Asked by: Lord Willis of Knaresborough (Liberal Democrat - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government, if Avastin is approved for safe use, whether it could be privately purchased for use by a patient being treated on the NHS.
Answered by Baroness Blackwood of North Oxford
For patients receiving private and National Health Service care for the same condition, NHS and private treatment can be supervised by one healthcare team. However, patients cannot choose to mix different parts of the same treatment between NHS and private care.
For example, a patient cannot have a cataract operation on the NHS and pay privately for special lens implants that are normally only available as part of private care.
Instead, a patient either has both the operation on the NHS and standard NHS lens implants or pay for both the operation and implants privately.
Asked by: Lord Willis of Knaresborough (Liberal Democrat - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government whether liver and bowel transplantation is currently approved by the National Institute for Health and Care Excellence for cancer patients; and if not, whether there are any clinical trials that have reached Phase 3.
Answered by Baroness Blackwood of North Oxford
The National Institute for Health and Care Excellence has not produced any guidance relating to combined liver and bowel transplants for cancer patients.
The Department funds research mainly through the National Institute for Health Research (NIHR). The usual practice of the NIHR and other research funders is not to ring-fence funds for expenditure on particular topics. The NIHR welcomes funding applications for research into any aspect of human health, including liver and bowel transplantation.
There has been one relevant clinical trial that reached Phase 3:
Study title: In open, prospective, single arm study investigating efficacy and safety of human hepatitis B immunoglobulin Zutectra in liver transplanted patients - the ZEUS Study.
Date: 22 November 2012 – 10 April 2014
Asked by: Lord Willis of Knaresborough (Liberal Democrat - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government whether there are (1) current applications, or (2) pending requests, for the use of Avastin following Phase 3 clinical trials.
Answered by Baroness Blackwood of North Oxford
To extend the indication of Avastin, the Marketing Authorisation Holder (Roche Registration GmbH) would need to submit the results of relevant clinical trials and other information to the European Medicines Agency (EMA) to demonstrate acceptable safety and efficacy and a positive balance of benefit to risk. At present, as Avastin has a European Community Marketing Authorisation, a national submission to the Medicines and Healthcare products Regulatory Agency to extend the indication is not possible.
There has not been any recent positive opinion from the EMA for a new indication of Avastin to be submitted to the European Commission and the EMA has not published any pending extension of indication applications.
Asked by: Lord Willis of Knaresborough (Liberal Democrat - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government why Avastin is not routinely made available on the NHS for certain groups of cancer patients.
Answered by Baroness Blackwood of North Oxford
Most new medicines are assessed by the National Institute for Health and Care Excellence (NICE) which makes recommendations for the National Health Service on whether they represent a clinically and cost effective use of NHS resources. Since 2016, NICE makes recommendations for the NHS on all new licensed cancer medicines through its technology appraisal programme. NHS commissioners are legally required to fund treatments recommended in NICE technology appraisal guidance.
NICE has appraised Avastin (bevacizumab) for use in the treatment of a number of different types of cancer and has unfortunately not been able to recommend it as a clinically and cost effective use of NHS resources for any type of cancer at the price offered by the drug company. Avastin is not therefore routinely funded by the NHS for any licensed indication.
Avastin is funded as an off-label treatment for some types of cancer through the Cancer Drugs Fund.
Asked by: Lord Willis of Knaresborough (Liberal Democrat - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government whether Avastin has approval from the European Medicines Authority to be used to treat cancer.
Answered by Baroness Blackwood of North Oxford
Avastin has approval from the European Medicines Agency to be used to treat cancer in combination with specific chemotherapies in the advanced stages of several cancers. They are:
- Metastatic colorectal cancer;
- Metastatic breast cancer;
- Certain types of unresectable advanced, metastatic or recurrent lung cancer;
- Advanced or metastatic renal cell cancer;
- Advanced or recurrent or resistant ovarian/fallopian tube cancer; and
- Persistent or recurrent or metastatic cervical cancer.
Full details of the indications that Avastin is licensed for can be found in the European public assessment report for Avastin. It explains how the Agency assessed the medicine to recommend its authorisation and its conditions of use and is publicly available on their website.
Asked by: Lord Willis of Knaresborough (Liberal Democrat - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government which clinical trials are currently recruiting patients with HER2+ breast cancer.
