Two new competitions, with £5m of funding, have been launched to help improve standards of end of life care and care for people with mental illnesses.

Businesses can win funding by creating new products or services that drive standards for patients with long-term conditions.

Health Minister Lord Howe (pictured) said that “small businesses play a crucial role in providing creative and innovative solutions to existing problems. That’s why we are supporting them.”

One competition challenges businesses to generate creative ideas and technologies that could see mental health illnesses diagnosed earlier – resulting in better management through a tailored approach.

The other focuses on how new technologies can assist people to have a better experience of end of life care.

Sir David Nicholson, NHS Chief Executive, said the NHS can be “proud of the innovation it has introduced” but it needs to get “smarter at making it easy for others to adopt”. He added that “technologies that can give people a better end of life or improve the management of mental illness could make a real difference to many.”

The competitions are part of the Small Business Research Initiative (SBRI), and will be managed by NHS Midlands and East.

NHS Chief Executive Sir David Nicholson has warned that the Government’s controversial health service reforms may end in “misery and failure”.

Sir David said that politically driven changes to any public sector body usually ends in disaster.

Speaking to doctors at the Royal College of General Practitioners conference, Nicholson said that “carpet bombing” the health service with private sector competition was not the right way to tackle rising costs.

The NHS’ leader said that the reforms would benefit patients by offering them increased choice and improved standards of care through competition. But he added that GPs would only benefit from the reforms if they are free from negotiating new services.

“If we are creating a system where general practitioners feel it is their job to do all that, then I think we have a massive problem,” he told delegates. “We need to create the right kind of people with the right kind of skills, which we are trying to do at the moment through commissioning support, to enable people to focus their attention on clinical decision-making.

“My advice to anyone – and I have been involved in the last five or six years with the national programme for IT, and I have, as they say, the scars on the back around all of that – is that big, high-profile, politically driven objectives and changes like this almost always end in misery and failure.”

Shadow Health Secretary Andy Burnham said Nicholson’s comments were a concern. “David Nicholson is a man who has the NHS at heart, so it is worrying to hear him talk in these terms,” he said. “He has put on a brave face in public, but clearly has private concerns about the real damage this reorganisation is doing.

“His open acknowledgment of the possibility of it ending in failure will send shock waves through the NHS and provide a stark illustration of the sheer scale of the gamble the Government is taking.”

A trust struggling to meet the Government’s efficiency savings targets is being forced to do without full time cleaners as hospital bosses continue to cut costs, a new report claims.

Nurses at Mid Yorkshire Hospital Trust are being forced to clean and tidy dirty working environments as it struggles to meet the £20bn Nicholson Challenge and the QIPP agenda.

The report by a former inspector at the Department of Health said the nurses being forced to clean impacts patient care and is something that requires “urgent attention”.

The investigation by Brian Duerden, a former inspector of microbiology and infection control at the DH, found that nurses were mopping and cleaning beds despite not being trained to do so.

The Trust was forced to reduce the hours of professional cleaners earlier this year to just two days per week in measures to control finances. The cash-strapped trust is seeking to save £24m in the next financial year to meet Government targets.

A spokesperson for Mid Yorkshire Hospital Trust insisted the practice of nurses cleaning up wards was not reserved to the hospitals it controls. She said that the need for nurses to clean certain wards was not due to cost-cutting practices but to meet levels of high demand.

NHS Chief Executive Sir David Nicholson recently said the health service had enjoyed a “remarkable year” after it made £5.8bn in savings through the QIPP agenda.

However, those comments were in contrast to Jim Easton from the NHS Commissioning Board who insisted that cuts should not represent QIPP savings.

Sir David Nicholson, NHS Chief Executive, has admitted taking control of NHS finances whilst the Government’s reforms to the health service take shape.

Speaking at the Local Government Association, Sir David said he had a greater hold of NHS finances than ever before to oversee and control budgets.

He told delegates that despite talk about “localism” he has “more control nationally” and he refused to apologise for that.

Despite taking control of finances nationally, Sir David stressed the importance of “joined-up, integrated services” when the NHS reforms were fully functional.

The Chief Executive admitted that patients in the past had been failed by a “lot of services on the cusp of health and social care” and said there was a “strong case for bringing in innovation from the wider sector” to address previous errors.

He also admitted that the health service had “raided the public health budget” to “bail out” other parts of the system. The admission is likely to affect future public health budgets after the Government said it would base council funding on historical NHS spending.

A host of NHS trusts received bailouts totalling more than £1 billion in the last six years, a report from the National Audit Office (NAO) has shown.

The Department of Health was forced to issue four struggling foundation trusts and 17 other trusts the money between 2006 and 2012 to pay creditors and staff.

Amyas Morse, Head of the NAO, said that it was clear “parts of the service are under strain.”

Research found that South London Healthcare NHS Trust – which recently became the first to go into administration – needed a total of £356 from the DH to break even over the last six years. It is yet to pay back the money.

