Asked by: Lord Carlile of Berriew (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what action they are taking (1) to remedy any buprenorphine shortage, and (2) to ensure that in the long term there is consistent and adequate supply of this medication, that it is available across the country and is not subject to unpredictable price fluctuations.
Answered by Lord O'Shaughnessy
We are aware that there was a short-term supply issue which may have affected the availability in May 2018. This was because one of the main suppliers experienced delays in delivery, resulting in a short term out of stock period. Although supplies continued to remain available from other suppliers, we are aware that some may have struggled to support the increase in demand at short notice. The delivery issues were resolved quickly and the overall supply of buprenorphine tablets improved shortly afterwards.
Since this period, the Department has remained in regular contact with all United Kingdom licensed suppliers of buprenorphine and has been working closely with them to monitor their supply position. Based on these conversations, we have been assured that the available supplies are sufficient to meet the usual UK requirements for this drug. The Department continues to monitor this very closely to ensure that there is consistent and adequate supply of this medication across the country.
The Department is aware that since this short-term supply issue, the market price has increased. This increased purchase price is reflected in the reimbursement price paid to pharmacies, to ensure that supplies remain available to patients. The market for buprenorphine has generally been competitive and we expect the supply situation to improve over the coming weeks which is likely to result in an increasingly competitive market.
Asked by: Lord Carlile of Berriew (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what steps they are taking to support future patient access to new and clinically-effective medicines for glioblastoma multiforme.
Answered by Lord O'Shaughnessy
A number of drugs currently being developed for potential use in the treatment of glioblastoma have been referred to the National Institute for Health and Care Excellence (NICE) for the development of technology appraisal guidance. New arrangements for the assessment and adoption of cancer drugs were introduced in 2016 that are designed to ensure that patients benefit from rapid access to the most promising new cancer drugs. Under these arrangements, wherever possible, NICE aims to publish draft guidance on cancer drugs before the product receives a marketing authorisation for use in the United Kingdom, and drugs recommended in draft NICE guidance will be eligible for Cancer Drugs Fund funding from the time that the drug receives a marketing authorisation.
In May, the Government announced £40 million for brain cancer research in honour of Dame Tessa Jowell. Funding will be invested through the National Institute for Health Research to support a wide range of research from early translation (experimental medicine) through clinical and on to applied research. This will support the translation of laboratory discoveries into treatments and better care for patients.
Asked by: Lord Carlile of Berriew (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what assessment they have made of the implementation of the recommendations of the Independent Review of the Early Access to Medicines Scheme.
Answered by Lord O'Shaughnessy
Since the publication of the independent review of the Early Access to Medicines Scheme (EAMS) the Government has made a number of improvements.
Partners have worked together to provide updated guidance on the benefits and entry requirements for EAMS and are developing further guidance on collecting real world data in the scheme to support National Institute for Health and Care Excellence appraisal.
Furthermore, the EAMS task group exists to provide a forum for industry to engage with Government, the devolved administrations and arm’s length bodies regarding EAMS, as per the recommendations of the 2016 review.
Asked by: Lord Carlile of Berriew (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government whether new biomarker-linked treatments for glioblastoma multiforme would be considered candidate technologies for the Accelerated Access Pathway under the Accelerated Access Review.
Answered by Lord O'Shaughnessy
As set out in the response to the Accelerated Access Review, the Accelerated Access Pathway (AAP) will focus on affordable products which can dramatically improve efficiency, fill an unmet need or make a step change in patient outcomes.
There are no restrictions on what type of products the AAP should focus on. The AAP will be launched shortly after the next meeting of the Accelerated Access Collaborative.
Asked by: Lord Carlile of Berriew (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what steps they have taken to ensure any shortage of buprenorphine does not adversely affect people in treatment for opiate use; and what assessments they have carried out of the impact of any long-term buprenorphine shortages on individuals and substance misuse treatment providers.
