This is what a friend of mine wrote on my behalf unbeknown to me.
Dear Mr. Barclay,
I would like to tell you about my friend, Molly. She has blood cancer and has been shielding, on the advice of her oncologist, since the outbreak of Covid. As a result she has hardly left her home for two and a half years and this has had a terrible impact on her life.
Since the announcement that no decision will be made about the prescription of Evusheld for imuno-compromised people has been delayed until next spring she now faces a third winter of isolation. I ask that you would review the evidence that is available from over thirty countries already using Evusheld to transform the lives of their citizens like Molly and reverse this inexplicable delay.
Please let this British developed drug be made available to British people as soon as possible.
Yours sincerely,
This was the reply she got
Thank you for your correspondence of 14 August about Evusheld. I have been asked to reply.
I was sorry to read of your friend’s ill health, and I appreciate your concerns. It can be assured that the Government remains absolutely focused on protecting the most vulnerable, including through prioritised access to vaccines, treatments and testing.
The expert panel that advises the Government has made it clear that there is insufficient evidence available at this time to support procurement and deployment of Evusheld through emergency procedures. When the Medicines and Healthcare products Regulatory Agency (MHRA) gave marketing authorisation to Evusheld on 17 March, following trials conducted during the Delta wave, it noted a lack of data regarding dose and efficacy against the Omicron variant. A number of other countries’ regulatory authorities have noted similar issues, although many of those countries that had already procured Evusheld have decided to continue using it, in most cases doubling the dose to 600mg.
The decision has been made not to procure Evusheld at this time, drawing on expert advice from RAPID C-19 and a UK National Expert Policy Working Group as well as departmental officials, all of whom have collectively concluded that there is insufficient evidence of benefit to recommend deployment at this time. In its expert advice, RAPID C-19 notes that the risks of proceeding to patient access are considered to outweigh the risks of not providing this treatment in the current pandemic context.
RAPID C-19 has considered the evidence base for Evusheld 11 times in 18 months, starting in February 2021, and is keeping it under active review, including through monitoring the emerging data. A full range of evidence has been considered, including clinical trial data, in vitro analysis and emerging observational studies. The analysis of this evidence will be published in due course.
The Chief Medical Officer is content that the correct process for providing clinical advice has been followed and agrees that Evusheld should now be appraised by the National Institute for Health and Care Excellence (NICE) following the usual process for drugs being made available to NHS patients. Further information will be published on www.gov.uk in the near future.
In addition to this, the Government is unsure of Evusheld’s suitability or necessity for all immunosuppressed individuals. Evidence shows that different patient groups with immunosuppression have different levels of vaccine response. Identifying the correct cohorts would be essential, even if questions on effectiveness were sufficiently answered. Evusheld is not necessary for those patients who have a protective antibody response to COVID-19 vaccination. In order to understand better who within this group mounts a vaccine response, the Government is exploring the possibility of piloting a programme to test antibody levels in immunosuppressed patients. This could help develop a more accurate understanding of potential cohorts for prophylactic treatments in the future and could also help provide reassurance to some patients by identifying any who have mounted a protective antibody response following vaccination. Officials will follow up with patient groups separately to seek input into the development of this potential programme.
In order to gain further evidence, clinical advisers have also recommended a trial is considered. The trial would be a route to answering outstanding questions on the link between in vitro tests and clinical outcomes for current and future variants, which is currently not known, together with evaluating the effectiveness and safety of a dose of Evusheld of 600mg.
The evidence on preventative therapies will continue to be actively reviewed to ensure efficacy and safety.
The UK Government has made available a range of new treatment options within the community for NHS patients at greatest risk from COVID-19. These treatments are available for non-hospitalised patients to reduce the risk of hospitalisation and death.
Eligible patients who receive a positive test result will be contacted by a clinician from a COVID Medicines Delivery Unit to discuss what treatments would be most suitable for them. Treatment options include the monoclonal antibody sotrovimab or oral antiviral nirmatrelvir with ritonavir (Paxlovid), and those who are unable to receive these treatments will be offered remdesivir (Veklury) or molnupiravir.
Further information on COVID-19 treatments, including monoclonal antibody and antiviral treatments, can be found at www.cas.mhra.gov.uk/help/coronavirusalerts.aspx.
I hope this reply is of some help.
Yours sincerely,
C Winters
Ministerial Correspondence and Public Enquiries
Department of Health and Social Care
The usual flannel scattered with clear untruths……she was shocked by this response but it just feels usual to me….we clearly do not matter and we all know how hit and miss the CMDUs are!