The return of Sylvester Stallone in 2006 to the Rocky character may not have been Andrew Lansley’s first choice for Orange Wednesday when it was first released. But the character who famously took down the interpretation of the Soviet government in one fight and then Mr T. in another did have some wise words that may well be of interest to him. Especially after the battering he took last week.

Rocky, speaking to his son in a husky New York accent, said: “Let me tell you something you already know. The world ain't all sunshine and rainbows. It is a very mean and nasty place and it will beat you to your knees and keep you there permanently if you let it. You, me, or nobody is gonna hit as hard as life. But it ain't how hard you hit; it's about how hard you can get hit, and keep moving forward. How much you can take, and keep moving forward. That's how winning is done.”

While Lansley might not have taken any physical punches – yet – over his controversial reforms to the NHS, there can be no mistaking he’s been metaphorically beaten from pillar to post by various associations since the White Paper containing his reforms was published back in July 2010.

The latest combination of blows came from the RCGP and the Chartered Society of Physiotherapists. A swift right jab from Dr Clare Gerada came when she wrote directly to the Prime Minister urging him to withdraw the Health and Social Care Bill for the benefit of the NHS and patients.

The blow from Dr Gerada may not have been the first which knocked ‘Basher’ Lansley back in his stride, but it may be the one which takes his breath away more than any have before. GPs on the ground, which voted for the third time in a survey commissioned by the RCGP, hold more punching power where the changes are concerned. After all, it’s these same doctors which will be at the heart of clinical commissioning. Without these in his corner, how can Lansley possible punch through his reforms?

Whether or not Lansley will be able to continue his ‘rode-a-dope’ approach remains to be seen. However, if he continues to take hurtful body blows like he did last week, his reign as Health Secretary may be entering the last round as champion of the reforms.

After working within the industry and the NHS for the last two decades, John Fletcher uses his inside experience to explain how the shift to Foundation Trusts will affect hospitals, how completion may change the NHS, and the opportunities for the pharma.

Despite recent ‘backtracking’ by the Government, the 2010 White Paper on Health and the subsequent Health & Social Care Bill will bring both challenges and opportunities for NHS hospitals.

Clearly, financial constraints will cause the biggest problems in terms of care delivery, both for existing services and for newer ventures; however, acute trusts may also benefit if they can change and develop their services in such a way as to satisfy local needs better than their competition – be that private providers, neighbouring acute trusts or community providers.

Trusts need to develop pathways that are efficient, yet profitable, in conjunction with their commissioners. They must minimise their unprofitable emergency work, and maximise their income through the more profitable work, elective care.

Foundation Trust status

The Government has stated its desire to see all acute trusts become Foundation Trusts (FT) by 2013. In essence, a Foundation Trust has more freedom to adapt its services according to local needs, and is free from the control of SHAs. FTs are also able to re-invest their surpluses in local developments, and indeed borrow from commercial banks to support their plans, should they wish to do so.

The fate of trusts that fail to reach this FT status is at present unclear, but it is likely that they will be either subsumed by neighbouring, successful FTs, or, as in the case of Hinchingbrooke in Cambridgeshire, franchised out to a private provider.

The Trust I recently left achieved FT status, having been authorised by the regulator Monitor on 1 February. Given the problems associated with Mid Staffordshire Hospital FT, Monitor is ever more rigorous in its approval process, and it is by no means assured that all trusts will make the grade.

As a result, it can be expected that many trusts will fail in their aspirations, and the approvals process will be slow, given that many Trusts have not had their plans signed off by the DH, and Monitor will be snowed under with requests.

However, the drive towards a complete conversion to FTs will mean that every trust in the country will be its own discrete business, accountable to its local GPs and patients, overseen by a board of governors, and regulated by Monitor on its finances, and the CQC on its clinical quality. Each is also subject to ‘free market’ conditions, and can therefore ‘fail’.

Challenges for trusts

1. Competition: recent years have seen the number of competitor organisations to acute trusts rise considerably, and this is set to continue, although the Government has recently discouraged the undercutting of National Tariffs on the grounds that it may erode quality.

