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Profundizando en los antidiabéticos Forxiga (dapaglifozina) UE Francia Reino Unido Francia Escocia Alemania Alemania Invokana (canaglifozin) Jardiance (empaglifozina) Reino Unido Italia Países Bajos Escocia &MDBNJOPIBTUBBIPSB España Suecia &MMMBNBNJFOUPBDPMBCPSBSFOFWBMVB DJÓOFTFWJEFOUFTJTFPCTFSWBRVFFM HBTUPTBOJUBSJPUPUBMQÙCMJDPZQSJWBEP EFMB6&BTDJFOEFBCJMMPOFTEFFVSPT BOVBMFTVOBNFEJBEFMQPSDJFOUPEFM 1*#FVSPQFP&TBDJGSBJODMVZF NJMMPOFTQBSBNFEJDBNFOUPTZPUSPT QBSBEJTQPTJUJWPTNÊEJDPT:FT VOBGBDUVSBRVFDSFDFSÃBMUJFNQPRVF MPTFTUBEPTTFHVJSÃOFOGSFOUÃOEPTFB VOPTQSFTVQVFTUPTDPOTUSFÒJEPT-B TJUVBDJÓO SFRVJFSF USBCBKBS QPS MB FGJDJFODJBZBIÎFOUSBFOKVFHPMB)5" 1BSBBQPZBSFMUSBCBKPDPPQFSBUJWPTF DSFÓFOMB3FEEF5SBCBKPFO)5" DPNQVFTUBQPSSFQSFTFOUBOUFTEFMPT NJOJTUFSJPTEFTBMVEPMBTBVUPSJEBEFTFO FWBMVBDJÓO1FSPZBBOUFTMPTFTUBEPTZMB $PNJTJÓOUSBCBKBCBOKVOUPT&OFTUF NBSDPOBDJFSPOMBT+PJOU"DUJPOT)BTUB BIPSBTFIBODPGJOBODJBEPEPTBUSBWÊT EFMPTQSPHSBNBTFVSPQFPTFOTBMVEMB QSJNFSBFOUSFZDPOUÓDPO TFJTNJMMPOFTEFQSFTVQVFTUPMBTFHVOEB BCBSDÓIBTUBZFTUVWPEPUBEBEF NJMMPOFT-BUFSDFSBZÙMUJNBIBBVNFO UBEPDBTJBMEPCMFTVGJOBODJBDJÓO Suecia Diabetes tipo 2: evaluación HTA Datos de seguridad Comportamiento del medicamento en la vida real Resultado positivos Calidad de vida Datos de los ensayos clínicos Resultado positivos con limitaciones Evidencia económica Comparaciones indirectas Resultado negativos Otras fuentes Revisiones sistemáticas/Meta-análisis Bajo revisión Fuente: Comisión Europea. -B QBSUJDJQBDJÓO FO MBT BDDJPOFT DPOKVOUBTIBTJEPDSFDJFOUFDPNPMPT SFTVMUBEPTEFTVUSBCBKP4FIBOFMBCP SBEPJOGPSNFTDPOKVOUPTFOMPTEPT UJQPTEFFWBMVBDJPOFTRVFFYJTUFOMPT JOGPSNFT3&"EFFGFDUJWJEBESFMBUJWB RVFTÓMPDVCSFOEBUPTDMÎOJDPTZMPTEF )5"RVFUBNCJÊOBCBSDBODPOTJEFSB DJPOFT FDPOÓNJDBT ÊUJDBT MFHBMFT Z PSHBOJ[BUJWBT "EFNÃTMBDPPQFSBDJÓO IB QFSNJUJEP EFTBSSPMMBS NÃT EF EJÃMPHPTUFNQSBOPTFOUSFEFTBSSPMMBEP SFTEFMBTUFDOPMPHÎBTZPSHBOJTNPTEF FWBMVBDJÓOMPRVFBZVEBBMBJOEVTUSJBB EJTFÒBSFTUVEJPTRVFDVNQMBOMPTSFRVF SJNJFOUPTSFHVMBUPSJPT -PT QSPHSFTPT BVNFOUBSÃO FO MB UFSDFSB+PJOU"DUJPORVFQSFWÊMBFMBCP El Global SBDJÓOEFJOGPSNFTDPOKVOUPTZ EJÃMPHPTUFNQSBOPT"EFNÃTTFSFBMJ [BSÃVOBSFWJTJÓOEFMBTHVÎBTZNFUPEP MPHÎBT BDUVBMFT Z TF QSPNPWFSÃ FM EFTBSSPMMPEFPUSBTOVFWBTDPOFMPCKFUJWP EFGBDJMJUBSMBDPMBCPSBDJÓOFO&VSPQB NÃTBMMÃEFMGJOBMEFMQSPZFDUPFO $VBUSPEFGFDUPT 1FSPFTUFGVUVSPFTUÃMBTUSBEPQPSDVBUSP AEFGFDUPTPCTFSWBEPTFOMBQSÃDUJDB&O QSJNFSMVHBSMBBEPQDJÓOEFMUSBCBKP DPOKVOUPFVSPQFPFOMBUPNBEFEFDJTJP OFT OBDJPOBMFT IB QFSNBOFDJEP FO OJWFMFTCBKPTi&TJODPOHSVFOUFJOWFSUJS GPOEPTQÙCMJDPTFOVOBFTUSBUFHJBEF FWBMVBDJÓODPPQFSBUJWBBOJWFMFVSPQFP TJ FM SFTVMUBEP EF MPT USBCBKPT OP TF BEPQUBZOPTFFWJUBMBEVQMJDBDJÓOEF FTGVFS[PTuMBNFOUB#SVTFMBT )BTUB MB GFDIB OJOHÙO BOÃMJTJT IB EFUBMMBEPFMJNQBDUPEFMBFWBMVBDJÓOFO )5"TJCJFOBMHVOPTFTUVEJPTBUÎUVMP