Access to anti-Covid monoclonal antibody therapy Ronapreve

Access to Ronapreve for patients on immunoglobulin (IG) therapy

On the 4th of November 2021 the NHS published an updated version of the Interim Clinical Commissioning Policy: Casirivimab and imdevimab (Ronapreve) in the treatment of COVID-19 in hospitalised patients. This updated policy takes into account that low levels of antibodies to Covid-19 are now appearing at low levels in immunoglobulin (IG) replacement therapies.

Dr Matthew Buckland, Chair of our Medical Advisory Panel explains: ‘Some IG products may now contain low levels of antibodies to COVID, either, ‘S’ or Spike antibody or ‘N’ nucleocapsid antibodies. S antibody responses arise following infection or vaccination, N antibody responses only arise due to infection.

The initial policy for Ronapreve (see below) was to offer it to people who were antibody negative (S or N), since they would derive the greatest benefit from access to this treatment. There was concern that patients on IG replacement therapy who had not made a vaccine response would be excluded from receiving Ronapreve if they contracted Covid-19, because their antibody test would be positive due to the passive antibody from the IG therapy. However, the antibody in this treatment is at a low level in IG products at present and is unlikely to neutralise the virus.

Patients who have made an IgG response themselves who get Covid-19 are likely to generate much higher antibodies when they get Covid, aiding clearance of the virus and do not need the additional Ronapreve that can bring. Patients who are unable to make IgG antibodies due to their particular immunodeficiency will not be able to do this when they get Covid and so Ronapreve is likely to be beneficial.

Whilst it is great news that some antibody is now in IG products and will hopefully over time contribute to the protection of patients reliant on intravenous and subcutaneous IG for good health, it is even better news that they will also be eligible for additional support with Ronapreve. Added to the news of anti-virals that can be given in the community and prevent Covid-19 progression to its more severe form, things are looking much brighter for patients living with immune deficiencies.’

News in September 2021

As outlined in a Special Edition of the Newsletter (April 2021), monoclonal antibodies (mAbs) offer a novel approach to the prevention and the treatment of COVID-19 infections, especially in patients at increased risk of severe disease such as patients with immunodeficiencies, in whom a COVID-19 vaccine has limited or no effectiveness.

Immunodeficiency UK welcomed the news late August 2021 of the UK approval (licence) of Ronapreve by the Medicines and Healthcare products Regulatory Agency (MHRA) as the first monoclonal antibody combination product for use in the prevention (prophylaxis) and treatment of acute COVID-19 infection.

Ronapreve is supplied to the UK by Roche. It is a combination neutralising monoclonal antibody (casirivimab plus imdevimab) used to inhibit viral replication in individuals who have not yet mounted an adequate antibody response to the SARS-COV-2 virus following either exposure or vaccination.

On 17th September 2021, the UK government announced that this new medicine will be available across all four nations from the following week, initially for patients in hospital with no antibody response against COVID-19, “either aged 50 and over, or aged 12 to 49 and are considered to be immunocompromised”. The government have assured that there will be sufficient supply to treat these patients in all the UK home nations.

To gain access to the new treatment, hospitalised, immunocompromised patients will need to undergo antibody testing to check that they do not have any antibodies (i.e. they are seronegative) against COVID-19. If that is the case, they will receive Ronapreve.

Here you can find the interim clinical commissioning policy and the therapeutic alert concerning this treatment. The latter contains information on the results of the use of Ronapreve in patients in the Recovery clinical trial.

The patient information leaflet can be found here.

Please note: Ronapreve is NOT available for prophylactic use to PREVENT Covid infection. This is something that Immunodeficiency UK will be lobbying for.

Other mAbs have been undergoing clinical trials and it is hoped that their approval for similar indications as Ronapreve will follow in the coming months.

This article was written by Valerie Brisse-Uhlig, a volunteer for Immunodeficiency UK, and was approved by the Chair of the Immunodeficiency UK Medical Panel.

Posted 23rd September 2021; updated 9th November 2021