Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government, further to the Written Answer by Lord Markham on 14 March (HL5699), and as set out in the attachment to the Written Answer NICE nMABs appraisal committee paper, what assessment they have made of the finding that the prioritised list of people with conditions for which it may be clinically advantageous to receive neutralising monoclonal antibodies prophylaxis numbers 1.8 million.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Independent Advisory Group (IAG) chaired by Prof. Iain McInnes was commissioned by the Department to consider which cohorts should be eligible for treatment for COVID-19. The report was published on 30 May 2022 and has defined the cohort of patient eligible for neutralising monoclonal antibodies and antivirals treatments for COVID-19. In May, our estimate was that this cohort totals around 1.8 million patients in England.
The IAG was also commissioned to consider the cohorts that would potentially be eligible for COVID-19 prophylaxis (PrEP). This report formed part of the National Institute for Health and Care Excellence Single Technology Appraisal considerations into Evusheld as prophylaxis. Whilst estimates have been made as to the total size of this cohort, it is unclear who would be prioritised within these groups should a prophylactic treatment become available. An update to this PrEP IAG report will be published on GOV.UK in due course.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government, further to the Written Answer by Lord Markham on 7 February (HL4942) which confirmed that the expert working group established specifically to review Evusheld pre-exposure prophylaxis only met twice, the last meeting being on 19 May 2022, why the parliamentary Written Answers provided from that date until 4 July 2022 refer to asking clinicians to advise on the most appropriate option; and what other advice was being received during this period.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The National Expert Working Group is one of the sources of clinical opinion to develop clinical policies. During this period the RAPID C-19 cross-agency group was also set up to review COVID-19 therapies in response to the pandemic. They would consider evidence and analysis from a number of sources, including the Prophylaxis Oversight Group and the UK Health Security Agency. In addition, the Therapeutics Clinical Review Panel considered evidence for COVID-19 risk to help prioritise cohorts for prophylaxis. This informed thinking within the Department and was subsequently shared with the National Institute for Health and Care Excellence. These groups continued to consider emerging evidence, including published evidence from independent researchers and evidence from the company, after the last meeting of the Expert Working Group.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government, further to the Written Answer by Lord Markham on 7 March 2023 (HL5695), to which body the recommendations on the relevant cohorts for COVID-19 therapeutics are to be made, as discussed by the Chair of the Therapeutics Clinical Review Panel on 2 February; and whether the preparation of these recommendations included reviewing details within the report Qcovid 4 - Predicting risk of death or hospitalisation from COVID-19, published in August 2022.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Therapeutics Clinical Review Panel met on 31 January 2023 to review most recent evidence on COVID-19 risk, including the National Institute for Health and Care Research rapid study on those who remain vulnerable to poor outcomes from COVID-19 despite vaccination. Advice is then provided to the four United Kingdom Chief Medical Officers. The evidence considered by the Panel was also shared with the National Institute for Clinical Excellence.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government, further to the Written Answers by Lord Markham on 2 February (HL4910), 8 February (HL4944) and 7 March (HL5695 and HL5938), why the Therapeutics Clinical Review Panel (TCRP) did not review the report Qcovid 4 - Predicting risk of death or hospitalisation from COVID-19, published in August 2022, when it met in January; why this report was not provided by the TCRP to the National Institute for Clinical Excellence; and when the TCRP will meet to review this report.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Therapeutics Clinical Review Panel met on 31 January 2023 to review the most recent evidence on COVID-19 risk, including QCovid 4. The evidence considered by the Panel was shared with the National Institute for Health and Care Excellence (NICE). The report entitled QCovid 4 - Predicting risk of death or hospitalisation from COVID-19 is also in the public domain in an online-only format and available to NICE.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government, further to the Written Answer by Lord Markham on 7 February (HL4941), what standards are set for governance and reporting by (1) RAPID C-19, and (2) other Department of Health and Social Care committees; how they are audited against this standard; and how regularly that auditing takes place.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Research to Access Pathway for Investigational Drugs (RAPID C-19) is a multi-agency initiative, each with their own expertise. RAPID C-19 is operated in line with the interim process, full details can be found on the RAPID C-19 page on the National Institute for Health and Care Excellence website in an online-only format.
The focus will be on bodies that have directly informed decisions on COVID-19 treatments during the pandemic, in addition to RAPID C-19. These include the COVID-19 Prophylaxis Oversight Group, which was established in 2020 to guide the development of pre- and post-exposure prophylaxis for COVID-19 infection, and the Therapeutics Clinical Review Panel, which was launched by the Department in May 2022 to focus on at-risk patient cohorts that could be eligible for COVID-19 therapies. Arrangements to record possible conflicts of interest are also in place.
