The National Institute for Health and Care Excellence (NICE) has published a final guidance that does not recommend AstraZeneca’s Tagrisso (osimertinib) for untreated locally advanced or metastatic epidermal growth factor receptor (EGFR)-positive non-small-cell lung cancer (NSCLC).
The organisation revealed that the decision was based on a clinical trial, which despite showing that the drug stalled cancer-growth for around 18.9 months compared with 10.2 months in patients treated with erlotinib or gefitinib, did not show direct evidence that the drug would be more effective than afatinib, which may be more effective than erlotinib or gefitinib.
As it stands, the first line of treatment for locally advanced stages of NSCLC is a daily oral dose of afatinib, erlotinib, gefitinib or dacomitinib, which have all previously been recommended by NICE.
On top of the insufficient evidence of efficacy compared to afatinib, Tagrisso does not meet NICE’s end of life criteria - a status given to medicines for patients who have a short life expectancy, typically less than 24 months - and the cost-effectiveness estimates are higher than NICE normally considers an acceptable use of NHS resources.
Unfortunately, the drug is not considered eligible for inclusion in the Cancer Drugs Fund (CDF) as it does not have the potential to be cost-effective at the price offered.
AstraZeneca initially appealed the decision following a draft guidance in July 2019, but after careful reconsideration, the committee stood by the decision not to recommend Tagrisso in the indication.
The UK has the second worst five-year survival rate in Europe, with only Bulgaria having worse outcomes. Lung cancer is the leading cause of death by cancer in the UK and it is the most common type of cancer to spread to the brain.