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

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HCPW P/ PCW P m eeting: feedback from CHMP

Presented by Harald Enzmann (CHMP)

22 November 2017

HCPWP/ PCWP feedback from CHMP – November 2017 1

Sum m ary

• CHMP opinions on new medicines (October-November)
• Patients’ input provided (October-November)

HCPWP/ PCWP feedback from CHMP – November 2017 2

Positive opinions on new m edicines Oct – Nov 2 0 1 7 Cancer

Name Active S Indication Mvasi Bevacizumab (biosimimilar) Metastatic carcinoma

Orphan Restricted prescription

EC

Authorised

EC EC decision pending

monitored (supervision) HCP

EC

HCPWP/ PCWP feedback from CHMP – November 2017 3

Central Nervous System

Name Active S Indication Ocrevus

• crelizumab

Multiple sclerosis

Positive opinions on new m edicines Oct – Nov 2 0 1 7

EC I nfectious diseases

Name Active S Indication Prevym is letermovir prophylaxis of cytomegalovirus reactivation and disease

EC

HCPWP/ PCWP feedback from CHMP – November 2017 4

Positive opinions on new m edicines Oct – Nov 2 0 1 7

Name Active S Indication Jorveza budesonide eosinophilic esophagitis

EC Gastroenterology Haem atology

Name Active S Indication Adynovi rurioctocog alfa pegol haemophilia A

EC

HCPWP/ PCWP feedback from CHMP – November 2017 5

Positive opinions on new m edicines Oct – Nov 2 0 1 7

Name Active S Indication Fasenra benralizumab Asthma

EC Respiratory system Gynecology

Name Active S Indication I ntrarosa prasterone Vulvovaginal Atrophy

EC

HCPWP/ PCWP feedback from CHMP – November 2017 6

Cancer

Name Active S Indication Onzeald etirinotecan pegol Advanced breast cancer whit brain metastasis

Negative opinions on new m edicines Oct – Nov 2 0 1 7

Central Nervous System

Name Active S Indication Fanaptum iloperidone Treatment of schizophrenia

HCPWP/ PCWP feedback from CHMP – November 2017 7

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

End of 2 0 1 7 - W here are w e?

Presentation title (to edit, click View > Header and Footer) 8

Presentation title (to edit, click View > Header and Footer) 9

End of 2 0 1 7 - W here do w e w ant to go?

Patients’ and regulators’ tw o w ay com m unication

sentation title (to edit, click View > Header and Footer)

Patients, physicians (individual) Marketing authorization Evidence

• f positive

benefit risk Regulators

(national or EU)

Treatment decisions Expectation

• f treatment

success

Regulators’ assessment

• f benefits and risks

Patients’ value perception and value systems

How to prom ote role of patients’ perspective and advance beyond individual opinions?

sentation title (to edit, click View > Header and Footer)

Patients, physicians (individual) Marketing authorization Evidence

• f positive

benefit risk Regulators

(national or EU)

Treatment decisions Expectation

• f treatment

success

Regulators’ assessment

• f benefits and risks

Patients’ value perception and value systems

HCPWP/ PCWP feedback from CHMP – November 2017 12

Thank you!