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1700510

	registered interest
	date	12/04/2024
	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
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, if she will make it her policy to allow pharmacies to sell vitamin B12 injections.
	tabling member constituency	Loughborough
	tabling member printed	Jane Hunt
	uin	21397
	answer	answer is ministerial correction date of answer 16/04/2024 answer text <p>To make a medicinal product available for sale in a pharmacy without a prescription, the product must be reclassified to pharmacy only status, also known as [P] medicines, by the Medicines and Healthcare products Regulatory Agency (MHRA).</p><p>This process is triggered by an application submitted to the MHRA by a company which holds a licence for the particular product. The MHRA will consider all submitted applications, with a decision to reclassify a medicine reached following a robust evaluation of the relevant data, including evidence of the safe use and supply of the product without a prescription. The company must also demonstrate in their application that the criteria specified in relevant legislation, such as the Human Medicines Regulations 2012, have been met.</p><p>In accordance with the Human Medicines Regulations 2012, regulation 62(3), Prescription-Only Medicine status will apply where: a direct or indirect danger exists to human health, even when used correctly, if used without medical supervision; there is frequently incorrect use, which could lead to direct or indirect danger to human health; further investigation of the activity or side-effects is required; or the product is normally prescribed for parenteral administration, via injection.</p><p>Currently, United Kingdom law specifies that all products administered by injection must be subject to a prescription. The MHRA is therefore unable to reclassify the status of injections, including Vitamin B12, to [P] medicines, as this would not be consistent with the legislation.</p> answering member constituency Pendle answering member printed Andrew Stephenson question first answered 16/04/2024 11:03:29 answering member 4044 label Biography information for Andrew Stephenson
	tabling member	4839 label Biography information for Jane Hunt

1660142

	registered interest
	date	12/09/2023
	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
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, what estimate he has made of the rate of stillbirths in (a) 2021 and (b) 2022.
	tabling member constituency	Enfield North
	tabling member printed	Feryal Clark
	uin	199222
	answer	answer is ministerial correction date of answer 20/09/2023 answer text <p>Based on Office for National Statistics (ONS) data releases, the stillbirth rate was 4.1 per 1,000 total births in 2021 and 3.9 per 1,000 total births in 2022 for England and Wales.</p><p>Based on ONS data releases, the preterm birth rate for 2021 was 7.7 per 100 total births. The Department does not hold an estimate of the preterm birth rate for 2022.</p> answering member constituency Lewes answering member printed Maria Caulfield grouped question UIN 199223 question first answered 20/09/2023 14:57:57 answering member 4492 label Biography information for Maria Caulfield
	tabling member	4822 label Biography information for Feryal Clark

1660144

	registered interest
	date	12/09/2023
	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
	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 (a) funding and (b) amount of research undertaken on pregnancy.
	tabling member constituency	Enfield North
	tabling member printed	Feryal Clark
	uin	199224
	answer	answer is ministerial correction date of answer 20/09/2023 answer text <p>The Department commissions research through the National Institute for Health and Care Research (NIHR). Since 2018, approximately £68 million has been invested into research on pregnancy across NIHR’s research programmes. No assessment of the adequacy has been made and it is not usual practice for the NIHR to ringfence funds for particular topics or conditions. The NIHR welcomes funding applications for research into any aspect of human health, including pregnancy.</p> answering member constituency Colchester answering member printed Will Quince question first answered 20/09/2023 09:42:22 answering member 4423 label Biography information for Will Quince
	tabling member	4822 label Biography information for Feryal Clark

1668422

	registered interest
	date	08/11/2023
	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	Abiraterone
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, what recent assessment he has made of the potential impact of the level of availability of abiraterone on the NHS on the health of prostate cancer patients.
	tabling member constituency	Haltemprice and Howden
	tabling member printed	Mr David Davis
	uin	672
	answer	answer is ministerial correction date of answer 17/11/2023 answer text <p>The National Institute for Health and Care Excellence (NICE) is the independent body that provides evidence-based guidance for the National Health Service on whether new medicines represent a clinically- and cost-effective use of resources. The NHS is legally required to fund medicines recommended by NICE, usually within three months of final guidance.</p><p>NICE has published guidance recommending abiraterone for the treatment of hormone-relapsed metastatic prostate cancer before chemotherapy is indicated and for the castration-resistant variant of that cancer previously treated with a docetaxel-containing regimen. NHS England funds abiraterone for these indications of prostate cancer in line with NICE’s recommendations, making it routinely available for the treatment of eligible patients.</p><p>Abiraterone is not licensed for the treatment of non-metastatic prostate cancer and has therefore not been appraised by NICE for such use. NHS England is considering a clinical policy proposal for abiraterone as a treatment option for patients newly diagnosed with high risk, non-metastatic, hormone-sensitive prostate cancer, or in whom prostate cancer has relapsed after at least 12 months without treatment. This specific policy proposal is due to be discussed later in November 2023 and if supported by a clinical panel it will progress to stakeholder testing by January 2024.</p> answering member constituency Pendle answering member printed Andrew Stephenson grouped question UIN 673 674 question first answered 17/11/2023 12:37:56 answering member 4044 label Biography information for Andrew Stephenson
	tabling member	373 label Biography information for Sir David Davis

