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M άνος Κουταλάς Ειδικός Παθολόγος – Λοιμωξιολόγος Medical Affairs Director Janssen

Οι πυλώνες των εξελίξεων RWE/ registries στην Ελλάδα: Το HTA, η νέα νομοθεσία για τις MΠΚΜ­­­, τα μητρώα ασθενών, τα συνταγογραφικά πρωτόκολλα/e- prescription. M άνος Κουταλάς Ειδικός Παθολόγος – Λοιμωξιολόγος Medical Affairs Director Janssen.

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M άνος Κουταλάς Ειδικός Παθολόγος – Λοιμωξιολόγος Medical Affairs Director Janssen

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  1. Οι πυλώνες των εξελίξεων RWE/registries στην Ελλάδα: Το HTA, η νέα νομοθεσία για τις MΠΚΜ­­­, τα μητρώα ασθενών, τα συνταγογραφικά πρωτόκολλα/e-prescription Mάνος Κουταλάς Ειδικός Παθολόγος – Λοιμωξιολόγος Medical Affairs Director Janssen

  2. Θα ήθελα να ευχαριστήσω την ομάδα RWE της Janssen: Zavitsanou Asimina MPH, PhD Mid Sized Markets RWE Co-ordinator/RWE Expert Antonis Petropoulos, PhD Health Economics & Outcomes Research Manager

  3. Health Technology Assessment (HTA) Brian Jackson, Untitled 6
Artwork from Reflections Art in Health

  4. Τι σημαίνει HTA? Health technology assessment (HTA) is: a multidisciplinary process that summarises information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner. Its aim is to inform the formulation of safe, effective, health policies that are patient focusedand seek to achieve best value.

  5. Ποια τα βασικά στοιχεία ενός αποτελεσματικού συστήματος ΗΤΑ • The HTA & decision making processes should be transparent, clear and respect commercial data confidentiality All relevant stakeholders should be engaged formally – submission, consultation, assessment, appraisal • Independence between evaluators, decision-makers and payers Time bound process and clear accountability • Locallyapplicable, not directly translated “verbatim” across borders • All appropriate evidence in a value framework that reflects the unmet needs of patients and clinicians

  6. HTA in Greece

  7. Είναι αναγκαία/σημαντικά τα RWE για ένα ΗΤΑ? • Τι στοιχεία RWE θα μπορούσαν να αξιοποιηθούν σε ένα ΗΤΑ?

  8. Είναι αναγκαία/σημαντικά τα RWE για ένα ΗΤΑ? • Τι στοιχεία RWE θα μπορούσαν να αξιοποιηθούν σε ένα ΗΤΑ?

  9. STUDYDESIGN • This review wasconductedbysearchingHTAsindexedinthe ContextMatters MarketAccessPlatform thatwerepublished between2012 and2017 • Key marketsofinterestwereidentifiedas: Germany UK Scotland France Canada Australia SouthKorea IQWiG/G-BA NICE SMC HAS CADTH/pCODR PBAC HIRA CADTH,Canadian Agencyfor Drugsand Technologiesin Health; G-BA,FederalJointCommittee;HAS,French NationalAuthorityfor Health; HIRA,HealthInsurance Review& AssessmentService;IQWiG,InstituteforQualityand Efficiencyin Health Care;NICE,NationalInstituteforHealthand Care Excellence;PBAC,PharmaceuticalBenefits Advisory Committee; pCODR, pan-Canadian Oncology Drug Review;SMC,Scottish Medicine Consortium.

  10. RWESUBMISSIONVOLUMETREND • Of3,823publishedHTAs,144HTAs (4%),covering48diseasestates, reportedtheuseofRWE,andwereincludedinthisanalysis • The reportofRWE includedinHTAsubmissionswas relatively consistent from2012to2017 144 4% 15 10 5% Percentage 4% 4% 4% 3,679 96% 5 3% 3% 0 2012 (n=493) 2015 (n=1,109) 2013 (n=580) 2014 (n=747) 2016 (n=572) 2017 (n=311) Used RWE Didnot use RWE

  11. RWESUBMISSIONTYPEBYHTAAGENCY • RWE usedin resubmissions/reassessmentsareslightlyhigher than theuseinfirstsubmissionacrossall 144cases • 80%ofRWE submissionstoHAS arefor resubmission/reassessment Resubmissions/ Reassessments,n(%) First Submissions, n(%) Assessments UsingRWE,n(%) Agency HAS 56(80) 14(20) 70(100) SMC PBAC NICE G-BA IQWiG HIRA pCODR 11(48) 8(31) 3(17) 0 0 0 0 12(52) 18(69) 15(83) 3(100) 1(100) 1(100) 2(100) 23(100) 26(100) 18(100) 3(100) 1(100) 1(100) 2(100) Total 78(54) 66(46) 144(100)

