AstraZeneca’s Tagrisso▼ (osimertinib) rejected by NICE for use in NHS England

image of lungs, the left lung is bordered by orange, the right by blue to show AstraZeneca's Tagrisso▼ (osimertinib) rejected by NICE for use in NHS England

The National Institute for Health and Care Excellence (NICE) has published final guidance that does not recommend AstraZeneca’s Tagrisso▼ (osimertinib) for use within NHS England, in line with its licensed indication, for untreated locally-advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) in adults. This is following an appeal by the company.

AstraZeneca says that it is very disappointed with this decision. NHS patients in England and Wales will not have access to a treatment that the company says is becoming the standard of care in the 18 countries in which it is now reimbursed, including Germany, Spain, Italy and Canada.

AstraZeneca hopes to continue discussions with NHS England to enable patient access to this treatment.

The crux of this decision is whether or not osimertinib should have been eligible for end of life consideration by NICE. AstraZeneca remains firm in its belief that it should have been eligible, on the basis of real-world Public Health England data showing that overall survival for patients who would be eligible for osimertinib in this setting is estimated to be less than 17 months – within the 24 month threshold.

The company says that osimertinib is the only first-line medicine for EGFRm NSCLC that has been shown to deliver a median overall survival of more than three years in clinical trials. Osimertinib also offers other benefits to patients in this setting versus first-generation treatments in the same class, such as efficacy for patients whose cancer has spread to the brain and a favourable tolerability profile.

More than 32,000 people in England are diagnosed with NSCLC every year, and around 12% have tumours with EGFR mutations. The UK has the second-worst five-year survival rate for lung cancer in Europe, with only Bulgaria having worse outcomes. Recent data published in the Lancet by the International Cancer Benchmarking Partnership show that people with lung cancer in the UK are 50% more likely to die within five years compared to people in Australia, Canada and Norway.

In October, AstraZeneca presented new data on Tagrisso for for EGFR-mutated non-small cell lung cancer.