February 16, 2023

expert reaction to NICE draft guidance for tixagevimab-cilgavimab (Evusheld) for preventing COVID-19

The National Institute for Health and Care Excellence (NICE) has published draft guidance on the drug Evusheld for adults who are unlikely to have an adequate immune response or cannot have the vaccine against COVID-19.

Prof Alex Richter, Director of the Clinical Immunology Service, University of Birmingham said:

“NICE had a very difficult assessment to make. There was broad acknowledgement of an unmet clinical need to protect the immune vulnerable and that this population is being disproportionately affected by the on-going the pandemic. Vaccines don’t work as well in the immune vulnerable population and treatment options can’t be used in all patients due to underlying health conditions causing side effects.  This makes preventative antibody treatments, such as Evusheld, attractive.

“These treatments have been proven to work well to previous COVID-19 variants both as a treatment when infected with the virus and as a preventative treatment. However, there is laboratory evidence that Evusheld does not work against 85% of the COVID-19 variants currently circulating in the UK. As a result, the decision has been to not approve Evusheld at this time. NICE recognise that the virus is evolving faster than the evidence can be produced and their assessment process can be undertaken, so that they need to find a way of more rapidly assessing treatments for the immune vulnerable. This is essential to ensure that the immune vulnerable are not left behind as the rest of the population moves on.”

Dr Lennard Lee, Senior Clinical Research Fellow, University of Birmingham said:

“The pandemic is an everyday danger for immunovulnerable patients who still have to take precautions, and many are still shielding. As a result, there is an overwhelming clinical need for long-acting antibodies to protect those who aren’t protected from vaccines.

“While it’s right for NICE to ensure that treatment options are based on the best possible evidence for their safety, efficacy and cost-effectiveness, it must be recognised that those who remain extremely vulnerable to Covid need to be prioritised in trials akin to those early days of the pandemic to find treatments fit for them.

“Otherwise, we run the risk of consigning half a million people to continue to live in 2020, stuck in their homes not able to see their families and friends for fear of infection with no protection.”

The draft guidance for tixagevimab-cilgavimab for preventing COVID-19 was published on the NICE website at 00:01, Thursday 16 February.

Declared interests

Prof Alex Richter: “Clinical Expert: NICE Evusheld evaluation, Coinvestigator: PROTECT-V study GSK, Research funding: MRC, NIHR, Educational activities / Speaker fees: Astra Zeneca, Takeda, Oxford Immunotec, Biotest, CSL-Behring.”

Dr Lennard Lee: “No COIs.”