  12. RWESUBMISSIONBYEVIDENCECATEGORIES • HalfofRWE submittedwasforproductefficacy,including long-termefficacy • Economicmodels, 2%3% 14% Utilization, 17% 1% 10% 17% 17% Safety, 17% 44% 7% Efficacy, 51%

  13. RWESUBMISSIONBYDRUGTYPE • OnethirdofRWE submittedwasforoncologyand/ororphantreatments Orphan only, 4% Orphan+ Oncology,11% Oncology only, 19% Other,65% Orphan Orphan + Oncology Oncology Other Other includes:Actinic Keratosis,ACS,Age-relatedmacular degeneration,AnkylosingSpondylitis,Asthma,CHF,Crohn’sDisease,CF,Depression,Diabetes,DiabeticMacular Edema, Dyslipidemia,Epilepsy,Gaucher Disease,Hemophilia,HepatitisC,HIV, Insomnia,Lupus,MS,Parkinson’s,PAD,Psoriasis,PAH,RA,Schizophrenia,UlcerativeColitis,Vitreomacular Traction

  14. RWECONSIDERATIONINHTADECISION • Of the144HTAsevaluatingRWE,44%(n=63)mentionedtheRWE intheirdecision • Both neutralornegative mentions representmorethanone-thirdof thetotalofmentionedRWE inthedecisions,respectively Positive mention, 24% Neutral mention, 38% Negative mention, 38% n =63

  15. Τι στοιχεία RWE θα μπορούσαν να αξιοποιηθούν σε ένα ΗΤΑ? • Αρχική αξιολόγηση • Επιδημιολογικά στοιχεία αν υπάρχουν μητρώα/registries, • Τreatment patternsδεδομένου ότι το standard of care όχι μόνο μπορεί να διαφέρει από χώρα σε χώρα αλλά και σε σχέση με τις κλινικές μελέτες έγκρισης, και το • Προφίλ αποτελεσματικότητας και ασφάλειας των ανταγωνιστών στην καθημερινή κλινική πρακτική • Επαναξιολόγηση (Ειδικά μετά Managed Entry Agreements) • η αποτελεσματικότητα ενός προϊόντος επαναξιολογείται μετά από κάποια χρόνια εμπορικής διαθεσιμότητάς (πχ 2 χρόνια) • ενδιαφέρον για το ελληνικό ΗΤΑ, δεδομένου ότι αναφέρεται η επαναξιολόγηση των φαρμάκων

  16. Είναι αναγκαία/σημαντικά τα RWE για ένα ΗΤΑ? • Το ΗΤΑ είναι διαφορετικής μορφής αξιολόγηση σε σχέση με την ρυθμιστική, δηλ. EMA approval. • Στο ΗΤΑ υπάρχει το στοιχείο της εθνικής/τοπικής αξιολόγησης • Οποιαδήποτε data/evidence μπορούμε να πάρουμε από δεδομένα τοπικών Κλινικών μελετώνή εθνικά registriesείναι αναγκαία. • Δευτερογενή δεδομένα, όπως αυτά από την Ηλεκτρονική Συνταγογράφηση

  17. Non–Interventional Trials Article 4 of Ν. 4523/2018

  18. Non–Interventional Trials Now • Approval by the IRB, MBand EOF • Private investigators and Private Hospitals will have to obtain approval by the Managing Director of the relevant Health District. • Four-partite contracts for Private Physicians and Private Hospitals • There will be an EOF registry and approved trials and their results will be published there. • Obligation for the P.I. to update the disease registry (if it exists) Before • Approval by the IRB and MB • Private investigators were included under the auspices of a Hospital • Three-partite Contracts for Private Investigators and Private Hospitals were signed • Non-Interventional trials were published in the site of SFEE (Dilon)

  19. Medical Directors Committee 2017A5 sub-group [Registries] • The team performed mapping of current status/framework for Registries in EU countries & in Greece. • After reviewing the findings at the Medical Directors core team, the task assigned to A5 sub-group was to prepare a document supporting SFEE as an institutional interlocutor for the state, regarding registries. • The document was prepared by July 2017. • Awaits review by SFEE board of directors.

  20. Ευχαριστώ πολύ!

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