Asked by: Baroness Ritchie of Downpatrick (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government, further to the Written Answer by Baroness Merron on 8 October 2025 (HL10538), whether the NHS Supply Chain procurement exercises, including the Total Cardiology and Vascular Solutions Framework, are being developed in line with the draft Value Based Procurement Standard Guidance; and what assessment they have made of whether the evaluation criteria in that guidance include sufficient thresholds for non-price value criteria in particular (1) clinical outcomes, (2) patient quality of life, (3) innovation, (4) sustainability, and (5) whole system efficiencies.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
NHS Supply Chain has worked closely with the Department to support the implementation of its value based procurement (VBP) guidance. Within the Total Cardiology and Vascular Solutions Framework, the Department’s methodology has been piloted on a national procurement and integrated into the non-financial evaluation criteria, with appropriate adaptations made to reflect the specific clinical and operational requirements of the specialty. Value-based assessment criteria and associated non-financial questions have been included where supplier claims can be objectively assessed ensuring a fair, transparent, and equitable evaluation process.
Extensive pre-market engagement was undertaken between March 2025 and September 2025, providing suppliers, customers, clinical associations, and professional bodies with the opportunity to share insights, feedback, and observations on the proposed procurement strategy and overall approach. Communication has been conducted in forms such as team meetings, face to face meetings, and email exchanges with all stakeholders, including clinicians. Draft versions of the VBP questions were circulated during this period to support supplier readiness and to enable meaningful challenge and feedback in advance of tender publication. NHS Supply Chain clinical and category teams engaged extensively with key clinical stakeholder groups, including members of the British Heart Rhythm Society, members of the British Cardiovascular Intervention Society, and NHS England Device Working Groups, to inform the development and refinement of the VBP criteria. The final questions focus on areas where value can be clearly evidenced, including clinical outcomes, innovation, sustainability, social value, and whole-system costs and efficiencies.
While the NHS Supply Chain has successfully incorporated VBP principles into the cardiology and vascular framework evaluation, a key challenge remains the limited availability of standardised Patient Reported Outcome Measures, clinical registries, and other robust outcome datasets to enable consistent and comparable assessment of supplier value claims. Consequently, VBP evaluation has been focused on evidence that can be objectively assessed at the tender stage, with a clear commitment to further validate and measure value throughout the lifetime of the framework as more comprehensive clinical, operational, and patient outcome data becomes available. This approach balances fairness and transparency in procurement with the longer-term ambition of embedding a mature, evidence-based value assessment model across the specialty.
Asked by: Baroness Ritchie of Downpatrick (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what steps they have taken to seek input from (1) patients, (2) clinicians, (3) medical societies, and (4) suppliers, in the development of the NHS Supply Chain Total Cardiology and Vascular Solutions Framework; and how that input has informed the weighting and clinical assessment of value-based procurement criteria.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
NHS Supply Chain has worked closely with the Department to support the implementation of its value based procurement (VBP) guidance. Within the Total Cardiology and Vascular Solutions Framework, the Department’s methodology has been piloted on a national procurement and integrated into the non-financial evaluation criteria, with appropriate adaptations made to reflect the specific clinical and operational requirements of the specialty. Value-based assessment criteria and associated non-financial questions have been included where supplier claims can be objectively assessed ensuring a fair, transparent, and equitable evaluation process.
Extensive pre-market engagement was undertaken between March 2025 and September 2025, providing suppliers, customers, clinical associations, and professional bodies with the opportunity to share insights, feedback, and observations on the proposed procurement strategy and overall approach. Communication has been conducted in forms such as team meetings, face to face meetings, and email exchanges with all stakeholders, including clinicians. Draft versions of the VBP questions were circulated during this period to support supplier readiness and to enable meaningful challenge and feedback in advance of tender publication. NHS Supply Chain clinical and category teams engaged extensively with key clinical stakeholder groups, including members of the British Heart Rhythm Society, members of the British Cardiovascular Intervention Society, and NHS England Device Working Groups, to inform the development and refinement of the VBP criteria. The final questions focus on areas where value can be clearly evidenced, including clinical outcomes, innovation, sustainability, social value, and whole-system costs and efficiencies.