All activity within the Department is overseen by the audit and risk committee which meets quarterly and includes challenge from independent non-executive directors. This is further underpinned by the challenge of the health group internal audit service, and by other independent assurance processes, such as National Audit Office reviews and the scrutiny of the Health and Social Care Select Committee.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of the effect on patients of the lifting of the prescription waiver on anti-COVID medicines at the end of March; and what steps they will take to prevent health inequalities in COVID-19 medicine provision arising as a result of that.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
Approximately 89% of prescription items are currently dispensed free of charge and there are a range of exemptions from prescription charges for which those in need of COVID-19 medicines may meet the eligibility criteria and be in receipt of free prescriptions. Additionally, those on a low income who do not qualify for an exemption may be eligible for assistance with prescription charges through the NHS Low Income Scheme.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government, further to the Written Answer by Lord Markham on 14 February (HL5363), what data they are utilising (1) to monitor emerging COVID-19 variants, and (2) to assess their potential impact; and what specific surveillance arrangements are in place to assist this assessment.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The UK Health Security Agency (UKHSA) undertakes regular monitoring of United Kingdom and international SARS-CoV-2 genomic data to detect and characterise new variants. In the UK, this includes data from routine testing and surveillance studies, with variant evaluation currently based on data from multiple sources. UK genomics surveillance is primarily conducted through healthcare associated sites such as hospitals and Office for National Statistics community sampling, with international data being obtained from the Global Initiative on Sharing Avian Influenza Data which includes genetic sequence and related clinical and epidemiological data.
The potential impact is considered first based on the relative fitness advantage (the lineage growth rate), national and international geographic dispersion, and/or mutation profile in relation to immune response or therapeutic efficacy, using genomic sequence data. Analysis is discussed at multidisciplinary expert meetings where further laboratory virology investigations can be triggered to add confidence to the risk assessment.
UKHSA is utilising strong surveillance capabilities, rooted in the highest-quality data systems, data architecture and analytics to anticipate, prepare for and respond to health risks, including emerging COVID-19 variants. UKHSA is currently working with the Department to consider next steps for the future of surveillance programmes.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government, further to the Written Answer by Lord Markham on 1 February (HL4939), when the figures referred to in the Written Answer on 12 April 2022 (HL7711), which provide the number of clinically extremely vulnerable individuals who do not make antibodies through the vaccinations currently available but who would be protected by pre-exposure prophylaxis from monoclonal antibodies, will be updated.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Independent Advisory Group produced a report in July 2022 identifying a prioritised list of people with conditions for which it may be clinically advantageous to receive neutralising monoclonal antibodies prophylaxis, which was submitted to the National Institute for Health and Care Excellence (NICE) as part of their Health Technology Evaluation of Evusheld. A copy of NICE’s committee paper, published 16 February 2023, is attached, see Pages 972 – 987.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government, further to the Written Answer by Lord Markham on 2 February (HL4910), when the next Therapeutics Clinical Review Panel is scheduled to meet to consider more recent evidence on COVID-19 risk; and who are the members of that panel.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Therapeutics Clinical Review Panel (TCRP) met on 31 January to review new evidence on the definition and revision of eligible cohorts from COVID-19 therapeutics. There was further correspondence was conducted between the Chair and membership, and a meeting on 2 February between the Chair and Antivirals and Therapeutics Taskforce members to consider his recommendations. No further meetings are currently scheduled. The list below outlines the current membership of the panel:
- Professor James Palmer, National Medical Director Specialised Services, NHS England (chair);
- Dr Vin Diwakar, Regional Medical Director, NHS England (London region) and Medical Director of Secondary Care and Transformation;
- Dr Nikki Kanani, Medical Director of Primary Care for NHS England;
- Dr James Coulson, Consultant Physician, Clinical Pharmacologist and Toxicologist and Clinical Director of the All-Wales Therapeutics and Toxicology Centre;
- Professor Thomas Evans, Institute of Infection, Immunity and Inflammation, University of Glasgow;
- Dr Mark Cross Deputy Medical Director Risk and Governance, Belfast Health and Social Care Trust;
- Dr Matthew Boulter, Senior Clinical Adviser, UK Health Security Agency;
- Dr Nevila Kallfa, Adviser in Public Health Medicine, UK Health Security Agency; and
- Professor Jonathan Benger, Chief Medical Officer, NHS Digital, Professor of Emergency Care, Consultant in Emergency Medicine, University Hospitals Bristol and Weston.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government, further to the Written Answer by Lord Markham on 8 February (HL4944), when the clinical advice that was submitted to the National Institute for Health and Care Excellence (NICE) was agreed by the Therapeutics Clinical Review Panel; and what date was that submitted to NICE.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The report produced by the Independent Advisory Group on potential cohorts eligible for pre-exposure prophylaxis was reviewed by the Therapeutics Clinical Review Panel in April 2022. It was formally submitted to the National Institute for Health and Care Excellence on 13 January 2023.