The National Institute for Health and Care Excellence (NICE) and NHS England have published a joint 12-week consultation, 'Proposals for changes to the arrangements for evaluating and funding drugs and other health technologies appraised through NICE’s technology appraisal and highly specialised technologies programmes'.
The Times has led with this story on its front page, stating that 'patients with dementia and cancer will have their access to life-extending new drugs rationed by the NHS'. Commenting on the consultation's launch, Sir Andrew Dillion, Chief Executive of NICE, has stated “The fact that the NHS is in a really difficult position financially is certainly a reason for doing it now”.
The consultation document states that it aims to facilitate greater collaboration and earlier engagement between the life sciences industry and the NHS, whilst taking account of the “fixed resources available” in the health service. The proposals make reference to the recommendation of the House of Commons Public Accounts Committee that NHS England and NICE should “ensure affordability is considered when making decisions that have an impact on specialised services”.
NICE and NHS England are consulting on five broad proposals, further details of which are set out below:
- The introduction of a ‘budget impact threshold’ for the first three years of a treatment’s use in the NHS
- Amending the timescales for NICE-approved medicines to be funded where the proposed budget impact threshold is expected to be exceeded
- A ‘fast track’ NICE appraisal process for technologies with an incremental cost-effectiveness ration (ICER) of below £10,000 per quality adjusted life year (QALY)
- £100,000 QALY for highly specialised technologies appraised by NICE
- Amendments to the NICE single technology appraisal (STA) process to enable dialogue between manufacturers and NHS England where the budget impact threshold is likely to be met or exceeded
The Telegraph reports that a study undertaken by the Royal Marsden NHS Foundation Trust has found that patients taking part in trials of new cancer drugs have unrealistic expectations that experimental treatment will save them. The article explains that research on more than 300 patients living with cancer asked about taking part in early stage research found almost 50 per cent of patients believed their tumours would shrink.
In addition, the research showed that overall, patients were keen experiment with new drugs, with up to 84 per cent of those taking part in research saying they would be willing to enrol but 47 per cent of patients were keen to do so, because they expected the research to shrink tumours, which had often failed to respond to any other treatment.
Lead researcher Dr Udai Banerji, from The Royal Marsden NHS Foundation Trust and the Institute of Cancer Research, London, said: "There is a positive message in this, which is that 84 per cent of patients are willing to participate in Phase I oncology studies after a discussion with clinical and nursing staff who lay out the conservative estimates of benefit and requirements of hospital visits".
The full Telegraph article is available online here.
NHS England has published its planning guidance to cover the period April 2017 to March 2019. This is the first time planning guidance published by NHS England has spanned 24 months, and has been published three months earlier than in previous years to allow for its guidance to be incorporated within Sustainability and Transformation Plans (STPs). The guidance describes STPs as fundamental to “making a reality of the Five Year Forward View (FYFV)”, restoring a financial balance and delivering core access and quality standards. The guidance states that it is expected that providers and commissioners have a “relentless focus on efficiency” in 2017/18 and 2018/19.
The guidance notes that themes within the nine ‘must dos’ that NHS England previously set for STPs over 2016-17 will remain the same for the 2017-18 and 2018-19 period. NHS England will publish core baseline STP metrics in November covering finance, quality, health outcomes and care redesign, including progress against the NHS England national strategies for cancer and mental health.
The guidance includes detailed instructions for regions developing STPs based on the feedback provided on draft plans by NHS England. The early publication of the guidance is to allow for STPs to plan with knowledge of the planning assumptions made by NHS England. Final plans are to be submitted to NHS England by 21 October 2016, and are required to reflect the following requests:
- Address the feedback from NHS England in previous conversations
- Provide more depth and specificity
- Set out the measurable impact of the STP
- Include a brief statement setting out how they envisage better integration between health and social care
- Set out the degree of local consensus amongst organisations and plans for further engagement.
The planning guidance is available online here.