While the NHS Supply Chain has successfully incorporated VBP principles into the cardiology and vascular framework evaluation, a key challenge remains the limited availability of standardised Patient Reported Outcome Measures, clinical registries, and other robust outcome datasets to enable consistent and comparable assessment of supplier value claims. Consequently, VBP evaluation has been focused on evidence that can be objectively assessed at the tender stage, with a clear commitment to further validate and measure value throughout the lifetime of the framework as more comprehensive clinical, operational, and patient outcome data becomes available. This approach balances fairness and transparency in procurement with the longer-term ambition of embedding a mature, evidence-based value assessment model across the specialty.
Asked by: Baroness Ritchie of Downpatrick (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of whether current Government funding arrangements adequately support resilience, redundancy and preparedness across healthcare supply chains, including the UK blood supply chain.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The Government keeps the funding and wider arrangements that support the resilience and preparedness of health supply chains, including blood supplies, under review.
Through implementation of Value-Based Procurement (VBP), the Department and NHS England are prioritising resilience in future purchasing decisions. VBP enables consideration of a broader range of factors than upfront cost alone, including patient outcomes, workforce benefits, efficiency, and supply chain considerations.
Alongside this, the Government has committed up to £520 million through the Life Sciences Innovative Manufacturing Fund to support investment in the manufacture of medicines, medical diagnostics, and medical technologies in the United Kingdom. The fund is intended to strengthen domestic manufacturing capability and support wider private investment in UK life sciences manufacturing.
Specifically on blood stocks, NHS Blood and Transplant (NHSBT) is responsible for the blood service in England, working closely with the Department to review the criticality and resilience of blood services. NHSBT is taking forward a Blood Supply Chain and Conflict Preparedness Programme to strengthen resilience during routine operations and incidents, including mass casualty events, cyber-attacks, power outages, and conflict scenarios. The Joint Blood Stocks Working Group, jointly chaired by the Department and NHSBT, is also considering measures to support longer-term blood supply resilience. It is due to report in autumn 2026.
More broadly, the Government actively monitors emerging threats to supply resilience and has established shortage management procedures in place to help mitigate patient impact. These include buffer stocks, sourcing alternative products, and use of the Express Freight Service, a global logistics contingency to transport goods in a critical supply disruption.
Asked by: Baroness Ritchie of Downpatrick (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what estimate they have made of the impact of the lack of accessibility of the Enhertu drug for HER2-low metastatic breast cancer in England upon the objective of becoming one of the top three fastest places in Europe for patient access to medicines by 2030.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
HER2‑low breast cancer is managed with treatments for HER2‑negative breast cancer. The National Institute for Health and Care Excellence (NICE) has published guidance recommending a number of medicines for the treatment of HER2-negative breast cancer which are now available for the treatment of National Health Service patients in line with NICE’s guidance.
Trastuzumab deruxtecan (Enhertu) is the first licensed treatment for HER2‑low metastatic or unresectable breast cancer. The Government recognises how disappointing it was for all those affected that NICE was unable to recommend Enhertu for use in the treatment of HER2-low metastatic or unresectable breast cancer. This was because, at the price offered by the company in 2024, the treatment was too expensive for the benefits it provided, and NICE concluded it was not cost effective. Despite NICE and NHS England offering unprecedented flexibilities, the companies were unable to offer Enhertu at a cost-effective price. It is estimated that approximately 1,000 to 1,500 people would have been eligible for treatment with Enhertu for HER2-low metastatic or unresectable breast cancer after chemotherapy, had NICE been able to recommend it.
As part of the United States and United Kingdom partnership, announced in April 2026, NICE is now using a new higher cost-effectiveness threshold. The update to the NICE cost effectiveness threshold has already made a direct difference for NHS patients with several treatments, including treatments for cancer, that may not have been recommended under the previous threshold. Given these new circumstances, discussions involving NICE, the manufacturers, and NHS England have resumed to try to seek an agreement on a commercial offer that would make Enhertu cost-effective.
