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1604684

registered interest
date	15/03/2023
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Evusheld
house id	2
legislature	25277 pref label House of Lords
question text	To ask His Majesty's Government, further to the Written Answer by Lord Markham on 6 March (HL5937), why the National Institute for Clinical Excellence (NICE) request for referral of 8 June is described as for “referral of Evusheld for treatment of COVID-19” but, as confirmed in a NICE freedom of information response, the request was for “referral of tixagevimab-cilgavimab for preventing COVID-19 [ID6136] on 8 June 2022”, causing delay to the possibility of a decision at a time when the preventative prophylaxis Evusheld was highly efficacious.
tabling member printed	Lord Mendelsohn
uin	HL6531
answer	answer is ministerial correction date of answer 12/04/2023 answer text <p>The request made by the National Institute for Health and Care Excellence (NICE) to the Department on 8 June 2022 was for the referral of Evusheld for the treatment of COVID-19 for inclusion into its multiple technology appraisal on therapeutics for COVID-19, not Evusheld for prevention. I understand from NICE that an error was made in its response to the freedom of information request, and that a correction will be issued accordingly. I apologise that this happened.</p> answering member printed Lord Markham question first answered 12/04/2023 11:32:54 answering member 4948 label Biography information for Lord Markham
tabling member	4286 label Biography information for Lord Mendelsohn

1599736

registered interest
date	27/02/2023
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Evusheld
house id	2
legislature	25277 pref label House of Lords
question text	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.
tabling member printed	Lord Mendelsohn
uin	HL5935
answer	answer is ministerial correction date of answer 16/03/2023 answer text <p>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.</p><p> </p><p>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.</p><p> </p><p>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.</p> answering member printed Lord Markham question first answered 16/03/2023 14:21:30 answering member 4948 label Biography information for Lord Markham
tabling member	4286 label Biography information for Lord Mendelsohn

1599737

registered interest
date	27/02/2023
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Evusheld
house id	2
legislature	25277 pref label House of Lords
question text	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.
tabling member printed	Lord Mendelsohn
uin	HL5936
answer	answer is ministerial correction date of answer 05/04/2023 answer text <p>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.</p> answering member printed Lord Markham question first answered 05/04/2023 14:48:03 answering member 4948 label Biography information for Lord Markham
tabling member	4286 label Biography information for Lord Mendelsohn

1599738

registered interest
date	27/02/2023
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Evusheld
house id	2
legislature	25277 pref label House of Lords
question text	To ask His Majesty's Government why Evusheld was not referred to the National Institute for Health and Care Excellence (NICE) until 10 August 2022 despite the review process starting on 8 June 2022; and how timelines can be tightened in future decision making.
tabling member printed	Lord Mendelsohn
uin	HL5937
answer	answer is ministerial correction date of answer 06/03/2023 answer text <p>The National Institute for Health and Care Excellence (NICE) wrote to the Department on 8 June 2022 requesting the referral of Evusheld for the treatment of COVID-19 for inclusion into its multiple technology appraisal on therapeutics for COVID-19. This was different and unrelated to the referral letter sent by the Department to NICE on 10 August 2022, which was for Evusheld for prophylaxis.</p><p> </p><p>Following the referral, NICE has prioritised the appraisal of Evusheld for the prevention of COVID-19 and issued its draft guidance for consultation on 16 February 2023. NICE has been unable to recommend its use to protect against COVID-19 citing the lack of its clinical evidence against current variants and those likely to be circulating in the near future. Stakeholders now have until 9 March 2023 to comment on NICE’s draft recommendations.</p> answering member printed Lord Markham question first answered 06/03/2023 11:53:49 answering member 4948 label Biography information for Lord Markham
tabling member	4286 label Biography information for Lord Mendelsohn

1599739

registered interest
date	27/02/2023
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Evusheld
house id	2
legislature	25277 pref label House of Lords
question text	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.
tabling member printed	Lord Mendelsohn
uin	HL5938
answer	answer is ministerial correction date of answer 07/03/2023 answer text <p>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.</p> answering member printed Lord Markham question first answered 07/03/2023 16:30:59 answering member 4948 label Biography information for Lord Markham
tabling member	4286 label Biography information for Lord Mendelsohn

