AZ appeals against NICE rejection of Tagrisso in untreated lung cancer

AstraZeneca is appealing against NICE’s decision not to recommend funding for its lung cancer drug Tagrisso (osimertinib) in untreated patients with epidermal growth factor receptor (EGFR) mutations.

In final draft guidance, NICE said it had rejected regular NHS funding for Tagrisso, because the survival benefits compared with standard treatment such as AZ’s older drug Iressa (gefitinib) are unclear in first-line non-small cell lung cancer.

Tagrisso has been the driving force behind AZ's sales recovery after a steep patent cliff - it generated $630 million in Q1 alone and is the company's top selling drug after first approval in 2015 in a more advanced form of the disease.

NICE had been considering results from the FLAURA trial, comparing Tagrisso with Roche’s Tarceva (erlotinib) and AZ’s Iressa (gefitinib) in untreated patients.

Patients in the trial had either exon 19 deletion (del19) or exon 21 (L858R) mutations, accounting for around 90% of EGFR mutations.

NICE said it noted progression-free survival was 18.9 months on Tagrisso compared with 10.2 months on standard care.

Overall survival data is not mature but data gathered so far show that Tagrisso will likely extend this too.

However NICE is concerned that data so far do not show the size of treatment benefits, and that AZ’s economic model does not fully capture the benefits of subsequent treatments.

As a result Tagrisso’s cost per quality-adjusted life year (QALY) is greater than the £30,000 threshold that NICE usually applies.

However NICE also ruled that Tagrisso does not qualify for End of Life consideration, which gives extra financial leeway for drugs where patients typically have less than two years to live.

AZ said that analyses submitted to NICE show that it would be considered cost-effective if EoL status was granted.

[caption id="attachment_14218" align="alignnone" width="160"] AZ's Pascal Soriot[/caption]

AZ’s CEO Pascal Soriot said: “We are very disappointed with this decision and will appeal. The UK has the second worst lung cancer survival outcomes in Europe and patients need new innovative treatments.

“NHS data show that patients in England who would be eligible for our medicine have very low survival rates and therefore Tagrisso should qualify for End of Life consideration to evaluate cost-effectiveness.”

Dr Carles Escriu, medical oncology consultant at The Clatterbridge Cancer Centre and Honorary Research Fellow at the University of Liverpool, said: “I am surprised at this negative decision. While I understand the methodological challenge for NICE, the fact is that NHS data show that patients with this type of lung cancer survive for 17 months, which is within the 24-month short life expectancy threshold for End of Life consideration.”