The Department has made no assessment on the of the impact of the lack of accessibility of the Enhertu drug for HER2-low metastatic breast cancer in England upon the objective of becoming one of the top three fastest places in Europe for patient access to medicines by 2030.
Asked by: Baroness Ritchie of Downpatrick (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what estimate they have made of the number of patients who would have otherwise benefited from the HER2-low metastatic breast cancer drug Enhertu since it was rejected for use on the NHS in England in 2024.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
HER2‑low breast cancer is managed with treatments for HER2‑negative breast cancer. The National Institute for Health and Care Excellence (NICE) has published guidance recommending a number of medicines for the treatment of HER2-negative breast cancer which are now available for the treatment of National Health Service patients in line with NICE’s guidance.
Trastuzumab deruxtecan (Enhertu) is the first licensed treatment for HER2‑low metastatic or unresectable breast cancer. The Government recognises how disappointing it was for all those affected that NICE was unable to recommend Enhertu for use in the treatment of HER2-low metastatic or unresectable breast cancer. This was because, at the price offered by the company in 2024, the treatment was too expensive for the benefits it provided, and NICE concluded it was not cost effective. Despite NICE and NHS England offering unprecedented flexibilities, the companies were unable to offer Enhertu at a cost-effective price. It is estimated that approximately 1,000 to 1,500 people would have been eligible for treatment with Enhertu for HER2-low metastatic or unresectable breast cancer after chemotherapy, had NICE been able to recommend it.
As part of the United States and United Kingdom partnership, announced in April 2026, NICE is now using a new higher cost-effectiveness threshold. The update to the NICE cost effectiveness threshold has already made a direct difference for NHS patients with several treatments, including treatments for cancer, that may not have been recommended under the previous threshold. Given these new circumstances, discussions involving NICE, the manufacturers, and NHS England have resumed to try to seek an agreement on a commercial offer that would make Enhertu cost-effective.
The Department has made no assessment on the of the impact of the lack of accessibility of the Enhertu drug for HER2-low metastatic breast cancer in England upon the objective of becoming one of the top three fastest places in Europe for patient access to medicines by 2030.
Asked by: Baroness Ritchie of Downpatrick (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 the decision not to approve the use of Enhertu on the NHS for patients in England affected by HER2-low metastatic breast cancer.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
HER2‑low breast cancer is managed with treatments for HER2‑negative breast cancer. The National Institute for Health and Care Excellence (NICE) has published guidance recommending a number of medicines for the treatment of HER2-negative breast cancer which are now available for the treatment of National Health Service patients in line with NICE’s guidance.
Trastuzumab deruxtecan (Enhertu) is the first licensed treatment for HER2‑low metastatic or unresectable breast cancer. The Government recognises how disappointing it was for all those affected that NICE was unable to recommend Enhertu for use in the treatment of HER2-low metastatic or unresectable breast cancer. This was because, at the price offered by the company in 2024, the treatment was too expensive for the benefits it provided, and NICE concluded it was not cost effective. Despite NICE and NHS England offering unprecedented flexibilities, the companies were unable to offer Enhertu at a cost-effective price. It is estimated that approximately 1,000 to 1,500 people would have been eligible for treatment with Enhertu for HER2-low metastatic or unresectable breast cancer after chemotherapy, had NICE been able to recommend it.
As part of the United States and United Kingdom partnership, announced in April 2026, NICE is now using a new higher cost-effectiveness threshold. The update to the NICE cost effectiveness threshold has already made a direct difference for NHS patients with several treatments, including treatments for cancer, that may not have been recommended under the previous threshold. Given these new circumstances, discussions involving NICE, the manufacturers, and NHS England have resumed to try to seek an agreement on a commercial offer that would make Enhertu cost-effective.