This keeps trusts in a stronger position as they can preserve their income, and there is less temptation for commissioners to seek alternative, cheaper suppliers of healthcare. Nonetheless, competition comes from a number of sources:

• Neighbouring acute trusts
• Private hospitals/organisations bidding for NHS work
• Community providers
• GP organisations (providing, for example, cataracts or endoscopy)

In order to stimulate further competition, there are an increasing number of tenders appearing from PCTs for ‘Any Willing Providers’ to provide various services. This work is only offered at reduced tariffs compared to acute providers, often in the region of 75%. Furthermore, such work may only be delivered in a community setting.

Despite Government moves to allay fears about private competition, the likely result of this will be many more players entering the market, particularly for services that have a relative lack of complexity, with either low lengths of stay required in hospital, or ease of delivery in community/day-case settings.

The loss of work and/or the lower tariffs may cause severe income loss for some trust departments – ophthalmology and endoscopy have already been mentioned, but there is scope in many other specialties, either medical or surgical.

2. Efficiency requirements: although the NHS has been given a further year to deliver its £20 billion efficiency savings, all NHS bodies are working towards efficiency savings of 3.5% this financial year, and 4% thereafter.

Put simply, this means doing the same level of work for less, or doing 3.5-4% more work with the same resource. Given the levels of competition, gaining activity growth on profitable services – usually elective care – is going to be much tougher, and indeed trusts will be subject to various demand management schemes instigated by commissioners.

Reductions in national tariffs this year of 1.5% will reduce income further, and given inflationary cost pressure of at least 2%, it is not difficult to see the challenges ahead in order to achieve the required efficiency, or essentially become insolvent.

To make the challenge even harder, emergency admissions over and above 2008-09 levels now only attract 30% of the full tariff, and such admissions show no sign of declining – my own trust is 4% higher than last year, and considerably above the 2008-09 levels.

A recent report from Monitor, their Annual Plan Review 2011-12, showed that the number of trusts having high risk scores for their finances moved from four in 2010-11 to eleven. In other words, trusts themselves are forecasting tougher times.

Trusts will need to adopt strategies that enable them to either grow their way through the challenge, or cut unprofitable services, or reduce wards/staff numbers. Some trusts have indeed already started trimming their staff numbers. There may be cases for mergers, bringing some economies of scale.

3. Targets: despite much rhetoric around moving to more outcome-based targets, trusts will still face daunting goals in terms of A&E where 95% will have to be seen in four hours; two week wait for cancer patients; 18 week referral to treatment, plus MRSA & C.Difficile infection rates, to name but a few.

There is one new target which could also present a challenge for trusts, and that is re-admissions within 30 days. On the surface, the target may seem reasonable, but the reasons for readmission are often more to do with the lack of community care, rather than poor hospital treatment.

Many targets will be included in contractual negotiations, or appear as ‘CQUINs’.

There is not enough space within this article to go through every target, but suffice to say that the target culture remains, and there are penalties associated with failure, both financial and regulatory.

Opportunities for trusts

Thus far, it would appear that the poor old NHS hospital is well and truly under the cosh. Whilst there are clearly major hurdles to overcome, there are also tremendous opportunities to exploit. Trusts have many inherent strengths, and not all shared by their competition – they have significant estates, they have significant diagnostic capabilities, and they have significant expertise.

In some cases, they may have developed good relationships with their commissioners and GPs, and many have strong reputations in their communities. Successful acute trusts will take advantage of these strengths.

1. Community provision: whilst it is true that across all areas there are Community Units covering services such as district nursing, health visitors, and running community hospitals with step-up and step down beds for those patients not requiring acute care, the advent of competition will enable any provider to bid to provide these services. Some may not be attractive to trusts, but some may be of great benefit.

Given the pressure to keep emergency admissions down, and to ensure readmissions are minimised, a trust taking control of some elements of community provision may help to achieve this – for example, running community hospitals, or providing Chronic Disease Management teams to help prevent acute exacerbations.

