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1017055

registered interest
date	28/11/2018
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Cancer: Screening
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government, further to the Written Answer by Lord O'Shaughnessy on 27 November (HL11452), what was the average turnaround time from sample collection to clinical report for Genomic England's somatic whole genome sequencing for cancer patients in the last six months; what is the most clinically useful timeframe from sample collection to clinical report for such genome sequencing; and how many cancer patients in Genomic England's programme have died to date without receiving their clinical report.
tabling member printed	Lord Freyberg
uin	HL11900
answer	answer is ministerial correction date of answer 06/12/2018 answer text <p>Following reengineering of tumour provision to fresh tissue supply and creating 300 pathways for tumour supply across the 13 NHS Genomic Medicine Centres (GMCs), Genomics England has continued to work with the National Health Service to improve throughput over the life of the programme.</p><p>Over the past six months, the average (median) turnaround time for cancer cases from enrolment to return of analysis was 39 working days. For fast-tracked and clinically urgent cases, this average over the last six months is 25 working days. By September 2018, Genomics England were returning samples at scale in 20 days or less demonstrating the improvements in the majority of cases received.</p><p>The most clinically useful timeframe depends on each individual patient’s clinical circumstances. As the 100,000 Genomes Project is a research programme, patients were all offered the NHS standard of care for their condition, in addition to Whole Genome Sequencing, so their therapy could proceed as rapidly as needed. During the 100,000 Genomes Project about half of the cancer cases in the Project contained actionable findings identifying a potential targeted therapy or clinical trial opportunity.</p><p>To date, 5,801 participants results have been returned to NHS GMCs (some participants have multiple reports). In total, 506 participants in the 100,000 Genomes Project, many of whom had advanced disease at the time of enrolment, died before Genomics England returned a whole genome analysis to the NHS. Of these, 176 were participants who died before their DNA samples were received by Genomics England. In many cases the deceased cancer participants became part of the Project via consent by a nominated representative, relative or friend because of the value for research to help others even though it was too late for the individual concerned.</p> answering member printed Lord O'Shaughnessy question first answered 06/12/2018 14:46:02 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	2593 label Biography information for Lord Freyberg

1017056

registered interest
date	28/11/2018
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Cancer: Screening
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government what economic modelling NHS England has carried out on the net budgetary impact of introducing a national molecular pathology service in cancer; what estimate they have made of the direct annual cost of such a service; whether they have considered switching off any legacy services to help fund its introduction; and if so, which.
tabling member printed	Lord Freyberg
uin	HL11901
answer	answer is ministerial correction date of answer 06/12/2018 answer text <p>NHS England is developing a National Genomic Medicine service and this will bring together both existing clinical genetics services, and new genomic laboratory infrastructure to provide seamless service delivery for patients with rare and inherited disease and cancer. However, NHS England is not introducing a national molecular pathology service in cancer and therefore has not carried out economic modelling or an estimate of cost for such a service.</p><p>A key element of the Genomic Medicine Service is the National Genomic Test Directory which outlines the entire repertoire of genomic tests – from existing tests for single genes and molecular markers Whole Genomic Sequencing to Whole Genome Sequencing – that are available as part of the National Health Service clinical service. This includes cancer genomic tests.</p><p>As part of the NHS Genomic Medicine Service, a National Genomics Informatics System (NGIS) is being developed by Genomics England, on behalf of NHS England. When fully operational NGIS will enable NHS England to monitor the number of genomic tests being carried out across the country and benchmark activity.</p> answering member printed Lord O'Shaughnessy question first answered 06/12/2018 14:46:33 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	2593 label Biography information for Lord Freyberg