The Department has made no assessment on the of the impact of the lack of accessibility of the Enhertu drug for HER2-low metastatic breast cancer in England upon the objective of becoming one of the top three fastest places in Europe for patient access to medicines by 2030.
Asked by: Baroness Ritchie of Downpatrick (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 timeline for Enhertu medication for the treatment of patients with HER2-low metastatic breast cancer to be made available on the NHS.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
HER2‑low breast cancer is managed with treatments for HER2‑negative breast cancer. The National Institute for Health and Care Excellence (NICE) has published guidance recommending a number of medicines for the treatment of HER2-negative breast cancer which are now available for the treatment of National Health Service patients in line with NICE’s guidance.
Trastuzumab deruxtecan (Enhertu) is the first licensed treatment for HER2‑low metastatic or unresectable breast cancer. The Government recognises how disappointing it was for all those affected that NICE was unable to recommend Enhertu for use in the treatment of HER2-low metastatic or unresectable breast cancer. This was because, at the price offered by the company in 2024, the treatment was too expensive for the benefits it provided, and NICE concluded it was not cost effective. Despite NICE and NHS England offering unprecedented flexibilities, the companies were unable to offer Enhertu at a cost-effective price. It is estimated that approximately 1,000 to 1,500 people would have been eligible for treatment with Enhertu for HER2-low metastatic or unresectable breast cancer after chemotherapy, had NICE been able to recommend it.
As part of the United States and United Kingdom partnership, announced in April 2026, NICE is now using a new higher cost-effectiveness threshold. The update to the NICE cost effectiveness threshold has already made a direct difference for NHS patients with several treatments, including treatments for cancer, that may not have been recommended under the previous threshold. Given these new circumstances, discussions involving NICE, the manufacturers, and NHS England have resumed to try to seek an agreement on a commercial offer that would make Enhertu cost-effective.
The Department has made no assessment on the of the impact of the lack of accessibility of the Enhertu drug for HER2-low metastatic breast cancer in England upon the objective of becoming one of the top three fastest places in Europe for patient access to medicines by 2030.
Asked by: Baroness Ritchie of Downpatrick (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 medicines available to treat patients with HER2-low metastatic breast cancer.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
HER2‑low breast cancer is managed with treatments for HER2‑negative breast cancer. The National Institute for Health and Care Excellence (NICE) has published guidance recommending a number of medicines for the treatment of HER2-negative breast cancer which are now available for the treatment of National Health Service patients in line with NICE’s guidance.
Trastuzumab deruxtecan (Enhertu) is the first licensed treatment for HER2‑low metastatic or unresectable breast cancer. The Government recognises how disappointing it was for all those affected that NICE was unable to recommend Enhertu for use in the treatment of HER2-low metastatic or unresectable breast cancer. This was because, at the price offered by the company in 2024, the treatment was too expensive for the benefits it provided, and NICE concluded it was not cost effective. Despite NICE and NHS England offering unprecedented flexibilities, the companies were unable to offer Enhertu at a cost-effective price. It is estimated that approximately 1,000 to 1,500 people would have been eligible for treatment with Enhertu for HER2-low metastatic or unresectable breast cancer after chemotherapy, had NICE been able to recommend it.
As part of the United States and United Kingdom partnership, announced in April 2026, NICE is now using a new higher cost-effectiveness threshold. The update to the NICE cost effectiveness threshold has already made a direct difference for NHS patients with several treatments, including treatments for cancer, that may not have been recommended under the previous threshold. Given these new circumstances, discussions involving NICE, the manufacturers, and NHS England have resumed to try to seek an agreement on a commercial offer that would make Enhertu cost-effective.
The Department has made no assessment on the of the impact of the lack of accessibility of the Enhertu drug for HER2-low metastatic breast cancer in England upon the objective of becoming one of the top three fastest places in Europe for patient access to medicines by 2030.
