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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

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

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
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

1271496

registered interest
date	15/12/2020
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 assessment he has made of the adequacy of the level of patient involvement in the NICE process for evaluating and approving new medicines and treatment; and whether there are plans under the ongoing Methods Review to adjust that level of involvement.
tabling member constituency	Nottingham North
tabling member printed	Alex Norris
uin	130207
answer	answer is ministerial correction date of answer 27/01/2021 answer text <p>The National Institute for Health and Care Excellence (NICE) is an independent body and is therefore responsible for its own methods and processes for evaluations and approving new medicines and treatments. Consultee organisations for NICE’s technology appraisals include national groups representing patients and carers.</p><p>NICE has had patient involvement throughout its methods and process review, including a specific workstream led by patient representatives and senior NICE staff. Patient groups are also represented on its Methods Review Working Group.</p> answering member constituency Bury St Edmunds answering member printed Jo Churchill question first answered 27/01/2021 15:29:38 answering member 4380 label Biography information for Jo Churchill previous answer version 72723 answering member constituency Bury St Edmunds answering member printed Jo Churchill answering member 4380 label Biography information for Jo Churchill
tabling member	4641 label Biography information for Alex Norris