Novartis has launched its new, targeted lung cancer therapy Zykadia in the UK, but patients may have trouble accessing it given NICE’s proposals to reject the drug for NHS use and NHS England’s decision to put a freeze on new therapies for the Cancer Drugs Fund until April next year.

The European Medicines Agency issued a conditional approval for Zykadia (ceritinib) back in May for use in ALK+ metastatic non-small cell lung cancer who have progressed on or are intolerant to Pfizer's Xalkori (crizotinib), offering the first treatment option specifically for this group of patients.

The decision was based on data from two global, multicenter, open-label, single-arm studies, the first of which, Study A (also known as ASCEND-1), showed that patients given Zykadia experienced an overall response rate (tumour shrinkage) of 56.4%.

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. 

However, despite acknowledgement from NICE of the urgent the need for new options, and that Zykadia is one of the few treatments designated as a Promising Innovative Medicine by the MHRA, access to the drug in the UK remains “highly uncertain”, says Novartis. 

According to the Swiss drugs giant, NICE’s rejection of Zykadia is in part due to specific challenges associated with reviewing cancer medicines. “Challenges that need to be overcome with a new, more flexible reimbursement system,” said Margaret Dean, general manager, Novartis Oncology UK and Ireland. “With no interim route of access available through the CDF and patients in need right now, we urge NICE to reconsider its decision and will work closely with them in the hope of achieving a positive outcomes for patients.”

The current appraisals process has not been designed to evaluate medicines like Zykadia that have been licensed on the back of strong Phase II data, and this frequently results in negative decisions, the drugmaker stressed, noting that it is “confident” that Phase III data, due next year, will demonstrate the clinical value and cost-effectiveness of the drug to the NHS in England.

New CDF?

NHS England and NICE are now consulting on their proposals for the future of the CDF, under which new cancer drugs could be given a conditional recommendation by the Institute and their use enabled by the Fund for a pre-determined period, whilst further evidence on the longer-term benefits is collected before deciding on their routine use on the NHS in future.

But patients don’t have the time to wait for a new system. “With patients’ lives at stake, a solution to the current situation must be implemented as a matter of urgency,” said Dean. “The failure to adopt the latest cancer treatments, particularly in a traditionally underfunded area like lung cancer, represents a huge setback in cancer care in the UK.”

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.