Asked by: Cat Smith (Labour - Lancaster and Fleetwood)
Question
To ask the Minister for Women and Equalities, what steps the Government is taking to support women with epilepsy to make informed family planning choices and have safe pregnancies.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
Tighter restrictions continue to reduce the number of pregnancies exposed to sodium valproate and support women to make informed choices. The MHRA and Commission on Human Medicines (CHM) has announced it will introduce tighter restrictions to reduce pregnancies exposed to sodium valproate, including the recommendation for no new patients under 55 years of age to be prescribed valproate unless two specialists independently consider and document that no other medicine is effective or tolerated.
Asked by: Fleur Anderson (Labour - Putney)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what recent steps his Department has taken to help tackle child health (a) inequalities and (b) issues linked to child poverty.
Answered by Neil O'Brien
In November 2022, NHS England published Core20PLUS5, an approach to reducing health inequalities for children and young people at a national and system level. The approach defines a target population and identifies five clinical areas requiring accelerated improvement: asthma, diabetes, epilepsy, oral health, and mental health.
The Department leads a range of public health interventions and guidance for ages 0 to 19 years old that provide universal support, but also help identify further needs and safeguarding concerns. We also deliver programmes targeted at particular populations, including the Family Nurse Partnership to support vulnerable young mothers, the Healthy Start scheme for low-income families, and targeted Mental Health Support Teams in schools.
On 9 February 2023, the Government confirmed the 75 eligible local authorities who will deliver approximately £300 million Family Hubs and Start for Life programme, and the 14 local authorities selected as programme trailblazers. The programme’s objective is to join up and enhance services delivered through transformed Family Hubs. This will ensure all parents and carers can access the support they need at the time they need it.
By investing in 75 local authorities with high levels of deprivation, we aim to help reduce inequalities in health and education outcomes for babies, children, and families across England.
Asked by: Barry Sheerman (Labour (Co-op) - Huddersfield)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if he will take steps with the Intractable Epilepsy charity to arrange a roundtable meeting to help secure collaborative trials in epilepsy medicines for children.
Answered by Will Quince
The Department does not believe a roundtable discussion would be beneficial to securing collaborative trials at this time. Manufacturers are responsible for generating evidence to support the use of their products, and the Government encourages any researcher aiming to set up collaborative trials to contact the Medicines and Healthcare products Regulatory Agency and the National Institute for Health and Care Research (NIHR) for scientific and research advice. The NIHR remains open to receiving good quality proposals for research in this area as a priority and stands ready to support researchers to develop applications.
Asked by: Hilary Benn (Labour - Leeds Central)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment he has made of the potential merits of Bedrocan cannabis medicines for children suffering from epilepsy.
Answered by Will Quince
Clinical guidelines from the National Institute for Health and Care Excellence (NICE) state, there is insufficient evidence of safety and effectiveness to support a population-wide practice recommendation for the use of unlicensed cannabis-based products, including Bedrocan products, for the treatment of adults and children with severe treatment-resistant epilepsy. NICE also made recommendations for further research to inform future decisions on the routine prescribing and funding of unlicensed cannabis-based medicines on the National Health Service.
The National Institute for Health and Care Research (NIHR) has issued two calls for research proposals and a highlight notice on medicinal cannabis. Manufacturers, including those for Bedrocan products, are responsible for generating evidence to support the use of these products and to seek regulatory approval. The Government encourages manufacturers to do so and offers scientific and research advice from the Medicines and Healthcare products Regulatory Agency and the NIHR.
Asked by: Tulip Siddiq (Labour - Hampstead and Kilburn)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps his Department is taking to improve the treatment of epilepsy.
Answered by Helen Whately - Minister of State (Department of Health and Social Care)
The majority of health services for people with epilepsy are commissioned locally by integrated care boards (ICBs). ICBs are best placed to make decisions regarding the provision of health services to their local population, including for the treatment of epilepsy, subject to local prioritisation and funding.
At the national level, there are a number of initiatives supporting service improvement for those with epilepsy, including NHS England’s Neuroscience Service Transformation Programme and RightCare Epilepsy Toolkit.
Asked by: Andrew Gwynne (Labour - Denton and Reddish)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, for what reasons epilepsy is allocated only one achievement point in the General Medical Services Statement of Financial Entitlements (Amendment) Directions 2019; and what steps he is taking to ensure that GP's put women who are prescribed Valproate and able to have children on a pregnancy prevention programme.
Answered by Neil O'Brien
Epilepsy is allocated one achievement point within the Quality and Outcomes Framework (QOF) in the General Medical Services Statement of Financial Entitlements (Amendment) (No.2) Directions 2022. QOF clinical indicators are subject to approval by the National Institute for Health and Care Excellence (NICE) and are underpinned by NICE clinical guidelines and are subject to consultation with the General Practitioners Committee of the British Medical Association.
