Tag: Lord Freyberg

The below Parliamentary question was asked by Lord Freyberg on 2016-03-17.

To ask Her Majesty’s Government when they plan to publish a response to their consultation on accredited safe havens, Protecting personal health and care data: a consultation on proposals to introduce new regulations, which closed on 8 August 2014.

Lord Prior of Brampton

The Department received 278 responses to the 2014 consultation Protecting personal health and care data, but was unable to publish the Coalition Government’s response to that consultation before the 2015 election.

The consultation set the clear ambition to move as quickly as possible to a future state where:

– the Health and Social Care Information Centre (HSCIC) is the place for holding identifiable health and care information at the national level;

– access to data is more automated so that routine functions, including many commissioning functions, do not require access to identifiable data; and

– consent is used more widely as the means for sharing identifiable information.

Analysis of consultation responses demonstrated no obvious consensus about the function, purpose, number and controls required for Accredited Safe Havens (ASHs) to operate. Since the 2014 consultation, HSCIC, working with NHS England, local government, Public Health England and other key stakeholders has committed to the delivery of the future state within two years, without the need for interim ASHs. Delivery of these functions by HSCIC has the added benefits of:

– increasing the likelihood of the public that there are robust protections and safeguards in place for their health and care data and information and;

– reducing the need for the health and care system to use identifiable data as a basis for delivering their functions.

The Government has concluded that the focus should be on supporting the HSCIC and NHS England in taking forward the future state as soon as possible. This will address the need to support integration and, in the longer term, to ensure flexibility is built in to reflect future priorities and also developments in technology and data.

In September 2015, The Secretary of State for Health commissioned the Care Quality Commission to undertake a review of data security in the National Health Service, and in parallel commissioned Dame Fiona Caldicott, the National Data Guardian, to undertake an independent review of data security and consent, to:

– Develop new data security standards;

– Devise a method of testing compliance with the new standards, and;

– Propose a new consent/opt-out model for data sharing.

The National Data Guardian’s independent review will report shortly and the government will consult on the recommendations and respond to them in due course.

The below Parliamentary question was asked by Lord Freyberg on 2016-07-19.

To ask Her Majesty’s Government what discussions they have had about patients’ access to rare cancer medicines that have received a marketing authorisation after the closure of the old Cancer Drugs Fund list and before the launch of the new Cancer Drugs Fund on 29 July, but that have not yet been approved by NICE.

Lord Prior of Brampton

All cancer drugs licensed since July 2015, but unable to undergo assessment by the Cancer Drug Fund (CDF) in 2015-16 on account of its closure to new drugs, have been incorporated into the technology appraisal work programme of the National Institute for Health and Care Excellence.

In addition, NHS England has advised that for all of the indications covered by these newly licensed cancer drugs, there already exist treatment options for patients that are either funded from baseline commissioning or from the CDF.

The below Parliamentary question was asked by Lord Freyberg on 2015-11-30.

To ask Her Majesty’s Government what percentage of stage 2b cancer or higher patients in (1) tertiary, and (2) secondary, care centres were tested by NHS England in 2014 for genetic mutations that can confer resistance to targeted cancer therapies, in particular (a) AR amplification mutations, (b) ESR1 activation mutations, (c) PIK3CA mutations, (d) KRAS activation mutations, (e) EGFR amplification and activation mutations, (f) KRAS activation mutations, and (g) EGFR amplification and activation mutations.

Lord Prior of Brampton

NHS England has not, to date, undertaken a direct comparison of the English and French health systems in respect of genetic testing practice for cancer.

NHS England does not hold data on the percentage of stage 2b, or higher, cancer patients in secondary and tertiary centres who were genetically tested. Detailed information on the clinical circumstances, or reasons, for referral for genetic testing for individual patients is not currently collated on a national basis.

NHS England does not consider business cases from individual National Health Service trusts in relation to the adoption of new genetic tests. Instead, NHS England considers national clinical commissioning policy proposals on the eligibility of a particular test, or treatments to be made available in the presence of particular genetic markers. These are considered and where agreed, funded consistently across England for services falling within NHS England’s direct commissioning responsibilities.

