After the news yesterday about Bayer's sorafenib being rejected by NICE in liver cancer comes another oncology decision, this time a positive one, and good news for AstraZeneca and gefitinib (Iressa).
The new guidance states:
"Gefitinib is recommended as an option for the first-line treatment of people with locally advanced or metastatic non-small-cell lung cancer (NSCLC) if:
• they test positive for the epidermal growth factor receptor tyrosine kinase (EGFR-TK) mutation and
• the manufacturer provides gefitinib at the fixed price agreed under the patient access scheme."
Iressa has had a somewhat chequered history over the last few years, first with the fast track approval in the US on promising phase II data and then the down side of phase III trials failing to show any clear improvement in outcome while OSI/Roche's erlotinib (Tarceva) demonstrating a small but significant survival benefit.
It looks like Iressa is coming back from the dead after all, at least in Europe.
According to FiercePharma, a deal was successfully struck with the agency:
"The lung cancer pill got a recommendation from the cost-effectiveness watchdog for use by the National Health Service, but only after the company offered an unusual fixed-price arrangement. Iressa will be supplied to the NHS at £12,200 ($17,560) per patient, regardless of how long treatment lasts. And the NHS won't pay at all for patients who use Iressa for less than three months."
So in the UK, sorafenib would cost around £27K, whereas gefitinib would cost £13K, both offering a couple of months increased survival in liver and lung cancer, respectively. The difference in the two situations is that patients can be now screened for the EGFR mutation in lung cancer (which wasn't known at the time of the original approval), thereby preselecting which patients are most likely to respond. There is no biomarker associated with VEGF therapy yet, as far as I'm aware.
As to what will happen in the US, we'll have to wait and see.