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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
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3
TRES DIMENSIONES
Valor
Terapéutico
/ Clinico
Calidad de Vida
Socio- Económico
Fuente: Value of Innovation. Pharmaceutical
Forum. European Commission
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4
9
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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)
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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.
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13
La innovación en la Ley de Garantías (I)
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La innovación en la Ley de Garantías (II)
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La innovación en la Ley de Garantías (III)
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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
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Fuente: PPRI Report 2008
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Source: European Commission. DG Competition
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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
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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
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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
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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
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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
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Mejora del sistema de patentes
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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
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Muchas gracias por vuestra atención
[email protected]
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