Examples include the separate policies (published in July 2015) confirming eligibility for Ivacaftor for the treatment of cystic fibrosis in the presence of certain gene mutations, and confirming eligibility for testing for BRCA1 and BRCA2 gene mutations, respectively. Copies of the policies are attached.

In addition, the UK Genetic Testing Network currently presents new genetic testing proposals to NHS England for funding consideration based on the conclusions of their assurance programme. These are considered, alongside other new policy proposals, as part of the annual funding prioritisation process, where there is a net annual investment to be made to support their adoption.

Information on the average turnaround time for cancer genetic tests is not currently collated, or analysed, nationally. However, NHS England will be undertaking a procurement exercise in the coming months to support the strengthened provision of genetic testing across England. This includes more consistent reporting of activity and other performance indicators, including the timeliness of reporting on receipt on referrals. The supporting national service specification, setting out the standards required of commissioned providers, has been the subject of a recent public consultation.

The below Parliamentary question was asked by Lord Freyberg on 2016-01-25.

To ask Her Majesty’s Government what advice they received from the Wellcome Trust Sanger Institute during the set-up phase of Genomics England regarding the appropriateness in cases of cancer of using comparisons of tumour to normal whole genome sequencing at moderate sequence coverage, as opposed to focused actionable gene panel testing at deep sequence coverage; and what current technology is used by Genomics England.

Lord Prior of Brampton

The set up phase of the 100,00 Genomes Project was based on advice from Expert Working Groups which included experts from across the United Kingdom, including the Sanger Centre. The Working Group concluded that a more fundamental understanding of cancer would be delivered by whole genome sequencing compared to gene panels. This approach is part of the wider aim of the 100,000 Genomes Project to transform the National Health Service diagnostic pathway for patients and to build a dataset which will enable new scientific research. Adopting whole genome sequencing has already catalysed a fall in the costs which was also anticipated by the Expert Working Group.

The below Parliamentary question was asked by Lord Freyberg on 2016-04-21.

To ask Her Majesty’s Government, further to the Written Answer by Lord Prior of Brampton on 17 March (HL7132), whether they expect any new database of innovative medicines to be constructed outside the normal information governance channels.

Lord Prior of Brampton

The Access to Medical Treatments (Innovation) Act 2016 will create a database of innovative treatments, when the Secretary of State directs the Health and Social Care Information Centre to establish such a database. The Centre will implement the database in accordance with the common law duty of confidence, data protection law and the information governance rules to which the Centre is subject.

The below Parliamentary question was asked by Lord Freyberg on 2016-07-19.

To ask Her Majesty’s Government whether they plan to consider providing interim funding for innovative treatments for patients with radioactive-iodine refractory differentiated thyroid cancer where there are treatments available but they are yet to be reviewed by NICE.

Lord Prior of Brampton

The Cancer Drugs Fund (CDF) already provides access to sorafenib as a treatment option for the systemic therapy of locally advanced or metastatic differentiated radioiodine-refractory thyroid cancer.

The National Institute for Health and Care Excellence (NICE) has been asked to develop technology appraisal guidance on the use of sorafenib and lenvatinib for this indication.

NHS England published its new standard operating procedure for the CDF in July 2016 and a copy is attached.

NHS England has advised that it considered carefully the issue as to which drugs should be given interim funding and concluded, with the support of the majority of stakeholders, that interim funding should only be possible for those drugs that had been granted a marketing authorisation and were in receipt of a draft positive appraisal recommendation or a draft recommendation for use within the CDF from NICE.

The below Parliamentary question was asked by Lord Freyberg on 2015-11-30.

To ask Her Majesty’s Government how many business cases were created in NHS England trusts in 2014 that related to the business justification for introducing new tumour genetic tests; when reviewing those business cases, what percentage of trusts allowed drugs budget savings to be included, given that such savings occur outside the underlying NHS tariff; and what is their estimate of the staff hours and costs associated with creating and reviewing such business cases every year in England.

Lord Prior of Brampton

NHS England has not, to date, undertaken a direct comparison of the English and French health systems in respect of genetic testing practice for cancer.