1007501

registered interest
date	14/11/2018
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Cancer: Screening
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government what assessment they have made of (1) the economic importance of clinical trial recruitment, especially in cancer research, to the UK economy, and (2) the importance of timely molecular testing in modern cancer trial recruitment; and whether, as a result of any such assessment, NHS England will consider implementing national somatic gene testing in cancers with low survival rates to catalyse research.
tabling member printed	Lord Freyberg
uin	HL11501
answer	answer is ministerial correction date of answer 28/11/2018 answer text <p>Clinical trial recruitment is important to the United Kingdom economy, especially in cancer research. For example, an independent report, commissioned by the National Institute for Health Research (NIHR) Clinical Research Network (CRN) and produced by KPMG’s Economics team, provided an assessment of the economic impact of the NIHR Clinical Research Network’s activities to support clinical research in the UK. The report estimated the gross value added and employment in the UK from CRN supported clinical research activity. It estimated that in the period April 2014 to March 2015 (financial year 2014/15) this activity generated a total of £2.4 billion gross value added and almost 39,500 jobs. Studies on cancer comprise a major part of CRN activity. A copy of <em>NIHR Clinical Research Network: Impact and Value Assessment</em> is attached.</p><p>A growing proportion of cancer trials supported by the NIHR involve molecular testing. One of the main purposes of the NIHR is to initiate studies speedily, and deliver them to time and target. Therefore timely molecular testing is important. This involves working with National Health Service pathology services to ensure that all essential steps are in place to deliver research studies.</p><p>The Chief Scientific Adviser has not made a specific assessment of the importance of molecular testing to drive cancer trial treatment. If a clinical trial that is to be delivered by the NIHR involves somatic gene testing that is not already in place, then the NHS will set up this new somatic gene testing as part of the delivery of the trial. Thus it is the nature of the research that drives clinical trial recruitment rather than the nature of the somatic gene testing that is in place.</p> answering member printed Lord O'Shaughnessy grouped question UIN HL11502 question first answered 28/11/2018 14:50:06 answering member 4545 label Biography information for Lord O'Shaughnessy attachment 1 file name NIHR_CRN_Impact_and_Value_Assessment.pdf title NIHR_CRN_Impact_and_Value_Assessment
tabling member	2593 label Biography information for Lord Freyberg

1007502

registered interest
date	14/11/2018
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Cancer: Screening
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government what assessment the Chief Scientific Adviser has made of the importance of molecular testing to drive modern cancer trial recruitment, and of the introduction of such testing for which cancers offer the most value to the UK in terms of driving clinical trial recruitment.
tabling member printed	Lord Freyberg
uin	HL11502
answer	answer is ministerial correction date of answer 28/11/2018 answer text <p>Clinical trial recruitment is important to the United Kingdom economy, especially in cancer research. For example, an independent report, commissioned by the National Institute for Health Research (NIHR) Clinical Research Network (CRN) and produced by KPMG’s Economics team, provided an assessment of the economic impact of the NIHR Clinical Research Network’s activities to support clinical research in the UK. The report estimated the gross value added and employment in the UK from CRN supported clinical research activity. It estimated that in the period April 2014 to March 2015 (financial year 2014/15) this activity generated a total of £2.4 billion gross value added and almost 39,500 jobs. Studies on cancer comprise a major part of CRN activity. A copy of <em>NIHR Clinical Research Network: Impact and Value Assessment</em> is attached.</p><p>A growing proportion of cancer trials supported by the NIHR involve molecular testing. One of the main purposes of the NIHR is to initiate studies speedily, and deliver them to time and target. Therefore timely molecular testing is important. This involves working with National Health Service pathology services to ensure that all essential steps are in place to deliver research studies.</p><p>The Chief Scientific Adviser has not made a specific assessment of the importance of molecular testing to drive cancer trial treatment. If a clinical trial that is to be delivered by the NIHR involves somatic gene testing that is not already in place, then the NHS will set up this new somatic gene testing as part of the delivery of the trial. Thus it is the nature of the research that drives clinical trial recruitment rather than the nature of the somatic gene testing that is in place.</p> answering member printed Lord O'Shaughnessy grouped question UIN HL11501 question first answered 28/11/2018 14:50:06 answering member 4545 label Biography information for Lord O'Shaughnessy attachment 1 file name NIHR_CRN_Impact_and_Value_Assessment.pdf title NIHR_CRN_Impact_and_Value_Assessment
tabling member	2593 label Biography information for Lord Freyberg

