AstraZeneca’s cancer drug Iressa has suffered a further setback in the UK after cost regulators rejected its use on NHS Scotland as a treatment for patients with non-small cell lung cancer.

The Scottish Medicines Consortium said this week that AZ’s justification of Iressa’s (gefitinib) cost in relation to its health benefits for patients with EGFR mutation-positive advanced NSCLC was not sufficient and that the company failed to “present a sufficiently robust economic case” for its entry onto the NHS.

Naturally, AZ is disappointed with the decision, which it sees as a setback for both NSCLC patients in Scotland and personalised medicine, but it stressed that it intends to resubmit Iressa’s application to the SMC in the hope that it can change the cost watchdog’s mind.

“This is very disappointing news for lung cancer patients in Scotland who have an EGFR mutation in their tumour and for whom gefitinib does offer significant advantages over traditional treatment,” agreed Professor Keith Kerr, an expert on lung pathology in Scotland, and he pointed out that “for some time now we have had a genetic test which enables us to identify those patients who are highly likely to benefit from gefitinib, which means that NHS resources can be optimised”.

While accepting that the drug indeed offers significant advantages to people with NSCLC over existing treatment with double chemotherapy – with clinical trial data showing improved progression-free survival, quality of life and control of the disease’s symptoms - the SMC judged Iressa to be too expensive for use on the NHS.

This is because it was unable to take into account a patient access scheme proposed by AZ, under which the NHS is charged a single, fixed registration fee based on the overall population of patients with EGFR mutations, irrespective of actual duration of treatment, after the Patient Access Scheme Assessment Group ruled that such a scheme would not be feasible in Scotland. But the company said it is working with the Group to address its concerns.

NICE rejection?
The news follows a preliminary decision by the National Institute for Health and Clinical Excellence in February not to recommend the drug for use on the NHS in England and Wales, although a final ruling is still pending.

According to the Institute, it was unable to properly assess whether Iressa offers value for money because it did not have sufficient data from AZ to determine its likely incremental cost compared with standard platinum combination therapy or with Eli Lilly’s Alimta (pemetrexed) and cisplatin.

Therefore, the Institute has requested further data from AZ to better clarify the clinical and cost effectiveness of the drug, particularly in relation to progression-free survival, to help it reach a more informed conclusion.