LA EVIDENCE-BASED MEDICINE IN VACCINOLOGIA PIER LUIGI LOPALCO UNIVERSITÀ DI PISA

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1 LA EVIDENCE-BASED MEDICINE IN VACCINOLOGIA PIER LUIGI LOPALCO UNIVERSITÀ DI PISA BRESCIA, 29 APRILE 2016

Archibald Leman Cochrane 1909 1988 Autore del libro Effectiveness and

2 Archibald Leman Cochrane Autore del libro Effectiveness and Efficiency: Random Reflections on Health Services. Ispiratore di Cochrane.org

3 Il processo Evidence Based la piramide delle evidenze Revisioni sistematiche e metanalisi Trial Clinici Randomizzati in doppio cieco Studi di Coorte Studi Caso-Controllo Serie di casi Report di casi Opinioni di esperti Sperimentazione animale Sperimentazione in vitro

4 Il processo decisionale nella introduzione di nuovi vaccini

Il BCoDE Project - ECDC European Union Member States face the challenge of how to best allocate limited resources in healthcare protection and disease prevention to achieve maximum results.

5 Il BCoDE Project - ECDC European Union Member States face the challenge of how to best allocate limited resources in healthcare protection and disease prevention to achieve maximum results. Providing sound evidence improves the quality of health policy decision-making and promotes transparency and accountability. Measurement of the burden of disease provides evidence which can be taken into account in formulating healthrelated policies.

6 Elementi del processo decisionale per modifiche nelle politiche vaccinali malattia costi presenza di misure alternative peso sulla sanità priorità politiche

7 Alcuni esempi dalla esperienza europea malattia costi presenza di misure alternative peso sulla Sanità politica BCG Influenza nei bambini Rotavirus HPV

8 Evidence-based guidance development Internal data and information Systematic review Scientific panel EB guidance

9 Status of decision making process on HPV vaccine introduction (as to October 2007) EU + EEA countries Program implemented (5) Recommendation (7) not yet (17) source: VENICE

10 Status of decision making process on HPV vaccine introduction (as to January 2008) EU + EEA countries Program implemented (7) Recommendation (8) not yet (14) source: VENICE

11 Status of decision making process on HPV vaccine introduction (as to February 2009) EU + EEA countries Program implemented (9) Recommendation (6) not yet (14) source: VENICE

12 Status of decision making process on HPV vaccine introduction (as to February 2010) EU + EEA countries Program implemented (14) Recommendation (3) not yet (12) source: ECDC

13 Status of decision making process on HPV vaccine introduction (as to November 2014) EU + EEA countries Program implemented (22) Recommendation (3) not yet (4) source: ECDC

14 Report on the health technology assessments on human papillomavirus and rotavirus vaccinations in Europe, (29 countries, 2011) Status of HPV health technology assessment Countries Completed 6 21% Ongoing 1 3% FI Planned 2 7% AT RO Not planned 20 69% BE DE DK IR IT SE BG CY CZ ES EE FR GR HU IS LI LU LV MA NL NO PL PT SI SK GB VENICE II Report, available at

16 Incidenza di Epatite A in Italia e Puglia ,00 Puglia Italy w/o Puglia 140,00 120,00 100,00 80,00 60,00 40,00 20,00 0,

17 Incidenza di Epatite A in Italia e Puglia

18 N. di dosi di vaccino contenente DT somministrate ad un cittadino UE <18 anni, in base alla residenza countries number of countries countries 8 countries 3 countries 0 4 doses 5 doses 6 doses 7 doses

19 Gruppo di esperti sulla schedula DTP Current vaccination schedules are the result of historical tradition, compliance with provision of health services and national vaccine registration. Many studies on DT were conducted in 1950s and 1960s according to the methods available at that time Very hard to provide EBM guidance

20 Gruppo di esperti sulla schedula DTP All three primary series schedules (at 2, 3, 4; 2, 4, 6; and 3, 5 months) used in the EU induce priming. A three-dose priming schedule at 2, 3, 4 months of age induces priming against pertussis one month earlier than the 3, 5 months schedule, but at the price of an additional dose. One booster dose should be administered to infants or toddlers.

21 N. di dosi di vaccino contenente DT somministrate ad un cittadino UE <18 anni, in base alla residenza number of countries countries 9 countries 1 countries 1 countries 4 doses 5 doses 6 doses 7 doses

This study supports previous findings about the heterogeneity of NITAGs processes, potentially explain the disparity in access to vaccinations and immunization programs across Europe The decision

22 This study supports previous findings about the heterogeneity of NITAGs processes, potentially explain the disparity in access to vaccinations and immunization programs across Europe The decision analysis frameworks that are critical for transparent, structured, reproducible and reliable decision-making, were available for a limited number of NITAGs with only two countries (Germany and the US) using a detailed and standardized methodology for reliable, robust, and reproducible The lack of transparency in NITAGs interaction with the general public and healthcare professionals deserves improvement

23 La necessità di un modello decisionale efficiente e trasparente Gruppo tecnico di esperti (NITAG) Commissione governativa EBM Piano Nazionale Vaccini

24 Conclusioni L EBM rappresenta uno strumento irrinunciabile di supporto alle decisioni La mancanza di evidenze di elevata qualità, secondo i criteri EBM, non deve però rappresentare un ostacolo al processo decisionale

25 GRAZIE

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