Answered by Lord O'Shaughnessy
We are aware that there was a short-term supply issue which may have affected availability in May 2018. This was because one of the main generic suppliers experienced delays in delivery, resulting in a short-term out of stock period. Although supplies continued to remain available from other suppliers, we are aware that some may have struggled to support the increase in demand at short notice. The delivery issues were resolved quickly and the overall supply of buprenorphine tablets improved shortly afterwards. The Department has not been made aware of patients who were unable to access supplies of buprenorphine during this period.
Since this period, the Department has remained in regular contact with all United Kingdom licensed suppliers of buprenorphine and has been working closely with them to monitor their supply position. Based on these conversations, we have been assured that the available supplies are sufficient to meet the usual UK requirements for this drug. The Department continues to monitor this very closely.
As there have been no long-term shortages of buprenorphine tablets, no such assessment has been undertaken on the impact of this scenario on individuals and substance misuse treatment providers. The Department is aware that since the short-term supply issue affecting buprenorphine, the market price has increased. This increased purchase price is reflected in the reimbursement price paid to pharmacies, to ensure that supplies remain available to patients.
Asked by: Lord Carlile of Berriew (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government what assessment they have made of the availability and price of the opiate treatment medication buprenorphine; whether there is a shortage of buprenorphine; if so, what analysis they have made of the reasons of such a shortage; and whether there are mechanisms in place to monitor the long-term supply of the medication following the recent rise in deaths associated with opioid abuse.
Answered by Lord O'Shaughnessy
We are aware that there was a short-term supply issue which may have affected availability in May 2018. This was because one of the main generic suppliers experienced delays in delivery, resulting in a short-term out of stock period. Although supplies continued to remain available from other suppliers, we are aware that some may have struggled to support the increase in demand at short notice. The delivery issues were resolved quickly and the overall supply of buprenorphine tablets improved shortly afterwards. The Department has not been made aware of patients who were unable to access supplies of buprenorphine during this period.
Since this period, the Department has remained in regular contact with all United Kingdom licensed suppliers of buprenorphine and has been working closely with them to monitor their supply position. Based on these conversations, we have been assured that the available supplies are sufficient to meet the usual UK requirements for this drug. The Department continues to monitor this very closely.
As there have been no long-term shortages of buprenorphine tablets, no such assessment has been undertaken on the impact of this scenario on individuals and substance misuse treatment providers. The Department is aware that since the short-term supply issue affecting buprenorphine, the market price has increased. This increased purchase price is reflected in the reimbursement price paid to pharmacies, to ensure that supplies remain available to patients.
Asked by: Lord Carlile of Berriew (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government how many technology appraisals NICE has undertaken for medicines which have successfully passed through the Early Access to Medicines Scheme; and how long it has taken for a NICE recommendation to be reached on each of those appraisals.
Answered by Lord O'Shaughnessy
To date, the National Institute for Health and Care Excellence (NICE) has published final technology appraisal guidance on 18 drugs with a positive Scientific Opinion through the Early Access to Medicines Scheme. Information on the length of time between receipt of a positive Scientific Opinion and final NICE technology appraisal guidance for each drug is attached due to the size of the data.
Asked by: Lord Carlile of Berriew (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government whether they plan to carry out a review into the number of prisoners with mental health issues in the UK in order to establish ways in which those suffering from serious mental health problems can be diverted to mental health care outside prison before or on release.
Answered by Lord O'Shaughnessy
We recognise that there are high numbers of people in prison with mental ill health, and it is essential that they are treated in the most appropriate environment for their needs.
Whilst some prisoners may be mentally unwell, and despite sometimes complex emotional and behavioural needs, it may not be clinically appropriate for them to be transferred to a mental health inpatient bed. There may be other services more appropriate to their needs that can be delivered outside inpatient mental health facilities.
There are no plans for a review. However there is already work underway to ensure people are diverted to mental health care services outside prison either before or on their release, and to improve mental health services within prisons.
