Asked by: Lord Kamall (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what progress has been made regarding talks taking place between AstraZeneca, Daiichi Sankyo, NHS England and NICE about the HER2-low metastatic breast cancer treatment Enhertu.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
I am pleased to confirm that, on 17 September, the National Institute for Health and Care Excellence (NICE) announced that it is recommending Enhertu for use on the National Health Service for the treatment of certain types of breast cancer.
This is the result of an improved pricing arrangement from the companies, together with the impact of (a) recent changes to NICE's cost-effectiveness thresholds, arising from the UK-US Pharmaceutical Partnership announced on 2 April, and (b) new methods adopted by NICE for assessing quality of life, published on 27 August. Taken together, these changes mean the treatment can now be recommended for routine NHS use.
Asked by: Lord Kamall (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government, what action they are taking to ensure Enhertu, for HER2-low metastatic breast cancer, is being made available to those who need it.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
I am pleased to confirm that, on 17 September, the National Institute for Health and Care Excellence (NICE) announced that it is recommending Enhertu for use on the National Health Service for the treatment of certain types of breast cancer.
This is the result of an improved pricing arrangement from the companies, together with the impact of (a) recent changes to NICE's cost-effectiveness thresholds, arising from the UK-US Pharmaceutical Partnership announced on 2 April, and (b) new methods adopted by NICE for assessing quality of life, published on 27 August. Taken together, these changes mean the treatment can now be recommended for routine NHS use.
Asked by: Lord Kamall (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government whether the forthcoming Cancer Manuals will address inequalities in care for patients with low-grade glioma.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The Department and NHS England are reviewing the process for developing cancer manuals, including the criteria to use in relation to rare tumour types where survival improvements have been the slowest, as well as accountability mechanisms and consultation processes. We will provide further updates in the usual way in due course.
Asked by: Lord Kamall (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 role of speech and language therapy in the (1) diagnosis, and (2) treatment, of rare dementias.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
NHS England does not have specific guidance on the use of speech and language therapy for individual dementia subtypes. Similarly, the National Institute for Health and Care Excellence guideline on dementia does not make any recommendations regarding the provision of speech and language therapy for people based on dementia subtype. Referral to appropriate specialist services including speech and language therapy should be undertaken according to individual clinical presentation and need, clinical judgement, and in line with local pathways.
Asked by: Lord Kamall (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government how many appraisals by the National Institute for Health and Care Excellence for medicines indicated for kidney disease have (1) received a positive recommendation, (1) received a negative recommendation, and (3) been terminated, between June 2021 and July 2026.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
From June 2021 to July 2026 the National Institute for Health and Care Excellence has appraised a total of seven new active substances licensed for kidney disease, seven of which were positive and zero were negative. There was one further appraisal of a kidney disease medicine that was terminated. There were no appraisals of medicines with a licence extension for kidney disease, including for rare kidney disease.
Asked by: Lord Kamall (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what is the outcome of NHS England's gap analysis on fresh-frozen tissue preservation capacity; and what is the timetable for implementing any recommendations arising from it.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
NHS England is currently considering the sites requiring additional freezer capacity as a result of its gap analysis. Further details will be published in the usual way in due course.
Asked by: Lord Kamall (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of how NHS England's Ambient Voice Technology Supplier Registry is being used in practice by NHS organisations; and whether they plan to take any steps to ensure that AI-enabled scribing tools not included on the Registry, including those provided by incumbent electronic health record suppliers, are not deployed in place of Registry-assessed tools without meeting equivalent governance and clinical safety standards.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
NHS England's Ambient Voice Technology (AVT) Supplier Registry is designed to support National Health Service organisations in local procurement and assurance activities. It provides information on suppliers' capabilities and supporting evidence against NHS and regulatory requirements, including clinical safety, information governance, technology, and interoperability standards. The registry supports local assurance processes by providing reusable evidence and helping to reduce duplication in implementation and assurance activities.
Procurement and deployment decisions remain the responsibility of individual NHS organisations, in line with their local governance and assurance processes. Whether or not a product appears on the registry, organisations must ensure compliance with relevant legal, regulatory, and NHS requirements, including clinical safety standards, data protection legislation, cyber security requirements, and, where applicable, medical device regulations.
NHS England has established national interoperability and data standards to support the secure exchange of clinical information across settings, and is supporting both AVT and Electronic Health Record suppliers to develop these capabilities. As part of a test-and-learn approach to the adoption of AVT, NHS England is establishing a national AVT Centre of Excellence to support the sharing of learning, evidence, and implementation experience.
