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 5 April (HL 5936), what clinical evaluation they have commissioned of pre-exposure prophylaxis after 31 May 2022.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
Further to the reply we provided on 5 April, outlined below is the clinical advice commissioned on pre-exposure prophylaxis, including tixagevimab plus cilgavimab (known as ‘Evusheld’) after 31 May 2022.
During June 2022 Ministers received advice on the prophylactic antibody treatment tixagevimab plus cilgavimab (Evusheld), including clinical advice based on the report by the Research to Access Pathway for Investigational Drugs for COVID-19 collaboration (RAPID C-19) of 30 May 2022 regarding Evusheld, along with options for further evaluation by the National Institute for Health and Care Excellence (NICE).
On 28 June, Ministers agreed to refer Evusheld to NICE for a full appraisal of its clinical and cost effectiveness as pre-exposure prophylaxis, with the formal referral letter to NICE sent on 10 August. NICE published the draft scope for the appraisal on 29 July.
RAPID C-19 continued to monitor the available data and were requested to consider observational evidence from other countries. Its report dated 1 September 2022 concluded that, the quality of the data was insufficient to warrant action to progress to consideration of an access policy as an interim measure before NICE technology appraisal, there was uncertainty that tixagevimab plus cilgavimab would prevent symptomatic COVID-19 caused by the current Omicron variants in the vulnerable population who would potentially be eligible for this treatment and there was insufficient evidence to proceed to patient access in the current pandemic context.
The Department also requested advice through the Therapeutics Clinical Review Panel (TCRP) on the potential cohorts for pre-exposure prophylaxis. This advice was commissioned early in 2022 and initially helped inform the advice to ministers on Evusheld before being shared with NICE to support its ongoing appraisal of Evusheld. On 31 January 2023, the Panel considered an updated report taking into account more recent evidence.
The NICE appraisal is ongoing, with draft guidance made available on 16 February 2023 and final draft guidance made available on 5 May 2023. Final guidance is expected on 14 June 2023.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government when COVID-19 medicines delivery units are disbanded at the end of June, how they will ensure that (1) immunocompromised people who are in the vulnerable group for COVID-19 treatments, and who have contraindications for antivirals, are able to access Sotrovimab infusion treatment, and (2) such people and their GPs will be informed of any new approach.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
Following the National Institute for Health and Care Excellence (NICE) guidance on COVID-19 treatments on 29 March 2023, integrated care boards (ICBs) have a statutory duty to make funding available for these treatments within 90 days and to arrange access as part of routine services in the National Health Service. ICBs will therefore need to ensure access arrangements are in place for patients at potential highest risk from COVID-19 to be assessed for, and where indicated, receive a clinically appropriate treatment, which will include consideration of the NICE recommended medicines, nirmatrelvir plus ritonavir, Paxlovid, taken orally, or sotrovimab, Xevudy, administered intravenously. ICBs are also responsible for ensuring potentially eligible individuals and local services such as general practice teams, NHS 111 and hospital specialists are made aware of their local patient pathways for these treatments.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what steps they are taking to support stem cell transplant and CAR-T therapy patients in pursuing a safe return to work while maintaining protections for their health.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
There are no plans to assess the potential benefits and costs of establishing a patient travel fund for stem cell transplant and CAR-T recipients. NHS England does not provide any specific cost of living support for patients receiving stem cell transplantation, however, trusts can exercise discretion to provide accommodation and/or other support depending on local and individual patient circumstances. The Non-Emergency Patient Transport Services (NEPTS) provide funded transport where it is considered essential to ensuring an individual’s safety, safe mobilisation, condition management or recovery.
Depending on a patient’s financial circumstances, they may be eligible for financial support with costs via the NHS Low Income Scheme and Healthcare Travel Costs Scheme. Those who do not qualify for NEPTS and need financial help with travel can access the Healthcare Travel Costs Scheme. This is aimed specifically at those with a low income and allows patients to claim for all or part their travel costs should they meet the eligibility criteria.
We recognise the pressures people are facing with the rising cost of living. Our extensive arrangements to help people afford NHS prescription charges, means that almost 89% of prescription items dispensed in community pharmacies in England are already provided free of charge. For those not exempt from charges, pre-payment certificates can be used to cap costs at just over £2 a week for regular prescriptions.
People with long-term health conditions or disabilities, including those requiring stem cell transplants, may be entitled to financial support to contribute towards their extra costs such as Personal Independence Payment (PIP). Entitlement to PIP is assessed on the basis of the needs arising from a health condition or disability, rather than the health condition or disability itself.
