England catches up on cemiplimab for advanced lung cancer
NICE has recommended cemiplimab with platinum-based chemotherapy for use on the NHS in England and Wales, as a first-line treatment for advanced non-small cell lung cancer (PD-L1 expression of 1% or more, no EGFR, ALK or ROS1 alterations). Eligible people can now access the combination through the NHS, with funding required within 90 days of final guidance.
The combination has held European Commission authorisation since 2023, so the decision brings the NHS into line with a treatment already approved across the European Union. It adds another first-line immunotherapy option for people living with advanced lung cancer, which is welcome in a setting where individuals can respond very differently to treatment.
That is the good news. There is more to it, because the journey from an approved treatment to one a person can actually receive is rarely a straight line, and cemiplimab is a clear illustration of why.
What has actually been decided
The recommendation from the National Institute for Health and Care Excellence (NICE) applies to adults whose cancer is locally advanced and not suitable for definitive chemoradiation, or is metastatic, where the tumour has PD-L1 expression in 1% or more of tumour cells, with no EGFR, ALK or ROS1 alterations, and who would otherwise have been offered pembrolizumab with platinum-based chemotherapy.
The recommendation is narrower than the licence. Cemiplimab with chemotherapy is authorised for a broader group, but the guidance recommends it specifically for people who would otherwise be offered pembrolizumab with chemotherapy.
The evidence behind it
Cemiplimab is an immunotherapy that targets the PD-1 pathway, helping the immune system recognise and attack cancer cells. The case for using it alongside chemotherapy rests on the EMPOWER-Lung 3 trial, which compared cemiplimab plus platinum-doublet chemotherapy with chemotherapy alone in people with advanced NSCLC, across a range of PD-L1 levels and tumour types.
The benefit has held up over time. At a follow-up of around five years, people who received cemiplimab plus chemotherapy lived a median of roughly 21 months, compared with around 13 months for those on chemotherapy alone, which represents a reduction of about a third in the risk of death. Time before the cancer progressed was also longer. The safety profile was in line with what is already known about each treatment on its own.
These are real gains in a disease where outcomes have long been poor, though they describe an additional option that extends life for a defined group rather than a cure.
Authorisation is not the same as access
At European level, none of this is new. The European Commission authorised cemiplimab with platinum-based chemotherapy for first-line advanced NSCLC back in 2023, with the indication wording in place from May that year. A marketing authorisation of that kind applies across the European Union at once.
What it does not do is put the treatment in front of a person. That depends on a separate national decision about whether a health system will fund it. Each country runs its own health technology assessment and reimbursement process, weighing clinical benefit against cost, and these decisions arrive at very different times and reach different conclusions. A treatment can be authorised across the EU for years before some countries fund it, and in some it may never be routinely funded at all.
Even one country can take time
England shows how uneven that process can be even within a single system. NICE initially did not recommend the combination, concluding that the evidence did not show it to be value for money against existing options such as chemotherapy alone, immunotherapy alone, or immunotherapy with chemotherapy. The positive recommendation only followed after a revised commercial arrangement was reached and the recommended group was narrowed to those who would otherwise be offered pembrolizumab with chemotherapy.
In other words, the gap between a European authorisation in 2023 and NHS access years later was not closed by the science alone. It turned on price and on the specific group of people in question.
The European access question
Multiply that by the number of countries across Europe, each with its own assessment body, budget and negotiation, and the result is the pattern that defines so much of cancer care on the continent. A treatment can be authorised everywhere and available somewhere. Where a person lives still decides whether, and when, they can reach an option that the European Union approved for everyone at the same moment.
This is the heart of the access inequality that Lung Cancer Europe and its members continue to track. New first-line options are worth welcoming. The harder and longer task is making sure they reach people living with lung cancer wherever they are, and not only in the countries that happen to reach a funding agreement first.
In short
The NICE recommendation is good news for people with advanced lung cancer in England and Wales, and it brings the NHS into line with a treatment authorised across the EU since 2023. It is also a reminder that a European authorisation is the start of the access story, not the end of it.
European Commission marketing authorisation (2023)
EMPOWER-Lung 3 five-year results presented at the 2025 World Conference on Lung Cancer