The Medicines and Healthcare products Regulatory Agency (MHRA) is continuing its programme of regulatory reform in relation to medical devices to protect patient safety while supporting innovation. The Post Market Surveillance regulations came into force on 16 June 2025, strengthening requirements for monitoring devices once they are placed on the market in Great Britain. Further pre-market reforms are expected in 2026.
Finally, in September 2025, the MHRA also launched the independent National Commission into the Regulation of AI in Healthcare, and the Government will consider its recommendations following publication of the report.
Asked by: Lord Kamall (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what steps they are taking to reduce duplication in local clinical safety and implementation assurance processes for AI-enabled clinical tools that have already been assessed through a national evaluation route, such as the NHS England Ambient Voice Technology Supplier Registry.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
NHS England's Ambient Voice Technology (AVT) Supplier Registry is designed to support National Health Service organisations in local procurement and assurance activities. It provides information on suppliers' capabilities and supporting evidence against NHS and regulatory requirements, including clinical safety, information governance, technology, and interoperability standards. The registry supports local assurance processes by providing reusable evidence and helping to reduce duplication in implementation and assurance activities.
Procurement and deployment decisions remain the responsibility of individual NHS organisations, in line with their local governance and assurance processes. Whether or not a product appears on the registry, organisations must ensure compliance with relevant legal, regulatory, and NHS requirements, including clinical safety standards, data protection legislation, cyber security requirements, and, where applicable, medical device regulations.
NHS England has established national interoperability and data standards to support the secure exchange of clinical information across settings, and is supporting both AVT and Electronic Health Record suppliers to develop these capabilities. As part of a test-and-learn approach to the adoption of AVT, NHS England is establishing a national AVT Centre of Excellence to support the sharing of learning, evidence, and implementation experience.
The Medicines and Healthcare products Regulatory Agency (MHRA) is continuing its programme of regulatory reform in relation to medical devices to protect patient safety while supporting innovation. The Post Market Surveillance regulations came into force on 16 June 2025, strengthening requirements for monitoring devices once they are placed on the market in Great Britain. Further pre-market reforms are expected in 2026.
Finally, in September 2025, the MHRA also launched the independent National Commission into the Regulation of AI in Healthcare, and the Government will consider its recommendations following publication of the report.
Asked by: Lord Kamall (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what plans they have to require electronic health record systems to support open, standards-based interoperability, so that clinical documentation generated by AI-enabled tools can be exchanged securely across NHS settings.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
NHS England's Ambient Voice Technology (AVT) Supplier Registry is designed to support National Health Service organisations in local procurement and assurance activities. It provides information on suppliers' capabilities and supporting evidence against NHS and regulatory requirements, including clinical safety, information governance, technology, and interoperability standards. The registry supports local assurance processes by providing reusable evidence and helping to reduce duplication in implementation and assurance activities.
Procurement and deployment decisions remain the responsibility of individual NHS organisations, in line with their local governance and assurance processes. Whether or not a product appears on the registry, organisations must ensure compliance with relevant legal, regulatory, and NHS requirements, including clinical safety standards, data protection legislation, cyber security requirements, and, where applicable, medical device regulations.
NHS England has established national interoperability and data standards to support the secure exchange of clinical information across settings, and is supporting both AVT and Electronic Health Record suppliers to develop these capabilities. As part of a test-and-learn approach to the adoption of AVT, NHS England is establishing a national AVT Centre of Excellence to support the sharing of learning, evidence, and implementation experience.
The Medicines and Healthcare products Regulatory Agency (MHRA) is continuing its programme of regulatory reform in relation to medical devices to protect patient safety while supporting innovation. The Post Market Surveillance regulations came into force on 16 June 2025, strengthening requirements for monitoring devices once they are placed on the market in Great Britain. Further pre-market reforms are expected in 2026.
Finally, in September 2025, the MHRA also launched the independent National Commission into the Regulation of AI in Healthcare, and the Government will consider its recommendations following publication of the report.
Asked by: Lord Kamall (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government whether they intend to publish regular national and integrated care board-level progress reports against the metrics set out in the Cardiovascular Disease Modern Service Framework.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The Cardiovascular Disease Modern Service Framework, published in July 2026, sets out metrics for each of its 12 priority actions. These metrics will underpin performance monitoring and accountability for delivery of the framework.
The Department and NHS England will publish performance data routinely, using it to identify variation and outliers and drive improvement at system and provider level. We will say more about the timelines for these publications in due course.