Asked by: Lord Moylan (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what treatments exist for those mantle cell lymphoma patients unable to access allogeneic stem cell transplants due to (1) ethnicity, (2) age, and (3) ethnicity and age.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
A number of National Health Service treatment options are available for patients with mantle cell lymphoma, and may include:
- chemotherapy plus rituximab;
- autologous stem cell transplant;
- ibrutinib;
- zanubrutinib;
- brexucabtagene autoleucel, a type of chimeric antigen receptor T-cell therapy; and/or
- supportive care.
None of these treatments are precluded on the basis of ethnicity, age, or a combination of the two, but available options will be dependent on individual clinical circumstances and any prior treatment or treatments received.
Potential treatment options are also currently being appraised by the National Institute for Health and Care Excellence and therefore could be made available within England in the future, subject to positive recommendations on NHS adoption being reached. These are: Acalabrutinib with bendamustine and rituximab; and Ibrutinib with R-CHOP.
Asked by: Lord Moylan (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what safeguards exist to prevent patients from losing access to established, life-extending cancer treatments as a result of changes to NICE methodology.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The National Institute for Health and Care Excellence (NICE) evaluates all newly licensed cancer medicines and may recommend promising treatments for use through the Cancer Drugs Fund (CDF) where there is too much clinical uncertainty for routine commissioning. Under these arrangements, cancer medicines are made available to National Health Service patients for a defined period while further real‑world evidence is collected to address the uncertainties identified in NICE’s original appraisal.
At the end of the managed access period, NICE undertakes a full re‑appraisal of the medicine. This re‑appraisal considers all the evidence gathered during CDF use alongside updated clinical and cost‑effectiveness analyses. NICE then determines whether the medicine should be routinely funded by the NHS, or whether it cannot be recommended for routine commissioning. This re‑appraisal process is one of the limited circumstances in which NICE routinely re‑evaluates previous decisions.
In 2022, NICE updated its methods and replaced the earlier end‑of‑life flexibilities with the severity modifier. As a result, re‑appraisals of cancer medicines that originally entered the CDF under end‑of‑life criteria are now conducted in line with NICE’s current methods framework, ensuring consistency, fairness, and opportunity‑cost neutrality across all appraisals. NICE has recommended 96% of the medicines that it has re-appraised following a period of managed access for routine NHS use. Where NICE is unable to recommend a medicine for routine use following the period of managed access, it remains available for existing patients but is no longer routinely funded for new patients.
Asked by: Lord Moylan (Conservative - 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 of withdrawing access to an existing cancer treatment, namely CAR-T therapy for relapsed or refractory mantle cell lymphoma, which has been available on the NHS since 2021.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
202 patients have received brexucabtagene autoleucel, a form of CAR-T therapy, for the treatment of mantle cell lymphoma via the Cancer Drugs Fund (CDF). This data is taken from NHS England’s prior approval system. The National Institute for Health and Care Excellence (NICE) is currently re-evaluating the evidence on clinical outcomes collected through its use in the CDF in its ongoing re-evaluation of brexucabtagene autoleucel.
NICE published final draft guidance on 24 December 2025 in which it was not able to recommend brexucabtagene autoleucel for the treatment of relapsed or refractory mantle cell lymphoma in adults who have had two or more lines of systemic treatment that included a Bruton's tyrosine kinase inhibitor. This is because the extent of brexucabtagene autoleucel’s clinical benefit is uncertain. There are also uncertainties in the economic model because there is not enough evidence to tell if the cancer can be ‘cured’ in people having brexucabtagene autoleucel and it is not known how long people live after having brexucabtagene autoleucel. The cost-effectiveness estimates are also substantially above the range that NICE considers an acceptable use of National Health Service resources. NICE has not yet published final guidance and stakeholders have recently had an opportunity to appeal NICE’s recommendations.
The Government recognises that the potential withdrawal of brexucabtagene autoleucel as a treatment for future patients will be concerning for patients and their families, but it is right that these decisions are taken independently and on the basis of the available evidence. In line with an arrangement between NHS England and the company, if NICE’s final guidance does not recommend use, patients who started treatment during the managed access period can continue their treatment.
Asked by: Lord Moylan (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government how many patients have received CAR-T therapy for mantle cell lymphoma via the Cancer Drugs Fund; and what assessment has been made of the clinical outcomes for those patients.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
202 patients have received brexucabtagene autoleucel, a form of CAR-T therapy, for the treatment of mantle cell lymphoma via the Cancer Drugs Fund (CDF). This data is taken from NHS England’s prior approval system. The National Institute for Health and Care Excellence (NICE) is currently re-evaluating the evidence on clinical outcomes collected through its use in the CDF in its ongoing re-evaluation of brexucabtagene autoleucel.
NICE published final draft guidance on 24 December 2025 in which it was not able to recommend brexucabtagene autoleucel for the treatment of relapsed or refractory mantle cell lymphoma in adults who have had two or more lines of systemic treatment that included a Bruton's tyrosine kinase inhibitor. This is because the extent of brexucabtagene autoleucel’s clinical benefit is uncertain. There are also uncertainties in the economic model because there is not enough evidence to tell if the cancer can be ‘cured’ in people having brexucabtagene autoleucel and it is not known how long people live after having brexucabtagene autoleucel. The cost-effectiveness estimates are also substantially above the range that NICE considers an acceptable use of National Health Service resources. NICE has not yet published final guidance and stakeholders have recently had an opportunity to appeal NICE’s recommendations.