The Government does not any specific support to stem cell transplant and CAR-T therapy patients pursuing a safe return to work. However, the Government has a range of initiatives to support disabled people and people with health conditions, including stem cell transplant and CAR-T therapy patients, to start, stay and succeed in work. These include increasing Work Coach and Disability Employment Advisers’ support in Jobcentres, the Work and Health Programme, Intensive Personalised Employment Support, Access to Work grants, Disability Confident, the Information and Advice Service and support in partnership between Department for Work and Pensions and the health system, including Employment Advice in NHS Talking Therapies.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government whether they intend to assess (1) the potential benefit of establishing a patient travel fund for stem cell transplant and CAR-T therapy recipients, and (2) the potential cost to the Treasury.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
There are no plans to assess the potential benefits and costs of establishing a patient travel fund for stem cell transplant and CAR-T recipients. NHS England does not provide any specific cost of living support for patients receiving stem cell transplantation, however, trusts can exercise discretion to provide accommodation and/or other support depending on local and individual patient circumstances. The Non-Emergency Patient Transport Services (NEPTS) provide funded transport where it is considered essential to ensuring an individual’s safety, safe mobilisation, condition management or recovery.
Depending on a patient’s financial circumstances, they may be eligible for financial support with costs via the NHS Low Income Scheme and Healthcare Travel Costs Scheme. Those who do not qualify for NEPTS and need financial help with travel can access the Healthcare Travel Costs Scheme. This is aimed specifically at those with a low income and allows patients to claim for all or part their travel costs should they meet the eligibility criteria.
We recognise the pressures people are facing with the rising cost of living. Our extensive arrangements to help people afford NHS prescription charges, means that almost 89% of prescription items dispensed in community pharmacies in England are already provided free of charge. For those not exempt from charges, pre-payment certificates can be used to cap costs at just over £2 a week for regular prescriptions.
People with long-term health conditions or disabilities, including those requiring stem cell transplants, may be entitled to financial support to contribute towards their extra costs such as Personal Independence Payment (PIP). Entitlement to PIP is assessed on the basis of the needs arising from a health condition or disability, rather than the health condition or disability itself.
The Government does not any specific support to stem cell transplant and CAR-T therapy patients pursuing a safe return to work. However, the Government has a range of initiatives to support disabled people and people with health conditions, including stem cell transplant and CAR-T therapy patients, to start, stay and succeed in work. These include increasing Work Coach and Disability Employment Advisers’ support in Jobcentres, the Work and Health Programme, Intensive Personalised Employment Support, Access to Work grants, Disability Confident, the Information and Advice Service and support in partnership between Department for Work and Pensions and the health system, including Employment Advice in NHS Talking Therapies.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what steps they are taking to mitigate the impact of the increased cost of living on stem cell transplant and CAR-T therapy recipients.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
There are no plans to assess the potential benefits and costs of establishing a patient travel fund for stem cell transplant and CAR-T recipients. NHS England does not provide any specific cost of living support for patients receiving stem cell transplantation, however, trusts can exercise discretion to provide accommodation and/or other support depending on local and individual patient circumstances. The Non-Emergency Patient Transport Services (NEPTS) provide funded transport where it is considered essential to ensuring an individual’s safety, safe mobilisation, condition management or recovery.
Depending on a patient’s financial circumstances, they may be eligible for financial support with costs via the NHS Low Income Scheme and Healthcare Travel Costs Scheme. Those who do not qualify for NEPTS and need financial help with travel can access the Healthcare Travel Costs Scheme. This is aimed specifically at those with a low income and allows patients to claim for all or part their travel costs should they meet the eligibility criteria.
We recognise the pressures people are facing with the rising cost of living. Our extensive arrangements to help people afford NHS prescription charges, means that almost 89% of prescription items dispensed in community pharmacies in England are already provided free of charge. For those not exempt from charges, pre-payment certificates can be used to cap costs at just over £2 a week for regular prescriptions.
People with long-term health conditions or disabilities, including those requiring stem cell transplants, may be entitled to financial support to contribute towards their extra costs such as Personal Independence Payment (PIP). Entitlement to PIP is assessed on the basis of the needs arising from a health condition or disability, rather than the health condition or disability itself.
The Government does not any specific support to stem cell transplant and CAR-T therapy patients pursuing a safe return to work. However, the Government has a range of initiatives to support disabled people and people with health conditions, including stem cell transplant and CAR-T therapy patients, to start, stay and succeed in work. These include increasing Work Coach and Disability Employment Advisers’ support in Jobcentres, the Work and Health Programme, Intensive Personalised Employment Support, Access to Work grants, Disability Confident, the Information and Advice Service and support in partnership between Department for Work and Pensions and the health system, including Employment Advice in NHS Talking Therapies.
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 impact on patients with multiple myeloma of (1) updates to the NICE health technology evaluations manual, and (2) the forthcoming end of Cancer Drugs Fund access agreements for treatments.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The National Institute for Health and Care Excellence (NICE) published its updated manual for health technology evaluations in January 2022 and has introduced a number of changes to make its methods and processes fairer, faster and more consistent. This includes the introduction of a broader severity modifier in place of the end of life modifier. Analysis carried out by NICE in the development of the modifier indicates that the vast majority of cancer medicines, including for blood cancers, that would be eligible for the end of life modifier would also be eligible for a weighting under the severity modifier.