The APPG on Cancer publish 'Progress into the implementation of the England Cancer Strategy: One year on'
The All-Party Parliamentary Group on Cancer (APPGC) has published Progress into the implementation of the England Cancer Strategy: One year on. In the foreword, John Baron MP, Chair of the APPGC, states that the APPGC’s inquiry has found that progress in the delivery of the Cancer Strategy has started to “take shape” but that a number of concerns felt across the cancer community need to be addressed.
As a result the APPGC has put forward three recommendations to ensure that the ambition to improve outcomes for all cancer patients in England, as set out in the Strategy, can be achieved:
The APPGC calls on:
- The Government to clearly set out in a progress report (as per the details in recommendation number two), by the end of 2016, what funding will be made available for the England Cancer Strategy every year over the next four years to deliver recommendations for all parts of the cancer pathway. This should include how much funding has been allocated for each of the six strategic priority areas as outlined in the cancer strategy
- The Government, with NHS England, to respond to this report and set out how they will address the concerns of the cancer community. This response and the annual report by the Cancer Transformation Board should set out:
- How progress is being made on each of the 96 recommendations in the cancer strategy
- Detail of how the delivery of the cancer strategy is being aligned with wider changes in the NHS, including the Sustainability and Transformation Plan process being led by NHS England and NHS Improvement
- How the Department of Health is holding NHS England and other arms-length bodies to account for delivery of the England Cancer Strategy and how it will measure success by 2020
- The Cancer Transformation Board and the National Cancer Advisory Group is to set out how it will collaborate with organisations who have an expertise and interest in cancer. Most importantly, the Cancer Transformation Board should also set out how it will ensure that patients are closely involved in the delivery of the cancer strategy, both at a national and local level, over the next four years
The full report can be read here.
NHS England has published, Improving outcomes through personalised medicine. This document sets out the personalised medicine “story” and within the document, NHS England outlines that it will work with its partners to “pave the way for personalised medicine” approaches to be adopted across the health service.
The document has three chapters and the key points within each section are set out below:
A new era of medicine
- It is stated that the NHS will work closely with research and industry colleagues to ensure, as far as possible, existing and new treatments are available in an evidence-based and affordable way, giving best value to patients
Why adopt a personalised medicine approach?
- Within this section, the document outlines the benefits of personalised medicine, which are the following 'four P’s':
- Prediction and prevention of disease
- More precise diagnoses
- Targeted and personalised interventions
- A more participatory role for patients
Making personalised medicine a reality in the NHS
NHS England states that they have the foundations in place to bring science and data together, through integrated informatics and genetic laboratory infrastructure. NHS England is continuing to develop these by:
- Strengthening its informatics capability and developing data standards with NHS Digital through the Paperless2020 programme
- Creating the infrastructure for personalised medicine through 13 Genomic Medicine Centres
- Developing specialist genetic and molecular pathology laboratories – through NHS England’s forthcoming re-procurement and designation to create a national genomics laboratory structure for England
- Working with Health Education England (HEE) to develop the workforce capability and expertise to deliver genomic and personalised medicine
NHS England will work with Genomics England, NHS Digital, the Department of Health, Health Education England (HEE), Public Health England (PHE) and other partners to:
- Engage and involve the public, patients and patient groups, clinicians, academics, industry and others to inform and shape the NHS’s approach to personalised medicine
- Build the commissioning, data and informatics infrastructure
- Develop the enabling framework to ensure that personalised medicine approaches are proactively adopted based on strong evidence, value and ethics, learning from the 100,000 Genomes Project, and other health initiatives
- Roll out a personalised medicine approach in a small number of exemplars, linked to NHS England’s clinical priority areas
The full document can be read here.
On Thursday 1 September, the House of Commons Health Select Committee published a new report, Public health post-2013. The report touches upon a number of public health issues including funding, variation, leadership and data, and sets out a series of recommendations for Theresa May’s Government within these sections.