1569101

registered interest
date	20/01/2023
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Evusheld
house id	2
legislature	25277 pref label House of Lords
question text	To ask His Majesty's Government, further to the Written Answer by Lord Markham on 7 November 2022 (HL2600), how they can assure accountability in decision-making in relation to the RAPID C-19 independent advisory meetings if there are no minutes and attendee lists available.
tabling member printed	Lord Mendelsohn
uin	HL4941
answer	answer is ministerial correction date of answer 07/02/2023 answer text <p>RAPID C-19 is a multi-agency initiative which includes representatives from the National Institute for Health and Care Research, the National Institute for Health and Care Excellence (NICE), the Medicines and Healthcare products Regulatory Agency, NHS England and the devolved administrations.</p><p> </p><p>RAPID C-19 consists of scientific experts, including clinicians, pharmacists, evidence assessors and researchers, who provide independent clinical advice to the Chief Medical Officer for England. RAPID C-19’s expertise is related to the organisations represented, which include the main healthcare agencies involved in decisions on research, regulation, and introducing new treatments into the National Health Service. A list of the membership of the RAPID C-19 is available on the NICE website. The operation of RAPID C-19 was also governed by terms of reference, which included a requirement for the group to be quorate and for members to declare interests. Appropriate action and decision logs were maintained for all RAPID C-19 discussions.</p><p> </p><p>RAPID C-19's role was to provide advice on the strength of the signals of effectiveness from emerging evidence on potential treatments to the appropriate decision makers. The RAPID C-19 Oversight Group’s report: review of Evusheld was published on 6 October in an online only format. It concluded that the quality of data is insufficient to progress to patient access before the completion of NICE’s technology appraisal, which will determine the drug’s clinical and cost-effectiveness. The Department does not hold the minutes or a list of attendees from the meetings in which this decision was made, as RAPID C-19 is an independent advisory group.</p> answering member printed Lord Markham question first answered 07/02/2023 14:51:16 answering member 4948 label Biography information for Lord Markham
tabling member	4286 label Biography information for Lord Mendelsohn

1569103

registered interest
date	20/01/2023
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Evusheld
house id	2
legislature	25277 pref label House of Lords
question text	To ask His Majesty's Government, further to the Written Answer by Lord Markham on 28 November 2022 (HL3368), whether they can (1) provide further information on the equalities and impact assessment undertaken by the Antivirals and Therapeutics TaskForce, and (2) disclose which experts were involved in its production.
tabling member printed	Lord Mendelsohn
uin	HL4943
answer	answer is ministerial correction date of answer 21/02/2023 answer text <p>The Equalities and Impact Assessment analysed the impact of the decision not to procure Evusheld on all groups with protected characteristics, and the effect of the decision on immunosuppressed patients who are unable to complete vaccination or produce an adequate response to vaccination.</p><p> </p><p>The assessment considered a range of evidence, including the Independent Advisory Group report and OCTAVE study. The Independent Advisory Group report identified a cohort of patients who are unlikely to respond to vaccination and who could potentially benefit from a Pre-exposure Prophylaxis (PrEP) programme. The estimated cohort size is approximately 150,000, although there remains substantial uncertainty attached to these numbers. The Antivirals and Therapeutics Taskforce has also worked with the Therapeutics Clinical Review Panel, Prophylaxis Oversight Group and the Engagement Board, and these organisations consist of scientific experts, including clinicians, pharmacists, evidence assessors and researchers.</p><p> </p><p>The assessment shows that the availability of effective PrEP could particularly benefit those with disabilities. However, the impacts and benefits of a PrEP programme, for patients identified throughout the assessment, would only occur if a suitable prophylactic option existed. Uncertainty remains of the impact of Evusheld as a prophylactic treatment, with RAPID C-19 additionally still unsure if Evusheld would prevent symptomatic COVID-19 caused by current Omicron variants. In line with that advice, the Government will not be procuring Evusheld at this time.</p> answering member printed Lord Markham question first answered 21/02/2023 15:27:55 answering member 4948 label Biography information for Lord Markham
tabling member	4286 label Biography information for Lord Mendelsohn

