Amivantamab with carboplatin and pemetrexed can be used during the managed access period as an option for untreated advanced non-small-cell lung cancer (NSCLC) with activating EGFR exon 20 insertion (ex20ins) mutations in adults. It can only be used if the conditions in the managed access agreement for amivantamab with carboplatin and pemetrexed are followed.
This recommendation is not intended to affect treatment with amivantamab with carboplatin and pemetrexed that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS healthcare professional consider it appropriate to stop.
NICE, NHS England and Johnson & Johnson have a managed access agreement for amivantamab with carboplatin and pemetrexed. This means it can be used as an option in the NHS in England during the managed access period. During this time, more evidence will be collected to address any uncertainties. After this, NICE will review and update this guidance.
Amivantamab with carboplatin and pemetrexed can only be used if the conditions in the managed access agreement are followed.
NICE has produced tools and resources to support the implementation of this guidance.
Usual treatment for untreated advanced NSCLC with ex20ins mutations is carboplatin with pemetrexed or best supportive care.
Clinical trial evidence shows that amivantamab with carboplatin and pemetrexed increases how long people have before their condition gets worse compared with carboplatin with pemetrexed. But because the trial is ongoing, it is uncertain whether people who have amivantamab with carboplatin and pemetrexed live longer.
Because of the uncertainty in the clinical evidence, the most likely cost-effectiveness estimates are uncertain, and some are above the range that NICE considers an acceptable use of NHS resources. So amivantamab with pemetrexed and carboplatin cannot be recommended for routine use. But amivantamab with carboplatin and pemetrexed has the potential to be cost effective if some of the uncertainties in the evidence are resolved. This could be done by collecting more long-term evidence during a managed access period. So, amivantamab with carboplatin and pemetrexed is recommended for use with managed access.