Lord O’Shaughnessy, the minister responsible for the uptake of new drugs and medical technologies, confirmed that the Government will respond to the Accelerated Access Review by the end of October
The Parliamentary Under Secretary of State for Health pointed out that the uptake of new, life-changing technologies is a challenge that the government will address in this response, with medtech playing a central role in these plans. O’Shaughnessy pointed to July’s announcement of £86 million to fund the better uptake of technologies as evidence of the Government’s continued commitment to the life sciences sector.
After attending the recent NHS England Health and Care Innovation Expo, Lord O’Shaughnessy reiterated the innovation and diversity found within the UK medtech sector. The challenge moving forward, he stated, is to implement this innovation within the NHS and spread it through the healthcare system. Following the publication of Sir John Bell’s Life Sciences Industrial Strategy, O’Shaughnessy highlighted that work will now start on a ‘sector deal’ for life sciences which will suggest ideas for supporting the sector but also addressing regulatory barriers to innovation and growth.
The issue of Brexit was also touched on, with Lord O’Shaughnessy assuring industry that the UK will continue to play a leading role both in Europe and around the world. He also stressed the importance of products continuing to reach the UK market as efficiently as they do now.
The UK’s role in raising the standard of notified bodies was also mentioned. Lord O’Shaughnessy raised the point that British notified bodies assess a disproportionately high number of medical devices but also acknowledged the mutually beneficial nature of the UK’s existing relationship with the EU, which has led to NHS patients benefitting from Europe-wide scientific expertise.
Zero tariffs on trade in medtech, continued access to overseas talent and pursuing new trade relationships were among the developments Lord O’Shaughnessy expressed a desire to see as Brexit process progresses. He concluded by expressing the government’s commitment to the medtech sector and his confidence that Brexit would provide new opportunities for the life science industry.
The independent Life Sciences Industrial Strategy, written by the Government’s Life Sciences Champion Professor Sir John Bell, has been published.
Bell was commissioned by the Government to put forward proposals for a ‘sector deal’ for the life sciences sector – setting out ideas for how government can support the industry. The strategy will now be considered by the Government and used to work towards a final sector deal. The full report can be read here.
The strategy makes several recommendations which build on the Accelerated Access Review:
Collaboration between the NHS and industry
- Utilising and broadening the AAR to encourage UK investment in clinical and real-world studies. Deliver a conditional reimbursement approval, for implementation as soon as licensing and value milestones are delivered.
- Create a forum for early engagement between industry, NHS and arm’s-length bodies (e.g. NICE, MHRA) to agree commercial access agreements.
Adoption, access and diffusion
- The strategy endorses the following AAR recommendations:
- development of an enhanced horizon scanning process to enable thorough and joint planning between industry, NHS and government, and thereby more predictable NHS expenditure on technology.
- a transformative designation for those innovations with the potential for greatest impact.
- an Accelerated Access Pathway for strategically-important, transformative products.
- a single set of clear, national and local routes to get medical technologies, diagnostics, pharmaceuticals and digital products to patients.
- evolution of the process for assessing emerging technologies so that it is fit for the future.
- a range of incentives should support the local uptake and spread of innovation, enabling collaboration, and creating greater capacity and capability for change.
- broadening of conditional and adaptive approval pathways.
- Government should use the recommendations from the AAR to streamline the processes and methods of assessment for all new products, simplifying and accelerating access and using a single clear decision point.
- Value assessments should be evolved in the long-term with improved patient outcome measures, affordability and cost management data extending beyond one-year timeframes.
- NICE’s funding model for technology evaluation should be set up in a way that does not stifle SME engagement.
- The UK could host 4-6 centres of excellence that provide support for specific medtech themes focusing on research capability in a single medtech domain such as orthopaedics, cardiac, digital health, or molecular diagnostics.
The Alliance’s members were delighted to hear from Rachel Yates, Managing Director and Deputy SRO of the ‘Getting It Right First’ (GIRFT) programme, at our last meeting on 18th July.
Led by frontline clinicians, GIRFT is a national programme designed to reduce unwarranted variations in service and practice, and to improve the quality of medical and clinical care. The programme was born out of a 2012 report by Professor Tim Briggs. Having examined the state of England’s orthopaedic surgery provision, Briggs suggested changes to improve pathways to care, patient experience and outcomes. A first pilot for orthopaedic surgery, hosted at the NHS Royal National Orthopaedic Hospital Trust (RNOH) and NHS Improvement’s Productivity Directorate, has already helped to deliver efficiencies and savings of up to £30 million.
