Question to the Department of Health and Social Care:

To ask His Majesty's Government what steps they are taking to ensure that the stock of approved antiviral treatments of COVID-19, including those recommended by the National Institute for Health and Care Excellence in August are made readily available to all vulnerable patients.

Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)

The stock of COVID-19 antivirals owned by the Department is available to those who are eligible for treatment in line with an interim clinical commissioning policy for England and the Devolved Nations or National Institute for Health and Care Excellence (NICE) recommendations. Stocks are distributed in England in response to orders received from community pharmacies and National Health Service secondary care trusts who operate under arrangements put in place by the relevant NHS Commissioning Boards. Proportionate allocations have been made to the Devolved Nations and detailed distribution arrangements lie within the remit of the respective national systems.

Question to the Department of Health and Social Care:

To ask His Majesty's Government what plans they have to increase awareness of (1) eligibility for COVID-19 post-exposure treatments, and (2) how to access to COVID-19 post-exposure treatments.

Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)

Information for patients’ awareness of COVID-19 treatments and how to access treatments is published by the National Health Service and is available on the NHS.uk website in an online-only format. The NHS will continue to communicate to people, including those most vulnerable to COVID-19, about available clinical interventions, including vaccination and treatments, as well as testing and public health advice.

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, if he will publish guidance to Integrated Care Boards on the availability of antivirals for immunocompromised patients with a covid infection.

Answered by Will Quince

From 27 June, the pathway for COVID-19 treatments transitioned from the former national pandemic-specific arrangements to more routine local arrangements for assessment and treatment

This transition follows the National Institute for Health and Care Excellence’s (NICE) guidance that was published 29 March 2023 and which recommended two treatments for non-hospitalised patients at highest risk, and one treatment for use in those hospitalised due to COVID-19. These are Paxlovid (nirmatrelvir plus ritonavir) from Pfizer, Xevudy (sotrovimab) from GlaxoSmithKline and RoActemra (tocilizumab) from Roche.

This guidance will ensure that everyone with COVID-19 at the highest risk of progressing to severe disease, will have access to clinically and cost-effective treatments, which will be routinely available to eligible patients on the National Health Service. The NHS is required to have medicines available within 90 days of a positive NICE appraisal. Integrated Care Boards (ICBs) have therefore had up to 90 days to make funding available for these treatments and to secure arrange local access through routine NHS pathways.

NHS England continues to meet with regional colleagues on a weekly basis to help them to facilitate the local transition and to understand if ICBs have any new or emerging issues requiring support.

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether he has had recent discussions with representatives of charities supporting people who are vulnerable to Covid-19 on the transition of responsibility for the delivery of post-exposure treatments for Covid-19 from Covd-19 Medicine Delivery Units to Integrated Care Boards.

Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

NHS England is working closely with local health systems and supporting integrated care boards (ICBs) to develop service delivery plans which ensure continued timely access to assessment and treatment for COVID-19 that meet the needs of their local populations. To support the transition away from pandemic-specific arrangements NHS England is regularly engaging with charities, patient groups and other stakeholders to understand where national and local action may be required to ensure transition readiness. The NHS will continue to communicate to people most vulnerable to COVID-19 about available clinical interventions, including vaccination and treatments, as well as testing and public health advice.

ICBs are responsible for the continued delivery of COVID-19 treatments, including where appropriate transitioning the delivery of community-based COVID-19 treatments away from COVID-19 Medicine Delivery Units to routine care pathways by the end of this month. ICBs have the flexibility to create a routine patient access pathway that best meets local needs and circumstances, including for immunocompromised patients.

ICBs are responsible for their own plans and commissioning schedules. This information is not held centrally by the department.

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps he is taking to provide information to people vulnerable to Covid-19 on the transition of responsibility for delivering post-exposure treatments for Covid-19 from Covid-19 Medicine Delivery Units to Integrated Care Boards.

Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

NHS England is working closely with local health systems and supporting integrated care boards (ICBs) to develop service delivery plans which ensure continued timely access to assessment and treatment for COVID-19 that meet the needs of their local populations. To support the transition away from pandemic-specific arrangements NHS England is regularly engaging with charities, patient groups and other stakeholders to understand where national and local action may be required to ensure transition readiness. The NHS will continue to communicate to people most vulnerable to COVID-19 about available clinical interventions, including vaccination and treatments, as well as testing and public health advice.

ICBs are responsible for the continued delivery of COVID-19 treatments, including where appropriate transitioning the delivery of community-based COVID-19 treatments away from COVID-19 Medicine Delivery Units to routine care pathways by the end of this month. ICBs have the flexibility to create a routine patient access pathway that best meets local needs and circumstances, including for immunocompromised patients.

ICBs are responsible for their own plans and commissioning schedules. This information is not held centrally by the department.

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, how many Integrated Care Boards have produced plans for transitioning responsibility for the delivery of post-exposure treatments for Covid-19 from Covid-19 Medicine Delivery Units.

Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

NHS England is working closely with local health systems and supporting integrated care boards (ICBs) to develop service delivery plans which ensure continued timely access to assessment and treatment for COVID-19 that meet the needs of their local populations. To support the transition away from pandemic-specific arrangements NHS England is regularly engaging with charities, patient groups and other stakeholders to understand where national and local action may be required to ensure transition readiness. The NHS will continue to communicate to people most vulnerable to COVID-19 about available clinical interventions, including vaccination and treatments, as well as testing and public health advice.

ICBs are responsible for the continued delivery of COVID-19 treatments, including where appropriate transitioning the delivery of community-based COVID-19 treatments away from COVID-19 Medicine Delivery Units to routine care pathways by the end of this month. ICBs have the flexibility to create a routine patient access pathway that best meets local needs and circumstances, including for immunocompromised patients.

ICBs are responsible for their own plans and commissioning schedules. This information is not held centrally by the department.

Question to the Department of Health and Social Care:

To ask His Majesty's Government, in the light of pressure on primary care services and the challenges of out of hours, weekend and holiday access provision, how immunocompromised people can access anti-virals to mitigate COVID-19 infection once GPs are responsible for dispensing these; and what assurances they can provide that a system will be in place to ensure there are no difficulties in accessing treatments by the end of June when the Covid Medicines Delivery Units are disbanded.

Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)

The National Institute for Health and Care Excellence (NICE) published final guidance on COVID-19 treatments on 29 March 2023, a copy of which is attached, in line with their statutory responsibilities. Integrated care boards (ICBs) in England have 90 days from this date to make funding available and to implement the treatment recommendations. NHS England has asked ICBs to maintain access to COVID-19 treatments through COVID-19 Medicines Delivery Units (CMDUs), or equivalent local arrangements, during the NICE 90-day implementation period.

ICBs are responsible for the continued delivery of COVID-19 treatments, including where appropriate transitioning the delivery of community-based COVID-19 treatments away from CMDUs to routine care pathways by the end of June. ICBs have the flexibility to create a routine patient access pathway that best meets local needs and circumstances.

During the 90-day implementation period, NHS England is working closely with ICBs to ensure that new routine services continue to provide timely access to assessment and treatment for COVID-19 infection. In addition, NHS England is engaging with charities, patient groups and other stakeholders to understand where any further national support is required to facilitate the transition and providing national communications to patients, healthcare professionals and local system leaders to ensure clarity on upcoming changes.

Question to the Department of Health and Social Care:

To ask His Majesty's Government what provision is being made for immunocompromised people who are struggling financially from the financial impact of the COVID-19 pandemic and its ongoing challenges for those still vulnerable to the virus; and how they will support those affected in the light of their prescription waiver on anti-viral drugs being withdrawn

Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)

Treatments for COVID-19 are available free of charge on the National Health Service in England for eligible high-risk patients with a positive COVID-19 test result. In addition, the charge waiver will continue to apply to therapeutic treatments made available through the HEAL-COVID and STIMULATE-ICP trials.

