Together with its health reforms, the UK Government has developed a programme to accelerate the uptake of innovative therapies in the NHS that is not only ambitious but concrete and immediate. Thoreya Swage examines the new innovation agenda and what it offers to the pharma industry.

Although the main focus of Government health policy is reform, the development of new commissioning processes and structures and saving £20bn of annual NHS spend, the powers that be at the top at the NHS are still keen on accelerating the adoption of innovation in healthcare.

With that in mind a document, Innovation Health and Wealth, was published in December 2011 by the DH to speed up the process by establishing a set of measures to support change in the practice of healthcare and to identify a timetable for implementation. Unlike similar exhortations in the past to ‘speed up innovation’, this document has a sense of urgency, with a requirement to start immediately and build the actions set out in the report in the planning cycle for 2012–13.

The document recognises that by adopting innovation, the NHS can improve its own productivity – essential for achieving QIPP. It can also provide much-needed support to the life sciences industry at home and abroad through exporting new ideas and expertise, working in partnership with UK industry and generating new business for UK-based companies.

Of course, the ultimate outcome is to improve patient care.

What’s in store?

Innovation is defined in the document as “an idea, service or product, new to the NHS or applied in a way that is new to the NHS, which significantly improves the quality of health and care wherever it is applied”. The term covers a wide range of processes, technologies and uses of pharmaceutical products. The main thrust of the document is to ensure that change is disseminated throughout the NHS, and does not remain in isolated pockets in the more progressive parts of the healthcare system.

The listed barriers to the dissemination of new ideas are probably familiar to all in the pharma industry. They include:

• limited access to data and information

• lack of recognition of those who innovate

• inflexible financial levers that oppose change

• commissioners not having the tools or capability to drive innovation

• lack of consistent leadership to support change

• poor structure and processes to drive innovation.

The actions are highlighted to overcome these barriers are listed below.

1. Ensuring compliance with new ideas

In addition to introducing a value-based pricing structure for new medicines from 2014 – to ensure that patients can access effective treatments that reflect their value, the Government plans to set out in statutory form a NICE Compliance Regime that attaches funding to NICE Technology Appraisals in order to ensure rapid and consistent implementation throughout the NHS, so that patients receive the clinically and cost-effective technologies and medicines their doctors believe they need.

There will also be a requirement for all NICE Technology Appraisals to be added to relevant local NHS formularies, and a NICE Implementation Collaborative (NIC) will support timely implementation of NICE guidance. The NIC will be made up of the NHS Commissioning Board, NICE, the Chief Pharmaceutical Officer, the NHS Confederation, the Clinical Commissioning Coalition, the Royal Colleges and the life sciences industry. It will identify areas that require support and develop implementation guidance and solutions for the NHS, as well as helping pharma companies to improve their value propositions to NICE.

2. Improving information

There will be a single comprehensive web portal for innovation in the NHS, which, among other things, will ‘showcase’ and exchange ideas, and an ‘innovation scorecard’ to track compliance with NICE Technology Appraisals. Both of these will be available publicly.

The web portal will hold a database of case studies, implementation guides and tools, and e-learning programmes for clinical staff to support the introduction of new practice.

A later development will be the inclusion of the existing database of current clinical trials for drugs and medical technologies, which permits patients to participate in clinical studies. The aim will be to encourage more patients to get involved in research and so generate better data for new interventions.

Public awareness of innovations will be driven by consumer campaigns – developed by Which? – to promote effective new ideas in health.

A secure data linkage service will be set up by the Health and Social Care Information Centre by September 2012. ­ This will provide data extracts based on information generated by primary and secondary care and other sources, permitting an improved understanding of which interventions work best, when and why. A complementary secure data service, the Clinical Practice Research Datalink (CPRD) will be set up by the MHRA to support the needs of life science researchers.

3. Architecture for delivery of innovation

­This is a key action through which more robust relationships will be developed between academia, science and industry to develop solutions to healthcare problems and ensure the dissemination of ideas. A designated number of Academic Health Science Networks (AHSNs) will be established nationally, with the first to go live during 2012–13. Every NHS organisation will be affiliated to its local AHSN, which will act as a gateway for NHS professionals requiring help with innovation and provide industry with a point of access to the NHS. Details of the designation process will be published this spring.

The many existing organisations that have been set up to support innovation will be rationalised in a review of all DH/NHS-funded or sponsored bodies.

