Evusheld: Government is urged to expedite covid antibody treatment for vulnerable patients

Additional vaccine doses “not sufficient”

In a letter sent to the health and social care secretary for England, Thérèse Coffey, on 26 September, Saad Shakir, director of the independent Drug Safety Research Unit, urged the government to make Evusheld available for the most vulnerable patients, alongside robust real time monitoring of any adverse side effects.4

Shakir argued that such an approach was taken with other covid-19 treatments and vaccines and that the 500 000 immunosuppressed people in the UK, including organ donor recipients and patients with cancer or leukaemia, deserved the same expedient approach. He wrote, “With the winter months approaching it is becoming increasingly important to provide immunocompromised and vulnerable individuals with protection against covid-19, for these people, providing additional vaccine doses is not sufficient.

“Indeed, there have been covid-19 deaths among this patient subgroup since Evusheld was approved by the MRHA, which perhaps could have been prevented with use of this drug. There will be numerous covid-19 related hospitalisations among clinically extremely vulnerable people if they remain unprotected.”

Policy inconsistencies

The Drug Safety Research Unit argued that the “post-authorisation” approach that was used to roll out covid-19 vaccines and treatments straight after clinical trials, through observational studies and monitoring of adverse reactions through the UK’s yellow card scheme, should also be used for Evusheld.

Lennard Lee, an academic medical oncologist from Oxford University and a member of the National Clinical Expert Group for Immunocompromised Patients, told The BMJ, “We are isolated in this: 32 countries have rolled it out. France, Israel, and America all have data showing ongoing effectiveness against omicron.”

Lee said there was inconsistency between the government’s policy on covid vaccines and its approach to antibody treatments, and he warned that the window for protecting very vulnerable patents this winter was rapidly closing.

“We’ve already seen that the fourth wave of covid is coming now [in the UK], so I’m calling for a pilot—if not an implementation—this winter,” he said. “Other countries are reporting on their outcomes because they rolled this out for the immunocompromised patients in spring and summer [2022].5 We’re very much one of the last to do so.”

Department cites lack of evidence

In a statement sent to The BMJ a Department of Health and Social Care spokesperson said, “We are keeping the evidence under close review, and NICE have begun their appraisal of Evusheld. If they consider the treatment to be clinically and cost effective, it will be made available on the NHS in the usual way.”

The spokesperson added, “To increase the evidence base upon which Evusheld can be assessed, we are urgently exploring commissioning a clinical trial.”

On 6 October the department published a response to two letters from a coalition of charities that had urged the government to shift its stance on Evusheld.678

In response, Steve Barclay, Coffey’s predecessor as health secretary, said that the view of the expert panel that advises the government, RAPID C-19,9 was that there were limitations in sample sizes, methodologies, and overall robustness of the available data on Evusheld. He said that “there remained uncertainty that Evusheld would prevent symptomatic covid-19 caused by current omicron variants in the vulnerable population who would potentially be eligible.”5