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1690824

registered interest
date	21/02/2024
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 steps her Department is taking to ensure that the National Institute for Health and Care Excellence's evaluation processes complement the Medicines and Healthcare products Regulatory Agency's International Recognition Procedure.
tabling member constituency	Peterborough
tabling member printed	Paul Bristow
uin	15202
answer	answer is ministerial correction date of answer 28/02/2024 answer text <p>The National Institute for Health and Care Excellence (NICE) is an independent body and is responsible for the processes that it uses, in the development of its recommendations on new medicines. The NICE will continue aiming to publish guidance on new medicines within 90 days of the receipt of a United Kingdom marketing authorisation, and is working closely with the Department, the Medicines and Healthcare products Regulatory Agency, industry, and system partners to ensure that it is able to make timely recommendations on new medicines licensed through the International Recognition Procedure.</p> answering member constituency Pendle answering member printed Andrew Stephenson question first answered 28/02/2024 13:37:55 answering member 4044 label Biography information for Andrew Stephenson
tabling member	4792 label Biography information for Paul Bristow

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

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

1653811

registered interest
date	18/07/2023
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, what steps his Department is taking to ensure that NICE’s Topic Selection Oversight Panel considers (a) clinical and (b) patient expert insights in its decision-making processes.
tabling member constituency	Leeds North West
tabling member printed	Alex Sobel
uin	194779
answer	answer is ministerial correction date of answer 04/09/2023 answer text <p>The National Institute for Health and Care Excellence (NICE) is an independent body and is responsible for the decision-making processes that it operates.</p><p>NICE’s Topic Selection Oversight Panel (TSOP) is responsible for the selection of topics for guidance development in the Centre for Health Technology Evaluation. The group considers the available evidence as well as clinical and patient insights to apply the medicines and highly specialised technologies criteria and decide whether to route medicines to the technology appraisal or highly specialised technologies programmes, or to deselect the topic. The TSOP’s membership includes lay members to provide the perspective of patients, people who use services and carers in the selection and routing of topics. It also includes members with responsibility for providing clinical insights and expertise.</p> answering member constituency Colchester answering member printed Will Quince question first answered 04/09/2023 09:38:40 answering member 4423 label Biography information for Will Quince
tabling member	4658 label Biography information for Alex Sobel

1461042

registered interest
date	10/05/2022
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	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government whether they plan to publish the names of the organisations which took part in the early engagement programme with the National Institute for Health and Care Excellence before the publication of its new methods and processes for its health technology evaluation programme.
tabling member printed	Lord Hunt of Kings Heath
uin	HL69
answer	answer is ministerial correction date of answer 20/05/2022 answer text <p>While there was no specific early engagement programme, the National Institute for Health and Care Excellence’s (NICE) recent review of its methods and processes for health technology evaluation was overseen by a steering group and working group. The organisations which participated in these groups are as follows:</p><p>Centre for Health Technology Evaluation, NICE;</p><p>Centre for Guidelines, NICE;</p><p>Centre for Health Economics, University of York;</p><p>NHS England and NHS Improvement;</p><p>The Office for Life Sciences;</p><p>The Department of Health and Social Care;</p><p>NICE appraisal committee;</p><p>British In Vitro Diagnostics Association;</p><p>The Association of the British Pharmaceuticals Industry;</p><p>The Psoriasis and Psoriatic Arthritis Alliance;</p><p>The British Medical Journal Technology Assessment Group;</p><p>The Ethical Medicines Industry Group;</p><p>The BioIndustry Association;</p><p>Genetic Alliance;</p><p>ReCor Medical UK, Association of British HealthTech Industries;</p><p>School of Health and Related Research, the University of Sheffield;</p><p>Alzheimer's Research UK.</p> answering member printed Lord Kamall question first answered 20/05/2022 09:58:16 answering member 4909 label Biography information for Lord Kamall
tabling member	2024 label Biography information for Lord Hunt of Kings Heath

1461043

registered interest
date	10/05/2022
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	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government what work they are currently undertaking, if any, to identify topics which require modular updates by the National Institute for Health and Care Excellence and which may be facilitated for entry to managed access.
tabling member printed	Lord Hunt of Kings Heath
uin	HL70
answer	answer is ministerial correction date of answer 25/05/2022 answer text <p>The National Institute for Health and Care Excellence’s (NICE) outline for future modular updates was published in the January 2022 board paper Review of methods, processes and topic selection for health technology evaluation programmes: conclusions and final update. The paper states that NICE has identified potential topics for future modular reviews, including processes to facilitate rapid entry to managed access, methods issues for digital, genomic and antimicrobial technologies and the societal value of health benefits in severe diseases and health inequalities. A copy of the paper is attached. During the implementation of NICE’s strategy 2021 to 2026, it will prioritise developing a proportionate approach to health technology appraisals and MedTech early value assessment in the next 12 months.</p> answering member printed Lord Kamall question first answered 25/05/2022 11:19:37 answering member 4909 label Biography information for Lord Kamall attachment 1 file name Review of methods, processes and topic selection for health technology evaluation programmes conclusions and final update (1).docx title NICE
tabling member	2024 label Biography information for Lord Hunt of Kings Heath

1416468

registered interest
date	25/01/2022
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, pursuant to the Answer of 11 January 2022 to Question 96910 on National Institute for Health and Care Excellence, how many oncology technical appraisals have been rescheduled in the last six months directly as a result of NICE operational challenges; and what the average time taken has been to reschedule those appraisals.
tabling member constituency	Bolton West
tabling member printed	Chris Green
uin	111625
answer	answer is ministerial correction date of answer 31/01/2022 answer text <p>The National Institute for Health and Care Excellence (NICE) has rescheduled one appraisal of an oncology technology in the last six months for operational reasons. NICE’s appraisal of pembrolizumab in combination with chemotherapy for neoadjuvant treatment of triple negative breast cancer has been delayed by approximately three months due to the volume of topics in its work programme. NICE’s final guidance is expected to be published in November 2022.</p> answering member constituency Charnwood answering member printed Edward Argar question first answered 31/01/2022 17:57:59 answering member 4362 label Biography information for Edward Argar
tabling member	4398 label Biography information for Chris Green

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
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
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
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