Following the success of the pilot, GIRFT was initially expanded to a further 10 medical specialities and was recently expanded to 30+ specialities. GIRFT is firmly embedded within NHS Improvement’s thinking. NHS England’s ‘Next Steps on the Five Year Forward View’ estimates that the programme will deliver savings to the tune of £400m in 2017/18. Indeed, the programme’s latest report on national general surgery believes that if more acute hospitals introduced consultant-led surgical assessments at their ‘front door’ there could be as much as 30% fewer emergency admissions a year – saving £108m annually.
Despite its widely-acclaimed merits and projected benefits, the GIRFT programme still faces big challenges. The visits first conducted by the GIRFT team, for example, had varying impact and did not always meet with the desire audience – surgeons, most notably. Whilst the project is clinician-led, it requires a degree of buy-in from managerial staff – change cannot occur if both are not on-side. Similarly, it is not immediately clear exactly how GIRFT fits in with Sustainability and Transformation Plans (STPs) and there have been claims of overlap with NHS England’s ‘RightCare’ initiative, the body’s drive to reduce unwarranted variation in the commissioning of services, and to provide patients with better information and tools to decide on their own treatment.
To learn more about the Alliance’s meeting on the GIRFT programme and our forthcoming meetings and activities, please contact firstname.lastname@example.org
Rachel Yates, MD of the GIRFT programme presents the lessons learnt from the programme to members
The Government has today announced funding of up to £86 million as a first step in taking forward the Accelerated Access Review. The funding is split into four packages:
- £39 million of funding to the Academic Health Science Networks (AHSNs), to assess the benefits of new technologies and support NHS uptake of that that deliver real benefits to patients according to local need.
- £35 million Digital Health Technology Catalyst for innovators – which will match-fund the development of digital technologies for use by patients and the NHS.
- Up to £6 million over the next 3 years to help SMEs with innovative medicines and devices get the evidence they need by testing in the real-world, building on existing opportunities such as the Early Access to Medicine Scheme (EAMS).
- £6 million Pathway Transformation Found to help NHS organisations integrate new technologies into everyday practices – which will help overcome more practical obstacles such as training staff on using equipment.
Commenting, Health Minister Lord O’Shaugnessy said: “The government’s ambition is that NHS patients get world-leading, life-changing treatments as fast as possible. That can’t happen unless we support medical innovation and tear down the barriers – like speed to market and access to funding – that can get in the way, especially for SMEs. Our investment in innovation shows how much we value the UK life sciences sector.”
The new Department of Health ministerial responsibilities have now been announced. Lord O’Shaughnessy, Parliamentary Under Secretary of State for Health, is the minister responsible for the uptake of new drugs and medical technologies as well as the life sciences industry. O’Shaughnessy is also the ministerial lead for the Medicines and Healthcare products Regulatory Agency.
Meanwhile, Steve Brine MP, Parliamentary Under Secretary of State for Health, is the ministerial lead for NHS England while Philip Dunne MP, Minister of State for Health is the ministerial lead for NHS Improvement.
Following last week’s General Election, at which two serving Health Ministers lost their seats, Number 10 has announced the new Ministerial team at the Department of Health. Steve Brine MP and Jackie Doyle Price MP have joined the Department as Parliamentary Under Secretaries of State – their full Ministerial responsibilities are yet to be announced.
With the major parties all committed to further increases in healthcare spending, much of the debate in this area in the run up to the General Election has been dominated by a single acronym: STPs – sustainability and transformation plans. The Conservative manifesto pledges the continued introduction of STPs as part of the party’s commitments to implementing the Five Year Forward View (FYFV), provided they are ‘clinically led and locally supported’. Meanwhile, Labour has pledged to ‘halt and review’ their introduction, stating that they are ‘looking at closing health services across England’. In this environment, it is worth exploring what exactly STPs are and how they will impact the health technology sector.
What are STPs?
NHS England states that STPs are ‘place-based’ plans responsible for improving health and care services in their local areas, and are ‘built around the needs of the local population’. STPs are partnerships between NHS England and local councils, and are also supported by NHS Improvement, the Care Quality Commission, Health Education England, Public Health England and NICE. There are 44 of them across England and they hold responsibility for the local implementation of the Five Year Forward View.
Why have they been set up?
As explained by NHS England, STPs have been set up to help meet the so-called ‘triple challenge’ identified in the Five Year Forward View: achieving better health, transformed quality of care delivery, and sustainable finances. Clearly, the key challenge set out in the FYFV was the £22bn financial gap that it identified would open up by 2020/21 and NHS England sees the establishment of STPs as a key step in driving efficiencies.
