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922426

	registered interest
	date	12/06/2018
	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	Department of Health and Social Care: Re-employment
	house id	1
	legislature	25259 pref label House of Commons
	question text	Can the Secretary of State for Health and Social Care, how many staff made redundant by his Department between January and March 2017 have been reemployed by his Department on (a) permanent, (b) agency or (c) contractor contracts.
	tabling member constituency	Leeds North West
	tabling member printed	Alex Sobel
	uin	152853
	answer	answer is ministerial correction date of answer 20/06/2018 answer text <p>No staff have been reemployed by the Department who previously left under compulsory or voluntary redundancy, between January and March 2017.</p> answering member constituency Gosport answering member printed Caroline Dinenage question first answered 20/06/2018 11:09:19 answering member 4008 label Biography information for Dame Caroline Dinenage
	tabling member	4658 label Biography information for Alex Sobel

922991

	registered interest
	date	12/06/2018
	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	Leukaemia: Ibrutinib
	house id	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty's Government (1) what evidence NHS England considered, (2) which clinicians it consulted, and (3) which patient groups it consulted when deciding that ibrutinib should not be prescribed to people with chronic lymphocytic leukaemia who have been in remission for more than three years.
	tabling member printed	Lord Mendelsohn
	uin	HL8564
	answer	answer is ministerial correction date of answer 26/06/2018 answer text <p>NHS England has advised that it develops treatment criteria for cancer and other high cost drugs to support implementation of National Institute for Health and Care Excellence (NICE) guidance and to ensure approved treatments are available as intended, with access funded consistently across the country. These criteria are developed by relevant expert clinical advisers, drawn from NHS England’s 42 Clinical Reference Groups (CRGs). These CRGs have been established to support clinical commissioning across the entire specialised commissioning portfolio.</p><p>In the case of NICE Technology Appraisal TA429 for ibrutinib in previously treated chronic lymphocytic leukaemia and untreated chronic lymphocytic leukaemia with 17p deletion or TP53 mutation, NICE issued the following statement on 8 June 2018:</p><p><strong> </strong>“Given the evidence that was considered by the NICE appraisal committee, we consider it reasonable for the guidance to be read as referring to those patients considered unsuitable for retreatment. Because unsuitability for retreatment is not defined in the guidance, we consider it appropriate for NHS England, as the commissioner, to take clinical advice in order to do so.”</p><p>NHS England took clinical advice in setting the specific treatment criteria linked to this appraisal and we are advised that the criteria were derived from the main study that had underpinned the NICE guidance and are consistent with guidance issued by the European Society for Medical Oncology last updated in June 2017. Between January 2017 and May 2018, nearly 1,000 patients were registered to receive treatment with ibrutinib in this indication. This is in line with NICE’s estimates that 700 adults per year would be eligible for treatment as a result of its guidance.</p><p>However, NHS England has further advised that it is more than willing to receive and review by the end of July, any further evidence that patients and clinicians wish to submit on this matter. The evidence will first be considered by NHS England’s Chemotherapy CRG, with advice and recommendations from this group then being submitted to the National Medical Director, Professor Steve Powis, for consideration.</p><p>During 2017/18, 1,193 Individual Funding Requests were considered by NHS England. An analysis of how may related to treatments for blood cancer has not been conducted.</p><p> </p> answering member printed Lord O'Shaughnessy grouped question UIN HL8561 HL8562 HL8563 question first answered 26/06/2018 12:13:53 answering member 4545 label Biography information for Lord O'Shaughnessy
	tabling member	4286 label Biography information for Lord Mendelsohn

