Adults aged over 50 years, and people aged 12–49 years who are immunocompromised, will be among those eligible to receive the newly approved monoclonal antibody (MAb) cocktail, Ronapreve (casirivimab and imdevimab; Roche Products Ltd), and could do so from this week, the Department of Health and Social Care (DHSC) has said.
The eligibility criteria for the treatment — which was approved in August 2021 — were published in a joint interim clinical commissioning policy statement on 17 September 2021 by the DHSC, the Scottish government and the Welsh government.
The policy states that hospitalised patients are eligible to be considered for Ronapreve if they have confirmed COVID-19; are hospitalised specifically for the management of acute COVID-19 symptoms; do not have an adequate existing antibody response to the SAR-CoV-2 virus; and are either aged 50 years and over, or aged 12–49 years and determined to be immunocompromised.
Children who weigh less than 40kg or are aged under 12 years will be excluded, as will those who have previously received the MAb cocktail in hospital or who have a known hypersensitivity reaction to the active substances.
A press release, published by the DHSC on 17 September 2021, said that the government had “taken action” to secure supply of the treatment for NHS patients across the four nations, with treatment for eligible patients in hospital starting from the week beginning 20 September 2021.
In the statement, Sajid Javid, the health and social care secretary, said: “We have secured a brand new treatment for our most vulnerable patients in hospitals across the UK and I am thrilled it will be saving lives from as early as next week.
“The UK is leading the world in identifying and rolling out life-saving medicines, particularly for COVID-19, and we will continue our vital work to find the best treatments available to save lives and protect the NHS.”
Ronapreve is the first neutralising antibody medicine specifically designed to treat COVID-19 to be authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in the UK.
The DHSC said that antibody testing would first be used to determine whether patients are seronegative and can therefore receive the treatment. The cocktail of the two antibodies — casirivimab and imdevimab — will then be administered to patients as a combined single intravenous infusion, and works by binding to spike protein of the virus, stopping it from being able to infect the body’s cells.
The recommended dose of casirivimab and imdevimab is 2.4g (1.2g each of casirivimab and imdevimab).
Chief pharmacists have previously told The Pharmaceutical Journal that, following the start of treatment in hospitalised patients, provision of the MAb cocktail would later be extended to COVID-19 patients in community settings.
In June 2021, the randomised evaluation of COVID-19 therapy (RECOVERY) trial found that Ronapreve reduced the risk of death and the length of hospital stay for seronegative hospitalised patients with severe COVID-19.