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1385862

	registered interest
	date	07/12/2021
	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	National Institute for Health and Care Excellence
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, with reference to the NICE Methods Review, if he will hold discussions with NICE in the event that its new methods for appraising medicines impact on the number of patients receiving access to promising treatments.
	tabling member constituency	Bolton West
	tabling member printed	Chris Green
	uin	88744
	answer	answer is ministerial correction date of answer 15/12/2021 answer text <p>Departmental officials regularly discuss a range of issues with the National Institute for Health and Care Excellence (NICE), including the ongoing methods and process review.</p><p>NICE recommends the vast majority of medicines it appraises. It has consulted on proposed changes to its methods and processes which will ensure it retains global leadership in the evaluation of new medicines and technologies and provides more equitable access for patients with severe diseases. NICE has undertaken analysis of the impact of its proposed methods in developing the proposals.</p><p>NICE is proposing a number of changes to ensure its methods and process are fairer, more consistent and accelerate the introduction of emerging new types of technology. This will support the Life Sciences Vision’s commitment to make the United Kingdom the best place in the world to develop, trial, launch and adopt innovative new medicines, improving patient access to medicines.</p> answering member constituency Charnwood answering member printed Edward Argar grouped question UIN 88743 88745 question first answered 15/12/2021 17:02:13 answering member 4362 label Biography information for Edward Argar
	tabling member	4398 label Biography information for Chris Green

1129861

	registered interest
	date	04/06/2019
	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	National Institute for Health and Care Excellence
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, who will lead the planned methods and processes review of the National Institute for Health and Care Excellence.
	tabling member constituency	West Ham
	tabling member printed	Lyn Brown
	uin	259922
	answer	answer is ministerial correction date of answer 12/06/2019 answer text <p>The National Institute for Health and Care Excellence (NICE) is an independent body and is responsible for the methods and processes used in the development of its technology appraisal and highly specialised technology recommendations. NICE has now initiated the review of its technology appraisal and highly specialised technologies methods in line with the commitment made in the 2019 Voluntary Scheme for Branded Medicines Pricing and Access.</p><p> </p><p>The Voluntary Scheme states that industry and other relevant stakeholders will be active participants in the review, including inputting on scope, participating in working discussions, and providing views on recommendations. NICE’s updated methods guide will be subject to a public consultation.</p><p> </p><p>NICE has established a working group consisting of members from NICE, NHS England, the Department, patient organisations and the life sciences industry. The working group reports to a steering group, chaired by NICE and with members from NHS England, the Department, and an independent academic methodologist. The steering group will present its recommendations to NICE’s senior management team, which in turn will report to the NICE Board.</p><p> </p><p>NICE is in the process of scoping of the review of the methods for technology appraisal and highly specialised technologies evaluations, with input from the working group and steering group. The scope of the review - a list of the aspects of NICE’s current methods that will be considered in the review - will be presented to the NICE Board in July. Additional detail and more information will be made available on the NICE website in due course. NICE anticipate being in a position to confirm the revised methods guide by the end of 2020, following public consultation.</p> answering member constituency South Ribble answering member printed Seema Kennedy grouped question UIN 259921 259923 259924 question first answered 12/06/2019 16:31:07 answering member 4455 label Biography information for Seema Kennedy
	tabling member	1583 label Biography information for Ms Lyn Brown