In 2022/23, 89% of NICE’s final recommendations on cancer drugs were positive, including all of the cancer medicines appraised using NICE’s updated methods and processes. No cancer medicines have completed their exit from the Cancer Drugs Fund using NICE’s updated methods and processes. However, NICE has released positive final draft guidance for the first, which treats a blood cancer.
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 impact of updates to the NICE health technology evaluations manual on access to treatments at the end of a Cancer Drugs Fund access agreement.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The National Institute for Health and Care Excellence (NICE) published its updated manual for health technology evaluations in January 2022 and has introduced a number of changes to make its methods and processes fairer, faster and more consistent. This includes the introduction of a broader severity modifier in place of the end of life modifier. Analysis carried out by NICE in the development of the modifier indicates that the vast majority of cancer medicines, including for blood cancers, that would be eligible for the end of life modifier would also be eligible for a weighting under the severity modifier.
In 2022/23, 89% of NICE’s final recommendations on cancer drugs were positive, including all of the cancer medicines appraised using NICE’s updated methods and processes. No cancer medicines have completed their exit from the Cancer Drugs Fund using NICE’s updated methods and processes. However, NICE has released positive final draft guidance for the first, which treats a blood cancer.
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 impact on immunocompromised people arising from (1) shutting down the Anti-Viral task force, (2) ending any stakeholder engagement through the Enhanced Protection Programme, (3) withdrawing vaccine boosters for the families of the immunocompromised, (4) ending the collection of data on Covid infections via the Office for National Statistics, and (5) ending access to anti-virals through the Covid Medicines Delivery Units and transferring this to GPs; and what steps they are taking to enhance the protection of the clinically vulnerable community from COVID-19.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
Those that remain at higher risk from COVID-19 remain a priority for the Government and continue to be offered enhanced protections such as treatments, booster vaccines, free lateral flow tests and public health advice.
Functions of the Antivirals and Therapeutics Taskforce (ATTF) have now moved to different parts of the Department and the National Health Service. The NHS will continue to deliver treatment for COVID-19 patients and will operate in line with evidence-based recommendations from National Institute for Health and Care Excellence, following the established processes in this area.
Following the closure of the enhanced protection programme stakeholder forum, UK Health Security Agency (UKHSA) recognises the importance of continuing to engage with patient charities and other stakeholders, and further information on continuing stakeholder engagement will be shared in due course.
On 27 January 2023 the Government accepted Joint Committee on Vaccination and Immunisation (JCVI) interim advice that there could be a further booster programme in autumn 2023 for those at higher risk of severe COVID-19 in preparation for winter 2023 to 2024. JCVI will continue its rolling review of the vaccination programme and will provide further advice on which groups including carers and family members of immunosuppressed individuals should be included in the autumn 2023 COVID-19 vaccination programme in due course.
The approach to COVID-19 surveillance is being actively reviewed to ensure it is proportionate, cost effective and considered alongside how we monitor a range of other infectious diseases that present a similar threat.
The UKHSA will continue to publish regular reports on COVID-19 which will contribute to our situational awareness. These include our weekly surveillance reports, which provide data on infection rates and hospitalisation numbers. We also maintain the ability to track the latest variants through our genomics capabilities which assess the risks posed by different strains of the virus.
Integrated care boards (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 medicines delivery unit 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, including for immunocompromised patients.
NHS England is working closely with local health systems, supporting ICBs to develop service delivery plans which ensure continued timely access to assessment and treatment 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.
NHS England is providing national communications to patients, healthcare professionals and local system leaders to ensure clarity on upcoming changes.
Highest risk patients will continue to have access to free tests, however the way patients will access tests may change later this year.
Asked by: Lord Mendelsohn (Labour - Life peer)
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.
Asked by: Lord Mendelsohn (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what discussions they have had with patient groups on the updates to the NICE health technology evaluations manual, and in particular (1) treatments at the end of a Cancer Drugs Fund access agreement no longer being assessed against the criteria supporting their original recommendation, and (2) the replacement of the end of life criteria with a severity modifier.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Department has had no discussions and has made no current plans. The National Institute for Health and Care Excellence (NICE) is responsible for developing the methods and processes it uses and engaged with a wide range of stakeholders during the development of its updated manual for health technology evaluations, including on the severity modifier. Patient groups were directly involved in the methods review in the working group, task and finish groups and in two public consultations. Additionally, NICE engaged separately with industry and patient groups on the impact of the changes to it methods and processes for medicines currently in the Cancer Drugs Fund.
NICE also works closely with patient groups and other stakeholders in the development of its guidance on individual technologies. In 2022/23, 89% of NICE’s final recommendations on cancer drugs were positive, including all of the cancer medicines appraised using NICE’s updated methods and processes. No cancer medicines have completed their exit from the CDF using NICE’s updated methods and processes. However, NICE has released positive final draft guidance for the first, which treats a blood cancer.
If NICE determines at the end of a managed access period that a technology is not a good use of National Health Service resources, then people already having treatment may continue until they and their NHS clinician consider it appropriate to stop.