New Real World Evidence (RWE) Study Confirms Cost Effectiveness of Iressa® (gefitinib) Under Single Payment Access (SPA) Scheme

  New Real World Evidence (RWE) Study Confirms Cost Effectiveness of Iressa®
          (gefitinib) Under Single Payment Access (SPA) Scheme in UK

  PR Newswire

  LONDON, November 8, 2012

LONDON, November 8, 2012 /PRNewswire/ --

New RWE data presented today at the International Society for
Pharmacoeconomics and Outcomes Research (ISPOR) annual conference in Berlin
confirm that AstraZeneca's Iressa is a cost effective treatment for EGFR-TK
positive non-small cell lung cancer (NSCLC). ^[ ^1 ^]

The RWE data of 266 UK patients only, show that the average length of therapy
with Iressa is at least 12 months for those patients who the NHS paid for,
when supplied via the AstraZeneca SPA scheme. These data confirm benefit
beyond the value accepted by NICE in 2010. NICE determined Iressa to be cost
effective if used under the AstraZeneca SPA scheme on the basis that patients
would receive 8.8 months duration of treatment on average.

In the UK, Iressa is made available to the NHS via the AstraZeneca SPA scheme.
The scheme works by invoicing the NHS only once per NHS patient, which covers
the full duration of treatment regardless of how long that may be. The NHS is
only invoiced for those patients who receive a third pack of Iressa - no
charge is made if a registered patient only receives 2 packs (months) of

The SPA scheme was introduced by AstraZeneca and was designed to ensure value

money to enable budget impact to be predicted more accurately and to be easy
to implement across the NHS.

"The presentation of the real world evidence of the use of Iressa under the
AstraZeneca SPA scheme provides important evidence that demonstrates how
Iressa delivers value and cost effectiveness for clinicians and budget holders
under the SPA scheme. It is vital that pharmaceutical industry can provide
solutions like this which capture and generate usage data to demonstrate value
of treatments, as these are key to allow patient access to medicines," said
Steve Williamson MRPharmS (IPresc), MSc, FFCP, Consultant Pharmacist in Cancer


About Iressa

Iressa is indicated in adults for the treatment of adult patients with locally
advanced or metastatic non-small cell lung cancer (NSCLC) with activating
mutations of epidermal growth factor receptor tyrosine kinase (EGFR-TK). ^[ ^2

Iressa is a selective small molecule inhibitor of EGFR-TK and has been shown
to be an effective treatment for patients with tumours with activating
mutations of the EGFR tyrosine kinase domain regardless of line of therapy in
a number of clinical trials. ^[ ^2 ^]

The most frequently reported adverse drug reactions (ADRs), reported in
clinical trials included diarrhoea and skin reactions (including rash, acne,
dry skin and pruritus). ADRs usually occur within the first month of therapy
and are generally reversible. Approximately 8% of patients had a severe ADR
(common toxicity criteria, (CTC) grade 3 or 4). Approximately 3% of patients
stopped therapy due to an ADR. ^[ ^2 ^]

Interstitial lung disease (ILD) has occurred in 1.3% of patients, often severe
(CTC grade 3-4). Cases with fatal outcomes have been reported. ^[ ^2 ^]

About Non-Small Cell Lung Cancer (NSCLC)

NSCLCs include squamous cell cancers (the most common type of lung cancer),
adenocarcinoma and large cell carcinoma. About four in five cases of lung
cancer in the UK are NSCLC. ^[ ^3 ^]

EGFR-TK (epidermal growth factor receptor tyrosine kinase) is part of the
signal pathways involved in cell proliferation and therefore blocking this
slows the growth and spread of the tumour. 14% of patients with NSCLC will be
positive for EGFR-TK. ^[ ^4 ^]

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a
primary focus on the discovery, development and commercialisation of
prescription medicines for gastrointestinal, cardiovascular, neuroscience,
respiratory and inflammation, oncology and infectious disease. AstraZeneca
operates in over 100 countries and its innovative medicines are used by
millions of patients worldwide. For more information please visit: .


1.Vioix H, FranzenS, Selby D et al. Duration of gefitinib treatment in EGFR
    mutation positive NSCLC patients in a UK single payment access (SPA)
    scheme. Presented at ISPOR 3-7 November 2012.
2.Iressa Summary of Product Characteristics (SmPC)
    Accessed October 2012.
3.Patient UK. Lung Cancer. Accessed October
4.Pennycuick A, Simpson T, Crawley D et al. Routine EGFR and KRAS Mutation
    analysis using COLD-PCR in non-small cell lung cancer. Int J Clin Pract .
    2012; 66 (8): 748-752.

Contact: Media Enquiries: Isabelle Jouin, AstraZeneca UK +44-1582 836077, mob:
+44-7770-568269; Laura Good, RDC +44-208-392-8040, mob: +44-7889-757191
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