The key recommendations of interest are set out below:
- The Government must commit to protecting funding for public health
- It is recommended that the Government sets out how changes to local government funding and the removal of ring fencing can be managed
Systematically improving public health and addressing unnecessary variation
- It is recommended that local authority directors of public health should be required in their annual reports to publish information for the public on the actions they are taking to improve public health and what outcomes they expect to achieve, and to provide regular updates on progress. The Chief Executive of Public Health England (PHE) should publish an annual report bringing together and analysing local progress towards agreed plans
- The Government should set out clear milestones of what it expects public health spending to achieve, and by when. This recommendation was also made in the Committee’s report on the impact of the Spending Review on health and social care
Politics and evidence
- It is recommended that benchmarking standards for all local authorities’ prescribed public health functions should be introduced and should be transparently monitored to enhance accountability and provide reassurance that these functions are being maintained
Leadership for public health at a national level
- The Government should produce a statement of who does what in regards to the main system leaders (The Department of Health, PHE and NHS England) to show where national leadership for public health lies
- The Government is urged to take “bold and brave” action through its life chances and childhood obesity strategies to improve public health and reduce health inequalities
- It is recommended that a Minister in the Cabinet Office should be given specific responsibility for embedding health in all policies across Government, working closely with the Minister for Public Health in the Department of Health
- NHS England and PHE are urged to clarify how the two organisations are seeking to pool their expertise and resources around public health, to ensure that the local health system feels adequately supported and not conflicted by confusing messages or requirements
Access to data
- A co-ordinated national support programme is recommended to ensure that data is easily available to local authorities
You can read the full report online here.
The Department of Health has published the Government's response to the public consultation, How to keep health risks from drinking alcohol to a low level.
Accompanying the publication of the consultation response, the UK Chief Medical Officers (UK CMOs) have published new Low Risk Drinking Guidelines. These guidelines, which follow the UK CMOs' Alcohol Guidelines Review in January 2016, focus on the communication and public understanding of scientific advice relating to alcohol.
In January 2016 the Committee on Carcinogenicity concluded that ‘drinking alcohol increased the risk of getting cancers of the mouth and throat, voice box, gullet, large bowel, liver, of breast cancer in women and probably also cancer of the pancreas’. These risks start from any level of regular drinking and then rise with the amounts of alcohol being drunk. This was not fully understood when the previous guidelines were drawn up in 1995.
Of note, the new Low Risk Drinking Guidelines published this week include the following guidance:
Weekly drinking guidelines (this applies to adults who drink regularly or frequently i.e. most weeks)
- To keep health risks from alcohol to a low level it is safest not to drink more than 14 units a week on a regular basis
Pregnancy and drinking
- If you are pregnant or think you could become pregnant, the safest approach is not to drink alcohol at all, to keep risks to your baby to a minimum
The guidelines also incorporate advice for single occasion drinking episodes, including ways to limit the chance of accident, injury or misjudgement which might lead to increased risk of harm.
The Department of Health note that the intention of the new guidelines is not to prevent those who want to drink from doing so, nor to label everyone who drinks above the guidelines as a 'problem drinker'.
The new guidelines can be accessed here.
The Government has published their Childhood Obesity Strategy, with plans set out to encourage industry to cut the amount of sugar in food and drinks and ensure that primary school children are able to eat more healthily and stay active.
