase of treatment C Reimbursement of treatments after an agreed period D Reimbursement for treatments that do not result in anticipated benefits Sunitinib (SutentR) Unresectable or metastatic GIST Sorafenib (NexavarR) 1st and 2nd line advanced RCC NICE Rejected drug Sunitinib (SutentR) 2nd line advanced RCC NICE Rejected drug Cetuximab (ErbituxR) Lenalidomide (RevlimidR) Ranibizumab (LucentisR) Trabectedin (YondelisR) Lapatinib (TyverbR) Bortezomib (VelcadeR) Cetuximab (ErbituxR) Sorafenib (NexavarR) Metastatic colorectal cancer NICE Approved drug NICE Approved drug Relapsed myeloma NICE Approved drug Wet age related macular degeneration NICE Approved drug Treatment of advanced soft tissue sarcoma NICE Approved drug Metastatic breast cancer NICE Rejected drug Relapsed myeloma NICE Approved drug Metastatic colorectal cancer pretreated Hepatocellular carcinoma (advanced and metastatic) –1st line NICE Rejected drug NICE Approved drug E Discount applied to the total monthly cost Erlotinib (TarcevaR) Non small cell lung cancer NICE Approved drug Azacitidine (VidazaR) myelodysplastic syndrome, chronic myelomonocytic leukaemia and acute myeloid leukaemia NICE Rejected drug st F Bevacizumab (AvastinR) Other B+E 1 line treatment of metastatic colorectal cancer –negative ACD Not reviewed by NICE 1st line treatment of metastatic breast cancer in combination with taxane chemotherapy Not reviewed by NICE Degarelix (FirmagonR) advanced hormone dependent prostate cancer NICE Approved drug Everolimus (AfinitorR) 2nd line treatment of advanced and/or metastatic RCC– negative ACD Not reviewed by NICE Link: http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/risksharing_oncology_012011_en.pdf 25 26 13 Analyses of time to regional patient access according to the authorization with or without a risk-sharing agreement Source: Russo P, Mennini F.S., Siviero P. D., and Rasi G.. Time to market and patient access to new oncology products in Italy: a multistep pathway from European context to regional health care providers. Ann Oncol (2010) 21(10): 2081-2087 27 Mejora del sistema de patentes 28 14 Patentes - India • La Oficina de Patentes (OP) de Chennai, India, rechazó en enero de 2006 la solicitud de patente de Novartis para la forma beta-cristalina del mesilato de imatinib (Gleevec ) porque, entre otras razones, la OP juzgó que el producto era una nueva forma del imatinib –una sustancia ya conocida– que no había demostrado una mayor eficacia http://www.msfaccess.org/content/qa-patentsindia-and-novartis-case Fuente: http://www.fgcasal.org/politicafarmaceutica/docs/aidan_hollis_resumen.pdf 29 30 15 31 32 16 33 34 17 35 Muchas gracias por vuestra atención [email protected] 36 18
