Asked by: Julian Huppert (Liberal Democrat - Cambridge)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, if he will review regulations applying to the licensing of the drug Avastin for use in eye conditions, in response to recent research on that drug's safety and efficacy compared to licensed alternatives.
Answered by George Freeman
The European framework for licensing of medicines is designed to ensure medicines that are placed on the market have been tested for safety, quality and efficacy and the system confers important benefits for patients and the healthcare system. Avastin is not licensed for the treatment of eye conditions and has not been assessed by the regulatory authorities for the treatment of eye conditions. However, clinicians may decide to use an off label or unlicensed medicine in cases where there is not a licensed medicine available to meet the clinical needs of an individual patient. There are no plans at this time to review the regulations that apply to licensing of medicines.
Asked by: Julian Huppert (Liberal Democrat - Cambridge)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what progress has been made by the working group established to develop a robust process to support the sustainable long-term commissioning of cancer drugs; when he expects the outcomes of their work to be published; and what steps he will take to reduce variations in access to cancer drugs depending on when an application to the Cancer Drugs Fund is made.
Answered by George Freeman
NHS England has advised that its Cancer Drugs Fund Working Party has held its first meeting and discussed its draft principles and terms of reference for its work.
The Cancer Drugs Fund (CDF) runs a notification system for drug/indications included on the national CDF list. In order to commence treatment with these drugs, clinicians complete an application online and, where a patient’s needs meet the clinical criteria, they are able to access the drug(s) without any administrative delay. This is an equal system for all if the conditions are met for the drug/indication.
If the drug/indication is not on the national CDF list, an individual CDF request can be made. These are currently assessed on a regional basis. NHS England works closely with the regional teams to ensure consistency in decision making through training, sharing information and the use of a shared database.
Asked by: Julian Huppert (Liberal Democrat - Cambridge)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what estimate he has made of how many GP practices will be required to reduce patient services due to the phased withdrawal of the Minimum Practice Income Guarantee; what estimate he has made of how many GP practices he expects will be required to close for the same reason; what steps his Department has taken to support GP practices experiencing savings to their budgets as a consequence of that withdrawal; and what plans his Department has to revise the funding formula for postgraduate students.
Answered by Dan Poulter
Since April 2013, NHS England has been responsible for ensuring the provision of primary care services in England. NHS England is not aware of any that have closed as a result of the withdrawal of the Minimum Practice Income Guarantee (MPIG) and has not estimated whether any will have to reduce services.
The funding released from MPIG will be reinvested into the basic payments made to all General Medical Services practices. For the majority of practices, there will be a net gain in practice income. The phasing of these changes over seven years will allow the minority of practices that lose funding to adjust gradually to the reduction in payments and NHS England is supporting the most affected practices to adjust to the changes.
The Carr-Hill formula, which is used to determine allocations to general practitioner practices, is currently under review by NHS England.
Asked by: Julian Huppert (Liberal Democrat - Cambridge)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what plans he has to increase his Department's investment in cancer services; whether NHS England plans to provide increased funding to clinical reference groups to ensure they have sufficient resources to improve specialised services; and if he will create a recognised cancer leadership team to provide support and strategic oversight to NHS England, Public Health England (PHE) and his Department, in conjunction with the introduction of cancer lead roles at PHE and his Department.
Answered by Jane Ellison
On 11 January, NHS England announced a new independent cancer taskforce to develop a five-year action plan for cancer services that will improve survival rates and save thousands of lives. It will produce a new cross-system national cancer strategy to 2020, building on NHS England’s vision for improving cancer outcomes as set out in the NHS Five Year Forward View.
The taskforce will work in partnership with the cancer community and other health system leaders, and will be chaired by Dr Harpal Kumar, Chief Executive of Cancer Research UK. It will include cancer specialist doctors and clinicians, patients groups and charity leaders, including Macmillan Cancer Support, Public Health England, local councils, and the Royal College of general practitioners.
The action plan will set a clear direction covering the whole cancer pathway from prevention to living with and beyond cancer and end-of-life care and address issues such as data, workforce and research. It will also consider how services need to develop and innovate in future. The taskforce will assess the opportunity for improved cancer care and produce a statement of intent by March 2015, with the new strategy to be published in the summer.
NHS England has also launched a major new programme to test innovative ways of diagnosing cancer more quickly at more than 60 sites across the country, and committed a further £15 million over three years to evaluate and treat patients with a type of modern radiotherapy.
Decisions about future funding for cancer services and any changes to the structures nationally to support the delivery of cancer commissioning will be taken in light of the output from the Cancer Taskforce. Specialised commissioning teams will negotiate contracts with providers for 2015-16 in line with NHS England’s published commissioning intentions.