The Government recognises that the potential withdrawal of brexucabtagene autoleucel as a treatment for future patients will be concerning for patients and their families, but it is right that these decisions are taken independently and on the basis of the available evidence. In line with an arrangement between NHS England and the company, if NICE’s final guidance does not recommend use, patients who started treatment during the managed access period can continue their treatment.
Asked by: Lord Moylan (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what recent advice they have taken from the UK Statistics Authority on fulfilling their responsibility under the Abortion Act 1967 to produce abortion statistics.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
In accordance with the Abortion Act 1967, all abortions in England must be notified to the Chief Medical Officer within 14 days of the procedure. This information is used by the Department to monitor compliance with the act. The Department also publishes this data in line with the Code of Practice for Statistics, to ensure it is available to commissioners and providers of abortion services and others with an interest in abortion in England and Wales. There is no legal duty placed on the Department to publish data collected through abortion notification forms.
The Department regularly consults the Office for Statistics Regulation, which is the independent regulatory arm of the UK Statistics Authority, and provides independent regulation of all official statistics produced in the United Kingdom.
Asked by: Lord Moylan (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government whether the medical assessors for the Vaccine Damages Payment Scheme have access to the scientific advice given to ministers regarding the AstraZeneca Covid-19 Vaccine.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
All claims to the Vaccine Damage Payment Scheme (VDPS) are assessed on a case-by-case basis by experienced independent medical assessors, General Medical Council registered doctors with a licence to practise, who have undertaken specialised training in vaccine damage and disability assessment.
When making medical assessment through the VDPS, independent medical assessors consider not just the claimant’s full medical records once they are gathered, but also the claim form and a range of credible resources to support their assessment, as per NHS Business Services Authority’s published VDPS Principles of Medical Assessment. This includes, but is not limited to, the Medicines and Healthcare products Regulatory Agency’s data, including Yellow Card information on suspected safety concerns involving a healthcare product, vaccine product information and updates, the UK Health Security Agency's Green Book, and the World Health Organization’s Causality assessment of an adverse event following immunization. Medical assessors will also consider academic research, epidemiological evidence, and the current consensus of expert medical opinion.
Asked by: Lord Moylan (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government how many cases of Guillain-Barré syndrome have been recorded in each of the last ten years.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The information is not held in the format requested. However, the following table shows a count of the Finished Admission Episodes (FAEs) where the primary diagnosis was Guillain-Barré syndrome, for the period 2014/15 to 2023/24 in England:
Year | FAEs |
2014/15 | 1,403 |
2015/16 | 1,354 |
2016/17 | 1,412 |
2017/18 | 1,342 |
2018/19 | 1,337 |
2019/20 | 1,354 |
2020/21 | 921 |
2021/22 | 1,243 |
2022/23 | 1,374 |
2023/24 | 1,367 |
Source: data is from the Hospital Episode Statistics, by NHS England.
Notes:
Asked by: Lord Moylan (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government whether they will publish the scientific advice they received from the Joint Committee on Vaccination and Immunisation between 1 April and 6 May 2021 regarding age restrictions for the AstraZeneca COVID-19 Vaccine.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The Joint Committee on Vaccination and Immunisation (JCVI) provided advice to the Government between 1 April and 6 May 2021 regarding age restrictions for the AstraZeneca COVID-19 vaccine. This advice was published on the GOV.UK website, and states that the JCVI currently advises that it is preferable for adults aged less than 30 years old, without underlying health conditions that put them at higher risk of severe COVID-19 disease, to be offered an alternative COVID-19 vaccine, if available.
Discussions on the AstraZeneca vaccine also took place and are noted within the minutes of the JCVI’s COVID-19 sub-committee meetings held on 13, 22, and 29 April 2021. The outcome of the discussions held within these meetings was reflected in the updated JCVI advice on the use of the AstraZeneca vaccine, published on the 7 May 2021, which extended the preferential use of alternative vaccines to unvaccinated adults aged 30 to 39 years old, who are not in a clinical priority group at higher risk of severe COVID-19 disease.
Asked by: Lord Moylan (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government how many applicants to the Vaccine Damages Payment Scheme (VDPS) have made a claim relating to the AstraZeneca Covid-19 Vaccine; and how many applicants to the VDPS have been waiting for a decision for longer than (1) one year and (2) 18 months.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
As of 30 September 2024, the Vaccine Damage Payment Scheme (VDPS) has processed 3,825 claims relating to the AstraZeneca COVID-19 vaccine. A further 207 claims relating to the AstraZeneca COVID-19 vaccine are undergoing medical assessment. As of 30 September 2024, there were 7,335 live VDPS claims, of which 1,024 have been awaiting resolution for longer than 12 months, and 316 claims for longer than 18 months.
Asked by: Lord Moylan (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government when they received scientific advice detailing an increase in the incidence of autoimmune illness and a possible link between that increase and the AstraZeneca COVID-19 Vaccine.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
Following reports of extremely rare adverse events of concurrent thrombosis and thrombocytopenia following vaccination with the first dose of the AstraZeneca COVID-19 vaccine, the Joint Committee on Vaccination and Immunisation (JCVI) advised that adults aged under 30 years old and without underlying health conditions should be offered an alternative vaccine, if available. This advice was published on 7 April 2021. In parallel, the Medicines and Healthcare products Regulatory Agency updated its information for healthcare professionals on the COVID-19 AstraZeneca vaccine. On 7 May 2021, the JCVI published updated advice which extended the group who should be offered an alternative to include all unvaccinated adults aged 30 to 39 years old who were not in a clinical priority group at higher risk of severe COVID-19 disease. This advice is published online, and is available in an online only format.