NICE stays sour on AstraZeneca's Tagrisso
Months ago, British drugmaker AstraZeneca made its case for the use of Tagrisso as the first line of defense in certain patients with lung cancer with an analysis that showed the drug helped patients carrying the EGFR mutation live longer versus first-generation tyrosine kinase inhibitors. But the UK’s cost-effectiveness watchdog NICE is not convinced — on Wednesday, the agency issued its final guidance refusing to endorse the drug.
EGFR-positive non-small cell lung cancer occurs in around 10% of lung cancer cases. Currently, the first line of treatment, endorsed by NICE, for locally advanced stages of the disease is a daily oral dose of Boehringer Ingelheim’s afatinib (branded Gilotrif), Roche and Astellas’ erlotinib (Tarceva), AstraZeneca’s own gefitinib (Iressa) or Pfizer’s dacomitinib (Vizimpro). Afatinib is currently the most prescribed EGFR TKI in England for this population.
Data from the FLAURA trial, published in 2017, showed that Tagrisso (known chemically as osimertinib) helped stall cancer growth in the patient population for around 18.9 months, versus 10.2 months in patients who received erlotinib or gefitinib.
However, there is no direct evidence comparing the treatment with afatinib, which may be more effective than erlotinib or gefitinib, NICE said.
Overall survival data from FLAURA were very immature (25% of events), NICE said, but the interim results did show that osimertinib extended overall survival compared with standard care. “This produced a hazard ratio of 0.63 (95% CI 0.45 to 0.88; p=0.007) which was not statistically significant (a p value of less than 0.0015 was needed for the result to be significant).”
AstraZeneca appealed NICE’s negative draft guidance in July 2019.
Months later, the company unveiled overall survival data that showed that patients on Tagrisso saw 38.6 months versus 31.8 months on Tarceva or Iressa, eliciting a hazard ratio of 0.799 (p=0.0462).
The hope is that these new OS data can bolster Tagrisso’s standing as a first-line treatment, especially as AstraZeneca seeks reimbursement around the world, noted Dave Fredrickson, who heads AstraZeneca’s global oncology business, at the European Society for Medical Oncology (ESMO) meeting in Barcelona.
“Osimertinib does not meet NICE’s end of life criteria. The cost-effectiveness estimates are higher than NICE normally considers an acceptable use of NHS resources, so osimertinib is not recommended,” NICE said on Wednesday.
AstraZeneca expressed its disappointment in a statement.
“NHS patients in England and Wales will not have access to a treatment that 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 company said.
Tagrisso, which was AstraZeneca’s top-selling treatment in the first nine months of 2019, carries a list price of £5,770 for 80 mg and 40 mg. The company has a commercial arrangement (i.e. a discount), which would have applied if the drug had been recommended.