Asked by: Ivan Lewis (Independent - Bury South)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, if he will confirm that Serious Medicines Shortage Protocols will not be appropriate for epilepsy treatments and that will be included in published guidance on Serious Medicines Protocols.
Answered by Caroline Dinenage
A Serious Shortage Protocol is an additional tool to manage and mitigate medication shortages and may be used in the exceptional and rare situation when other measures have been exhausted or are likely to be ineffective.
As the explanatory memorandum of the amending Statutory Instrument acknowledges, Protocols for therapeutic or generic equivalents will not be suitable for all medicines and patients. For example, those types of protocols would not be suitable for treatments for epilepsy or treatments requiring biological products where the medicines that are prescribed need to be prescribed by brand for clinical reasons. In these cases, patients would always be referred back to the prescriber for any decision about their treatment before any therapeutic or generic alternative is supplied.
Asked by: Ivan Lewis (Independent - Bury South)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps the Government is taking to maintain levels of funding for epilepsy (a) research and (b) treatment after the UK leaves the EU.
Answered by Caroline Dinenage
The Government funds research on health and social care through the National Institute for Health Research (NIHR). The NIHR welcomes funding applications for research into any aspect of human health and the healthcare system, including epilepsy. It is not usual practice to ring-fence funds for particular topics. After the United Kingdom leaves the European Union, the NIHR will continue to welcome applications for funding, which will be subject to peer review and judged in open competition, with awards being made on the basis of the importance of the topic to patients and health and care services, value for money, and scientific quality.
There have been 10 studies directly funded by the NIHR relating to epilepsy in the last five financial years, from 2013/14 to 2017/18, with total spend of £9.4 million. Additionally, over the same period, there has been support through the NIHR Clinical Research Networks for 180 studies, with total expenditure of £16.7 million, as well as support for 95 studies through other NIHR infrastructure. There are a further four NIHR-funded studies starting in 2019 related to epilepsy.
Asked by: Ivan Lewis (Independent - Bury South)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what plans he has to (a) monitor and (b) mitigate the risks to patient safety that could result from a Serious Shortage Protocol and planning for the UK leaving the EU without a deal; and if he will make a statement.
Answered by Steve Brine
Serious shortage protocols can help patients get timely access to medicines. In order to monitor and mitigate the risks to patient safety that could result from a serious shortage protocol, any protocol would only be introduced if clinicians with expertise in the relevant area think it is appropriate. Pharmacists still have to use their professional discretion as to whether supplying against the protocol rather than the prescription is appropriate, or whether the patient needs to be referred back to their prescriber.
The operation of the serious shortage protocol legislation will be reviewed one year after the first protocol has been issued.
Asked by: Ivan Lewis (Independent - Bury South)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, for what reason there is no national service specification for ceroid lipofuscinosis type 2 (CLN2).
Answered by Steve Brine
The NHS England service specifications for Metabolic disorders (children) and Metabolic disorders (adults) both include ceroid lipofuscinosis type 2 (CLN2). These can be found on the NHS England website at the following links:
https://www.england.nhs.uk/wp-content/uploads/2013/06/e06-metab-disorders-child.pdf
https://www.england.nhs.uk/wp-content/uploads/2013/06/e06-metab-disorders-adult.pdf
Asked by: Ivan Lewis (Independent - Bury South)
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 make cerliponase alfa available to eligible children in advance of an agreement being signed between NHS and the manufacturer of the drug.
Answered by Steve Brine
The National Institute for Health and Care Excellence (NICE) is currently evaluating cerliponase alfa for use in the treatment of neuronal ceroid lipofuscinosis type 2, through its highly specialised technologies programme. NICE published draft guidance on cerliponase alfa in February 2018 that does not recommend use of the drug as there is considerable uncertainty about the long-term effects of the drug.
NHS England is in discussions with Biomarin, the manufacturer of cerliponase alfa, to seek to agree a managed access agreement (MAA) that may address the uncertainty and enable NICE to recommend the drug as value for money. Cerliponase alfa is not therefore currently routinely funded on the National Health Service, but NHS England and the company are working jointly to agree a MAA.
In the absence of final guidance from NICE, clinicians can apply to NHS England for funding in exceptional cases through the individual funding request process.