1668423

	registered interest
	date	08/11/2023
	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	Abiraterone
	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 make an assessment of the potential merits of bringing forward the planned review of abiraterone as a treatment for prostate cancer on the NHS.
	tabling member constituency	Haltemprice and Howden
	tabling member printed	Mr David Davis
	uin	673
	answer	answer is ministerial correction date of answer 17/11/2023 answer text <p>The National Institute for Health and Care Excellence (NICE) is the independent body that provides evidence-based guidance for the National Health Service on whether new medicines represent a clinically- and cost-effective use of resources. The NHS is legally required to fund medicines recommended by NICE, usually within three months of final guidance.</p><p>NICE has published guidance recommending abiraterone for the treatment of hormone-relapsed metastatic prostate cancer before chemotherapy is indicated and for the castration-resistant variant of that cancer previously treated with a docetaxel-containing regimen. NHS England funds abiraterone for these indications of prostate cancer in line with NICE’s recommendations, making it routinely available for the treatment of eligible patients.</p><p>Abiraterone is not licensed for the treatment of non-metastatic prostate cancer and has therefore not been appraised by NICE for such use. NHS England is considering a clinical policy proposal for abiraterone as a treatment option for patients newly diagnosed with high risk, non-metastatic, hormone-sensitive prostate cancer, or in whom prostate cancer has relapsed after at least 12 months without treatment. This specific policy proposal is due to be discussed later in November 2023 and if supported by a clinical panel it will progress to stakeholder testing by January 2024.</p> answering member constituency Pendle answering member printed Andrew Stephenson grouped question UIN 672 674 question first answered 17/11/2023 12:37:56 answering member 4044 label Biography information for Andrew Stephenson
	tabling member	373 label Biography information for Sir David Davis

1668424

	registered interest
	date	08/11/2023
	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	Abiraterone
	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 cost effectiveness of the use of abiraterone as a treatment for prostate cancer by the NHS.
	tabling member constituency	Haltemprice and Howden
	tabling member printed	Mr David Davis
	uin	674
	answer	answer is ministerial correction date of answer 17/11/2023 answer text <p>The National Institute for Health and Care Excellence (NICE) is the independent body that provides evidence-based guidance for the National Health Service on whether new medicines represent a clinically- and cost-effective use of resources. The NHS is legally required to fund medicines recommended by NICE, usually within three months of final guidance.</p><p>NICE has published guidance recommending abiraterone for the treatment of hormone-relapsed metastatic prostate cancer before chemotherapy is indicated and for the castration-resistant variant of that cancer previously treated with a docetaxel-containing regimen. NHS England funds abiraterone for these indications of prostate cancer in line with NICE’s recommendations, making it routinely available for the treatment of eligible patients.</p><p>Abiraterone is not licensed for the treatment of non-metastatic prostate cancer and has therefore not been appraised by NICE for such use. NHS England is considering a clinical policy proposal for abiraterone as a treatment option for patients newly diagnosed with high risk, non-metastatic, hormone-sensitive prostate cancer, or in whom prostate cancer has relapsed after at least 12 months without treatment. This specific policy proposal is due to be discussed later in November 2023 and if supported by a clinical panel it will progress to stakeholder testing by January 2024.</p> answering member constituency Pendle answering member printed Andrew Stephenson grouped question UIN 672 673 question first answered 17/11/2023 12:37:56 answering member 4044 label Biography information for Andrew Stephenson
	tabling member	373 label Biography information for Sir David Davis

1668018

	registered interest
	date	07/11/2023
	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	Abiraterone
	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 review the decision to reject the use of the drug Abiraterone to tackle prostate cancer.
	tabling member constituency	Richmond Park
	tabling member printed	Sarah Olney
	uin	377
	answer	answer is ministerial correction date of answer 09/11/2023 answer text <p>The National Institute for Health and Care Excellence (NICE) is the independent body that guides the National Health Service on funding new medicines, based on clinical and cost-effectiveness.. The NHS is legally required to fund medicines recommended by NICE, usually within 3 months of final guidance.</p><p>NICE has recommended abiraterone for the treatment of metastatic hormone-relapsed prostate cancer before chemotherapy is indicated and for castration-resistant metastatic prostate cancer previously treated with a docetaxel-containing regimen. NHS England funds abiraterone in line with NICE’s recommendations, ensuring access for eligible patients.</p><p>Abiraterone is not licensed for the treatment of non-metastatic prostate cancer and has therefore not been appraised by NICE for such use. NHS England is currently considering a clinical policy proposal for abiraterone as a treatment option for potential use in specific cases. The proposal is due to be discussed later this month, with potential stakeholder testing by January 2024, if supported.</p> answering member constituency Colchester answering member printed Will Quince question first answered 09/11/2023 11:00:41 answering member 4423 label Biography information for Will Quince
	tabling member	4591 label Biography information for Sarah Olney

