Experience of Tyrosine-Kinase Inhibitors (TKI) for 1st line NSCLC Dr Jill Gardiner, Consultant Medical Oncologist, Newcastle & Mr Steve Williamson, Consultant Pharmacist, NECN April 2012 CONFIDENTIAL INFORMATION – DATA PROVIDED BY ASTRAZENECA UNDER LEGAL AGREEMENT

Review Of Gefitinib Use in NECN In October 2010 NICE approved gefitinib (Iressa) for 1st line treatment of EGFR mutation +ve NSCLC patients Gefitinib was approved by NICE with a Patient Access Scheme (PAS), AstraZeneca, via its supply data, was able to analyse the use of gefitinib and use the information to demonstrate the uptake in the NHS. NECN has worked with AZ have to review Network use and assess the value gained from the PAS scheme The data only applies to NHS patients initiated via the AstraZeneca Single Payment Access (SPA) scheme.

Single Payment Access (SPA) Scheme The SPA scheme is only available to the NHS for sourcing AstraZeneca Oncology Products.

Analysis Methodology Note – this assessment measures “Duration of Treatment” – Not Progression Free Survival (PFS). As such, no clinical inference to the PFS benefit may be assumed.

Disclaimers & Assumptions Background Since September 2009, AstraZeneca has been providing Iressa®▼ (gefitinib) via   a Patient Access Scheme known as the Single Payment Access (SPA) scheme. The scheme is DOH approved, and forms part of the NICE approval of gefitinib.* Following a one-off charge at month 3 initiation, patients will be supplied treatment until no longer required. Objectives This resource will help estimate the value of the SPA scheme, as well as demonstrating the duration of treatment for NHS initiated patients at a national, cancer network and trust level. Methods An economic model, based on the UK real life experience is used to estimate the value of the SPA scheme and the effectiveness in those patients treated at different geographic and NHS levels by using real world evidence data collected as part of the SPA scheme. Assumption In this model the assumption has been made that one supplied pack is equivalent to one month of treatment.

National Level Data (For 2010 Initiated Patients)

Cancer Network Level – Gefitinib Use To Date Cancer Network: North of England   Year 2009 2010 2011 2012* New patients inititated 15 23 7 * 2012 is until the end of March 2012 Cancer Network PURCHASERS Grand Total North of England Queen Elizabeth Hospital 6   James Cook University Hospital 7 North Tyneside General Hospital (Northumbria) 9 University Hosp of Hartlepool 5 University Hospital Nth Durham Freeman Hospital Darlington Memorial Hospital 3 North Cumberland Infirmary 1 Cumberland Infirmary South Tyneside District Hospital 45

Cancer Network Level – Analysis (2010 Initiated Pt’s)

Note this data applies to patients started in 2010 TRUST LEVEL DATA DISCLAIMER Note this data applies to patients started in 2010 Further data sets on 2011 & 2012 patients awaited from AZ

ERROR WITH DATA – TO UPDATE

In Conclusion Re Iressa Scheme AZ believe at a national level, Gefitinib is over delivering vs. expectation to justify price set in relation to NICE approval At a NECN level gefitinib is meeting the NICE & clinical evidence expected durations of use At a Trust level experience is low however.... Overall.... Scheme appears to deliver value, average number of packs patient = 9.4 ……? 9.4 months PFS But confirmation via clinical audit needed….