1131740

	registered interest
	date	12/06/2019
	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	National Institute for Health and Care Excellence
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, which topics have been identified for inclusion in the upcoming review of the appraisal methods used by NICE.
	tabling member constituency	Cambridge
	tabling member printed	Daniel Zeichner
	uin	263870
	answer	answer is ministerial correction date of answer 20/06/2019 answer text <p>The National Institute for Health and Care Excellence (NICE) is an independent body and is responsible for the methods and processes used in the development of its technology appraisal and highly specialised technologies recommendations. NICE has now initiated the review of its technology appraisal and highly specialised technologies methods in line with the commitment made in the 2019 Voluntary Scheme for Branded Medicines Pricing and Access.</p><p> </p><p>The Voluntary Scheme states that industry and other relevant stakeholders will be active participants in the review, including inputting on scope, participating in working discussions, and providing views on recommendations. NICE’s updated methods guide will also be subject to a public consultation.</p><p> </p><p>NICE has established a working group, consisting of members from NICE, NHS England, the Department, patient organisations and the life sciences industry. The working group reports to a steering group, chaired by NICE and with members from NHS England, the Department, and an independent academic methodologist. The steering group will present its recommendations to NICE’s Senior Management Team, which in turn will report to the NICE Board. NICE approached patient groups with experience of NICE and its processes and methods. There are three patient group representatives on the working group with a wide range of experience, covering a range of topic areas, reflecting the programmes under review. Membership of the working group will be published in due course.</p><p> </p><p>NICE is now in the process of scoping the review of the methods for technology appraisal and highly specialised technologies evaluations with input from the working group and steering group. The scope of the review - a list of the aspects of NICE’s current methods that will be considered in the review - will be presented to the NICE Board in July. Additional detail and more information will be made available on the NICE website in due course. NICE anticipates being in a position to confirm the revised methods guide by the end of 2020, following public consultation.</p><p> </p><p><strong> </strong></p><p><strong> </strong></p> answering member constituency South Ribble answering member printed Seema Kennedy grouped question UIN 263871 263872 263873 263874 question first answered 20/06/2019 13:18:08 answering member 4455 label Biography information for Seema Kennedy
	tabling member	4382 label Biography information for Daniel Zeichner

1175547

	registered interest
	date	03/02/2020
	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	National Institute for Health and Care Excellence
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, which patient organisations are members of the (a) modifiers considered in decision-making, (b) exploring uncertainty, (c) types of evidence, (d) health-related quality of life, (e) technology specific issues, (f) discounting, (g) cost-minimisation methods (h) costs used in HTA, (i) equality considerations in guideline development, (j) general approach to decision-making and (k) position of technologies in care pathway, NICE methods review task and finish groups.
	tabling member constituency	Sheffield South East
	tabling member printed	Mr Clive Betts
	uin	11443
	answer	answer is ministerial correction date of answer 06/02/2020 answer text <p>The following patient groups are currently involved across the programme of task and finish groups. The National Institute for Health and Care Excellence (NICE) has advised that it continues to seek further members for the task and finish groups, and a full list of members is still to be finalised.</p><p>- Alzheimer's Research UK;</p><p>- Breast Cancer Now;</p><p>- Cancer52;</p><p>- Cystic Fibrosis Trust ;</p><p>- Diabetes UK;</p><p>- Genetic Alliance UK;</p><p>- Leukaemia CARE;</p><p>- Multiple Sclerosis Society;</p><p>- Muscular Dystrophy UK;</p><p>- Myeloma UK;</p><p>- Neuroendocrine Cancer UK;</p><p>- Prostate cancer UK; and</p><p>- Sarcoma UK.</p><p> </p><p>In recruiting patient organisations to the NICE methods review task and finish groups, patients on the methods working group were asked to nominate representatives with a range of experience. Additional representatives were nominated by NICE where particular expertise or input was required. The organisations involved in the task and finish groups cover a broad spectrum of disease areas including cancer, non-cancer and rare diseases.<strong> </strong></p> answering member constituency Bury St Edmunds answering member printed Jo Churchill grouped question UIN 11444 question first answered 06/02/2020 17:20:14 answering member 4380 label Biography information for Jo Churchill
	tabling member	394 label Biography information for Mr Clive Betts

1654470

	registered interest
	date	19/07/2023
	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	National Institute for Health and Care Excellence
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, whether his Department has provided guidance to NICE on the evidence used to inform the criteria updates to its Highly Specialised Technology processes.
	tabling member constituency	Leeds North West
	tabling member printed	Alex Sobel
	uin	195282
	answer	answer is ministerial correction date of answer 04/09/2023 answer text <p>The Department has not issued any such guidance. The National Institute for Health and Care Excellence (NICE) is an independent body and is responsible for the methods and processes that it uses in the development of its guidance, including the criteria used to determine whether topics should be routed to the technology appraisal or highly specialised technologies programmes. NICE made changes to its health technology evaluation manual in January 2022 following a comprehensive review of its methods and processes, including public consultation. As part of these changes, the eligibility criteria for the highly specialised technologies programme were clarified to make them clearer and more predictable.</p> answering member constituency Colchester answering member printed Will Quince question first answered 04/09/2023 10:12:05 answering member 4423 label Biography information for Will Quince
	tabling member	4658 label Biography information for Alex Sobel

