EMEA Performance Indicators Extensions of Indications Manuel Haas - - PowerPoint PPT Presentation

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EMEA Performance Indicators Extensions of Indications

Manuel Haas EMEA-EFPIA Info Day 2009

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Contents

• Methods
• Procedures

– Overview – Requests for supplementary information & Major

• bjections

– Review times – Scientific Advisory Groups & ad-hoc expert groups – Outcome

• Questionnaires

– Outcomes & relation with procedures outcome /assessment

• Conclusions

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Methods

• Study periods:

EFPIA Info Day 2009: 01/01/2007 – 31/12/2008 EFPIA Info Day 2007: 01/06/2005 – 31/09/2006

• Includes:

All extension of indication procedures with outcome in study period (positive, negative, withdrawal)

• Excludes:

Double-applications

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Overview

8 (9%) 1 (3%) SAGs/ ad-hoc expert groups 10 (12%) 3 (8%) OE 46 (54%) 14 (36%) MO 13 (15%) 8 (21%) EMEA SA 85 39 Sample 2007-2008 (24 months) Jun.05-Sep.06 (16 months)

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Requests for Supplementary Information and Major Objections

3% 12% 59% 52% 35% 28% 3% 8%

Jun 05-Sep 06 2007-2008 0 RSI 1 RSI 2 RSI >2 RSI

36% 54% 46% 64%

Jun 05-Sep 06 2007-2008 MO: Yes MO: No

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Median Review Times

216 64 188 223 37 78 148 158 152

50 100 150 200 250 Jun 05 - Sep 06 2007 2008 Overall Clock-stop Active

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Median clock-stop times with & without MO

44 27 80 84 67 28

10 20 30 40 50 60 70 80 90 Jun 05 - Sep 06 2007 2008 MO: Yes MO: No

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Scientific Advisory Groups & ad-hoc expert groups

9 2 1 1 2 3 Total 8 1 1 1 2 3* 2007-2008 1 1 Jun.05-Sep.06

Total Ad-hoc expert group SAG Oncology SAG Diabetes/End. SAG Anti-inf. SAG Cardiovascular

SAGs / ad-hoc expert groups typically convened to assess the clinical relevance of data to the population applied for, or adequate sub-populations in the context of a concern relating to safety, methodology or effect size/consistency.

* 3 SAGs for 2 procedures

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Scientific Advisory Groups & ad-hoc expert groups

• Of the 8 procedures with SAG / ad-hoc expert

group: – 4 resulted in a new indication – 4 resulted in a negative opinion or a withdrawal

• Procedure outcome always consistent (except in
• ne instance) with SAG recommendations in this

sample

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Procedure Outcomes

90% 83% 7% 10% 6% 4%

• Jun. 2005-Sep. 2006 (N=39)

2007-2008 (N=85) Positive (4.1) Positive (other than 4.1) Withdrawn Negative

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ATC Distribution: new indications vs. initial CAPs

11% 8% 19% 21% 10% 26% 8% 8% 15% 39% 8% 20%

A B J L N Other Distribution of initial CAPs as of 2008 Distribution of Ext. of indications granted in 2007-2008

A = Alimentary tract and metabolism; B = Blood and blood forming organs; J = Anti-infective for systemic use; L = Antineoplastic and immuno-modulating agents; N = Nervous system

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Questionnaires

Question 1: Was the dossier presented in a satisfactory way (layout, organisation of data, etc)? Question 2: Were all important data/analysis included in the dossier thereby making benefit risk assessment easy? Question 3: Was the “scientific overview” (expert report) sufficiently critical? Percentage of procedures with (Co-)Rapporteurs’ response: 62% (72% in 2005-06)

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Questionnaires: outcome (means)

• Q1=6.9
• Q2=6.6
• Q3=6.1
• Global=6.6

Slightly better scores than in 2005-06

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Questionnaires

• No clear relation between Question 2 score

(5 or >5) and Major Objections (Yes/No)

(Calculated 2 value = 0.03 < tabled 2 value (3.84), = 0.05)

• No clear relation between Question 2 score

(5 or >5) and outcome (new indication or not) (Calculated 2 value = 1.20 < tabled 2 value (3.84), = 0.05)

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Conclusions

• Higher volume of procedures in 2007-08 compared to 2005-06.
• Longer review times in 2007-08 compared to 2005-06, with

longest times in 2007.

• Stabilisation of review times in 2008, in particular due to

decreasing clock-stops for procedures without MO.

• More procedures led to MO and required extra CHMP expertise

(SAGs) than in 2005-06. Procedure outcomes consistent with SAG recommendations.

• High rate of success (i.e. granting of a new indication), although

slightly inferior to that of 2005-06.

• Good level of Rapporteurs’ satisfaction with dossier

presentation/content. However, no clear relation with procedure

• utcome/complexity.