Asked by: Mark Tami (Labour - Alyn and Deeside)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, how much funding her Department has provided for research that has led to clinical trials for (a) paediatric cancer, (b) neuroblastoma and (c) other rare cancers in each of the last five years.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The information requested is shown in the attached table.
Asked by: Mark Tami (Labour - Alyn and Deeside)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment her Department has made of the adequacy apheresis capacity; and what plans her Department has to increase that capacity.
Answered by Andrea Leadsom - Parliamentary Under-Secretary (Department of Health and Social Care)
The NHS England Specialised Commissioning, via the Bone Marrow Transplant Clinical Reference Group (CRG), is undertaking an assessment of the available apheresis capacity across England, working with NHS Blood and Transplant. The first phase of this assessment is complete and the CRG will define the next phase of this assessment at its meeting in November.
NHS Blood and Transplant is the largest provider of apheresis services and has been increasing capacity significantly over a number of years, averaging an increase of about 10% per annum. There are a number of projects expected in the next 12 months to both increase nursing capacity and the physical space in which apheresis occurs.
Horizon scanning within the advanced therapy area suggests that a significant increase in cell collection will be required within the next three to five years. The MedTech Funding Mandate for Spectra Optia in sickle cell disease has assisted in funding the expansion of services. NHS England is working in partnership with the Health Innovation Network to deliver the requirements of the MedTech Funding Mandate Policy which mandates the delivery of the Spectra Optia Apheresis System for the automation of red cell exchange for sickle cell patients. Funding has been provided to increase access to this technology across the country.
Asked by: Mark Tami (Labour - Alyn and Deeside)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps her Department is taking to help ensure that (a) NICE, (b) NHS England and (c) he pharmaceutical industry work together to increase patient access to new therapies for Graft-versus-host disease.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The National Institute for Health and Care Excellence (NICE) is the independent body responsible for developing authoritative, evidence-based guidance for the National Health Service on whether new medicines represent a clinically- and cost-effective use of NHS resources. The NHS in England is legally required to make funding available in line with NICE’s recommendations within 90 days of a NICE decision, ensuring consistent access for all NHS patients in England to NICE recommended treatments.
NICE works closely with NHS England and pharmaceutical companies throughout the guidance development process to ensure that companies can put forward as strong a value proposition as possible. NICE can recommend most new medicines for use in the NHS in England. Health is a devolved matter and decisions on access to medicines in Scotland, Northern Ireland, and Wales are a matter for the devolved administrations.
NICE is currently evaluating the medicine belumosudil for treating chronic graft versus host disease after two or more lines of systemic therapy. NICE’s draft guidance does not recommend belumosudil but is subject to a public consultation and is not final guidance. NICE’s committee will carefully consider all evidence as well as comments received during the consultation in developing its final guidance.
Asked by: Mark Tami (Labour - Alyn and Deeside)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps her Department is taking to address regional disparities in access to newer treatments for Graft-versus-host disease.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The National Institute for Health and Care Excellence (NICE) is the independent body responsible for developing authoritative, evidence-based guidance for the National Health Service on whether new medicines represent a clinically- and cost-effective use of NHS resources. The NHS in England is legally required to make funding available in line with NICE’s recommendations within 90 days of a NICE decision, ensuring consistent access for all NHS patients in England to NICE recommended treatments.
NICE works closely with NHS England and pharmaceutical companies throughout the guidance development process to ensure that companies can put forward as strong a value proposition as possible. NICE can recommend most new medicines for use in the NHS in England. Health is a devolved matter and decisions on access to medicines in Scotland, Northern Ireland, and Wales are a matter for the devolved administrations.
NICE is currently evaluating the medicine belumosudil for treating chronic graft versus host disease after two or more lines of systemic therapy. NICE’s draft guidance does not recommend belumosudil but is subject to a public consultation and is not final guidance. NICE’s committee will carefully consider all evidence as well as comments received during the consultation in developing its final guidance.