Barking, Havering and Redbridge University Hospitals NHS Trust also required £195 by the DH to cover its debts.

Last year, trusts needed £253m from the DH, the report found – a huge increase from the £76m requested between 2010 and 2011.

The NAO now estimates that NHS trusts and foundation trusts will need approximately £300m more in bailouts next year to cover ailing finances – despite a surplus of £2.1bn across the NHS.

Meanwhile, official figures from the Department of Health showed ten NHS hospital trust recorded deficits last year.

Mid Yorkshire Hospitals was £19m in the red, Surrey and Sussex Healthcare ended with a £6m deficit, Mid Essex Hospital Services Trust ended up with £2m debts and Newham University Trust recorded losses of £200,000.

Hospital trusts in the capital struggled to control finances more than any other part of the country with the region finishing £96m in the red overall.

Sir David Nicholson, NHS Chief Executive, said the “demands of an ageing population and increased costs owing to developments in drugs and advancing medical technologies present challenging financial conditions in a constrained economic environment.”

He added that “all parts of the NHS” will need to take “bold, long-term measures” to meet financial challenges.

NHS Chief Executive Sir David Nicholson has said he expects the remaining work on the NHS' organisational design to be completed by May.

In a letter to NHS staff following Royal Assent of the Health and Social Care Bill, Sir David said that the future of employees would be confirmed by the end of the year, when the transition will be complete.

But he warned that jobs will undoubtedly be lost by the time new statutory organisations take effect next April.

"The passage of the Bill gives us real clarity and certainty about our future direction,” he said, but “there is an enormous amount to do to prepare for the bulk of the statutory changes”.

In terms of the timetable, the remaining senior appointments will be made within the commissioning structure during May and June. Then, from July to December 2012, the NHS will complete the remaining phases of the transition to ensure new organisations are fully operational from April 2013.

The document outlines a “particular need to retain the skills of certain staff in business critical roles” but admits jobs will be lost with redundancies impacting the budgets of new organisations from 2013/2014. Key milestones for the development of CCGs were also outlined. In July 2012, the first wave of authorisation applications will be accepted – followed by dates in September, October and November.

The NHS Commissioning Board will begin as an Executive Non-Departmental Public Body in October and take on the responsibility for the authorisation of CCGs before it and authorised CCGs take on full statutory powers from April 2013.

In a separate letter released on the same day, Health Secretary Andrew Lansley wrote to NHS staff thanking them for their work during the passage of the Health Bill to Royal Assent.

Mr Lansley said: “The Health and Social Care Act will, in reality, empower NHS clinicians to determine the type of health services needed in their local area, using their clinical expertise and their knowledge to ensure NHS services meet the needs of patients.

“I hope you and your colleagues in the NHS will take advantage of the new freedoms the Act has put in place.”

The year 2012/13 marks the last phase of the transition to the new NHS for England, and the next NHS Operating Framework sets out the template for this. Alan Jones looks into its implications for pharma.

As we approach the next NHS financial year, it is time to examine what the Department of Health expects of the NHS and what this might mean for pharma. The new Operating Framework for the NHS in England 2012/13 is rather dry, but nevertheless is one of the ’must-read’ documents as you start to prepare your business plans for the year ahead. We pick out some highlights here.

First off, the document sets out the business and planning arrangements for the NHS and describes the national priorities and the ‘system levers and enablers’ needed for NHS organisations to improve the quality of services provided, while both delivering transformational change and maintaining financial stability (aka ‘grip’). It also sets out the practical steps that need to be taken to carry the NHS through a stable transition over the coming year as it moves towards its new structures.

There is much about transforming service delivery and the major shift to a more outcomes-focused approach. The main chapters are on quality, the reform process, finance and ‘business rules’, and planning and accountability. Note that this will be the final Operating Framework for the current delivery system of PCTs and SHAs, and probably the last one of its kind, since this is the final year of transition to the new system.

Outcomes to the fore
This document is rather dry, because there is now a lot of other ‘sexy’ health policy stuff around in documents such as those on clinical commissioning group (CCG) authorisation, clinical commissioning support and the more recent 2012/13 NHS Outcomes Framework – again, all important documents to peruse, and with major implications for pharma.

Pinched from the latest Outcomes Framework are new national performance measures laid out according to the various domains, described in detail in the Annex to the document. For example, from ‘Domain 2: Enhancing quality of life for people with long-term conditions’ there are measures around early intervention (mental health measures) and unplanned hospitalisation in diabetes patients (long-term condition measures). By 2013/14 both the NHS Commissioning Board (NHSCB) and the CCGs will be held to account for such outcomes delivery, and will be expected to publish data on achievement against the indicators in the Outcomes Framework at a local level. This will be linked to the proposals for the new Commissioning Outcomes Framework (COF), which is due to go live in 2013/14.