Liaison and Diversion services operate at police stations and courts, to identify and assess people with vulnerabilities (substance misuse, mental health problems) and refer them into appropriate services and, where appropriate, away from the justice system altogether. Information from Liaison and Diversion assessments is used by the police and courts to inform sentencing decisions. These services cover 82% of the population with full roll out expected by 2020.
The Department of Health and Social Care and the Ministry of Justice have worked with NHS England and Public Health England to develop a Community Sentence Treatment Requirement ‘protocol’. The protocol aims to increase the use of community sentences with drug, alcohol and mental health treatment requirements as an alternative to custody to improve health outcomes and reduce reoffending. It sets out what is expected from all involved agencies to ensure improved access to mental health and substance misuse treatment for offenders who need it.
Work is also underway to improve support for prisoners whilst they are in prison. NHS England is focussing on an offender mental health pathway which will ensure that offenders are directed to the most appropriate intervention to their needs at the right time in the criminal justice system. The programme of work includes ensuring timely and appropriate transfers to a mental health hospital, timely remission to prison as part of a planned episode of care, and to ensure that those requiring treatment for mental ill health have access to high quality care.
New service specifications have been published for both low and medium secure hospitals as well as prison mental health services. The Prison Mental Health Specification embeds the Quality Standards for Prison Mental Health Services developed by the Royal College of Psychiatrists to ensure high quality care for all. Draft guidance for timely and appropriate transfers and remissions of care to and from a mental health hospital is currently in production.
Following release from prison, NHS England is working with partners to develop better pathways of care from custody. Drawing on learning from existing services we are investigating how best to ensure continuity of care post custody.
Asked by: Lord Carlile of Berriew (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask Her Majesty's Government whether they intend to provide improved mental health care for prisoners following the estimates produced by the Centre for Mental Health, published in June, which suggest that there are 21,000 mentally ill people in prison but only 3,600 beds available for mental health patients.
Answered by Lord O'Shaughnessy
We recognise that there are high numbers of people in prison with mental ill health, and it is essential that they are treated in the most appropriate environment for their needs.
Whilst some prisoners may be mentally unwell, and despite sometimes complex emotional and behavioural needs, it may not be clinically appropriate for them to be transferred to a mental health inpatient bed. There may be other services more appropriate to their needs that can be delivered outside inpatient mental health facilities.
There are no plans for a review. However there is already work underway to ensure people are diverted to mental health care services outside prison either before or on their release, and to improve mental health services within prisons.
Liaison and Diversion services operate at police stations and courts, to identify and assess people with vulnerabilities (substance misuse, mental health problems) and refer them into appropriate services and, where appropriate, away from the justice system altogether. Information from Liaison and Diversion assessments is used by the police and courts to inform sentencing decisions. These services cover 82% of the population with full roll out expected by 2020.
The Department of Health and Social Care and the Ministry of Justice have worked with NHS England and Public Health England to develop a Community Sentence Treatment Requirement ‘protocol’. The protocol aims to increase the use of community sentences with drug, alcohol and mental health treatment requirements as an alternative to custody to improve health outcomes and reduce reoffending. It sets out what is expected from all involved agencies to ensure improved access to mental health and substance misuse treatment for offenders who need it.
Work is also underway to improve support for prisoners whilst they are in prison. NHS England is focussing on an offender mental health pathway which will ensure that offenders are directed to the most appropriate intervention to their needs at the right time in the criminal justice system. The programme of work includes ensuring timely and appropriate transfers to a mental health hospital, timely remission to prison as part of a planned episode of care, and to ensure that those requiring treatment for mental ill health have access to high quality care.
New service specifications have been published for both low and medium secure hospitals as well as prison mental health services. The Prison Mental Health Specification embeds the Quality Standards for Prison Mental Health Services developed by the Royal College of Psychiatrists to ensure high quality care for all. Draft guidance for timely and appropriate transfers and remissions of care to and from a mental health hospital is currently in production.
Following release from prison, NHS England is working with partners to develop better pathways of care from custody. Drawing on learning from existing services we are investigating how best to ensure continuity of care post custody.