The UK’s National Institute for Health and Care Excellence (NICE) has recommended the use of Boehringer’s personalised oncology drug Giotrif for use in the treatment of certain lung cancer patients.
In draft guidance NICE, which assesses the cost-effectiveness of treatments for NHS use in England and Wales, said Giotrif (afatinib) should be available for use in people with advanced or metastatic non-small-cell lung cancer (NSCLC) whose tumours test positive for the epidermal growth factor receptor (EGFR) genetic mutation and who have not previously received an EGFR inhibitor.
It is estimated that around 10-15 per cent of NSCLC patients are EGFR-positive in the US and EU, although the proportion increases to around 40 per cent in Asia. NSCLC itself counts for around 85 per cent of all lung cancers.
Boehringer’s drug will face two EGFR inhibitors already approved by NICE for NHS use: AstraZeneca and Teva’s Iressa (gefitinib) and Roche’s Tarceva (erlotinib). As per these two treatments, Giotrif will also be provided at a discount through a patient access scheme.
Due to the personalised nature of Giotrif, it needs to be used in combination with a diagnostic to assess which patients have the EGFR mutation and could therefore benefit from the drug.
In anticipation of the greater use of personalised cancer medicines, NICE released guidance last year on the type of diagnostics that should be used. Recommended devices included Roche’s cobas EGFR Mutation Test and Qiagen’s therascreen EGFR RGQ PCR Kit, although neither is recommended alongside a specific medicine.
The draft NICE guidance is another significant step for Boehringer’s oncology ambitions, which have been gaining steam since afatinib was approved as its first cancer drug in the US in the summer of 2013 under the name Gilotrif.
Since then it has been approved in Europe under the Giotrif brand, contributing to Boehringer’s improves sales performance for 2013 as seen in PMLiVE’s Top Pharma List.
The company’s second oncology drug nintedanib is also on its way to approval, and is currently under review in Europe.
As for Giotrif, the NICE guidance is now out for consultation, after which final draft guidance will be published.