Some of the COF indicators will be based on NICE quality standards, and as with the Outcomes Framework there will be a particular focus on clinical effectiveness. Also stressed is the link of COF not only to the NHS Outcomes Framework but also to the Public Health and Adult Social Care Outcomes Frameworks. Readers might want to examine these closely to see where they overlap with shared indicators – this is particularly relevant with the new drive towards better integration of care in long-term conditions such as schizophrenia.

QIPP and innovation
The NHS Operating Framework spends a fair amount of time going through some of the outcome measures or proxies in the five domains of the NHS Outcomes Framework – all hugely relevant to pharma. CHD/CVD, diabetes, mental health, cancer, asthma, COPD, epilepsy and venous thrombolembolism are all in the mix. With payers no longer wanting to be sold ‘pills and gadgets’ but solutions that unlock quality and value, now is the time for brand managers to finally step up to the NHS mark.

Early diagnosis and treatment are stressed, as are NICE quality standards. There is to be a renewed push on implementation of the national dementia strategy, and commissioners need to ensure that providers are compliant with NICE quality standards and that diagnosis rates improve.

Interestingly, there are some reform indicators for the first time – e.g. the percentage authorisation of CCGs. NHS and NHSCB Chief Executive Sir David Nicholson points out in his foreword to the document that this is the second year of the quality and productivity challenge, and he emphasises the need for the NHS response to this challenge to accelerate.

QIPP gets considerable coverage, with examples of good practice being given and available resources noted – such as the NHS Evidence website and the Atlas of Variation, with Volume 2 of the latter now published with prescribing maps. Sir David wants more rapid diffusion of good practice (industry should be able to help here), and the new Innovation Review sets out specific measures to achieve this. Service change and clinical service redesign are seen as key, and again this is something that pharma must factor into its forward plans.

New customers galore
2012/13 is seen by the Government as a critical year for the building of the new NHS architecture and delivery system. The CCGs will have to focus on improving care of long-term conditions; clinical networks and clinical senates will be established; and the Health and Wellbeing Boards plus the NHS Commissioning Board will go onstream. There will be more NHS Foundation Trusts, though it is expected that around 20 hospitals will not make the grade. There will be continued rollout of Any Qualified Providers plus the new commissioning support organisations, and there is mention of the newly-integrated organisations that have arisen via the Transforming Community Services programme.

So there are many new industry customer groups since this time last year! Note that the first time, the document states that the Health and Wellbeing Boards should be the ‘local systems leader’ with the key role of integrating local commissioning and overseeing a clear local strategy across the three separate systems of the NHS, public health and social care through joint strategic needs assessments (JSNAs). Please remember that local government is where the director of public health will be based in future, which is another good reason to put local authorities on your radar…

CQUIN and PbR
The document also proposes new national CQUIN goals, and the amount that providers can earn goes up to 2.5% of income. It is suggested that they may want to use the measures of the Innovation Review to help them set up such schemes. Commissioners must share agreed schemes on the NHS Institute website, and if you have not visited this site there is a real treasure trove of local schemes there. Some of these case studies could usefully be shared with customers. Click here for further information.

Local CQUIN schemes that are developing will need to be watched. And watch out too for developments within PbR in 2012/13, aimed at improving the links with quality of care, driving integration and incentivising the implementation of QIPP. That means expanding best practice tariffs, incentivising the performance of procedures in a less acute setting, pathway and mental health tariffs, and both chemotherapy and HIV joining the PbR club.

Clinical Commissioning Groups
Finally, note that CCGs are expected to be given £25 per head of population to be spent on management costs. This is before any entitlement to a COF ‘quality premium’. This sum is at the lower end of the expected range for the running cost allowance, and probably places the future of some of the smaller CCGs in doubt. Indeed, some CCG mergers have already begun. Through the coming year, folk will need to track the authorisation (or not) of each CGG, as this again is essential key account management stuff!

CCGs will also be thinking now about commissioning support and whether or not they need external support. This must be highly relevant to the pharma account management strategies beginning to take shape for the new ‘payers’, as well as the folk in head office considering new ‘support offerings’. Note that some aspects of medicines management also seem to be in the mix, and some of these providers could well be private companies.

Wrapping up
So there we are: another outline sketch of the key annual NHS business planning document and the year ahead. This is all key need-to-know stuff regarding the future new customers of pharma. With an acceleration of new customer groups springing up, industry account managers will have a lot to think about. The onward development of the CCGs particularly needs to be tracked, as does the commissioning support system being proposed. The development of the NHS Commissioning Board will also need to be watched, as it will be a brand new and critically important national account. It will, for example, have a ‘medicines optimisation’ role. Who will be the gatekeeper(s) in head office?

As the journey’s end draws near, the NHS at the end of 2012/13 will look and feel very different to the NHS at the beginning of the year. Are you getting ready for the final transition?

Alan Jones is an occasional contributor to Pf. He commentates and presents widely on the ongoing reform within the NHS and its implications for pharma and is a consultant to Wellards. An independent healthcare policy analyst, adviser and NHS trainer and mentor, he can be contacted here.

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.