4. Incentivising innovation

­The funding structure of the NHS will be altered to allow savings yielded to be used for innovation, to prevent ‘silo budgeting’ and to permit cross-boundary working. Tariffs for healthcare will continue to be developed on the basis of outcomes, thereby promoting cost-effective approaches. At the local level, there will be opportunities to use existing tariffs flexibilities to improve care through the development of ‘Best Practice’ tariffs.

NICE will be responsible for stating which activities and tariffs should be decommissioned or reduced as a consequence of new and improved practice or medicines being introduced.

Achieving change will be slow – however, a few high-impact innovations are identified to kick-start this process. Most of these interventions are technologies, but the management of dementia in accordance with NICESCIE guidelines is highlighted.

From 2013, compliance with high impact innovations will be incorporated into the CQUIN requirements.

5. Procurement

Procurement processes will be smartened up, beginning with a procurement strategy that will be produced shortly to enable delivery of about £1.2bn of the £20bn savings required of the NHS. Among other priorities, there will be a focus on innovation and the emphasis will be on building partnerships with industry that deliver mutual value rather than just transactions.

6. Education and leadership

Innovation will be established as an integral part of clinical and managerial education, training programmes, continuous professional development and competency frameworks in the NHS.

A jointly funded industry and NHS training and education programme will be established to enable senior NHS managers and clinicians to work and train with their industry counterparts, together with a new industry and NHS CEO network.

An NHS Innovation Fellowship Scheme, drawing experts from different sectors including industry, will provide coaching and mentoring for senior NHS staff, conduct master classes and provide advice and support on innovation strategies.

An Innovation Pipeline Project to accelerate the adoption and dissemination of proven interventions will be established by the ABPI, the ABHI and the NHS Confederation. Between 15 and 20 joint working projects will be up and running by December 2013.

Chief executives of Clinical Commissioning Groups (CCGs) and the NHS Commissioning Board will be personally responsible for ensuring that research, innovation and adoption are taken up and are part of commissioning plans. This will be reinforced by a statutory duty on CCGs to seek out and adopt best practice.

What’s new for pharma?

Although much of the Innovation document is focused on medical technologies, there are a few key actions for the pharmaceutical industry.

A few more details are still required, but the action is starting now, with NHS commissioners prioritising the adoption and spread of innovation and good practice using the CQUIN mechanism of payment.

­The Government appears quite serious about forging closer links with the industry through joint training and joint working projects with the NHS, and this is a good a time as any to take the initiative.

At all levels pharma has an opportunity to engage with NHS colleagues to demonstrate how their products could streamline care and improve efficiency. The breaking down of budgetary barriers will make it easier to develop a business case, for example, for a particular medicine in primary care reducing the need for a service or intervention in secondary care.

For the first time, encouraging innovation will be put on a statutory footing for commissioners, and this will develop further as commissioning for outcomes becomes the norm. Another opportunity presents itself for the industry to put forward the argument that their products can improve outcomes, and to provide examples of excellence using the local best practice tariffs.

One greatly encouraging feature is the attention given to raising awareness of innovations among patients and the public. They can be the best advocates for the uptake of new interventions, and perhaps will be more willing to support research undertaken by the industry by getting involved in clinical trials.

This document provides the best direction so far on how the NHS and the pharmaceutical industry can work together for mutual benefit.

Dr Thoreya Swage was formerly an NHS clinician and a senior manager in various NHS organisations covering acute and primary care. She has expertise in commissioning health services and is currently working for a number of NHS organisations, including DH agencies, to develop a more commercial approach to the commissioning of healthcare.

NICE has produced a new ‘best practice guide’ to stop ‘postcode prescribing’ and ensure that medicines it has recommended are included in local formularies.

The guide, which covers the creation and review of local formularies, states that medicines approved by NICE should be “automatically incorporated” into lists of available drugs within 90 days.

This measure is intended to combat the growing trend of PCT clusters and CCGs placing more expensive new drugs on a ‘red list’ of products to be avoided in order to achieve spending cuts.

The recent DH report Innovation Health and Wealth highlighted the barriers to innovation at local level, where formularies often do not take account of recent NICE drug appraisals; in some cases, these appraisals are challenged by local bodies.

Refusal to provide more expensive drugs (such as cancer drugs) and over-dependence on the cheapest generics were both identified as issues.

The report said that there should be no barrier to the use of new NICE-approved drugs “beyond a clinical decision relating to an individual patient”.

Dr Gillian Leng, Deputy Chief Executive of NICE, commented on the best practice guide: “We want all patients to have access to medicines that we consider to be effective.”

NICE will publish details of any measures to be taken against local prescribers for ignoring the new guidance this autumn.

