Lung cancer patients in England and Wales could soon get 'routine' NHS access to Novartis' Zykadia after the National Institute for Health and Care Excellence backed its use in final draft guidelines.
Zykadia (ceritinib) has been recommended in line with its marketing authorisation, that is for the treatment of advanced anaplastic lymphoma kinase (ALK) positive non-small-cell lung cancer (NSCLC) in adults who have previously had Pfizer's Xalkori (crizotinib).
However, the cost regulator's endorsement is dependent on the continued provision of a patient access scheme by the drugmaker, under which it offers the drug to the NHS at a confidential, discounted price to secure its value for money.
The NHS list price of Zykadia is £4,923 for a 30-day supply, and NICE's Committee concluded that, on balance, the most plausible incremental cost effectiveness ratio (ICER) was likely to be lower than £50,000 per QALY gained when including the PAS discount.
Lung cancer is the most common cause of cancer death in the UK, accounting for 22% of all cancer deaths - more than breast, prostate, bladder cancer and leukaemia combined. This year, there will be over 40,000 new cases of lung cancer in the country around 87% of which will be NSCLC. Up to 7% of NSCLC cases are classed as ALK-positive.
Xalkori is the current standard care, but not all patients respond to treatment with this drug, and disease progression typically occurs in any case, leaving patients in dire need of more treatment options.
The European Medicines Agency issued a conditional approval for Zykadia in May last year, on data from two global, multicenter, open-label, single-arm studies, the first of which, Study A (also known as ASCEND-1), showed an overall response rate (tumour shrinkage) of 56.4% in those treated with the drug.
The Scottish Medicines Committee accepted Zykadia for NHS use back in December; final guidance from NICE is expected in June.