1669501

	registered interest
	date	13/11/2023
	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	Abiraterone
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, whether she plans to take steps to increase access to Abiraterone.
	tabling member constituency	The Wrekin
	tabling member printed	Mark Pritchard
	uin	1504
	answer	answer is ministerial correction date of answer 16/11/2023 answer text <p>The National Institute for Health and Care Excellence (NICE) is the independent body that provides evidence-based guidance for the National Health Service on whether new licensed medicines represent a clinically and cost-effective use of resources. The NHS is legally required to fund medicines recommended by NICE, usually within three months of final guidance.</p><p> </p><p>NICE has published guidance recommending abiraterone for the treatment of metastatic hormone-relapsed prostate cancer before chemotherapy is indicated and for castration-resistant metastatic prostate cancer previously treated with a docetaxel-containing regimen. NHS England funds abiraterone for these indications of prostate cancer in line with NICE’s recommendations, making it routinely available for the treatment of eligible patients.</p><p> </p><p>Abiraterone is not licensed for the treatment of non-metastatic prostate cancer and has therefore not been appraised by NICE for such use. NHS England is currently considering a clinical policy proposal for abiraterone as a treatment option for patients newly diagnosed with high risk, non-metastatic, hormone-sensitive prostate cancer, or in whom prostate cancer has relapsed after at least 12 months without treatment. This specific policy proposal is due to be discussed later this month, and if supported by a clinical panel it will progress to stakeholder testing by January 2024.</p> answering member constituency Pendle answering member printed Andrew Stephenson question first answered 16/11/2023 16:58:35 answering member 4044 label Biography information for Andrew Stephenson
	tabling member	1576 label Biography information for Mark Pritchard

1683608

	registered interest
	date	19/01/2024
	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	Abiraterone
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, which NHS bodies have a role in the consideration of Abiraterone for inclusion in the drug repurposing programme for the treatment of locally advanced high-risk non-metastatic prostate cancer; and what the remit of each body is in that process.
	tabling member constituency	Brighton, Kemptown
	tabling member printed	Lloyd Russell-Moyle
	uin	10649
	answer	answer is ministerial correction date of answer 29/01/2024 answer text <p>The national, multi-agency Medicines Repurposing Programme is hosted and funded by NHS England and is overseen by a steering group, including decision-making members from the Department, the Medicines and Healthcare products Regulatory Agency, the National Institute for Health and Care Excellence, the National Institute for Health and Care Research, and NHS England. Each of the national agencies brings a different contribution to the programme, in line with their respective regulatory and statutory responsibilities.</p><p>The programme steering group has not discussed adopting abiraterone for high-risk, non-metastatic hormone sensitive prostate cancer into the repurposing programme. This is because an off-label clinical commissioning policy covering the off-label use of abiraterone in this indication is being developed by NHS England and, in this case, NHS England considers this to be the most appropriate route to support a decision on routine patient access in the National Health Service. The policy is being considered through the established process in line with the current methods, which are available at the following link:</p><p><a href="https://www.england.nhs.uk/wp-content/uploads/2016/12/Methods-National-clinical-policies-updated-July-2020-v2.pdf" target="_blank">https://www.england.nhs.uk/wp-content/uploads/2016/12/Methods-National-clinical-policies-updated-July-2020-v2.pdf</a></p><p> </p> answering member constituency Pendle answering member printed Andrew Stephenson question first answered 29/01/2024 10:23:23 answering member 4044 label Biography information for Andrew Stephenson
	tabling member	4615 label Biography information for Lloyd Russell-Moyle

1695653

	registered interest
	date	13/03/2024
	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	Abiraterone
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, for what reason abiraterone is not available for free through the NHS in England.
	tabling member constituency	Colne Valley
	tabling member printed	Jason McCartney
	uin	18415
	answer	answer is ministerial correction date of answer 20/03/2024 answer text <p>The National Health Service in England funds abiraterone for eligible NHS patients in line with recommendations published by the National Institute for Health and Care Excellence (NICE). It has been recommended by the NICE for the treatment of metastatic hormone-relapsed prostate cancer before chemotherapy is indicated, and for castration-resistant metastatic prostate cancer previously treated with a docetaxel-containing regimen.</p><p>NHS England is in the process of considering a clinical policy proposal for the use of abiraterone as an off-label treatment option for patients newly diagnosed with high risk, non-metastatic, hormone-sensitive prostate cancer, or in whom prostate cancer has relapsed after at least 12 months without treatment. The policy proposal was sent out to stakeholder testing between the 30 November and 14 December 2023, and will now be considered by NHS England’s Clinical Priorities Advisory Group, who make recommendations on NHS England’s approach to commissioning services, treatments, and technologies, and considers which of these should be prioritised for investment.</p> answering member constituency Pendle answering member printed Andrew Stephenson question first answered 20/03/2024 11:29:52 answering member 4044 label Biography information for Andrew Stephenson
	tabling member	3953 label Biography information for Jason McCartney