Dr Bill Beeby, Chairman of the prescribing subcommittee of the BMA’s GPs’ Committee, said that these measures were to be welcomed, but that more money had to be made available for prescription of more expensive drugs.

The new formulary guide is the first attempt to standardise the process of developing local formularies across the NHS in England. It reflects the complexity of seeking to give local prescribers more choice while imposing budget cuts.

Further plans outlined by the Innovation report include the introduction of a NICE Compliance Regime to drive rapid and consistent uptake of NICE-recommended products, and the establishment of a NICE Implementation Collaborative bringing NHS and DH organisations together with industry.

The Government’s new strategy to support growth in the life sciences and innovation in healthcare aims to have industry working ‘hand-in-glove’ with the NHS to change care pathways and transform service delivery. Is this the new deal that the pharma industry has been waiting for – or just a sweetener for the medicine of NHS spending cuts?

The Government’s new strategy for the UK life sciences was presented by Prime Minister David Cameron to an audience of leaders from pharma and other life science sectors. Cameron announced measures to support early-stage research, make more NHS patient data available for clinical trials and improve the implementation of NICE guidance. He stated: “The endgame is for the NHS to be working hand-in-glove with industry as the fastest adopter of new ideas in the world.”

The background to the new strategy is complex. It builds on the ‘blueprint’ published in 2009 by the Office for Life Sciences, a ‘virtual department’ launched by the previous Government. The dissolution of the OLS and the abolition of the Regional Development Agencies had left a gap in the life science innovation landscape which the new strategy aims to fill.

In addition, the strategy is a response to calls from the Work Foundation and other expert sources for more investment in the ‘knowledge-based industries’ – and to a growing recognition of the clinical and commercial potential of ‘stratified medicine’: personalised drugs and companion diagnostics based on the new technology of genetic profiling.

Finally, the strategy seeks to improve the confidence of life science companies in the UK market at a time of upheaval and hardship. NHS spending will be subject to unprecedented constraints, and the envisaged growth of private healthcare will not rapidly counter the impact of this on the market for medical products. By promising a better commercial environment for life science companies in the UK, the Government hopes to stop the industry taking its business elsewhere.

From research to market
In December 2011, the Government published two closely related strategy documents: Strategy for UK Life Sciences and Innovation Health and Wealth: Accelerating adoption and diffusion in the NHS. The two documents came from different departments (the BIS and the DH respectively) and will be implemented through separate arrangements, but are two sides of the same coin.

The Strategy document speaks of the need to place the UK at the forefront of global medical R&D. Key measures announced include:

• In early 2012, MHRA will consult on proposals for a new Early Access Scheme to ease the route to market for ‘breakthrough therapies’.
• The Government will invest £180m in a new Biomedical Catalyst Fund to support early-stage research and a further £130m specifically to support R&D in stratified medicine.
• Pending consultation, the NHS constitution will be amended to allow companies conducting “approved research” to use anonymised NHS patient data, and to approach patients who may be eligible to participate in clinical trials.

The document notes that the UK life science industry (pharmaceuticals, biotechnology and medical technology) “is growing faster than the economy as a whole and is a key source of high-skill, high-tech jobs”. However, it comments that the time and cost of developing new treatments are increasing rapidly, and that the industry’s reliance on huge research establishments is not sustainable as products and their markets become more specialised.

Life science companies, the document promises, “will be able to operate in a streamlined regulatory framework, enabling quick entry to the market for new discoveries and innovations”. The Government will “nurture innovation through the translational funding gap,” and more generally will work to build “a life sciences ecosystem” that integrates the academic, industry and clinical sectors.  

Investments in clinical research infrastructure include the establishment of a new Cell Therapy Technology Innovation Centre in London; a new technical hub for bioinformatics in Cambridge; a number of academic health science networks across the country; and a national NIHR ‘Bioresource’ that builds on the existing facilities.

The £130m investment in stratified medicine by the Medical Research Council will consist of: £60m over three years to investigate disease mechanisms, particularly for chronic diseases; 60m over the next four years to support collaborations between academia, industry and clinicians to develop targeted treatments; and £10m to support work with AstraZeneca, who have made 22 compounds available to academic researchers.

The £180m Biomedical Catalyst Fund, invested by the MRC and the Technology Strategy Board, is intended to “nurture innovative technologies from the academic or commercial sector through to companies with products or technology platforms”. The document refers to the ‘open innovation’ model, whereby companies engage with partners in a wider R&D environment.