922989

	registered interest
	date	12/06/2018
	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	NHS: Drugs
	house id	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty's Government how NHS England formulates approval criteria for drugs already approved by the National Institute for Health and Clinical Excellence; and how it involves (1) patients, and (2) clinicians in this process.
	tabling member printed	Lord Mendelsohn
	uin	HL8562
	answer	answer is ministerial correction date of answer 26/06/2018 answer text <p>NHS England has advised that it develops treatment criteria for cancer and other high cost drugs to support implementation of National Institute for Health and Care Excellence (NICE) guidance and to ensure approved treatments are available as intended, with access funded consistently across the country. These criteria are developed by relevant expert clinical advisers, drawn from NHS England’s 42 Clinical Reference Groups (CRGs). These CRGs have been established to support clinical commissioning across the entire specialised commissioning portfolio.</p><p>In the case of NICE Technology Appraisal TA429 for ibrutinib in previously treated chronic lymphocytic leukaemia and untreated chronic lymphocytic leukaemia with 17p deletion or TP53 mutation, NICE issued the following statement on 8 June 2018:</p><p><strong> </strong>“Given the evidence that was considered by the NICE appraisal committee, we consider it reasonable for the guidance to be read as referring to those patients considered unsuitable for retreatment. Because unsuitability for retreatment is not defined in the guidance, we consider it appropriate for NHS England, as the commissioner, to take clinical advice in order to do so.”</p><p>NHS England took clinical advice in setting the specific treatment criteria linked to this appraisal and we are advised that the criteria were derived from the main study that had underpinned the NICE guidance and are consistent with guidance issued by the European Society for Medical Oncology last updated in June 2017. Between January 2017 and May 2018, nearly 1,000 patients were registered to receive treatment with ibrutinib in this indication. This is in line with NICE’s estimates that 700 adults per year would be eligible for treatment as a result of its guidance.</p><p>However, NHS England has further advised that it is more than willing to receive and review by the end of July, any further evidence that patients and clinicians wish to submit on this matter. The evidence will first be considered by NHS England’s Chemotherapy CRG, with advice and recommendations from this group then being submitted to the National Medical Director, Professor Steve Powis, for consideration.</p><p>During 2017/18, 1,193 Individual Funding Requests were considered by NHS England. An analysis of how may related to treatments for blood cancer has not been conducted.</p><p> </p> answering member printed Lord O'Shaughnessy grouped question UIN HL8561 HL8563 HL8564 question first answered 26/06/2018 12:13:53 answering member 4545 label Biography information for Lord O'Shaughnessy
	tabling member	4286 label Biography information for Lord Mendelsohn

922990

	registered interest
	date	12/06/2018
	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	Blood Cancer
	house id	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty's Government how many Individual Funding Requests have been submitted to the NHS for the treatment of blood cancer; and of those, how many requests were (1) successful, and (2) unsuccessful.
	tabling member printed	Lord Mendelsohn
	uin	HL8563
	answer	answer is ministerial correction date of answer 26/06/2018 answer text <p>NHS England has advised that it develops treatment criteria for cancer and other high cost drugs to support implementation of National Institute for Health and Care Excellence (NICE) guidance and to ensure approved treatments are available as intended, with access funded consistently across the country. These criteria are developed by relevant expert clinical advisers, drawn from NHS England’s 42 Clinical Reference Groups (CRGs). These CRGs have been established to support clinical commissioning across the entire specialised commissioning portfolio.</p><p>In the case of NICE Technology Appraisal TA429 for ibrutinib in previously treated chronic lymphocytic leukaemia and untreated chronic lymphocytic leukaemia with 17p deletion or TP53 mutation, NICE issued the following statement on 8 June 2018:</p><p><strong> </strong>“Given the evidence that was considered by the NICE appraisal committee, we consider it reasonable for the guidance to be read as referring to those patients considered unsuitable for retreatment. Because unsuitability for retreatment is not defined in the guidance, we consider it appropriate for NHS England, as the commissioner, to take clinical advice in order to do so.”</p><p>NHS England took clinical advice in setting the specific treatment criteria linked to this appraisal and we are advised that the criteria were derived from the main study that had underpinned the NICE guidance and are consistent with guidance issued by the European Society for Medical Oncology last updated in June 2017. Between January 2017 and May 2018, nearly 1,000 patients were registered to receive treatment with ibrutinib in this indication. This is in line with NICE’s estimates that 700 adults per year would be eligible for treatment as a result of its guidance.</p><p>However, NHS England has further advised that it is more than willing to receive and review by the end of July, any further evidence that patients and clinicians wish to submit on this matter. The evidence will first be considered by NHS England’s Chemotherapy CRG, with advice and recommendations from this group then being submitted to the National Medical Director, Professor Steve Powis, for consideration.</p><p>During 2017/18, 1,193 Individual Funding Requests were considered by NHS England. An analysis of how may related to treatments for blood cancer has not been conducted.</p><p> </p> answering member printed Lord O'Shaughnessy grouped question UIN HL8561 HL8562 HL8564 question first answered 26/06/2018 12:13:53 answering member 4545 label Biography information for Lord O'Shaughnessy
	tabling member	4286 label Biography information for Lord Mendelsohn