Answered by Baroness Blackwood of North Oxford
The Department’s National Institute for Health Research (NIHR) is currently recruiting to 15 clinical trials for people with HER2+ breast cancer via its Clinical Research Network. The majority of these are commercially funded. To date, a total of 7,986 participants have been recruited to these 15 trials.
Of the 15 clinical trials, 12 are commercially sensitive, with appropriate cost recovery from the companies. The data for these commercial trials has been provided from the relevant companies as ‘commercial in confidence’ hence we are unable to provide details about these trials such as their titles.
However, the three clinical trials which are not commercially sensitive are:
- Cancer Research UK; NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC). Title: The UK plasma based Molecular profiling of Advanced breast cancer to inform Therapeutic Choices (plasmaMATCH);
- Cancer Research UK. Title: Response to Optimal Selection of neo-adjuvant Chemotherapy in Operable breast cancer; and
- Medical Research Council. Title: A mechanistic non-invasive imaging study of HER2 expression in breast cancer using [18F]GE-226 positron emission tomography.
Asked by: Lord Willis of Knaresborough (Liberal Democrat - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what are the drugs approved by NICE to treat HER2+ breast cancer; and what assessment they have made of the efficacy of such drugs.
Answered by Baroness Blackwood of North Oxford
The National Institute for Health and Care Excellence (NICE) is the independent body responsible for making recommendations for the National Health Service on whether drugs and other treatments represent a clinically and cost effective use of NHS resources.
NICE has recommended the following drugs for the treatment of HER2-positive breast cancer: trastuzumab emtansine (Kadcyla) for treating HER2-positive advanced breast cancer after trastuzumab (Herceptin) and a taxane; pertuzumab (Perjeta) with trastuzumab (Herceptin) and docetaxel for treating HER2-positive breast cancer; pertuzumab (Perjeta) for the neoadjuvant treatment of HER2-positive breast cancer; and pertuzumab (Perjeta) for adjuvant treatment of HER2-positive early stage breast cancer.
NHS commissioners are legally required to fund drugs recommended in NICE technology appraisal guidance. It is for clinicians to decide on the most appropriate treatment for an individual patient based on their clinical judgement and in discussion with the patient.
Asked by: Lord Willis of Knaresborough (Liberal Democrat - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what advice they provide to clinicians for the use of Pertuzumab rather than Herceptin for the treatment of HER2+ breast cancer.
Answered by Baroness Blackwood of North Oxford
The National Institute for Health and Care Excellence (NICE) is the independent body responsible for making recommendations for the National Health Service on whether drugs and other treatments represent a clinically and cost effective use of NHS resources.
NICE has recommended the following drugs for the treatment of HER2-positive breast cancer: trastuzumab emtansine (Kadcyla) for treating HER2-positive advanced breast cancer after trastuzumab (Herceptin) and a taxane; pertuzumab (Perjeta) with trastuzumab (Herceptin) and docetaxel for treating HER2-positive breast cancer; pertuzumab (Perjeta) for the neoadjuvant treatment of HER2-positive breast cancer; and pertuzumab (Perjeta) for adjuvant treatment of HER2-positive early stage breast cancer.
NHS commissioners are legally required to fund drugs recommended in NICE technology appraisal guidance. It is for clinicians to decide on the most appropriate treatment for an individual patient based on their clinical judgement and in discussion with the patient.
Asked by: Lord Willis of Knaresborough (Liberal Democrat - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what assessment they have made of whether the innovations arising from the current phase of Academic Health Science Centres are being made available to patients throughout the NHS.
Answered by Baroness Blackwood of North Oxford
The Department-designated Academic Health Science Centres (AHSCs) along with the Academic Health Science Networks (AHSNs) and the National Institute for Health Research (NIHR) Applied Research Collaborations (ARCs) are all important components of the country’s health research and innovation ecosystem.
The six current Department-designated AHSCs were made on the basis of an open competition, which was open to eligible National Health Service and University partnerships across England. The recommendations for designation were made to the Department by an international independent panel.
The remit of the Accelerated Access Collaborative (AAC) has recently been expanded to become the umbrella body across the United Kingdom health innovation eco-system. The AAC has been asked to consider the role of new AHSCs within the health system and to ensure that they complement the innovation landscape, rather than add further complexity to it.