There are also a wide range of exemptions from prescription charges already in place, covering children, pregnant women, those over 60 years old, people on certain income related benefits or whose partner is in receipt of those benefits as well as those with specific medical conditions. Around 89% of prescription items are free on the NHS in England. On top of that, people on a low income can apply for support through the NHS Low Income Scheme, and all patients can also buy a pre-payment certificate which covers all the items they need for just over £2 per week.

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.

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.

Question to the Department of Health and Social Care:

To ask His Majesty's Government how many meetings of the RAPID C-19 independent advisory group there have been since September 2022; and what plans they have to continue to review these processes to ensure that new treatments for COVID-19 are made available safely to National Health Service patients as soon as possible after they are approved by the Medicines and Healthcare products Regulatory Agency (MHRA).

Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)

The RAPID C-19 individual advisory group has met five times since 1 September 2022. As we move from emergency pandemic arrangements towards routine commissioning of COVID-19 medicines, the time-limited role of RAPID C-19 is effectively at an end.

RAPID C-19’s role was to monitor emerging trial evidence for the clinical effectiveness of potential treatments in real time during the pandemic and was essential to assess whether evidence was strong enough to warrant consideration of interim access prior to National Institute for Health and Care Excellence (NICE) assessment.

The NICE Multiple Technology Appraisal (MTA) for COVID-19 treatments and Single Technology Appraisal (STA) for tixagevimab and cilgavimab (Evusheld) prophylaxis are in progress and moving rapidly and NICE’s final guidance will replace current interim pandemic arrangements when published. To support movement towards routine commissioning activity for COVID-19 medicines and clarify routes to access for stakeholders, RAPID C-19 is no longer reviewing information on the medicines currently in the MTA and STA.

Following publication of the final guidance, NICE will monitor for emerging evidence that may affect the current recommendations as part of standard guidance surveillance processes. New treatments in clinical development for COVID-19 will be identified and selected in accordance with NICE’s health technology evaluation topic selection processes.

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps his Department are taking to improve (a) the uptake of and (b) access to Covid-19 treatments.

Answered by Will Quince

In England, eligible patients who test positive for COVID-19 will be contacted by a clinician from a COVID Medicines Delivery Unit (CMDU) to discuss treatment suitability. The clinician will be responsible for assessing the patient and deciding which treatment option is most appropriate for them. Guidance has been provided to general practitioners, NHS 111 and hospital doctors to ensure information is available to support patients.

Currently, immunocompromised patients who form part of the high-risk cohort are eligible for receiving COVID-19 treatments within the community following a positive test. The Therapeutics Clinical Review Panel has been established to review the patient cohorts which could be eligible for COVID-19 therapies. On 30 May 2022 the Department published an Independent Advisory Group report which revised the high-risk cohort and included additional groups of patients. As a result of these changes and improved identification by the National Health Service, the cohort of eligible patients has grown to an estimated 1.8 million patients in the United Kingdom. Access to treatments could be extended further if evidence from clinical trials supports doing so. The PANORAMIC study aims to improve understanding of the effectiveness antivirals in preventing hospitalisation and/or death in a largely vaccinated population will provide data for the NHS to determine which patient groups could benefit most from antiviral treatments.

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps his Department plans to take to (a) improve (i) awareness of and (ii) access to Covid-19 antivirals for people who are eligible to receive them and (b) review the eligibility criteria for Covid-19 antivirals.

Answered by Will Quince

In England, eligible patients who test positive for COVID-19 will be contacted by a clinician from a COVID Medicines Delivery Unit (CMDU) to discuss treatment suitability. The clinician will be responsible for assessing the patient and deciding which treatment option is most appropriate for them. Guidance has been provided to general practitioners, NHS 111 and hospital doctors to ensure information is available to support patients.

