Novartis launch drug for rare lung cancer subtype but patients in England may be denied access

Novartis announced today that the new advanced lung cancer medicine, Zykadia® (ceritinib), is now launched and available in the UK, however the recent negative draft decision from the National Institute for Health and Care Excellence (NICE) means that immediate access for patients with limited treatment options is uncertain1.

Ceritinib is licensed for the treatment of adult patients with anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) who have previously been treated with the ALK inhibitor crizotinib.2. This is the first and only targeted therapy to be licensed for lung cancer patients whose disease has progressed on their current treatment.

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 3. This year, there will be over 40,000 new cases of lung cancer in the UK and over 35,000 deaths.4

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for nearly 87% of all cases in the UK, and a significant number of cases in non-smokers.5,6

It can be caused by many factors, including genetic changes that can drive the growth and development of cancer cells. The abnormal fusion of the anaplastic lymphoma kinase (ALK) gene with the EML4 gene leads to the production of a faulty protein that promotes and maintains malignant behaviour in cancer cells. Ceritinib works by specifically blocking the activity of this protein.

ALK-positive (ALK+) NSCLC affects roughly 72,000 patients worldwide – around 3-7% of NSCLC patients – and can be identified by a molecular test of the tumour. 7,8,9,10

“In the UK, improvement in lung cancer outcomes has remained disappointingly slow for many years due to lack of investment in lung cancer research compared to other cancers”, said Dr Rohit Lal, Consultant Oncologist, Guy’s and St Thomas’ NHS Foundation Trust. “Zykadia is part of a new wave of treatments that specifically target the genetic make up of the disease. This targeted approach is a hugely important development and has the potential to transform the way we treat lung cancer in the future.”

Access uncertainty for ceritinib

Access to ceritinib remains uncertain due to the recent draft negative decision by NICE1 as well as the recent decision from NHS England not to review any new cancer medicines through the Cancer Drugs Fund (CDF) until at least April 2016.

“NICE has both acknowledged the need for additional treatment options and that ceritinib is one of the few treatments designated as a Promising Innovative Medicine by the MHRA. Despite this, ceritinib has not been recommended, 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 positive outcomes for patients.”

Ceritinib was licensed under a conditional approval by the European Medicines Agency (EMA), a route designed to allow medicines to reach patients with high unmet need earlier than might otherwise be the case. This means that approval is often given on the basis of positive phase II data.

However, the current NICE appraisal process was not designed to evaluate medicines that have been licensed with phase II data, and this frequently results in negative decisions.

Novartis is confident that new phase III data due in 2016 will help demonstrate the clinical and cost-effectiveness value of ceritinib to the NHS in England.

“We have been working with stakeholders over the past year to discuss our thinking on the necessary elements for a future reimbursement system from NICE and NHS England and we will be responding to the consultation from NICE and NHS England that was announced last week”, said Margaret Dean. “However, with patients’ lives at stake, a solution to the current situation must be implemented as a matter of urgency. 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.”


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