1657697

	registered interest
	date	04/09/2023
	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	National Institute for Health and Care Excellence
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, whether he has held discussions with the National Institute for Health and Care Excellence on the adequacy of the single technology appraisal pathway for the assessment of (a) innovative technologies and (b) advanced therapy medicinal products.
	tabling member constituency	Strangford
	tabling member printed	Jim Shannon
	uin	197395
	answer	answer is ministerial correction date of answer 11/09/2023 answer text <p>The Department regularly meets with the National Institute for Health and Care Excellence (NICE) to discuss a range of issues. NICE’s technology appraisal programme has been proven to be suitable for the assessment of innovative medicines and advanced therapy medicinal products (ATMPs) where companies are able to price their products in a way that represents value to the taxpayer.</p><p>NICE has recommended several ATMPs through its technology appraisal programme that are now available to patients in the National Health Service. NICE concluded a review of its methods and processes for health technology evaluation in January 2022 and has introduced changes that ensure that its appraisal processes are suitable for emerging new medicines, including a broader severity modifier and changes to better respond to uncertainty.</p> answering member constituency Colchester answering member printed Will Quince question first answered 11/09/2023 13:30:18 answering member 4423 label Biography information for Will Quince
	tabling member	4131 label Biography information for Jim Shannon

1131743

	registered interest
	date	12/06/2019
	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	National Institute for Health and Care Excellence
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, whether changes to NICE’s appraisal methods identified during the NICE Methods review will be cost-neutral.
	tabling member constituency	Cambridge
	tabling member printed	Daniel Zeichner
	uin	263872
	answer	answer is ministerial correction date of answer 20/06/2019 answer text <p>The National Institute for Health and Care Excellence (NICE) is an independent body and is responsible for the methods and processes used in the development of its technology appraisal and highly specialised technologies recommendations. NICE has now initiated the review of its technology appraisal and highly specialised technologies methods in line with the commitment made in the 2019 Voluntary Scheme for Branded Medicines Pricing and Access.</p><p> </p><p>The Voluntary Scheme states that industry and other relevant stakeholders will be active participants in the review, including inputting on scope, participating in working discussions, and providing views on recommendations. NICE’s updated methods guide will also be subject to a public consultation.</p><p> </p><p>NICE has established a working group, consisting of members from NICE, NHS England, the Department, patient organisations and the life sciences industry. The working group reports to a steering group, chaired by NICE and with members from NHS England, the Department, and an independent academic methodologist. The steering group will present its recommendations to NICE’s Senior Management Team, which in turn will report to the NICE Board. NICE approached patient groups with experience of NICE and its processes and methods. There are three patient group representatives on the working group with a wide range of experience, covering a range of topic areas, reflecting the programmes under review. Membership of the working group will be published in due course.</p><p> </p><p>NICE is now in the process of scoping the review of the methods for technology appraisal and highly specialised technologies evaluations with input from the working group and steering group. The scope of the review - a list of the aspects of NICE’s current methods that will be considered in the review - will be presented to the NICE Board in July. Additional detail and more information will be made available on the NICE website in due course. NICE anticipates being in a position to confirm the revised methods guide by the end of 2020, following public consultation.</p><p> </p><p><strong> </strong></p><p><strong> </strong></p> answering member constituency South Ribble answering member printed Seema Kennedy grouped question UIN 263870 263871 263873 263874 question first answered 20/06/2019 13:18:08 answering member 4455 label Biography information for Seema Kennedy
	tabling member	4382 label Biography information for Daniel Zeichner