It is not possible to provide specific details of the scope and nature of the new designation process at this stage given that the AAC is currently actively considering this. However, it is expected that the future designation process would be open to all NHS and University partnerships across England which meet the published specification to apply, including partnerships in areas of England where there is currently no Departmental-AHSC. As with the previous AHSC designation process, any future process will be run via a full and open competition, assessed by an independent expert panel. Rigorous conflict of interest policies will also be in place throughout the process for all involved to ensure any potential conflicts are dealt with appropriately.
The existing Departmental-AHSC designation will be extended until the end of March 2020 to enable a new designation process to be undertaken. The Department’s expectation is that AHSCs will play an increasingly important role in the health innovation and research landscape over the coming years.
As currently, the success of any newly designated AHSCs will require close interplay and cooperation between research infrastructure, including NIHR Biomedical Research Centres (BRCs) and the NIHR ARCs, and with the AHSNs and wider innovation landscape.
As part of annual monitoring of the existing Department-designated AHSCs, examples of innovations arising from them have been reported to have been made available to patients in the NHS. These include:
- The King’s Health Partners Heart Failure Service, which brings together clinical, research and educational expertise to deliver world class heart care in south London, helping people with heart failure live longer and with better quality of life;
- University College London Partners AHSC adoption of a Learning Health System to standardise data entry and allowing the widespread trialling of novel tools to detect atrial fibrillation early;
- The Manchester AHSC working with partners to align research around core health and social care priorities; and supporting the roll out of a single blood test driven decision-aid for patients presenting with chest pain at local emergency departments; and
- The roll out of the innovative Sleepio app by the Oxford AHSN to support those suffering from insomnia across Oxfordshire, Berkshire and Buckinghamshire.
Asked by: Lord Willis of Knaresborough (Liberal Democrat - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what the future relationship will be between Academic Health Science Networks, Academic Health Science Centres and Academic Research Collaborations with regard to the future applied health science ecosystem.
Answered by Baroness Blackwood of North Oxford
The Department-designated Academic Health Science Centres (AHSCs) along with the Academic Health Science Networks (AHSNs) and the National Institute for Health Research (NIHR) Applied Research Collaborations (ARCs) are all important components of the country’s health research and innovation ecosystem.
The six current Department-designated AHSCs were made on the basis of an open competition, which was open to eligible National Health Service and University partnerships across England. The recommendations for designation were made to the Department by an international independent panel.
The remit of the Accelerated Access Collaborative (AAC) has recently been expanded to become the umbrella body across the United Kingdom health innovation eco-system. The AAC has been asked to consider the role of new AHSCs within the health system and to ensure that they complement the innovation landscape, rather than add further complexity to it.
It is not possible to provide specific details of the scope and nature of the new designation process at this stage given that the AAC is currently actively considering this. However, it is expected that the future designation process would be open to all NHS and University partnerships across England which meet the published specification to apply, including partnerships in areas of England where there is currently no Departmental-AHSC. As with the previous AHSC designation process, any future process will be run via a full and open competition, assessed by an independent expert panel. Rigorous conflict of interest policies will also be in place throughout the process for all involved to ensure any potential conflicts are dealt with appropriately.
The existing Departmental-AHSC designation will be extended until the end of March 2020 to enable a new designation process to be undertaken. The Department’s expectation is that AHSCs will play an increasingly important role in the health innovation and research landscape over the coming years.
As currently, the success of any newly designated AHSCs will require close interplay and cooperation between research infrastructure, including NIHR Biomedical Research Centres (BRCs) and the NIHR ARCs, and with the AHSNs and wider innovation landscape.
As part of annual monitoring of the existing Department-designated AHSCs, examples of innovations arising from them have been reported to have been made available to patients in the NHS. These include:
- The King’s Health Partners Heart Failure Service, which brings together clinical, research and educational expertise to deliver world class heart care in south London, helping people with heart failure live longer and with better quality of life;
- University College London Partners AHSC adoption of a Learning Health System to standardise data entry and allowing the widespread trialling of novel tools to detect atrial fibrillation early;
- The Manchester AHSC working with partners to align research around core health and social care priorities; and supporting the roll out of a single blood test driven decision-aid for patients presenting with chest pain at local emergency departments; and
- The roll out of the innovative Sleepio app by the Oxford AHSN to support those suffering from insomnia across Oxfordshire, Berkshire and Buckinghamshire.