JOEJWJEVBMIBOEFKBEPFOUSFWFSTVQPUFO DJBM6OUSBCBKPSFBMJ[BEPFO3FJOP6OJEP RVFUVWPDPNPPCKFUPMBFWBMVBDJÓOEF UFDOPMPHÎBTBSSPKÓVOCFOFGJDJPQPUFO DJBM EF NJMMPOFT BOVBMFT TJ TF TJHVJFSBOMBTSFDPNFOEBDJPOFTEFMBT FWBMVBDJPOFT-BDPOTVMUBPGSFDFTVT QSPQJBTDJGSBT&TUJNBRVFDBEBFWBMVB DJÓOUJFOFVODPTUFBQSPYJNBEPBOJWFM OBDJPOBM EF FVSPT QBSB MPT PSHBOJTNPTOBDJPOBMFTZEF QBSBMBJOEVTUSJB"TVNJFOEPRVFEJF[ FTUBEPTEFDJEBOSFBMJ[BSFWBMVBDJPOFT BMEFEJDJFNCSFEF &-(-0#"-r 1PMÓUJDB JOEFQFOEJFOUFTEFVOBNJTNBUFDOPMP HÎBZRVFFTBTFWBMVBDJPOFTQVEJFSBOTFS SFFNQMB[BEBTQPSVOJOGPSNFDPOKVOUP TF DPOTFHVJSÎBO BIPSSPT EFM QPS DJFOUPRVFQFSNJUJSÎBOBCPSEBSOVFWBT FWBMVBDJPOFT:MBDJGSBJODMVZFMPTDPTUFT JOIFSFOUFTBVOBFWBMVBDJÓODPOKVOUB RVFTPOUSFTWFDFTNÃTDBSPTRVFMPTEF VOBFWBMVBDJÓOOBDJPOBM &OMB6&IBZNÃTEFDVFSQPTEF FWBMVBDJÓOOBDJPOBMFTZSFHJPOBMFTMP DVBMMMFWBBMTFHVOEPEFGFDUPEFUFDUBEP IBZ EJGFSFODJBT UBOUP FO FM QSPDFEJ NJFOUPWFSHSÃGJDP DPNPFOMBDBQBDJ EBEBENJOJTUSBUJWBEFMPTFTUBEPTQBSB SFBMJ[BSFWBMVBDJPOFTi/JMPTDVFSQPT NÃTBWBO[BEPTSFTBMUBMBDPOTVMUB TPOQFSJUPTFOUPEBTMBTÃSFBTZUPEPTFO DBNCJPTFFOGSFOUBOBVOPTSFDVSTPT MJNJUBEPTMPRVFTVQPOFRVFOPUPEBTMBT UFDOPMPHÎBTQVFEFOTFSFWBMVBEBTPRVF MBSFWBMVBDJÓOOPFTQPTJCMFVOBWF[TF IBMBO[BEPFMQSPEVDUPu 5BNCJÊO IBZ EJGFSFODJBT FO MBT NFUPEPMPHÎBTOBDJPOBMFTMPRVFFYQMJDB MBWBSJFEBEEFEBUPTRVFTFFYJHFOBMB JOEVTUSJB -PT EBUPT DMÎOJDPT TPO VO SFRVFSJNJFOUP DMBWF QBSB UPEBT MBT BHFODJBTMPTEFTFHVSJEBEDBMJEBEEF WJEBZBOÃMJTJTFDPOÓNJDPTTPOTPMJDJUB EPTQPSBMHVOBTZTÓMPVOBTQPDBTUJFOFO FODVFOUBMBFWJEFODJBEFMVTPSFBMZEF &MNFOTBKFEF#SVTFMBTFT UBKBOUFFMBDUVBMNPEFMPEF DPPQFSBDJØOFO)5"OPFT TPTUFOJCMFGJOBODJFSBNFOUF -BUFSDFSB+PJOU"DUJPOFO)5" QSFWÏMBFMBCPSBDJØOEF JOGPSNFTDPOKVOUPTZ EJÈMPHPTUFNQSBOPT PUSBTGVFOUFT#SVTFMBTSFDPOPDFRVFiMB DPNQMFKJEBEDBVTBEBQPSFTUBGSBHNFO UBDJÓOOPFTJEFBMQBSBMBTJOWFSTJPOFT TPCSFUPEPEFQZNFTRVFSFRVJFSFOVO NBSDPQSFEFDJCMFu .ÃTBMMÃEFMJNQBDUPQBSBMBTDPNQB ÒÎBTMBTEJGFSFOUFTNFUPEPMPHÎBTMMFWBO El futuro de la evaluación conjunta en la UE Características básicas Opción 1 Status quo. Cooperación voluntaria en HTA hasta 2020 Opción 2 Cooperación voluntaria a largo plazo en HTA (más allá de 2020) Opción 3 Cooperación para recopilar, compartir y usar herramientas y datos comunes Opción 4 Cooperación en la producción de informes REA conjuntos Regulatorias No legislativa No legislativa Legislativa Legislativa Legislativa Obligatoria para las herramientas. Obligatoria para las herramientas. Voluntaria para HTA Obligatoria o voluntaria para la HTA Obligatoria o voluntaria para la HTA Obligatoria para las herramientas. Opción 5 Cooperación en la producción de informes HTA conjuntos Participación de la industria y de los cuerpos de HTA Voluntaria Adopción de resultados conjuntos Voluntaria Voluntaria Obligatoria para las herramientas Obligatoria para las herramientas y los informes REA Obligatoria Financiación Presupuestos europeos, sobre todo Presupuestos europeos, sobre todo Financiación mixta: UE + estados + industria Financiación mixta: UE + estados + industria Financiación mixta: UE + estados + industria Hasta 2020 A largo plazo A largo plazo A largo plazo A largo plazo (✓) (✓) (✓) (✓) ✓ (✓) (✓) ✓ ✓ ✓ (✓) ✓ Voluntaria Resultados esperables (✓) (✓) (✓) (✓) 1. Herramientas/modelos conjuntos 2. Informes REA conjuntos 3. Informes HTA conjuntos 4. 