Question to the Department of Health and Social Care:

To ask His Majesty's Government what discussions they have had with the National Institute for Health and Care Excellence regarding the licensing of Amivantamab for the treatment of NHS cancer patients; and when they expect a licence to be granted.

Department officials have regular discussions with colleagues in the National Institute for Health and Care Excellence (NICE) about a range of issues, including access to new treatments for a range of diseases and conditions.

Amivantamab was granted a conditional marketing authorisation by the Medicines and Healthcare products Regulatory Agency for the treatment of adults with advanced non-small-cell lung cancer with activating EGFR exon 20 insertion mutations, after failure of platinum-based therapy, in November 2021.

The NICE makes evidence-based recommendations for the National Health Service on whether new, licensed medicines should be routinely funded by the NHS, based on an assessment of their costs and benefits. The NICE was unable to recommend amivantamab as a clinically and cost-effective use of NHS resources for treating EGFR exon 20 insertion mutation-positive advanced non-small-cell lung cancer after platinum-based chemotherapy in final guidance published in December 2022.

The NICE is planning to appraise amivantamab with lazertinib for untreated EGFR mutation-positive advanced non-small-cell lung cancer and amivantamab with carboplatin and pemetrexed for untreated EGFR exon 20 insertion mutation-positive advanced non-small-cell lung cancer, subject to a licence being granted for these indications. The NICE is expected to publish final guidance on both next year.