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1124902

	registered interest
	date	07/05/2019
	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	2
	legislature	25277 pref label House of Lords
	question text	To ask Her Majesty's Government when they estimate that NICE will publish the outcome of the NICE Evaluation Committee meeting held on 6 March.
	tabling member printed	Baroness Thomas of Winchester
	type	WrittenParliamentaryQuestion
	uin	HL15577
	answer	answer is ministerial correction date of answer 17/05/2019 answer text <p>Departmental officials are in regular contact with colleagues in the National Institute for Health and Care Excellence (NICE) and NHS England about a range of issues, including progress in discussions about a potential managed access agreement for Spinraza (nusinersen). 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>NHS England and NICE have made stakeholders and the public aware of the outcome of its appraisal committee meeting and NICE is now able to recommend the use of Spinraza for National Health Service patients in England, subject to a managed access agreement agreed between NHS England and Biogen. The final appraisal document will be published in due course.</p><p> </p> answering member printed Baroness Blackwood of North Oxford grouped question UIN HL15576 question first answered 17/05/2019 11:07:46 answering member 4019 label Biography information for Baroness Blackwood of North Oxford
	tabling member	3785 label Biography information for Baroness Thomas of Winchester

1399150

	registered interest
	date	04/01/2022
	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Care, what discussions his Department has had with NICE on their (a) current and (b) future capacity to deliver final draft guidance on medicines within three months of regulatory approval by the MHRA.
	tabling member constituency	Bolton West
	tabling member printed	Chris Green
	type	WrittenParliamentaryQuestion
	uin	96908
	answer	answer is ministerial correction date of answer 11/01/2022 answer text <p>The National Institute for Health and Care Excellence (NICE) is committed to publishing draft recommendations on new medicines around the time of licensing, with final guidance within three months of licensing wherever possible. The Department holds regular accountability meetings with NICE on a range of topics, including capacity issues. NICE delivers timely guidance on new medicines in the vast majority of cases and expects to continue to do so.</p><p>Project Orbis has been established to allow participating partners, including the United Kingdom, to review and approve applications for promising cancer treatments efficiently. The Medicines and Healthcare products Regulatory Agency, NICE and NHS England and NHS Improvement are ensuring an integrated, timely approach to access new products, including those licensed through Project Orbis. NHS England and NHS Improvement and NICE have agreed principles to allow potential interim access ahead of NICE’s guidance where timely guidance is not anticipated, which has supported early patient access for a number of medicines licensed through Project Orbis.</p> answering member constituency Charnwood answering member printed Edward Argar grouped question UIN 96909 96910 question first answered 11/01/2022 09:29:32 answering member 4362 label Biography information for Edward Argar
	tabling member	4398 label Biography information for Chris Green

1399156

	registered interest
	date	04/01/2022
	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 assessment he has made of the impact of operational challenges faced by NICE on its ability to deliver timely patient access to new medicines.
	tabling member constituency	Bolton West
	tabling member printed	Chris Green
	type	WrittenParliamentaryQuestion
	uin	96910
	answer	answer is ministerial correction date of answer 11/01/2022 answer text <p>The National Institute for Health and Care Excellence (NICE) is committed to publishing draft recommendations on new medicines around the time of licensing, with final guidance within three months of licensing wherever possible. The Department holds regular accountability meetings with NICE on a range of topics, including capacity issues. NICE delivers timely guidance on new medicines in the vast majority of cases and expects to continue to do so.</p><p>Project Orbis has been established to allow participating partners, including the United Kingdom, to review and approve applications for promising cancer treatments efficiently. The Medicines and Healthcare products Regulatory Agency, NICE and NHS England and NHS Improvement are ensuring an integrated, timely approach to access new products, including those licensed through Project Orbis. NHS England and NHS Improvement and NICE have agreed principles to allow potential interim access ahead of NICE’s guidance where timely guidance is not anticipated, which has supported early patient access for a number of medicines licensed through Project Orbis.</p> answering member constituency Charnwood answering member printed Edward Argar grouped question UIN 96908 96909 question first answered 11/01/2022 09:29:32 answering member 4362 label Biography information for Edward Argar
	tabling member	4398 label Biography information for Chris Green

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
	type	WrittenParliamentaryQuestion
	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

1385863

	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, if he will hold discussions with NICE on ensuring that their Methods Review achieves the Government's commitment for life sciences as set out in the Life Sciences Vision, published in July 2021.
	tabling member constituency	Bolton West
	tabling member printed	Chris Green
	type	WrittenParliamentaryQuestion
	uin	88745
	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 88744 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

1186534

	registered interest
	date	19/03/2020
	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, if he will support the National Institute for Health and Care Excellence to undertake its methods and processes in a way that (a) enables the attractiveness of the UK as a place to conduct clinical trials or supply human medicines and (b) enables that organisation to fulfil its statutory duty to promote innovation.
	tabling member constituency	Reigate
	tabling member printed	Crispin Blunt
	type	WrittenParliamentaryQuestion
	uin	32039
	answer	answer is ministerial correction date of answer 29/05/2020 answer text <p>The National Institute for Health and Care Excellence (NICE) is reviewing its methods for the development of technology appraisal and highly specialised technology recommendations in line with the commitment in the 2019 voluntary scheme for branded medicines pricing and access. The scheme also states the Government’s expectations for the review as follows: ‘“The Department expects that any future changes to NICE methods and processes would respond to the new types of innovation coming to the market, be consistent with improving the health gain achieved by spending on new innovative medicines, and support faster adoption of the most clinically and cost effective medicines.”’</p><p> </p><p><strong> </strong></p><p><strong> </strong></p> answering member constituency Bury St Edmunds answering member printed Jo Churchill grouped question UIN 32038 question first answered 29/05/2020 16:49:06 answering member 4380 label Biography information for Jo Churchill
	tabling member	104 label Biography information for Crispin Blunt

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
	type	WrittenParliamentaryQuestion
	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

1131742

	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, what the timescale is for NICE's Methods review.
	tabling member constituency	Cambridge
	tabling member printed	Daniel Zeichner
	type	WrittenParliamentaryQuestion
	uin	263871
	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 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

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
	type	WrittenParliamentaryQuestion
	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

1131744

	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, what criteria was used by NICE to determine which patient organisations were offered membership of the NICE Methods Working Group.
	tabling member constituency	Cambridge
	tabling member printed	Daniel Zeichner
	type	WrittenParliamentaryQuestion
	uin	263873
	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 263872 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