Scottish cost regulators have stuck with their decision to bar patients with lung cancer from access to AstraZeneca’s Iressa on the National Health Service, after deeming the drug too expensive.

The Scottish Medicines Consortium has again turned down the use of Iressa (gefitinib) in the country for use in its approved indication - the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of epidermal growth factor receptor (EGFR) tyrosine kinase - following a resubmission by the drugmaker.
 
A comparative study in previously untreated patients has shown that Iressa is superior to a platinum-based doublet chemotherapy regimen in terms of progression-free survival, and a subgroup analysis supported this finding in patients with activating mutations of EGFR-TK.  
 
But AstraZeneca’s justification of the treatment’s cost in relation to its health benefits was not sufficient and the economic case was not sufficiently robust to gain acceptance by SMC, the watchdog said.

The decision comes despite the offer of a single payment access scheme by the company in Scotland, and its calculation that the drug’s cost effectiveness is likely to be around £14,210 cost per QALY, and so well below the cost threshold. The SMC’s own model, however, came up with a figure of £73,827 per QALY when compared with a treatment regimen of Eli Lilly’s Gemzar (gemcitabine) and cisplatin, and so well above what would normally be considered a cost-effective use of NHS resources.

The news will be particularly disappointing as earlier this year the SMC’s sister body, the National Institute for Health and Clinical Excellence, published draft guidance recommending the use of Iressa as a first-line treatment option for the 70% or so of patients with advanced NSCLC who have EGFR mutation positive tumours.

The Institute ruled that the drug does represent a cost-effective use of NHS resources, when taking into account the patient access scheme proposed by AstraZeneca under which Iressa is provided at no cost for patients treated for up to two months and, for all others, at a single fixed cost irrespective of the duration of treatment.

Disappointing decision

Unsurprisingly, AstraZeneca UK said it is disappointed with the SMC’s decision, which, it says, “creates inequality north of the border” as patients in England and Wales are able to access the drug on the NHS and was based on different assumptions to those used in NICE’s model.

“Since gefitinib is already available in England following the NICE review, it is disappointing for patients in Scotland that they do not yet have access to this effective and tolerable medicine,” commented Marianne Nicolson, a leading medical oncologist in Scotland. “Gefitinib is the therapy of choice for those with the specific genetic changes in their lung cancer that give them a high chance of durable response with fewer side-effects than we see with chemotherapy,” she added.

AstraZeneca said it is considering its options and response to the SMC’s decision.