1006668

registered interest
date	13/11/2018
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Cancer: Screening
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government which cancers have been recommended by NICE for molecular testing; and of those cancers, for which biomarkers in relation to (1) prognostic tests, and (2) theranostic or treatment predictive tests.
tabling member printed	Lord Freyberg
uin	HL11448
answer	answer is ministerial correction date of answer 27/11/2018 answer text <p>The National Institute for Health and Care Excellence (NICE) recommends molecular testing for the following cancers:</p><p>- Acute myeloid leukaemia;</p><p>- Bladder;</p><p>- Brain;</p><p>- Breast;</p><p>- Chronic lymphocytic leukaemia;</p><p>- Chronic myeloid leukaemia;</p><p>- Colorectal;</p><p>- Non-small-cell lung cancer;</p><p>- Melanoma;</p><p>- Oesophago-gastric;</p><p>- Ovarian, fallopian tube and peritoneal;</p><p>- Pancreatic;</p><p>- Prostate;</p><p>- Upper aerodigestive tract; and</p><p>- Unknown primary origin.</p><p>NICE refers to the following companion diagnostic biomarkers in its guidance:</p><p>- c-Kit (CD117);</p><p>- HER2;</p><p>- KRAS;</p><p>- EGFR-TK;</p><p>- Philadelphia chromosome;</p><p>- BRAF V600;</p><p>- ALK;</p><p>- BRCA;</p><p>- p53;</p><p>- PD-L1;</p><p>- RAS;</p><p>- BCR-ABL1;</p><p>- FLT3;</p><p>- ROS1;</p><p>- BRCA1 (germline); and</p><p>- Somatostatin receptor-positive.</p><p> </p><p>Tests that are primarily used for diagnosis, monitoring or screening often provide prognostic information. Consequently, there are a large number of biomarkers, many of which are used in standard testing practice and so are not specifically referred to in NICE guidance. Multiple and combinations of biomarkers are often used to provide prognostic information and companies developing tests often create their own combinations.</p><p>As many tests look for multiple biomarkers for a single purpose and many tests in standard practice provide prognostic information, NICE is unable to provide categorical information on prognostic tests.</p> answering member printed Lord O'Shaughnessy question first answered 27/11/2018 15:29:48 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	2593 label Biography information for Lord Freyberg

1006669

registered interest
date	13/11/2018
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Cancer: Screening
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government which NHS England trusts currently carry out cancer tests in compliance with NICE guidelines; and in relation to which cancers.
tabling member printed	Lord Freyberg
uin	HL11449
answer	answer is ministerial correction date of answer 27/11/2018 answer text <p>NHS England does not hold this information.</p> answering member printed Lord O'Shaughnessy grouped question UIN HL11450 HL11451 question first answered 27/11/2018 15:48:20 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	2593 label Biography information for Lord Freyberg

1006670

registered interest
date	13/11/2018
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Cancer: Screening
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government which NHS England trusts, if any, have secured funding to test for cancers clinically beyond the NICE guidelines, including through use of theranostic tests and somatic gene panels that can report back to patients within a clinically actionable time frame; and in relation to which cancers.
tabling member printed	Lord Freyberg
uin	HL11450
answer	answer is ministerial correction date of answer 27/11/2018 answer text <p>NHS England does not hold this information.</p> answering member printed Lord O'Shaughnessy grouped question UIN HL11449 HL11451 question first answered 27/11/2018 15:48:20 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	2593 label Biography information for Lord Freyberg

1006671

registered interest
date	13/11/2018
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Cancer: Screening
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government what assessment they have made of the main reasons for non-compliance with NICE guidelines for testing for cancer by NHS England trusts.
tabling member printed	Lord Freyberg
uin	HL11451
answer	answer is ministerial correction date of answer 27/11/2018 answer text <p>NHS England does not hold this information.</p> answering member printed Lord O'Shaughnessy grouped question UIN HL11449 HL11450 question first answered 27/11/2018 15:48:20 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	2593 label Biography information for Lord Freyberg

1006672

registered interest
date	13/11/2018
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	Cancer: Screening
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government what progress they have made towards the Cancer Task Force’s recommendation for a national molecular pathology service; and when they anticipate to implement this fully in relation to adult cancer diagnosis and care.
tabling member printed	Lord Freyberg
uin	HL11452
answer	answer is ministerial correction date of answer 27/11/2018 answer text <p>In 2015, the Independent Cancer Taskforce Report highlighted limited access to molecular diagnostics across the National Health Service and limited use of technology to systematically identify patients with cancer and suggested that this has resulted in the NHS falling behind other countries in the delivery of high-quality, cost-effective cancer care.</p><p>To address this, building on the world leading 100,000 Genomes Project and the existing infrastructure, NHS England announced in October 2018 that over the next 18 months work to mobilise the NHS Genomic Medicine Service (GMS) would get underway. The GMS will bring together existing clinical genetics services and the new genomic laboratory infrastructure to provide seamless service delivery for patients with rare and inherited disease and cancer.</p> answering member printed Lord O'Shaughnessy question first answered 27/11/2018 15:48:42 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	2593 label Biography information for Lord Freyberg