922977

	registered interest
	date	12/06/2018
	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	Pharmaceutical Price Regulation Scheme
	house id	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty's Government how much income they have received from the profit cap in the Pharmaceutical Price Regulation Scheme since 2014; and to which department the rebate is paid.
	tabling member printed	Lord Freyberg
	uin	HL8550
	answer	answer is ministerial correction date of answer 26/06/2018 answer text <p>Under the 2014 Pharmaceutical Price Regulation Scheme (PPRS), scheme members make payments to the Department based on the difference between allowed percentage growth rate and actual percentage growth rate in National Health Service expenditure on branded medicines.</p><p>The 2014 PPRS has now delivered over £2.1 billion of PPRS payments.</p><table><tbody><tr><td><p>Year</p></td><td><p>Aggregate PPRS Payments</p></td></tr><tr><td><p>2014</p></td><td><p>£311 million</p></td></tr><tr><td><p>2015</p></td><td><p>£846 million</p></td></tr><tr><td><p>2016</p></td><td><p>£628 million</p></td></tr><tr><td><p>2017 Q1</p></td><td><p>£95 million</p></td></tr><tr><td><p>2017 Q2</p></td><td><p>£95 million</p></td></tr><tr><td><p>2017 Q3</p></td><td><p>£97 million</p></td></tr><tr><td><p>2017 Q4</p></td><td><p>£99 million</p></td></tr></tbody></table><p> </p><p>The Department receives the income on behalf of the United Kingdom, and then apportions the monies between ‎the four countries. All funds are reinvested in health services for patient benefit.</p><p>Following normal Government accounting rules, there is no separately identified or ring-fenced funding stream associated with PPRS payments.</p><p> </p> answering member printed Lord O'Shaughnessy question first answered 26/06/2018 12:17:54 answering member 4545 label Biography information for Lord O'Shaughnessy
	tabling member	2593 label Biography information for Lord Freyberg

922992

	registered interest
	date	12/06/2018
	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: Clinical Reference Groups
	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 transparency of the decision-making process of NHS England in relation to cancer clinical reference groups and the frequency with which such groups meet.
	tabling member printed	Lord Mendelsohn
	uin	HL8565
	answer	answer is ministerial correction date of answer 26/06/2018 answer text <p>NHS England’s current model of Clinical Reference Groups (CRG) was established following an extensive public engagement process which was completed during April 2016.</p><p>Since April 2016, the Cancer National Programme of Care has been supported by five CRGs (Chemotherapy, Radiotherapy, Specialised Cancer Surgery, Specialised Cancer Diagnostics and Children’s and Young People’s Cancer Services). The role of each CRG is to provide the primary source of clinical advice and leadership to NHS England on those services that are nationally commissioned. Each CRG comprises clinicians, patient and public voice representatives, professional association representation, public health experts and a commissioner and will usually meet between two and four times per year.</p><p>Transparency of decision making is important to NHS England. As a result, both stakeholder testing and public consultation are conducted regularly, in accordance with NHS England’s published Service Development Policy and Methods, in relation to the development of new clinical commissioning policy and service specifications.</p> answering member printed Lord O'Shaughnessy question first answered 26/06/2018 12:17:33 answering member 4545 label Biography information for Lord O'Shaughnessy
	tabling member	4286 label Biography information for Lord Mendelsohn

922993

	registered interest
	date	12/06/2018
	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	Obesity
	house id	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty's Government what is the estimated cost to the NHS of the treatment of obesity in (1) 2016, and (2) 2017.
	tabling member printed	Lord Pendry
	uin	HL8566
	answer	answer is ministerial correction date of answer 26/06/2018 answer text <p><em>The economic burden of ill health due to diet, physical inactivity, smoking, alcohol and obesity in the UK: an update to 2006-07 NHS costs</em> estimated that overweight and obesity cost the National Health Service in the United Kingdom £5.1 billion per year. This figure was uplifted to £6.1 billion in 2014/15 to take account of inflation. No estimates have been made centrally of the cost of obesity in 2016 or 2017.</p><p> </p><p>A copy of <em>The economic burden of ill health due to diet, physical inactivity, smoking, alcohol and obesity in the UK: an update to 2006-07 NHS costs</em> is attached.</p> answering member printed Lord O'Shaughnessy question first answered 26/06/2018 12:08:25 answering member 4545 label Biography information for Lord O'Shaughnessy attachment 1 file name Cost of obesity.pdf title The economic burden of ill health due to diet
	tabling member	457 label Biography information for Lord Pendry

