HCPW P/ PCW P m eeting: feedback from CHMP Presented by Harald - PowerPoint PPT Presentation

HCPW P/ PCW P m eeting: feedback from CHMP Presented by Harald Enzmann (CHMP) 22 November 2017 An agency of the European Union

Sum m ary • CHMP opinions on new medicines (October-November) • Patients’ input provided (October-November) 1 HCPWP/ PCWP feedback from CHMP – November 2017

Positive opinions on new m edicines Oct – Nov 2 0 1 7 Cancer Name Active S Indication Bevacizumab EC Mvasi Metastatic carcinoma (biosimimilar) EC EC EC decision pending monitored (supervision) HCP Authorised Orphan Restricted prescription 2 HCPWP/ PCWP feedback from CHMP – November 2017

Positive opinions on new m edicines Oct – Nov 2 0 1 7 Central Nervous System Name Active S Indication EC Ocrevus ocrelizumab Multiple sclerosis I nfectious diseases Name Active S Indication prophylaxis of cytomegalovirus EC Prevym is letermovir reactivation and disease 3 HCPWP/ PCWP feedback from CHMP – November 2017

Positive opinions on new m edicines Oct – Nov 2 0 1 7 Gastroenterology Name Active S Indication EC Jorveza budesonide eosinophilic esophagitis Haem atology Name Active S Indication EC Adynovi rurioctocog alfa pegol haemophilia A 4 HCPWP/ PCWP feedback from CHMP – November 2017

Positive opinions on new m edicines Oct – Nov 2 0 1 7 Respiratory system Name Active S Indication EC Fasenra benralizumab Asthma Gynecology Name Active S Indication EC I ntrarosa prasterone Vulvovaginal Atrophy 5 HCPWP/ PCWP feedback from CHMP – November 2017

Negative opinions on new m edicines Oct – Nov 2 0 1 7 Cancer Name Active S Indication Onzeald etirinotecan pegol Advanced breast cancer whit brain metastasis Central Nervous System Name Active S Indication Fanaptum iloperidone Treatment of schizophrenia 6 HCPWP/ PCWP feedback from CHMP – November 2017

I nteraction betw een CHMP, HCP and patients: SAG and Ad-Hoc Experts Groups  Contributing for decision on recom endations Name Active S Therapeutic area Alcover sodium oxybate CNS Fanaptum iloperidone CNS Valproate CNS Zinbryta daclizumab CNS Prolia denosumab Musculo-Skeletal Blincyto blinatumomab Oncology Opdivo nivolumab Oncology 7 HCPWP/ PCWP feedback from CHMP – November 2017

End of 2 0 1 7 - W here are w e? 8 Presentation title (to edit, click View > Header and Footer)

End of 2 0 1 7 - W here do w e w ant to go? 9 Presentation title (to edit, click View > Header and Footer)

Patients’ and regulators’ tw o w ay com m unication Marketing Treatment authorization decisions Regulators’ assessment of benefits and risks Patients, Regulators physicians (national or EU) (individual) Evidence Expectation Patients’ value perception of positive of treatment and value systems benefit risk success sentation title (to edit, click View > Header and Footer)

How to prom ote role of patients’ perspective and advance beyond individual opinions? Marketing Treatment authorization decisions Regulators’ assessment of benefits and risks Patients, Regulators physicians (national or EU) (individual) Evidence Expectation Patients’ value perception of positive of treatment and value systems benefit risk success sentation title (to edit, click View > Header and Footer)

Thank you! 12 HCPWP/ PCWP feedback from CHMP – November 2017