Asked by: Julian Huppert (Liberal Democrat - Cambridge)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what steps the Government is taking to raise awareness of mesothelioma and its cause by (a) exposure to asbestos and (b) other causes.
Answered by Jane Ellison
The Health and Safety Executive (HSE) has run a number of asbestos related awareness raising campaigns including the ‘Hidden Killer’ campaign in 2008-09; the asbestos ‘Training Pledge’ in 2010; and the current ‘Beware Asbestos’ campaign.
The ‘Beware Asbestos’ campaign was launched in October 2014 and is aimed at trades in which people who may disturb asbestos-containing materials in their day to day work. It includes information on identifying asbestos-containing materials and simple, easy to understand advice on how to avoid exposure to asbestos when carrying out a range of common work activities on such materials. It features a smartphone ‘app’ as a means of delivering this information to.
HSE has guidance on the health risks from asbestos, including mesothelioma on its dedicated asbestos related web pages, together with comprehensive information on how to comply with the legal controls covering work with asbestos. This is available at
Information about causes and symptoms of mesothelioma and advice on seeking help is also available on NHS Choices at
www.nhs.uk/Livewell/Lungcancer/Pages/Asbestosandlungcancer.aspx
Asked by: Julian Huppert (Liberal Democrat - Cambridge)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what steps he is taking to ensure that emerging treatments for Duchenne muscular dystrophy which receive conditional approval are available through the Early Access to Medicines Scheme as early as possible; what steps he is taking to encourage flexible approaches to the licensing process for potential new treatments for rare conditions; what progress NHS England has made on development of a commissioning policy for the Translarna treatment for Duchenne muscular dystrophy; and if he will make a statement.
Answered by George Freeman
The Early Access to Medicines Scheme (EAMS) aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for the scientific aspects of the scheme and the scientific opinion will be provided after a two-step evaluation process:
- step I, the promising innovative medicine (PIM) designation
- step II, the early access to medicines scientific opinion
The PIM designation will give an indication that a product may be eligible for the EAMS (based on early clinical data) and that the development programme is on track. The PIM designation will be issued after an MHRA scientific meeting and could be given several years before the product is licensed.
The scheme is voluntary and the opinion from MHRA does not replace the normal licensing procedures for medicines.
There have been no applications from companies with products for Duchene Muscular Dystrophy.
The opinion will support the prescriber and patient to make a decision on whether to use the medicine before its licence is approved. The EAMS scientific opinion is valid for one year in the first instance and lapses at this time or at the time of the grant of a marketing authorisation e.g. conditional marketing authorisation.
For certain categories of medicines going through the centralised marketing authorisation procedure (European procedure), in order to meet unmet medical needs of patients and in the interest of public health, it may be necessary to grant marketing authorisations on the basis of less complete data than is normally required. In such cases, it is possible to recommend the granting of a marketing authorisation subject to certain specific obligations to be reviewed annually, a conditional approval. The granting of a conditional marketing authorisation will allow medicines to reach patients with unmet medical needs earlier than might otherwise be the case.
A conditional marketing authorisation for the first in class medicinal product Translarna (ataluren) was granted this year. Translarna is an orphan medicinal product that is used to treat patients aged five years and older with Duchenne muscular dystrophy (DMD) who are able to walk. Translarna is expected to slow down the loss of walking ability in DMD patients. As part of the conditional marketing authorisation, the company will be required to provide comprehensive data on the efficacy of Translarna from an ongoing confirmatory study.
Rare diseases are classified as conditions affecting no more than 5 in 10,000 people in European Union and patients with rare conditions deserve the same quality, safety and efficacy in medicines as other patients with more common conditions. Since the pharmaceutical industry has little interest, under normal market conditions, in developing and marketing medicines intended for small numbers of patients (orphan medicinal products), the European Union offers a range of incentives to encourage the development of these medicines in order to address the unmet clinical need (orphan drug legislation, Regulation (EC) No 141/2000). These incentives include a period of 10 years market exclusivity, the provision of Protocol Assistance (scientific advice specifically tailored for orphan medicinal products) and fee reductions and waivers for regulatory procedures. Products intended for treatment of Duchenne muscular dystrophy qualify for incentives in the orphan drug legislation.
