NICE Publishes a Technology Appraisal Guidance for Ceritinib for Untreated ALK-positive NSCLC

Ceritinib as monotherapy is indicated for the first-line treatment of adult patients with ALK-positive advanced NSCLC

On 24 January 2018, the NICE issued evidence-based recommendations on ceritinib (Zykadia, Novartis) for untreated anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) in adults. Ceritinib is recommended, within its marketing authorisation, as an option for untreated ALK‑positive advanced NSCLC in adults, only if the company provides it with the discount agreed in the patient access scheme.

Most patients with untreated ALK‑positive advanced NSCLC are offered crizotinib. Chemotherapy may be offered if the patient's ALK mutation status isn't known, and therefore is not a relevant comparator for ceritinib. There are no trials directly comparing ceritinib with crizotinib; the clinical trial compares ceritinib with chemotherapy.

Because the clinical trial has not finished, it is unable to show how much ceritinib prolongs life compared with chemotherapy. But it shows that ceritinib is more effective than chemotherapy at increasing the progression-free survival. An indirect comparison suggests that ceritinib is more effective than crizotinib. Clinical experts support using ceritinib instead of crizotinib.

The most plausible cost-effectiveness estimate for ceritinib compared with crizotinib is around what NICE normally considers acceptable. Therefore, ceritinib can be recommended as an option for adults with untreated ALK‑positive advanced NSCLC.

Ceritinib is taken orally, without food, at the same time each day. The recommended dose is 750 mg once daily. The summary of product characteristics for ceritinib, and the protocol for the phase III clinical trial of ceritinib (ASCEND‑4), states that treatment should continue as long as clinical benefit is observed.

A 30‑day supply of ceritinib (150 capsules) costs 4,923.45 GBP (excluding VAT; British national formulary [BNF] online [accessed October 2017]).

The company has agreed a patient access scheme with the Department of Health. This scheme provides a simple discount to the list price of ceritinib, with the discount applied at the point of purchase or invoice. The level of the discount is commercial in confidence. The Department of Health considered that this patient access scheme does not constitute an excessive administrative burden on the NHS.