Asked by: James Frith (Labour - Bury North)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what estimate he has made of the cost to the public purse of funding the outstanding retrospective claims under the continuing care programme; what interest rate is being applied to such claims; and what estimate he has made of the average cost to the public purse of those outstanding claims.
Answered by Caroline Dinenage
The estimated cost of reimbursement for the outstanding claims from periods of care between 1 April 2004 and 31 March 2012 is £14.5 million. Data on claims for previously unassessed periods of care from 1 April 2012 is not held.
The ‘NHS Continuing Healthcare Refreshed Redress Guidance’, published on 1 April 2015, advises clinical commissioning groups to calculate interest using the Retail Price Index. The estimated average cost per claim is £23,000.
Asked by: James Frith (Labour - Bury North)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what measures he is taking to utilise UK genomic medical research to improve outcomes for patients living with rare diseases.
Answered by Caroline Dinenage
The Government’s 2013 UK Strategy for Rare Diseases aims to improve the lives all those with a rare disease and is currently being implemented across England. The Strategy covers five areas including the role of research, with significant support from the National Institute of Health Research.
In October 2018, the Secretary of State announced his ambition to sequence 5 million genomes in the next five years including 1 million whole genome sequences. This builds on the success of the transformative 100,000 Genomes Project which recruited people with rare, undiagnosed genetic diseases, and with cancer, and which reached 100,000 sequences in December 2018.
The NHS Long Term Plan published on 7 January sets out the National Health Service’s commitment to research and innovation to drive outcome improvement, including through targeted investment in genomics. It confirmed that the new NHS Genomic Medicine Service will sequence 500,000 whole genomes by 2023/24 as part of the NHS’s contribution to the Government’s ambition for genomics. The NHS has become the first national health care system to offer whole genome sequencing as part of routine care. Another 500,000 whole genomes will be sequenced through UK Biobank as was announced in the 2017 Life Sciences Sector deal. Together, these activities will significantly increase the volume of high-quality genomic data for research to advance our knowledge to diagnose and treat rare diseases and other conditions to complement the research dataset already generated by the 100,000 Genomes Project.
Asked by: James Frith (Labour - Bury North)
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 19 December 2018 to Question 201214 on Rare Diseases: Drugs, on how many occasions NICE has made a conditional recommendation for a rare disease treatment that do not qualify for conditional recommendation through the cancer drugs fund; and what criteria NICE uses to determine whether such treatments are eligible for conditional recommendations.
Answered by Steve Brine
The National Institute for Health and Care Excellence (NICE) is able to take into account the commercial terms offered by a manufacturer during a NICE appraisal through a mechanism known as a commercial access agreement. On two occasions NICE has issued optimised recommendations to make rare disease medicines routinely available for the appropriate group of National Health Service patients that are conditional on it being supplied in accordance with the terms of the commercial access arrangements. These were Sorafenib, for advanced hepatocellular carcinoma, and ibrutinib for relapsed or refractory mantle cell lymphoma.
This is different from the process of a conditional recommendation for use within the Cancer Drugs Fund (CDF) for oncology drugs, where there is significant remaining clinical uncertainty which needs more investigation through data collection. In these cases funding is provided from the CDF for a time-limited period to allow patient access whilst this data is collected, before guidance is then reviewed again for routine commissioning.
NICE does not have any particular criteria to determine whether treatments are eligible for conditional recommendations. However, the process guide for patient access schemes and commercial access agreements and the CDF can be found at the following link:
Asked by: James Frith (Labour - Bury North)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to his policy paper of 5 December 2018 entitled Voluntary scheme for branded medicines pricing and access, whether NICE plans to review the suitability of its technology appraisal methods for rare disease treatments that do not qualify for the highly specialised technologies programme.
Answered by Steve Brine
The National Institute for Health and Care Excellence (NICE) is not yet able to advise what will be included in the scope of the review of its technology appraisal methods. NICE will begin scoping the planned review in 2019/20 with the involvement of industry and other relevant stakeholders.
Asked by: James Frith (Labour - Bury North)
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 12 November 2018 to Question 188234 on Rare Diseases: Drugs, whether NICE can make a conditional recommendation for treatment for rare diseases that do not qualify for conditional recommendation through the cancer drugs fund.
Answered by Steve Brine
The National Institute of Health and Care Excellence can make a conditional recommendation for treatment for rare diseases that do not qualify for conditional recommendation through the cancer drugs fund. For example, it has recommended the use of belimumab for the treatment of lupus subject to the conditions of a managed access agreement.
Asked by: James Frith (Labour - Bury North)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, when NHS England plans to publish the commercial framework referred to in the policy paper of 5 December 2018 entitled Voluntary scheme for branded medicines pricing and access.
Answered by Steve Brine
NHS England, with input from the National Institute for Health and Care Excellence, will develop a ’commercial framework’ setting out the parameters for the commercial approach for medicines in the health service in England. This framework will be tested with and informed through consultation with stakeholders once the voluntary scheme is operational. The intention is to publish the framework early in 2019.
Asked by: James Frith (Labour - Bury North)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether officials in his Department have had discussions with the Scottish Government on the (a) Patient and Clinician Engagement system, (b) its effect on approval rates for new rare disease medicines in Scotland and (c) potential lessons from that system for NHS England.
Answered by Steve Brine
Officials have had no such discussions. Health is a devolved matter and the availability of medicines for the treatment of rare diseases in Scotland is an issue for the Scottish Government.
Asked by: James Frith (Labour - Bury North)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to paragraph 4.12 the UK Rare Diseases Strategy, what assessment his Department has made of whether the National Institute for Health and Care Excellence’s Single Technology Appraisal Programme meets the ambition of suitability for assessing rare disease treatments.
Answered by Steve Brine
Where a company is willing to set a fair price for a drug, the National Institute for Health and Care Excellence (NICE) technology appraisal process has been proven to be suitable for the assessment of drugs for rare diseases. NICE has been able to recommend a number of drugs for patients with rare diseases through its technology appraisal programme; recent examples include dinutuximab beta for neuroblastoma and daratumumab for relapsed and refractory multiple myeloma.
With the aim of improving the lives of all those affected by a rare disease, the United Kingdom Government published the UK Strategy for Rare Diseases in 2013, a high-level framework containing 51 commitments which sets out a seven-year strategic vision (2013-2020). The Government is committed to implementing the Strategy’s commitments and has, in January 2018, published Implementation Plans setting out its actions for England.
Asked by: James Frith (Labour - Bury North)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what estimate he has made of NHS England’s outturn expenditure against its £25 million budget for discretionary investment in specialised services in (a) 2016-17 and (b) 2017-18.
Answered by Steve Brine
NHS England’s outturn expenditure against its £25 million budget for discretionary investment in specialised services is not separately identified within the overall specialised commissioning spend. Therefore, no estimate can be made on actual spend on the discretionary investments approved for specialised services for 2016-17 and 2017-18.