1127500

	registered interest
	date	20/05/2019
	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	National Institute for Health and Care Excellence
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, when NICE will publish the outcome of the NICE Evaluation Committee meeting held on 6 March 2019.
	tabling member constituency	West Lancashire
	tabling member printed	Rosie Cooper
	uin	256255
	answer	answer is ministerial correction date of answer 29/05/2019 answer text <p>Discussions about managed access agreements for technologies undergoing assessment by the National Institute for Health and Care Excellence (NICE) are rightly held between NHS England as an independent body and the manufacturer concerned. Departmental officials play no role in such discussions, but are in regular contact with NICE and NHS England colleagues about a range of issues, including progress in discussions about a potential managed access agreement for Spinraza (nusinersen) for the treatment of spinal muscular atrophy. Ministers have also held meetings with Biogen, NICE and NHS England on a number of occasions, at which the availability of Spinraza was discussed.</p><p> </p><p>NHS England and NICE have made stakeholders and the public aware of the outcome of its appraisal committee meeting of 8 May and NICE is now able to recommend the use of Spinraza for NHS patients in England, subject to a managed access agreement agreed between NHS England and Biogen which makes Spinraza available to children with the most severe form of spinal muscular atrophy available with immediate effect. NICE’s Appraisal Committee’s considerations and recommendations will be contained in the final appraisal document which will be published in due course, with final guidance expected in June 2019.</p> answering member constituency South Ribble answering member printed Seema Kennedy grouped question UIN 256254 question first answered 29/05/2019 10:38:01 answering member 4455 label Biography information for Seema Kennedy
	tabling member	1538 label Biography information for Rosie Cooper

1175550

	registered interest
	date	03/02/2020
	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	National Institute for Health and Care Excellence
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, what the timetable is for the publication of the full consultation on the proposed reforms to NICE methods and processes.
	tabling member constituency	Sheffield South East
	tabling member printed	Mr Clive Betts
	uin	11446
	answer	answer is ministerial correction date of answer 06/02/2020 answer text <p>The National Institute for Heath and Care Excellence (NICE) has advised that a six week public consultation on the proposals for changing its methods and processes will take place this summer. We understand that further work on the timetable is in progress and will be communicated in due course.</p><p>The wider health charity sector will have an opportunity to review the proposals for change from the task and finish groups during this consultation.</p><p>NICE also held a webinar with stakeholders in November 2019 to share how and why health technology evaluation is changing and what it means for patients. The webinar is available on the NICE website at the following link:</p><p><a href="https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guidance/changes-to-health-technology-evaluation" target="_blank">https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guidance/changes-to-health-technology-evaluation</a></p><p>NICE staff have also participated in a number of events to engage with the patient community, including the charity sector and about the methods review.</p><p><strong> </strong></p> answering member constituency Bury St Edmunds answering member printed Jo Churchill grouped question UIN 11445 question first answered 06/02/2020 17:21:30 answering member 4380 label Biography information for Jo Churchill
	tabling member	394 label Biography information for Mr Clive Betts

1129860

	registered interest
	date	04/06/2019
	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	National Institute for Health and Care Excellence
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, what the timescale is for the planned methods and processes review of the National Institute for Health and Care Excellence.
	tabling member constituency	West Ham
	tabling member printed	Lyn Brown
	uin	259921
	answer	answer is ministerial correction date of answer 12/06/2019 answer text <p>The National Institute for Health and Care Excellence (NICE) is an independent body and is responsible for the methods and processes used in the development of its technology appraisal and highly specialised technology recommendations. NICE has now initiated the review of its technology appraisal and highly specialised technologies methods in line with the commitment made in the 2019 Voluntary Scheme for Branded Medicines Pricing and Access.</p><p> </p><p>The Voluntary Scheme states that industry and other relevant stakeholders will be active participants in the review, including inputting on scope, participating in working discussions, and providing views on recommendations. NICE’s updated methods guide will be subject to a public consultation.</p><p> </p><p>NICE has established a working group consisting of members from NICE, NHS England, the Department, patient organisations and the life sciences industry. The working group reports to a steering group, chaired by NICE and with members from NHS England, the Department, and an independent academic methodologist. The steering group will present its recommendations to NICE’s senior management team, which in turn will report to the NICE Board.</p><p> </p><p>NICE is in the process of scoping of the review of the methods for technology appraisal and highly specialised technologies evaluations, with input from the working group and steering group. The scope of the review - a list of the aspects of NICE’s current methods that will be considered in the review - will be presented to the NICE Board in July. Additional detail and more information will be made available on the NICE website in due course. NICE anticipate being in a position to confirm the revised methods guide by the end of 2020, following public consultation.</p> answering member constituency South Ribble answering member printed Seema Kennedy grouped question UIN 259922 259923 259924 question first answered 12/06/2019 16:31:07 answering member 4455 label Biography information for Seema Kennedy
	tabling member	1583 label Biography information for Ms Lyn Brown