What impact will STPs have on the NHS and what does this mean for health tech?
Respected health think tank The King’s Fund describes STPs as marking ‘a decisive shift away from competition as a means of improving health services by requiring NHS organisations to collaborate with each other and with local partners’. Although there is no sign that STPs will replace CCGs, it is widely expected that they will increasingly be used to coordinate commissioning plans. This is intended to assist NHS England in finding efficiencies through commissioning at scale. It is clear that, if STPs continue to be introduced, companies in the health tech sector will need improve their understanding of the changing commissioning environment and the challenges and opportunities it brings.
Critics of STPs have claimed that their development has lacked involvement from patients, the general public and staff and that local authorities also have not been engaged with sufficiently. Furthermore, some STP proposals which would change the roles of hospitals and specialist services in their communities have attracted criticism.
What does the future hold?
After a series of delays, draft proposals for all 44 STPs have been published and are now being discussed by a range of stakeholders, including clinicians, local staff and communities, trade unions, the voluntary sector and others. With most polls still predicting a majority Conservative government, it is very likely that – despite their troubled beginning and likely future obstacles – the introduction of STPs will continue.
NICE is launching the Medtech Early Technical Assessment (META) tool that will allow for medical technology to reach patients faster. Members of the Health Tech Alliance were given an exclusive look at the tool at a recent meeting, hearing from Carla Deakin (Associate Director – NICE Office for Market Access) and Deborah Morrison (Senior Scientific Adviser, NICE Scientific Advice).
It was explained to members that the tool will help medtech companies generate evidence to show that their products are both clinically effective and cost effective. The META tool will need to be paid for by companies, and is intended to help them identify what evidence a company needs in order to satisfy payer requirements. The tool can be licensed by partner organisations working with medtech companies, which will make the tool available internationally.
The tool is the outcome of collaborative work between NICE’s Scientific Advice service and the Greater Manchester Academic Health Science Network (GMAHSN). The Health Tech Alliance has been invited to attend the official launch of the META tool on the 3rd July. The event is free to attend and online registration is available here.
Last week, Theresa May launched the Conservative manifesto. The manifesto included a number of eye-catching pledges of relevance to the health tech sector and the NHS more broadly.
Regarding technology, the manifesto committed the Conservatives to:
- Implement the recommendations of the Accelerated Access Review to ensure the NHS gets the best value for money and ‘remains at the forefront of innovation’.
- The ‘most ambitious programme of investment in buildings and technology the NHS has ever seen’. Therefore enabling ‘more care to be delivered closer to home by building and upgrading primary care facilities, mental health clinics and hospitals in every part of England’.
- Expand the number of NHS approved apps that can help monitor care and provide support for physical and mental health conditions.
- Pilot the live publication of waiting times data for A&Es and other urgent care service.
Away from technology, the other headline health announcements were:
- To increase NHS spending by a minimum of £8 billion in real terms over the next five years.
- To support the implementation of the Five Year Forward View through the introduction of Sustainability and Transformation Plans ‘providing they are clinically led and locally supported’.
- To introduce a Mental Health Bill – the first for 35 years.
- To ‘make it a priority’ in Brexit negotiations that 140,000 EU nationals working in health and care system ‘can carry on making their vital contribution’.
The manifesto’s references to health tech, specifically the commitments to implement the recommendations of the Accelerated Access Review and embark on ‘the most ambitious programme of investment in buildings and the technology the NHS has ever seen’, are welcome. Details on the latter promise remain light currently. However, it will be interesting to see whether the Prime Minister releases any further information on this in the remaining weeks of the campaign.
Yesterday’s leaked Labour manifesto, made available only hours before it was to be signed off, offers an insight into the party’s plans for the NHS – an area of policy which the party typically polls well on.
The manifesto commits the party to over £6 billion extra in annual funding for the NHS and sets out plans to establish a new Office for Budget Responsibility for Health to oversee health spending and scrutinise how and where it is spent.
Labour say they will halt Sustainability and Transformation Plans, create ‘NHS Excellence’ – a new quality, safety and excellence regulator, and repeal the Health & Social Care Act.
Whilst the leaked document is light on health tech, it does mention a commitment to ensuring “that NHS patients get fast access to the most effective new drugs and treatments”.
Health policy is yet to properly be debated in this election campaign, which thus far has been understandably dominated by Brexit. The Party and its leadership may, however, continue to feel that the NHS is one area where they could and should be polling higher than the Tories.