The Government will introduce a new Seed Enterprise Investment Scheme in 2012 offering 50% income tax relief on investments in small early-stage companies. In 2013, it will introduce an above the line R&D tax credit to attract large-scale investment in innovation.

The proposed new Early Access Scheme for ‘breakthrough’ drugs would typically be “available for drugs prior to authorisation but at the end of Phase III trials”, but could be extended to an earlier stage in some cases. The scheme would give patients access to drugs (and ensure reimbursement) where “there is a high unmet clinical need”, the likely benefits outweigh the known risks, the product is cost-effective for the NHS, and “the UK economy” will benefit.

In general, the measures outlined in the Strategy document shift the goalposts for the pharma industry only slightly, but could make a significant difference to some companies and R&D initiatives. They will promote the development of stratified and personalised medicine – and while the additional funding is very limited, the various measures could add up to a change in the innovation climate.

Changing patient pathways
The Strategy document argues that to facilitate innovation, the NHS needs to be “the ‘pull’ behind the industry ‘push’ for new therapeutic innovations”. The Innovation document expands on that statement, detailing measures to improve patient access to significant new therapies. It places more overt emphasis on medical devices than on drugs, but has major implications for the pharmaceutical sector.

The foreword by Sir David Nicholson, NHS Chief Executive, calls for a “commitment to innovation” in the NHS. He lists several opportunities open to the NHS to pioneer new treatments, including the “revolution in genome sequencing to monitor cancer and deliver personalised treatments; and to transform the detection, diagnosis and treatment of infectious diseases”.

The document states the economic case for innovation, both within healthcare (as a means of delivering care more cheaply and effectively) and in a wider context (by creating business growth and export opportunities). It emphasises the concept of the ‘value proposition’, whereby price is based on the value delivered by the product in use, including any changes it enables in the care pathway.

A number of priorities are identified for improving the climate for innovation in the NHS: reducing variation, compliance with NICE guidance, incentives, investment, procurement and adoption of ‘high impact innovations’. The document sums these up by saying: “We need an entirely new relationship with industry based on partnership, not just transactions.”

For the pharma industry, the most important changes outlined relate to NICE appraisals. The Government plans to:

• Introduce a NICE Compliance Regime to ensure rapid and consistent implementation of NICE guidance.
• Require that NICE technology appraisal recommendations are incorporated into relevant local NHS formularies in a planned way.
• Establish a NICE Implementation Collaborative, including industry representatives, to support prompt implementation of NICE guidance by helping NHS organisations to develop solutions and helping companies to optimise their value proposition to the NHS.

The Government will develop the tariff further in the direction of payment for outcomes. It will double its investment in the Small Business Research Initiative, and improve the protection of intellectual property. The NHS Confederation will work with the ABPI and the ABHI to establish an Innovation Pipeline Project that will drive “the adoption and diffusion of proven technologies in areas of high clinical need”. Finally, the new Clinical Commissioning Groups (CCGs) will have “a legal duty to promote innovation”.
The document concludes that having “a single model for driving transformation and change” will “avoid the problems of fragmentation and duplication that have previously beset the system”. Despite the impressive measures that precede it, this statement may give industry pause for thought. In an increasingly fragmented and diverse NHS, with Foundation Trusts competing for business and CCGs facing severe budgetary pressures, how can a single model for the adoption of innovation be either defined or enforced?

Deal or no deal?
Much of the Government’s life science strategy is aimed at emerging SMEs in the biotech and medtech sectors, rather than pharma companies (which tend to be larger and better-established). However, as drugs become more specialised and targeted, the dividing lines will blur – and what benefits a small biotech firm may benefit a pharmaceutical partner or parent company. Open innovation is the key to personalised medicine, and expertise is increasingly transferable between sectors.

The measures outlined in the Strategy document have less for the pharma industry than might at first appear, but the reverse is true of the Innovation document. In combination, they represent a significant initiative for the industry. There are opportunities for pharma companies in the stimulus offered to stratified medicine; in the emphasis on the value proposition and the patient pathway; in the prospect of early patient access to certain drugs; and in the more effective implementation of NICE guidance. The sharing of NHS clinical data with companies, which dominated press coverage of the new strategy, will also be of value.

What neither document explains is how the strategy will play out in a health system where private health providers play an increasingly major role, both in providing NHS care and in providing alternatives to what the funding-starved NHS can afford. A few days after launching the life science strategy, the Government passed legislation allowing NHS hospitals to allocate 49% of their beds to private patients. The new health providers may be crucial in determining whether the strategy is truly a new deal for industry or just a bribe.