Applications for the designation of orphan medicines are reviewed by the European Medicines Agency through the Committee for Orphan Medicinal Products (COMP). For orphan designation, the following criteria must be fulfilled. The medicinal product is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting no more than 5 in 10,000 persons in the European Union or without incentives it is unlikely that expected sales of the medicinal product would cover the investment in its development and no satisfactory method of diagnosis, prevention or treatment of the condition concerned is authorised, or, if such method exists, the medicinal product will be of significant benefit to those affected by the condition. Via the MHRA, the United Kingdom takes an active role in the decision making process at the COMP, ensuring applications for Orphan Drug designation of potential drug candidates for rare diseases are appropriately recognised, encouraging companies to develop their products further. For licensing, it is compulsory for designated orphan medicinal products to use the centralised procedure to gain a marketing authorisation.
The UK is fully represented at the Committee on Human Medicinal Products, ensuring that applications for a Marketing Authorisation (MA) for an Orphan Drug are thoroughly and rapidly evaluated for quality, safety and efficacy and a MA is granted without undue delay for the treatment of rare diseases.
In some circumstances, marketing authorisations may undergo a more rapid regulatory review called ‘accelerated assessment’. This occurs where the Applicant can demonstrate that the medicinal product is expected to be of major public health interest (particularly from the point of view of therapeutic innovation). For drugs for rare diseases, marketing authorisation applications may be granted as a conditional authorisation or an authorisation under exceptional circumstances. The granting of a conditional marketing authorisation allow medicines to reach patients with unmet medical needs earlier than might otherwise be the case, and ensures that additional data on a product are generated, submitted, assessed and acted upon. Under exceptional circumstances, the MA Applicant must demonstrate that he is unable to provide comprehensive data on the efficacy and safety under normal conditions of use, because, for example, the indications for which the product in question is intended are encountered so rarely that the Applicant cannot reasonably be expected to provide comprehensive evidence.
NHS England can confirm that a draft clinical commissioning policy for Translarna treatment for Duchenne muscular dystrophy has been developed and is being considered as part of the annual funding prioritisation process for 2015-16.
Asked by: Julian Huppert (Liberal Democrat - Cambridge)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, how many clinicians not affiliated with his Department and NHS England his Department consulted on the Off-patent Drugs Bill.
Answered by George Freeman
We have not consulted on this Bill. In developing our response to the Bill, we have taken advice from clinicians and officials at NHS England, the National Institute for Health and Care Excellence and the Medicines and Healthcare products Regulatory Agency, and taken account of views expressed by other stakeholder organisations.
Asked by: Julian Huppert (Liberal Democrat - Cambridge)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, how many times he has exercised his powers under the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 to refer an unlicensed indication of a drug for a NICE technology appraisal.
Answered by George Freeman
Since the ‘National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013’ came into force on 1 April 2013, the Department has not asked the National Institute for Health and Care Excellence (NICE) to develop under Regulation 7 any technology appraisal guidance on the use of an unlicensed drug. The Department has, however, under Regulation 5, asked NICE to develop guidance and recommendations on the use of a combination therapy for use in the treatment of ovarian cancer outside the terms of its marketing authorisation.
Asked by: Julian Huppert (Liberal Democrat - Cambridge)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what discussions he has had with (a) charities and (b) clinicians who support the Off-patent Drugs Bill.
Answered by George Freeman
Departmental Ministers have met with the hon. Member for Cardiff North (Jonathan Evans), with regard to his Off-Patent Drugs Bill and officials have also had discussions with Breast Cancer Campaign to understand their concerns around the prescribing of off-patent drugs and the implications for patients.
We are in the process of setting up a round-table discussion with key stakeholders, NHS England and the National Institute for Health and Care Excellence to review the evidence and develop a strategy to better support use of off-label medicines in areas where the evidence suggests that they can deliver patient benefit.
Asked by: Julian Huppert (Liberal Democrat - Cambridge)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, pursuant to the Answer of 22 October 2014 to Question 210807, what the anticipated payments were in respect of England in 2014-15; whether the anticipated payments have been passed to NHS England through the mandate; and whether the actual rebate payments for 2014-15 are on course to match or exceed those anticipated payments.
Answered by George Freeman
The anticipated Pharmaceutical Price Regulation Scheme (PPRS) payment for 2014-15 in respect of England was estimated to be £375 million and this was taken into account when setting the 2014-15 NHS England Mandate and overall NHS budget.
The actual amount received in financial year 2014-15 will depend on actual sales covered by the PPRS in Quarters 2-4 2014 and Quarter 1 in 2015, and also on the adjusted payment percentage for 2015 which will affect Quarter 1 2015.
The Government has committed to publishing PPRS payment data quarterly. In line with this commitment, the Department has published the first two quarters PPRS payments for 2014 and will be announcing the third and fourth quarter payments, which will depend on growth in those quarters, together with the adjusted payment percentage for 2015, in due course.