GPs could soon begin referring Covid-positive patients for a ‘promising’ new IV treatment designed to reduce the risk of severe illness and death, NHS England has said.
In a letter to integrated care systems last week (15 June), NHS England said neutralising monoclonal antibodies have now been identified as a ‘potentially promising treatment’ against Covid, and that these laboratory-produced drugs could be offered to patients ‘as early as summer 2021’.
ICSs will therefore need to set up Covid monoclonal antibody delivery units (CMDUs), with contact and booking arrangements going through ‘referrals mainly from general practice and NHS111’, according to the letter.
The units may be ‘a mixture of community outreach, Covid positive hospital outpatient capacity or use of Covid assessment centres or other clinic facilities’, it said.
The services will need to be able to deliver the drug to adults and ‘potentially’ children aged over 12, and initial treatments will need to be based on IV administration, as most of the research has been based on this method, it added.
Monoclonal antibodies, which are artificially produced in laboratories, are injected directly into patients and are designed to mimic the immune system’s ability to fight off harmful antigens such as viruses.
The UK RECOVERY trial recently found that REGEN-COV drug – a combination of two antiviral monoclonal antibodies – reduces the risk of death from Covid by a fifth in people who are unable to mount a natural antibody response of their own. In its study of 9,785 patients who were hospitalised due to Covid, it found that roughly a third did not have natural antibodies.
The NHS England letter said: ‘Neutralising monoclonal antibodies have now been identified as a potentially promising treatment. Marketing authorisation by the MHRA and a clinical commissioning policy have not yet been determined but there is a potential for nMABs to be offered as a treatment to prioritised cohorts within the NHS as early as Summer 2021.
‘Integrated care systems (ICSs) are by this letter therefore now being asked to identify intravenous (IV) infusion service options and plan capacity to meet potential demand ahead of a potential roll out of neutralising monoclonal antibodies as a treatment for Covid-19.’
In terms of funding, NHS England said: ‘Local systems are asked to identify resources to deliver this activity from within local funding envelopes, in line with other Covid response activity’.
NHS England chief executive Sir Simon Stevens repeated the call for health services to prepare to deliver monoclonal antibody treatments in the coming months while speaking at the NHS Confederation conference on Tuesday.
He said: ‘Today, I’m asking the health service to gear up for what is likely to be a new category of treatments – so-called self-neutralising monoclonal antibodies, which are potentially going to become available to us in the next several months.
‘We are setting out our set of asks around how to bring that about in each integrated care system so that as and when those treatments become available to us, they can immediately begin to be deployed.’
He added that patients will be infused with the treatment ‘before they are hospitalised – typically within a three day window from the date of infection’.
Earlier this year, the Government announced that Tocilizumab – an anti-inflammatory monoclonal antibody usually used for treating rheumatoid arthritis – would be used to treat patients hospitalised due to Covid-19, after the RECOVERY trial showed it could help reduce mortality by 14% and time spent in hospital.