As part of its goal to reduce England’s rate of childhood obesity within the next ten years (public health is a fully devolved issue), the Government’s plan proposes the following:
- Introduction of a soft drinks industry levy - placed on producers and importers, to be legislated on in the 2017 Budget
- Reducing sugar in products by 20 per cent by 2020 - initially focusing on nine categories that largely contribute to children’s sugar intake, this aim will then move on to cover other relevant food and drinks, including milk-based drinks that may be out of the scope of the soft drinks industry levy
- Encouraging innovation to help businesses to make their products healthier - through the work of Innovate UK, Agri-Food technology Council and the Food Innovation Network
- Updating the nutrient profile model - Public Health England is currently working with academics, industry, NGOs and other stakeholders to ensure the nutrient profile reflects the latest dietary guidelines
- Make healthy options more available in the public sector - working with local authorities to ensure they adopt the Government Buying Standards for Food and Catering Services (GBSF) and to make sure central government departments adopt them
- Re-committing to the Healthy Start scheme - in 2015/2016, the Healthy Start scheme provided an estimated £60m worth of vouchers for fruit, vegetables and milk to low income families across England
- Helping children enjoy an hour of physical activity every day - funding for this will be provided by the soft drinks industry levy and made available for school sports. PHE will also be developing advice to schools for the academic year 2017/2018
- Improving co-ordination of quality sport and physical activity programmes for schools - including through offering sport programmes to every primary school, and increasing investment in walking and cycling to school
- Creating a new healthy rating scheme for primary schools - the criteria for the rating scheme will be developed in consultation with schools and experts
- Making school food healthier - updating the School Food Standards (2015) to reflect refreshed Government dietary recommendations, and encourage academies and free schools to commit to the standards
- Clearer food labeling
- Supporting early years settings - the Children’s Food Trust are currently working on revised menus for early years settings, with the campaign set to launch in early 2017
- Harnessing the best technology - working with PHE and Innovate UK to develop apps to enable consumers to use technology and data to inform eating decisions
- Enabling health professionals to support families - through the launch of a resource suite called “Make Every Contact Count”
In conjunction with the above, the Government has opened a consultation on the soft drinks industry levy, which can be viewed and responded to here. The consultation closes on 13 October 2016.
Commenting on the strategy, Financial Secretary to the Treasury, Jane Ellison MP, said that it was “an important step forward in the fight to halt our obesity crisis and create a Britain fit for the future”, while Public Health Minister, Nicola Blackwood MP, said that one of the best ways to reduce childhood obesity is to “boost sports in schools”, and encouraged schools and parents to ensure children do an extra hour of a physical activity every day.
You can read the Government's strategy online here.
NHS England has announced the appointment of 40 Clinical Reference Group (CRG) clinical leads following the changes made to CRGs earlier in the year. Chairs have been appointed to serve for three years and, for the first time, the role of CRG Chair will be a formal, remunerated NHS England position.
Of particular note, the following appointments have been made:
- Cancer Diagnostics – Dr Wai Lup Wong, Consultant Cancer Radiologist at East and North Herts NHS Trust
- Children and Young Adult Cancer – Dr Rachael Hough, Consultant Haematologist and Transplant Physician at University College London Hospital’s NHS Foundation Trust
- Chemotherapy – Professor Peter Clark, Consultant Medical Oncologist at Clatterbridge Cancer Centre NHS FT
- Specialised Cancer Surgery – Mr Vijay Sangar, Consultant Urological Surgeon at University Hospital of South Manchester NHS Foundation Trust
- Radiotherapy – Professor Nicholas Slevin, Consultant in Clinical Oncology at The Christie NHS Foundation Trust
NHS England has also announced the establishment of four cross-CRG working parties:
- Research – building an interface with the National Institute for Health Research (NIHR) to advise how future research strategies align with commissioning and maximising opportunities
- Data and Resource – working with NHS Digital and NHS Improvement to provide clinical advice to these organisations in their work to improve information that guides commissioning
- Guidance – working with NICE as a stakeholder in their guidance development and providing clinical advice as needed
- Value – to better understand, and therefore reduce, variations in services and, where appropriate, ceasing treatments/ways of working that are no longer of clinical or patient benefit
The NHS England press release can be accessed online here.
Research from Macmillan Cancer Support has found that 170,000 people diagnosed with cancer more than thirty years ago are still alive today, and that people are now twice as likely to live for ten years after a cancer diagnosis that they were in the 1970s. One in four people diagnosed at least 25 years ago are still suffering ill-effects, with 42,000 people diagnosed in the 1970s and 1980s experiencing problems with poor health or disability. The report focuses on the pressures placed on the NHS to care for patients experiencing ill health and long-term side effects from cancer treatments.
Commenting on the findings, Lynda Thomas, Chief Executive of Macmillan Cancer Support, states that “More and more people are being diagnosed with cancer and, in general, having a more sophisticated life with their cancer than perhaps they would have done. What we are now seeing is that lot of people are coming in and out of treatment, so all of that does put pressure on the NHS.”