Currently, immunocompromised patients who form part of the high-risk cohort are eligible for receiving COVID-19 treatments within the community following a positive test. The Therapeutics Clinical Review Panel has been established to review the patient cohorts which could be eligible for COVID-19 therapies. On 30 May 2022 the Department published an Independent Advisory Group report which revised the high-risk cohort and included additional groups of patients. As a result of these changes and improved identification by the National Health Service, the cohort of eligible patients has grown to an estimated 1.8 million patients in the United Kingdom. Access to treatments could be extended further if evidence from clinical trials supports doing so. The PANORAMIC study aims to improve understanding of the effectiveness antivirals in preventing hospitalisation and/or death in a largely vaccinated population will provide data for the NHS to determine which patient groups could benefit most from antiviral treatments.

Question to the Department of Health and Social Care:

To ask His Majesty's Government, further to the creation by NHS England of a national expert working group (EWG), why it has only met twice; and whether it still has an active role in supporting the development of a national clinical policy.

Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)

As part of pandemic-specific arrangements, NHS England was asked to utilise its national clinical policy making expertise to lead on the development of United Kingdom-wide clinical access policy drafts enabling access to evidence-based COVID treatments. These draft policies are then considered and approved by the UK Chief Medical Officers ahead of publication, to guide the decisions of treating clinicians, and supporting medicines supply arrangements.

NHS England has been supported in this role by a range of clinical and academic experts, including representatives from the devolved administrations in Northern Ireland, Scotland and Wales, who meet as part of Expert Working Group arrangements. There is not a standing or single expert working group but rather a series of clinical policy-specific expert working groups that have been established and that meet, as required, with clinical expertise specific to the medicine or medicines being considered. For example, an expert working group was established specific to Evusheld as pre-exposure prophylaxis, which met twice.

Through this expert working group approach, clinicians and academics have provided advice which has helped clinical policy makers to better understand the supporting clinical trial information, to identify any important contraindications or drug to drug interactions that need to be considered, and to understand how best to place a potential new medicine option alongside current treatment choices. This has provided NHS England with both clinical subject matter and specialty expertise and a valuable ‘front line’ perspective in developing access policy proposals.

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 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.

Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)

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.

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.

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.

Question to the Department of Health and Social Care:

To ask His Majesty's Government how they will (1) assess, and (2) report on, the effectiveness of COVID-19 Medicine Delivery Units (CMDUs) in providing treatments for COVID-19 to vulnerable patients; and whether they have any plans (a) to disband CMDUs and devolve this responsibility to a primary care model, or (b) implement any other change of process.

Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)

NHS England regularly meets with patient groups and charities, such as Blood Cancer UK, to hear feedback on the experience of individuals who have sought and/or received treatment via a COVID-19 Medicine Delivery Unit (CMDU), and with representatives of the care home sector to identify ways to facilitate timely contact and clinical assessment for potentially eligible individuals in their care. Publications reporting on treatment via CMDUs are available in an online-only format on the National Health Service website.

In the future, access to COVID-19 treatments will be determined by the guidance of the National Institute for Health and Care Excellence, which is currently undertaking a multiple technology appraisal covering a range of potential COVID-19 treatments. Once its final determination has been made and published, setting out which COVID-19 treatments should be made routinely available by the NHS, it will be for local integrated care boards to determine access pathways for these medicines within their local communities. The expectation is for treatment to be deployed through more routine access routes, including through GPs and other forms of primary care.

Question to the Department of Health and Social Care:

To ask His Majesty's Government, further to the Written Answer by Lord Kamall on 23 June 2022 (HL731), whether they will publish the observational data on treatment outcomes referred to in the Answer.

Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)

NHS England continues to work closely with the research community, and relies on the expert and impartial analysis, and publication, of treatment outcome data by specialist study teams who will be better placed to consider potentially confounding factors and draw potential conclusions from the data. It has no plans to undertake its own study to separately analyse and report treatment outcomes data.

The PANORAMIC trial team has published the results of its molnupirivir arm, Molnupiravir plus usual care versus usual care alone as early treatment for adults with COVID-19 at increased risk of adverse outcomes (PANORAMIC): an open-label, platformadaptive randomised controlled trial. A copy of this document is attached.

The trial remains open and is currently studying a second oral antiviral treatment, Paxlovid (nirmatrelvir+ritonavir.), in the same population.