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Valenciana 98,6 98,6 0 Deuda aproximada en diciembre de 2015 (millones de euros) Deuda aproximada en diciembre de 2016 (millones de euros) Diferencia entre diciembre de 2015 y diciembre de 2016 * En Baleares, desde octubre los pagos tienen un retraso en torno a seis días. Fuente: Elaboración propia. 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Evolución en los últimos doce meses 170 145 120 Índice Global: -1,55 95 BE 500 -2,57 IBEX 35 -4,05 70 Dic 2015 Ene 2016 Feb 2016 Mar 2016 Abr 2016 May 2016 Jun 2016 Jul 2016 Ago 2016 Sep 2016 Oct 2016 Nov 2016 9 diciembre 2016 El Índice Global, referencia en bolsa del sector farmacéutico, está integrado por 29 valores internacionales. La ponderación de cada uno está en función de su capitalización bursatil. El valor de este índice el 1 de enero del 2000, se tomó como base 100, de manera que su valor actual indica la revalorización o depreciación que dicho índice acumula respecto a la base. Las variaciones de cada uno de los índices se calculan respecto a la misma frecha del mes anterior, mientras que las variaciones recogidas en el texto de la noticia hacen referencia a la semana. Para conocer los valores del Índice Global, consulte: www.elgobal.net Fuente: elaboración propia. 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candidaturas y cronograma de evaluación octubre noviembre 2017 25-28 octubre 18 23-26 27-30 2017 2017 2017 2017 9 16 22 septiembre 28 8 octubre 6 octubre octubre 26 31 30 diciembre 8 20 septiembre 2017 1 14 julio 2017 julio 2017 6 2017 junio noviembre noviembre 20 junio 14 octubre 2017 29-1 septiembre 20 junio septiembre 2017 2017 septiembre 18 12 noviembre 2017 ago-sep 23 12 2017 3-6 2017 2017 agosto 5 septiembre julio 28 mayo 2017 junio 6-9 2017 2017 31 21 mayo julio junio abril mayo 2017 mayo 2-5 12 2017 2017 26 abril 9 diciembre 2017 mayo 2017 abril 3-6 2017 2017 29 23 14 enero enero enero 11 19 25 2018 abril 6 17 2017 6-9 marzo 2017 abril 2017 2017 marzo 9 marzo 2017 marzo 1 2017 6-9 2017 2017 2017 marzo marzo 2017 febrero 1 2017 2017 2017 2017 febrero 9 2017 23 9-12 2018 11ª 17 4 2017 10ª febrero 2018 9ª febrero 2017 8ª febrero 2017 7ª enero 2017 6ª enero 2017 5ª Adopción por parte del CHMP**** 2017 4ª Recomendación del CAT** de la EMA*** 2017 3ª Recomendación del SAWP 2017 2ª 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