2 Information about alectinib

2 Information about alectinib

Marketing authorisation indication

Alectinib (Alecensa, Roche) as monotherapy is indicated 'for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)'.

Alectinib has been available in the UK through the early access to medicines scheme.

Dosage in the marketing authorisation

The recommended dose of alectinib is 600 mg (4×150 mg capsules) taken twice daily with food (total daily dose of 1,200 mg).

A validated ALK assay is necessary to identify ALK-positive NSCLC status, which should be established before alectinib therapy starts.

Treatment with alectinib should be continued until disease progression or unacceptable toxicity. Management of adverse events may need dose reduction, temporary interruption, or discontinuation of alectinib. The dose of alectinib should be reduced in steps of 150 mg twice daily based on tolerability. Alectinib should be permanently discontinued if patients cannot tolerate the 300 mg twice daily dose.

Price

£5,032.00 per pack of 224×150 mg capsules (British national formulary [BNF] online [accessed February 2018]). Based on the company's economic model, if the mean treatment duration is 32 months, the average cost of a course of treatment is approximately £87,000 using the list price for alectinib.

The company has a commercial arrangement. This makes alectinib available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.

  • National Institute for Health and Care Excellence (NICE)