Asked by: Baroness Ritchie of Downpatrick (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government, in interventional commercial clinical trials, what the average time taken for (1) regulatory review, (2) study opening, and (3) recruitment of the first participant, was in the reporting period used to support their 15 April statement that the 150 day target had been met.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The UK Clinical Research Delivery key performance indicators report brings together data to monitor the delivery of globally competitive clinical research across the United Kingdom.
The report includes several indicators relating to study set-up. Indicator 1 measures the time it takes for commercial interventional clinical trials to recruit their first participant from the date that initial clinical trial authorisation is submitted. The measure links the different stages of the study set-up process, such as regulatory review, study opening, and recruitment of the first participant.
The information requested is shown in the following tables, as an unpublished subset of the statistics that were published on 15 April 2026 as part of the UK Clinical Research Delivery key performance indicators report, a copy of which is attached. The information is taken from studies held on the National Institute for Health and Care Research (NIHR) Research Delivery Network’s Central Portfolio Management System.
The following table shows the average number of days taken for each of the stages of the study set-up process that makes up indicator 1 of the report:
| Median number of days taken |
Days from submission to first participant | 122 |
Days from submission to regulatory approval | 34 |
Days from regulatory approval to opening | 62 |
Days from opening to first participant recruited | 28 |
Studies are included where the application was submitted between 1 April 2025 and 30 September 2025. This is a total of 73 studies. The median days taken for each of the stages are calculated independently and therefore do not sum to the overall median for days from submission to first participant. These data were processed and assured by the NIHR in the same way as those provided to the Department for publication in April 2026 of 150-day set-up performance, using established data checking processes within the NIHR's Research Delivery Network data and analytics and specialty teams. The same reporting period was used to support the 15 April 2026 press release Government drives forward its 150-day clinical trial target, a copy of which is attached.
The Department is committed to turbocharging clinical research and delivering better patient care, to make the UK a world-leading destination for clinical research. We are working to fast-track clinical trials to drive global investment into life sciences, improve health outcomes, and accelerate the development of medicines and therapies of the future.
Asked by: Baroness Ritchie of Downpatrick (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what the average study set-up time was for interventional commercial clinical trials relating to (1) dementia, (2) cancer, (3) strokes, and (4) coronary heart disease, in the reporting period used to support their 15 April statement that the 150-day target had been met.
Answered by Baroness Merron - Parliamentary Under-Secretary (Department of Health and Social Care)
The UK Clinical Research Delivery key performance indicators report brings together data to monitor the delivery of globally competitive clinical research across the United Kingdom.
The report includes several indicators relating to study set-up. Indicator 1 measures the time it takes for commercial interventional clinical trials to recruit their first participant from the date initial clinical trial authorisation is submitted.
The information requested is shown in the following tables, as an unpublished subset of the statistics that were published on 15 April 2026 as part of the UK Clinical Research Delivery key performance indicators report, a copy of which is attached. The information is taken from studies held on the National Institute for Health and Care Research (NIHR) Research Delivery Network’s Central Portfolio Management System.
The following table shows the average number of days taken for commercial interventional clinical trials to recruit their first participant from the date initial clinical trial authorisation is submitted, for each of the disease types:
| Number of trials open to recruitment | Median number of days taken |
|
All | 73 | 122 | |
Dementia | 6 | 113 | |
Cancer | 23 | 123 | |
Stroke | 9 | 95 | |
Coronary heart disease | 5 | 108 | |
Studies are included where the application was submitted between 1 April 2025 and 30 September 2025. These data were processed and assured by the NIHR in the same way as those provided to the Department for publication in April 2026 of 150-day set-up performance, using established data checking processes within the NIHR's Research Delivery Network data and analytics and specialty teams. The same reporting period was used to support the 15 April 2026 press release Government drives forward its 150-day clinical trial target, a copy of which is attached.
The Department is committed to turbocharging clinical research and delivering better patient care, to make the UK a world-leading destination for clinical research. We are working to fast-track clinical trials to drive global investment into life sciences, improve health outcomes, and accelerate the development of medicines and therapies of the future, including for dementia, cancer, stroke and coronary heart disease.