NHS England does not hold data on the percentage of stage 2b, or higher, cancer patients in secondary and tertiary centres who were genetically tested. Detailed information on the clinical circumstances, or reasons, for referral for genetic testing for individual patients is not currently collated on a national basis.

NHS England does not consider business cases from individual National Health Service trusts in relation to the adoption of new genetic tests. Instead, NHS England considers national clinical commissioning policy proposals on the eligibility of a particular test, or treatments to be made available in the presence of particular genetic markers. These are considered and where agreed, funded consistently across England for services falling within NHS England’s direct commissioning responsibilities.

Examples include the separate policies (published in July 2015) confirming eligibility for Ivacaftor for the treatment of cystic fibrosis in the presence of certain gene mutations, and confirming eligibility for testing for BRCA1 and BRCA2 gene mutations, respectively. Copies of the policies are attached.

In addition, the UK Genetic Testing Network currently presents new genetic testing proposals to NHS England for funding consideration based on the conclusions of their assurance programme. These are considered, alongside other new policy proposals, as part of the annual funding prioritisation process, where there is a net annual investment to be made to support their adoption.

Information on the average turnaround time for cancer genetic tests is not currently collated, or analysed, nationally. However, NHS England will be undertaking a procurement exercise in the coming months to support the strengthened provision of genetic testing across England. This includes more consistent reporting of activity and other performance indicators, including the timeliness of reporting on receipt on referrals. The supporting national service specification, setting out the standards required of commissioned providers, has been the subject of a recent public consultation.

The below Parliamentary question was asked by Lord Freyberg on 2016-02-03.

To ask Her Majesty’s Government, further to the Written Answer by Lord Bridges of Headley on 26 January (HL5030), what historic data they hold on cancer registrations and deaths in England over the past 15 years owing to: (1) C50, malignant neoplasm of breast, (2) C61, malignant neoplasm of prostate, (3) C33-C34, malignant neoplasm of trachea, bronchus and lung, (4) C18-C20, malignant neoplasm of colon and rectum, (5) C43, malignant melanoma of skin, (6) C82-C85, non-Hodgkin’s lymphoma, (7) C67, malignant neoplasm of bladder, (8) C64, malignant neoplasm of kidney, except renal pelvis, (9) C91-C95, leukaemia, (10) C25, malignant neoplasm of pancreas, (11) C54-C55, malignant neoplasm of corpus uteri and uterus, part unspecified, (12) C15, malignant neoplasm of oesophagus, (13) C00-C14, malignant neoplasm of lip, oral cavity and pharynx, (14) C56-C57, malignant neoplasm of ovary and other unspecified female genital organs, (15) C16, malignant neoplasm of stomach, (16) all other neoplasms, (17) tumours listed in (1) to (5) in total, and (18) tumours listed in (6) to (15) in total.

Lord Bridges of Headley

The information requested falls within the responsibility of the UK Statistics Authority. I have asked the Authority to reply.

The below Parliamentary question was asked by Lord Freyberg on 2016-04-21.

To ask Her Majesty’s Government, further to the Written Answer by Lord Prior of Brampton on 17 March (HL7133) concerning the protection of personal health and social care data, what was the date on which the stakeholders committed to the delivery of the future state, without the need for interim Accredited Safe Havens.

Lord Prior of Brampton

The Data Services for Commissioners Programme Board, which is the oversight mechanism with responsibility for the delivery of the future state, and comprises representatives from the stakeholder groups committed to its delivery, met for the first time on 9 December 2014. The delivery of the programme is ongoing and on track to deliver increasing levels of functionality from 2017 onwards.

The below Parliamentary question was asked by Lord Freyberg on 2016-07-19.

To ask Her Majesty’s Government what steps they are taking to ensure that patients suffering with radioactive iodine-refractory differentiated thyroid cancer are not denied treatment due to the timeframes applied by NHS England for access to the new Cancer Drugs Fund.

Lord Prior of Brampton

NHS England has advised that systemic therapy is available for patients with radioiodine-refractory thyroid cancer through the continued funding of sorafenib for this indication via the Cancer Drugs Fund. The National Institute for Health and Care Excellence has been asked to develop technology appraisal guidance on the use of sorafenib and lenvatinib for this indication.