Asked by: Mark Tami (Labour - Alyn and Deeside)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps her Department is taking to support (a) IMPACT, (b) AGAVE and (c) other clinical trials for new Graft-versus-host disease treatments.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
NHS Blood and Transplant (NHSBT) have received funding from the Department to set up a process for manufacturing and supplying mesenchymal stromal cells for the treatment of Graft-versus-host disease (GvHD). This process has been set up and the first batches of cells will be available for supply from NHSBT in 2024. These will be issued upon request from hospitals under the Specials program but is not routinely commissioned.
NHSBT funded the IMPACT clinical trials network and subsequently Advancing Clinical Trials Ltd (ACT). The network is currently running two trials in the area of GvHD. NHSBT with the National Institute for Health and Care Research (NIHR) fund research into transplantation and cellular therapy via the Blood and Transplant Research Unit based in Oxford. While at an early stage, some of the projects leading from this aim to reduce and/or treat GvHD. The NIHR has further supported the delivery of the AGAVE clinical trial via the NIHR infrastructure.
Asked by: Mark Tami (Labour - Alyn and Deeside)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps her Department is taking to help ensure that (a) new clinical trials have the support they need to recruit patients and (b) patients are made aware of clinical trials as a potential way to access new medicines.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Department funds research through the National Institute for Health and Care Research (NIHR). NIHR invests in expertise, specialist facilities, a research delivery workforce and support services to support recruitment to clinical trials. The NIHR Clinical Research Facilities support the delivery of early phase trials and the NIHR Clinical Research Network (CRN) and Patient Recruitment Centres support delivery and participation in later phase clinical trials.
The NIHR also provides the online platform 'Be Part of Research' which allow users to search for and register interest in clinical trials, matching people to trials of relevance to them.
Asked by: Mark Tami (Labour - Alyn and Deeside)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what discussions his Department has had with representatives of young people on the development of the Major Conditions Strategy.
Answered by Will Quince
The Department is engaging with several stakeholders in the development of the Major Conditions Strategy including organisations that represent babies, children and young people.
Asked by: Mark Tami (Labour - Alyn and Deeside)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps he plans to take to ensure that implementation of the recommendations made in the Lord O’Shaughnessy review of commercial clinical trials in the UK takes into account the particular needs of (a) teenagers and (b) young adults with cancer.
Answered by Will Quince
The Government will publish a full response to the Lord O’Shaughnessy independent review into commercial clinical trials in autumn 2023. The response will include an update on progress and implementation of the initial five headline commitments and foundational actions that the Government made in May 2023.
Asked by: Mark Tami (Labour - Alyn and Deeside)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the potential impact of the voluntary scheme for branded medicines pricing and access on (a) development of and (b) access to (i) Graft-versus-Host disease therapies, (ii) CAR-T therapies and (iii) other innovative therapies for rare conditions.
Answered by Will Quince
The voluntary scheme for branded medicines pricing and access (VPAS) includes strong commercial incentives to launch new products in the form of freedom of list pricing and exemptions from payments for innovative medicines containing a new active substance. At the mid-scheme review for the 2019 VPAS, the Department and NHS England concluded that the scheme had been effective in supporting patient access to innovative medicines.
The terms of the successor to VPAS are subject to ongoing confidential negotiations. Supporting patient access to innovative medicines will continue to be one of the scheme’s objectives, alongside ensuring the affordability of National Health Service spend on medicines and supporting the life sciences sector and the wider economy.
Asked by: Mark Tami (Labour - Alyn and Deeside)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether his Department is taking steps to help ensure cooperation between NICE and the pharmaceutical industry to provide all stem cell transplant patients with adequate access to new Graft-versus-Host Disease treatments.
Answered by Will Quince
The National Institute for Health and Care Excellence (NICE) makes recommendations for the National Health Service on the clinical and cost effectiveness of all new medicines and aims to publish guidance close to the point of licensing wherever possible. The NHS in England is legally required to make funding available for medicines in line with NICE’s recommendations. NICE works closely with pharmaceutical companies and other stakeholders in the development of its recommendations on individual treatments.
NICE is developing technology appraisal guidance on belumosudil for treating chronic graft versus host disease after two or more lines of systemic therapy and expects to publish final guidance in November 2023.