The view and opinions expressed are those of the individual presenter and should not be attributed to AIFA Entela Xoxi in accordance with the Conflict of Interest Regulations approved by AIFA Board o ID: 844705
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1 Agenda item 4 -Real world evidence data
Agenda item 4 -Real world evidence data collectionItalian Experience on RegistriesEntela XoxiCommission expert group on "Safe and Timely Access to Medicines for Patie
2 nts" (STAMP) Brussels, 10 March 2016 The
nts" (STAMP) Brussels, 10 March 2016 The view and opinions expressed are those of the individual presenter and should not be attributed to AIFA Entela Xoxi, in accord
3 ance with the Conflict of Interest Regul
ance with the Conflict of Interest Regulations approved by AIFA Board of Directors (25.03.2015) and published on theOfficial Journal of 15.05.2015 according to EMA po
4 licy /626261/2014 on the handling of the
licy /626261/2014 on the handling of the conflicts of interest for scientific committee members and experts. Interests in pharmaceutical industry NO Current From 0
5 to 3 previous years Over 3 preavious
to 3 previous years Over 3 preavious years DIRECT INTERESTS: Employment with a company: pharmaceutical company in an executive role mandatory Employmentwith a
6 company: in a lead role in the developm
company: in a lead role in the development of a medicinal product mandatory Employment with a company: other activities x optional Consultancy for a company
7 x optional Strategic advisory role
x optional Strategic advisory role for a company x optional Financial interests x optional Ownership of a patent x optional INDIRECT INTERESTS: P
8 rincipal investigator x optional In
rincipal investigator x optional Investigator x optional Grant or other funding x optional Family members interests x optional N.B. ot receiving
9 any compensati&#x I a;&#xm n6;&#x.100;on
any compensati&#x I a;&#xm n6;&#x.100;on healthcare coverage to the Italian po, the system is decentralized resulting :The Ministry of Health formulates every three
10 years a healthcare plan PSN (Piano Sanit
years a healthcare plan PSN (Piano SanitarioN:Twenty regions implement the PSN with their own resources :Local health units ASL (Azienda Sanitaria Locale) provide the
11 health care services e.g. primary medi
health care services e.g. primary medi How to achieve better outcomes and control the cost curves? Whatis the cut-off to be considered between therapeutic utility o
12 f a new medicine The welfaresystemscanno
f a new medicine The welfaresystemscannottake anymore responsibility for thefailuresin frontofsuchhighcostsIdentification ofresponders patientsin ordertoensurean effe
13 ctive therapyagainstthe poorpredictionof
ctive therapyagainstthe poorpredictionofclinical responseat the timeofrecruitment in some cases for the authorizedoff-label (*) 648/96 Law: thatenables the NSH deli
14 ver temporarily when theres no validthe
ver temporarily when theres no validtherapeutic option The Italian model:Data collection & Conditional reimbursement (R)EvolutionY 2006Version 1.0Y 2013Version 2.0 L
15 aw n. 135/2012 Law Decree 19/06/2015 Use
aw n. 135/2012 Law Decree 19/06/2015 UsersNetwork Figures All fields are mandatoryFup controls: temporally rangeTreatment record Ferrario & Kanavos (2013) Italian ma
16 nagement in red 1.Even if cost-effectiv
nagement in red 1.Even if cost-effectiveness analysis did provide a reliable 2.Specific MEA for each therapeutic indication 3.The Ferrario & Kanavos (2013) Methodol
17 ogy in cancer areaKaplan-Meier curves ra
ogy in cancer areaKaplan-Meier curves ration of the treatment, on the1.Tumor progression2.Dropouts due to side effects (discontinuation of treatment)3.Patient death -
18 appropriateness: for all registries! Con
appropriateness: for all registries! Continuation treatment: generally for all registriesDefinition of non responders: only for outcome-basedFollow up timing: general
19 ly for all registriesReimbursement rate:
ly for all registriesReimbursement rate: is specific for each registries with MEA Evaluation of RR by Pharma company Proposal for payback Evaluation of PP by public
20 Pharmacy register for a specific Reimbu
Pharmacy register for a specific Reimbursement Request Data AnalysisOther conditions., refundable Treatment Payback flowThe value cashed in 2015 is about 353.9m
21 ln MEAs in reimbursement and Innovation
ln MEAs in reimbursement and Innovation Y 2015: Hepatitis CFinancial-based MEA 1.AIFA established the 2.Stimulate the activation of the compassionate use (D.M. 08/05/
22 2003)to try to manage in a timely ma3.Ma
2003)to try to manage in a timely ma3.Made available an Algorithm to support the prescription4.Developed with priority the 5.Support to the Ministry of Health w innov
23 ative medicines & in the technical defin
ative medicines & in the technical definition of the decree provided for in the 2015 Stability Law DAAs Treatments/ Criterion & Regional mosaic From HER2+ to DAAs to
24 PDL1 to .. Appropriateness Clinic Uncert
PDL1 to .. Appropriateness Clinic Uncertainty Clinic UncertaintyClinic & Economic Uncertainty Clinic & Economic Uncertainty A strengthened scientific dialogueDrug eva
25 luation becomes a continuum MEAsmechan
luation becomes a continuum MEAsmechanisms are intended to responsibility with all the stakeholders.introducing a system of Entela Xoxie.xoxi@aifa.gov.it #AIFARegi