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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Care, what discussions his Department has had with NICE on their (a) current and (b) future capacity to deliver final draft guidance on medicines within three months of regulatory approval by the MHRA.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

1204449

registered interest
date	16/06/2020
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 steps his Department is taking to improve the methodology used by NICE to appraise combination therapies in the ongoing NICE Methods Review.
tabling member constituency	Nottingham North
tabling member printed	Alex Norris
uin	59876
answer	answer is ministerial correction date of answer 07/07/2020 answer text <p>The National Institute for Health and Care Excellence (NICE) is an independent body and is responsible for the methods it uses in developing its guidance. While NICE is currently undertaking a review of its methods for health technology evaluation, the review is not considering combination treatments as a specific topic.</p><p>Commercial and policy-related challenges for combination treatments are being explored in other projects in line with the commitments in the Voluntary Scheme for Branded Medicines Pricing and Access. As stated in the Scheme, the Department and NHS England and NHS Improvement will support the Association of the British Pharmaceutical Industry’s efforts to find solutions to these challenges.</p><p> </p> answering member constituency Bury St Edmunds answering member printed Jo Churchill question first answered 07/07/2020 15:03:10 answering member 4380 label Biography information for Jo Churchill previous answer version 31043 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

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
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

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

1175548

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, how patient organisations were recruited to the 11 NICE methods review task and finish groups.
tabling member constituency	Sheffield South East
tabling member printed	Mr Clive Betts
uin	11444
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 11443 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

1175549

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 steps the NICE methods review task and finish groups will take to consult with the wider health charity sector.
tabling member constituency	Sheffield South East
tabling member printed	Mr Clive Betts
uin	11445
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 11446 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