922988

	registered interest
	date	12/06/2018
	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	Medical Treatments
	house id	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty's Government what process NHS England used to interpret guidance on individual treatments issued by the National Institute of Health and Clinical Excellence; and how they ensure such guidance is implemented consistently across England.
	tabling member printed	Lord Mendelsohn
	uin	HL8561
	answer	answer is ministerial correction date of answer 26/06/2018 answer text <p>NHS England has advised that it develops treatment criteria for cancer and other high cost drugs to support implementation of National Institute for Health and Care Excellence (NICE) guidance and to ensure approved treatments are available as intended, with access funded consistently across the country. These criteria are developed by relevant expert clinical advisers, drawn from NHS England’s 42 Clinical Reference Groups (CRGs). These CRGs have been established to support clinical commissioning across the entire specialised commissioning portfolio.</p><p>In the case of NICE Technology Appraisal TA429 for ibrutinib in previously treated chronic lymphocytic leukaemia and untreated chronic lymphocytic leukaemia with 17p deletion or TP53 mutation, NICE issued the following statement on 8 June 2018:</p><p><strong> </strong>“Given the evidence that was considered by the NICE appraisal committee, we consider it reasonable for the guidance to be read as referring to those patients considered unsuitable for retreatment. Because unsuitability for retreatment is not defined in the guidance, we consider it appropriate for NHS England, as the commissioner, to take clinical advice in order to do so.”</p><p>NHS England took clinical advice in setting the specific treatment criteria linked to this appraisal and we are advised that the criteria were derived from the main study that had underpinned the NICE guidance and are consistent with guidance issued by the European Society for Medical Oncology last updated in June 2017. Between January 2017 and May 2018, nearly 1,000 patients were registered to receive treatment with ibrutinib in this indication. This is in line with NICE’s estimates that 700 adults per year would be eligible for treatment as a result of its guidance.</p><p>However, NHS England has further advised that it is more than willing to receive and review by the end of July, any further evidence that patients and clinicians wish to submit on this matter. The evidence will first be considered by NHS England’s Chemotherapy CRG, with advice and recommendations from this group then being submitted to the National Medical Director, Professor Steve Powis, for consideration.</p><p>During 2017/18, 1,193 Individual Funding Requests were considered by NHS England. An analysis of how may related to treatments for blood cancer has not been conducted.</p><p> </p> answering member printed Lord O'Shaughnessy grouped question UIN HL8562 HL8563 HL8564 question first answered 26/06/2018 12:13:53 answering member 4545 label Biography information for Lord O'Shaughnessy
	tabling member	4286 label Biography information for Lord Mendelsohn

922978

	registered interest
	date	12/06/2018
	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	DeepMind
	house id	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty's Government whether any underlying data from the Royal Free London and Moorfields Eye hospitals used by DeepMind is subject to contractual constraints that would prevent other innovators from developing similar commercial algorithms using the same data.
	tabling member printed	Lord Freyberg
	uin	HL8551
	answer	answer is ministerial correction date of answer 26/06/2018 answer text <p>These agreements were entered into with DeepMind locally and separately by the two trusts. We are not aware of any exclusivity in either set of contractual arrangements. The Royal Free’s contract with DeepMind <em>Services Agreement between DeepMind Technologies Limited and Royal Free London NHS Foundation Trust </em>is publicly available, and a copy is attached.</p><p>The use of innovative technologies offers great opportunities to improve patient care, reduce pressure on clinicians and provide more efficient, sustainable and personalised health and care services. However, patients’ privacy and right to consent to the sharing of their data outside direct care must be respected and data must only be shared on the correct legal basis, and in line with guidance from the Information Commissioner’s Office and the National Data Guardian.</p> answering member printed Lord O'Shaughnessy question first answered 26/06/2018 12:15:19 answering member 4545 label Biography information for Lord O'Shaughnessy attachment 1 file name REDACTED - FULLY EXECUTED DeepMind RFL Services Agreement.pdf title Services Agreement DeepMind and Royal Free
	tabling member	2593 label Biography information for Lord Freyberg

922984

	registered interest
	date	12/06/2018
	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	Drugs: Marketing
	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 5 June (HL8120), whether they will publish details of the changes to Marketing Authorisation Holder fee models they are calling for at a (1) national, and (2) European level to take account of the specific situation of small companies; and whether they are calling for fee waivers for a wider number of Marketing Authorisation Holders than in SecurMed’s new fee waiver scheme.
	tabling member printed	Lord Hunt of Kings Heath
	uin	HL8557
	answer	answer is ministerial correction date of answer 26/06/2018 answer text <p>In their supervisory capacity, the Department and the Medicines and Healthcare products Regulatory Agency’s aim is to ensure that SecurMed is complying with the regulation in a fair and proportionate way and this includes consideration of their fee structure. We are not seeking changes to SecurMed’s fee model at this time, including wider fee waivers. We have no current plans to publish details of our supervisory role, but to date this has included scrutiny over the European Medicines Verification Organisation’s blue print resulting from their assessment of different cost-allocation models; aligning the United Kingdom’s approach with other European Union National Medicines Verification Organisations; and seeking to ensure that the fee model is fit for purpose for the UK.</p> answering member printed Lord O'Shaughnessy question first answered 26/06/2018 12:10:15 answering member 4545 label Biography information for Lord O'Shaughnessy
	tabling member	2024 label Biography information for Lord Hunt of Kings Heath