Sodium valproate must not be used in any woman or girl able to have children unless she has a Pregnancy Prevention Programme in place. This is laid out in guidance issued by the Medicines and Healthcare products Regulatory Agency, last updated in February 2021, which can be found at the following link:
https://www.gov.uk/guidance/valproate-use-by-women-and-girls.
The programme is designed to make sure patients are fully aware of the risks and the need to avoid becoming pregnant. It includes the completion of a signed risk acknowledgement form when their treatment is reviewed by a specialist, which must take place at least annually.
A Valproate Registry has been set up which, in line with a recommendation of the Cumberlege review, has been extended to other antiepileptic drugs taken during pregnancy. It includes all women in England who are taking National Health Service (NHS) prescribed valproate and identifies when they are pregnant and accessing NHS care for that pregnancy. The registry improves our ability to monitor implementation and compliance with the Pregnancy Prevention Programme.
Asked by: Alex Sobel (Labour (Co-op) - Leeds North West)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether his Department plans to take steps to establish trials on the use of Bedrocan cannabis medicines for paediatric drug-resistant epilepsy.
Answered by Will Quince
The licensed cannabis-based medicine Epidyolex is routinely prescribed on the National Health Service for two forms of epilepsy. However, clinical guidelines from the National Institute for Health and Care Excellence demonstrate a clear need for further evidence to support routine prescribing and funding decisions for unlicensed cannabis-based medicines on the NHS.
The National Institute for Health and Care Research (NIHR) has issued two calls for research proposals and a highlight notice on medicinal cannabis. Manufacturers, including those for Bedrocan Oils, are responsible for generating evidence to support the use of these products and to seek regulatory approval. The Government encourages manufacturers to do so and offers scientific and research advice from the Medicines and Healthcare products Regulatory Agency and the NIHR.
Asked by: Catherine West (Labour - Hornsey and Wood Green)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps he is taking to help ensure the availability of cannabis-based medicines on the NHS for patients with epilepsy.
Answered by Will Quince
The licensed cannabis-based medicine Epidyolex is routinely prescribed on the National Health Service for two forms of epilepsy. However, clinical guidelines from the National Institute for Health and Care Excellence demonstrate a clear need for further evidence to support routine prescribing and funding decisions for unlicensed cannabis-based medicines on the NHS.
The National Institute for Health and Care Research (NIHR) has issued two calls for research proposals and a highlight notice on medicinal cannabis. Manufacturers, including those for Bedrocan Oils, are responsible for generating evidence to support the use of these products and to seek regulatory approval. The Government encourages manufacturers to do so and offers scientific and research advice from the Medicines and Healthcare products Regulatory Agency and the NIHR.
Asked by: Rachael Maskell (Labour (Co-op) - York Central)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if he will set targets for the (a) reduction and (b) end of the use of sodium valproate other than in exceptional circumstances.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
While sodium valproate is authorised for the treatment of epilepsy and bipolar disorder, other medicines are available to treat these conditions. Currently, sodium valproate should not be used in pregnancy unless another suitable treatment is unavailable. It should not be used in women of childbearing potential unless the conditions of the Valproate Pregnancy Prevention Programme are fulfilled.
On 12 December, the Medicines and Healthcare products Regulatory Agency highlighted concerns regarding ongoing exposure to valproate in pregnancy and made recommendations for new safety measures to be put in place. Concerns on the use of sodium valproate are associated with reproduction and may not be applicable to all patients. In due course, the new safety measures will require all patients under 55 years old receiving sodium valproate to be reviewed and for two specialists to independently consider and document that there are no other effective or tolerated treatments. No specific targets have been determined, as it is unclear what proportion of patients require sodium valproate when other medicines are not effective or tolerated.
Asked by: Rachael Maskell (Labour (Co-op) - York Central)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps his Department is taking to replace sodium valproate therapy.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
While sodium valproate is authorised for the treatment of epilepsy and bipolar disorder, other medicines are available to treat these conditions. Currently, sodium valproate should not be used in pregnancy unless another suitable treatment is unavailable. It should not be used in women of childbearing potential unless the conditions of the Valproate Pregnancy Prevention Programme are fulfilled.
On 12 December, the Medicines and Healthcare products Regulatory Agency highlighted concerns regarding ongoing exposure to valproate in pregnancy and made recommendations for new safety measures to be put in place. Concerns on the use of sodium valproate are associated with reproduction and may not be applicable to all patients. In due course, the new safety measures will require all patients under 55 years old receiving sodium valproate to be reviewed and for two specialists to independently consider and document that there are no other effective or tolerated treatments. No specific targets have been determined, as it is unclear what proportion of patients require sodium valproate when other medicines are not effective or tolerated.