Asked by: Mike Penning (Conservative - Hemel Hempstead)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 22 October 2021 to Question 58780, on Fibrodysplasia Ossificans Progressiva: Research, if he will provide details of the eight studies into fibrodysplasia ossificans progressive (FOP) supported by funding through the National Institute for Health Research.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
The titles of seven of the studies supported by the National Institute for Health Research on fibrodysplasia ossificans progressiva (FOP) are as follows:
- Saracatinib Trial TO Prevent FOP (Fibrodysplasia Ossificans Progressiva);
- Isolation and Generation of Blood-derived Progenitor Cells from Patients with Cardiovascular Disease and TGF-beta Superfamily-related Diseases;
- A Phase 2 Randomized, Double Blind, Placebo Controlled Efficacy and Safety Study of a RARγ-Specific Agonist (Palovarotene) in the Treatment of Preosseous Flareups in Subjects with Fibrodysplasia Ossificans Progressiva;
- A Phase 2, Open-Label Extension, Efficacy and Safety Study of a RARγ-Specific Agonist (Palovarotene) in the Treatment of Preosseous Flare-ups in Subjects with Fibrodysplasia Ossificans Progressiva;
- A randomized, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and effects on heterotopic bone formation of REGN2477 in patients with Fibrodysplasia Ossificans Progressiva;
- A Phase 3, Efficacy and Safety Study of Oral Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva; and
- A Phase 2, two-part, placebo-controlled, parallel-group, double-blind study to assess the efficacy and safety of two dosage regimens of oral IPN60130 for the treatment of fibrodysplasia ossificans progressiva in male and female participants five years of age and older.
We are unable to provide details of the remaining study as this information is commercially sensitive.
Asked by: Mike Penning (Conservative - Hemel Hempstead)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what level of funding his Department is providing for research into (a) slowing the symptoms of and (b) finding a cure for fibrodysplasia ossificans progressiva.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
I refer the Rt hon. Member to the answer I gave on 22 October 2021 to Question 58780.
Asked by: Mike Penning (Conservative - Hemel Hempstead)
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 that children with intractable epilepsy are able to access medicinal cannabis on prescription.
Answered by Edward Argar - Minister of State (Ministry of Justice)
Whether to prescribe any medicine is a clinical decision and the Government has enabled the prescription of cannabis-based products for medicinal use where it is clinically appropriate. The Chief Medical Officer and NHS England have written to doctors and pharmacists to highlight the available guidance on the prescribing and use of unlicensed medicines and to clarify the procedure for prescribing and supplying cannabis-based products for medicinal use. Health Education England has also published an e-learning module on medicinal cannabis.
The licensed cannabis-based medicine Epidyolex is prescribed and routinely funded by the National Health Service for Dravet syndrome and Lennox-Gastaut syndrome. The Medicines and Healthcare products Regulatory Agency has recently approved Epidyolex for a third form of epilepsy and it is now being assessed by the National Institute for Health and Care Excellence (NICE) for this indication. The licensed medicine Sativex is also routinely funded to treat moderate to severe spasticity in adults with multiple sclerosis. On 6 September, NHS England issued a reminder to clinical commissioning groups of NICE’s guidance relating to Sativex and will be monitoring its uptake.
The latest NICE guidelines demonstrate a clear need for more evidence to support routine prescribing and funding decisions for unlicensed cannabis-based products on the NHS. The Government continues to support the establishment of clinical trials with NHS England and NHS Improvement and the National Institute for Health Research and from 1 April introduced a national patient registry to record patient outcomes. Since January 2020, the Refractory Epilepsy Specialist Clinical Advisory Service has been in place to provide advice and support for doctors to optimise the treatment of refractory epilepsy.
Asked by: Mike Penning (Conservative - Hemel Hempstead)
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 inform the clinicians listed on the Specialist Register of the General Medical Council that they can legally prescribe medicinal cannabis to their patients.
Answered by Edward Argar - Minister of State (Ministry of Justice)
Whether to prescribe any medicine is a clinical decision and the Government has enabled the prescription of cannabis-based products for medicinal use where it is clinically appropriate. The Chief Medical Officer and NHS England have written to doctors and pharmacists to highlight the available guidance on the prescribing and use of unlicensed medicines and to clarify the procedure for prescribing and supplying cannabis-based products for medicinal use. Health Education England has also published an e-learning module on medicinal cannabis.
The licensed cannabis-based medicine Epidyolex is prescribed and routinely funded by the National Health Service for Dravet syndrome and Lennox-Gastaut syndrome. The Medicines and Healthcare products Regulatory Agency has recently approved Epidyolex for a third form of epilepsy and it is now being assessed by the National Institute for Health and Care Excellence (NICE) for this indication. The licensed medicine Sativex is also routinely funded to treat moderate to severe spasticity in adults with multiple sclerosis. On 6 September, NHS England issued a reminder to clinical commissioning groups of NICE’s guidance relating to Sativex and will be monitoring its uptake.
