NICE Terminates Appraisal for Alectinib in Previously Treated ALK-positive Advanced NSCLC

NICE is unable to make a recommendation about the use in the NHS of alectinib

NICE announced on 28 March 2017 that it is unable to make a recommendation about the use in the NHS of alectinib for anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib because no evidence submission was received from Roche. NICE will review this decision if the company decides to make a submission. 

Roche was invited to submit evidence for single technology appraisal guidance [TA438] for alectinib in June 2016.

The company informed NICE that it would be difficult to demonstrate the cost effectiveness of alectinib in people who have had crizotinib. This is because the evidence base is a single arm, phase II clinical trial and the assessment of relative effectiveness would have to be based on naive indirect comparisons. Given this insufficient evidence and the availability of an alternative option, ceritinib, recently recommended by NICE, the company will not be submitting evidence for this appraisal.

The company stated that the evidence emerging from a trial directly comparing alectinib with crizotinib suggests that the value of alectinib to the NHS will be shown in people with untreated disease.

NICE has therefore terminated this single technology appraisal.

NHS organisations should take into account the reasons why the company did not make an evidence submission when considering whether or not to recommend local use of alectinib for previously treated ALK-positive advanced NSCLC. If, after doing this, organisations still wish to consider alectinib for previously treated ALK-positive advanced NSCLC, they should follow the advice on rational local decision-making in the NHS Constitution for England and the NHS Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012. This outlines the approach that should be taken when NICE guidance is unavailable.

NICE will review the position if the company decides that it wants to make a full submission.