1569104

registered interest
date	20/01/2023
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Evusheld
house id	2
legislature	25277 pref label House of Lords
question text	To ask His Majesty's Government, further to the Written Answer by Lord Markham on 28 November 2022 (HL3401), whether they can provide further information on (1) the additional expert advice received, (2) when this advice was sought and received, (3) who were the experts, and (4) who they reported to.
tabling member printed	Lord Mendelsohn
uin	HL4944
answer	answer is ministerial correction date of answer 08/02/2023 answer text <p>The expert advice used to determine the cohorts eligible for COVID-19 treatment was led by the Therapeutics Clinical Review Panel. The panel periodically reviews new evidence on the definition and revision of eligible cohorts for COVID-19 therapeutics from several sources, including clinical evidence and expert groups. The Independent Advisory Group, led by Professor Iain McInnes, produced a report on the potential cohorts eligible for pre-exposure prophylaxis. This clinical advice was agreed by the panel and has been submitted to the National Institute for Health and Care Excellence (NICE) as part of their Health Technology Evaluation of Evusheld.</p><p> </p><p>The materials submitted to the NICE committee will be published once the process has completed.</p> answering member printed Lord Markham question first answered 08/02/2023 13:09:18 answering member 4948 label Biography information for Lord Markham
tabling member	4286 label Biography information for Lord Mendelsohn

1565243

registered interest
date	09/01/2023
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Evusheld
house id	2
legislature	25277 pref label House of Lords
question text	To ask His Majesty's Government what assessment they have made of the cost effectiveness of Evusheld in the treatment of immuno-compromised persons with complex health needs against the cost of an admission to hospital, given the increase in COVID-19 hospital admissions and the pressure on the NHS.
tabling member printed	The Lord Bishop of Exeter
uin	HL4549
answer	answer is ministerial correction date of answer 23/01/2023 answer text <p>The decision not to procure Evusheld for prevention through emergency routes is not based on cost considerations, but rather on independent clinical advice by RAPID C-19 (a multi-agency group) and a UK National Expert Policy Working Group. These groups considered a full range of evidence, including clinical trial data, in vitro analysis and emerging observational studies, as well as the epidemiological context of Omicron and wider policies in the Government’s pandemic response and recovery. Their conclusion is that there is insufficient evidence of benefit to recommend deployment at this time.</p><p> </p><p>The National Institute for Health and Care Excellence (NICE) is now conducting a Health Technology Evaluation of Evusheld, which is the routine process for new medicines to be evaluated for clinical and cost effectiveness and will provide recommendations through NICE’s guidance on the use of Evusheld in the National Health Service.</p> answering member printed Lord Markham question first answered 23/01/2023 15:38:42 answering member 4948 label Biography information for Lord Markham
tabling member	4929 label Biography information for The Lord Bishop of Exeter

1542088

registered interest
date	14/11/2022
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Evusheld
house id	2
legislature	25277 pref label House of Lords
question text	To ask His Majesty's Government what assessment they have made of the number of immunocompromised people in England who could potentially benefit from Evusheld if it is found to be appropriate for prescription on the NHS.
tabling member printed	Baroness Whitaker
uin	HL3401
answer	answer is ministerial correction date of answer 28/11/2022 answer text <p>The National Health Service estimates approximately 500,000 patients in England are immunosuppressed. A minority of these patients may not respond adequately to vaccines and could potentially benefit from pre-exposure prophylaxis. The OCTAVE study found that 11% of immunocompromised patients fail to generate antibodies following vaccination and 40% mounted a low serological response. The use of antibody testing could potentially identify which patients have lower levels of protection and should be prioritised for treatment.</p><p> </p><p>This data is approximate and the Department has commissioned additional advice from independent experts to refine its understanding of vaccine response and the patient cohorts which could be prioritised for prophylaxis and for other interventions. If the National Institute for Health and Care Excellence (NICE) ascertains that Evusheld as a pre-exposure prophylaxis is clinically and cost effective, the National Health Service will make Evusheld available as appropriate. NICE’s appraisal will also consider suitable patient cohorts.</p> answering member printed Lord Markham question first answered 28/11/2022 12:44:57 answering member 4948 label Biography information for Lord Markham
tabling member	2510 label Biography information for Baroness Whitaker