The latest NICE guidelines demonstrate a clear need for more evidence to support routine prescribing and funding decisions for unlicensed cannabis-based products on the NHS. The Government continues to support the establishment of clinical trials with NHS England and NHS Improvement and the National Institute for Health Research and from 1 April introduced a national patient registry to record patient outcomes. Since January 2020, the Refractory Epilepsy Specialist Clinical Advisory Service has been in place to provide advice and support for doctors to optimise the treatment of refractory epilepsy.
Asked by: Mike Penning (Conservative - Hemel Hempstead)
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 access to NHS funded medicinal cannabis prescriptions.
Answered by Edward Argar - Minister of State (Ministry of Justice)
Whether to prescribe any medicine is a clinical decision and the Government has enabled the prescription of cannabis-based products for medicinal use where it is clinically appropriate. The Chief Medical Officer and NHS England have written to doctors and pharmacists to highlight the available guidance on the prescribing and use of unlicensed medicines and to clarify the procedure for prescribing and supplying cannabis-based products for medicinal use. Health Education England has also published an e-learning module on medicinal cannabis.
The licensed cannabis-based medicine Epidyolex is prescribed and routinely funded by the National Health Service for Dravet syndrome and Lennox-Gastaut syndrome. The Medicines and Healthcare products Regulatory Agency has recently approved Epidyolex for a third form of epilepsy and it is now being assessed by the National Institute for Health and Care Excellence (NICE) for this indication. The licensed medicine Sativex is also routinely funded to treat moderate to severe spasticity in adults with multiple sclerosis. On 6 September, NHS England issued a reminder to clinical commissioning groups of NICE’s guidance relating to Sativex and will be monitoring its uptake.
The latest NICE guidelines demonstrate a clear need for more evidence to support routine prescribing and funding decisions for unlicensed cannabis-based products on the NHS. The Government continues to support the establishment of clinical trials with NHS England and NHS Improvement and the National Institute for Health Research and from 1 April introduced a national patient registry to record patient outcomes. Since January 2020, the Refractory Epilepsy Specialist Clinical Advisory Service has been in place to provide advice and support for doctors to optimise the treatment of refractory epilepsy.
Asked by: Mike Penning (Conservative - Hemel Hempstead)
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 (a) support patients receiving cannabis-based treatment and (b) help ensure that they can continue to access that treatment; and if he will make a statement.
Answered by Edward Argar - Minister of State (Ministry of Justice)
Whether to prescribe any medicine is a clinical decision and the Government has enabled the prescription of cannabis-based products for medicinal use where it is clinically appropriate. The Chief Medical Officer and NHS England have written to doctors and pharmacists to highlight the available guidance on the prescribing and use of unlicensed medicines and to clarify the procedure for prescribing and supplying cannabis-based products for medicinal use. Health Education England has also published an e-learning module on medicinal cannabis.
The licensed cannabis-based medicine Epidyolex is prescribed and routinely funded by the National Health Service for Dravet syndrome and Lennox-Gastaut syndrome. The Medicines and Healthcare products Regulatory Agency has recently approved Epidyolex for a third form of epilepsy and it is now being assessed by the National Institute for Health and Care Excellence (NICE) for this indication. The licensed medicine Sativex is also routinely funded to treat moderate to severe spasticity in adults with multiple sclerosis. On 6 September, NHS England issued a reminder to clinical commissioning groups of NICE’s guidance relating to Sativex and will be monitoring its uptake.
The latest NICE guidelines demonstrate a clear need for more evidence to support routine prescribing and funding decisions for unlicensed cannabis-based products on the NHS. The Government continues to support the establishment of clinical trials with NHS England and NHS Improvement and the National Institute for Health Research and from 1 April introduced a national patient registry to record patient outcomes. Since January 2020, the Refractory Epilepsy Specialist Clinical Advisory Service has been in place to provide advice and support for doctors to optimise the treatment of refractory epilepsy.
Asked by: Mike Penning (Conservative - Hemel Hempstead)
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 improve new-born screening and genetic testing for fibrodysplasia ossificans progressiva.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
There is no newborn screening programme for fibrodysplasia ossificans progressiva (FOP) using genetic testing and it is not currently being considered for a national screening programme. National population screening programmes are implemented on the advice of the United Kingdom National Screening Committee (UK NSC), which makes independent, evidence-based recommendations to Ministers in the four UK nations. Proposals to screen for new conditions, such as FOP, can be submitted to the UK NSC via its annual call for new topics, which closes on 6 December 2021.