2. GP commissioning: whilst the Health & Social Care Bill is yet to be approved by the House of Lords, it seems likely that PCTs will be abolished by 2013, and commissioning will pass to Clinical Commissioning Groups. Indeed, a timetable for the handing over of powers to commissioning groups has been issued from the DH in August.

There will be a far greater emphasis on local care through these groups, and trusts that build up strong working relationships with their GPs will be in a much stronger position to defend their markets. Some services may well be decommissioned, particularly if GPs feel they can provide them cheaper, but trusts would still be able to keep their core services profitable.

3. Private income: the Health Bill also brings a possible opportunity for trusts to engage in more private work. Some time back, levels of private work were capped as a percentage of income; this cap is to be removed, opening up the private market fully.

Whilst such work cannot interfere with a trust’s ability to see its NHS patients according to the relevant targets, there are means of gaining such work, either as a separate ward in the trust, or in partnership with another private provider.

Private work in a recession may not sound like a big market – which explains why private hospitals ‘mop up’ their spare capacity with NHS work, but recessions come and go, and private work will increase.

4. QIPP: the QIPP agenda is essentially a mechanism for increasing efficiency, and decreasing cost, whilst maintaining the highest quality of care. Those trusts with the greatest ability to innovate safely will be better placed to weather the storm.

5. Section 52: some FTs may fall foul of this clause within the National Health Service Act, 2006. In essence, it gives Monitor the power to formally intervene in the running of the trust, including sacking the board, if it deems that there has been significant breaches in the trust’s terms of authorisation.

These terms include both governance – as in the case of Mid Staffs – and finance. Whether a hospital would be declared bankrupt is open to debate, but Monitor does have the power to force through whatever solution they feel appropriate. Cost pressures will undoubtedly raise the spectre of this event in the minds of many trust CEOs.

Opportunities for pharma

Given the landscape that trusts operate in, there are several opportunities for pharmaceutical companies to help:

• Development of drugs/formulations and treatments that decrease length of stay in trusts – this will help increase bed-utilisation, or indeed cut the number of beds required resulting in big savings.
• Development of drugs/formulations that enable more efficient treatment in the community, particularly for conditions that regularly translate into emergency admissions – this will reduce a trust’s exposure to lower emergency tariffs, and save the community money.
• Development of tools that enable commissioners and trusts to understand the impact of any intervention on the patient pathway, particularly cost, but also other quality parameters. These tools have to show VALUE – evidence is the key, and must be robust enough to persuade the stakeholders to amend the current pathway.
• Bringing GPs and hospitals together in a single forum to assess the primary and secondary care pathways as one, rather than two separate entities. Undoubtedly, there can be an adversarial feel to trust-commissioner relationships – bringing single solutions to joint problems is the only real way to maintain and improve patient care with no additional resource. Pharma could facilitate this in various disease areas.
• Share expertise – most staff within the NHS, including management, have never worked in the ‘cut and thrust’ of the commercial world. Expertise from any part of a pharmaceutical company may help the NHS innovate, and it will certainly build greater rapport for a more fertile commercial relationship.

John Fletcher now works for Pathway Communications, developing patient pathway simulation models and enabling pharmaceutical companies to assess the value of their treatments.

London & Essex Medicines Management
Cardiology Discussion Forum Hosted by iRx Solutions, July 2011

Pharmacists have the appetite for medicines commissioning

The NHS landscape is changing, the shape of medicines commissioning especially. At a time when the NHS – like other parts of the public sector – is in financial dire straits, the Government is driving a radical overhaul of the structure of health and social care services, in England at least. But incoming CGCs will be crying out of support around medicines management and commissioning. It’s time for pharmacy to step forward.

According to Stuart Saw, Director of Finance at NHS East London and the City Alliance, the recent listening exercise and “pause” of the Health and Social Care Bill’s journey through Parliament has not resulted in substantial changes to the direction of travel. “Irrespective of what people thought the pause might bring, the momentum was already there before the pause was called and it’s impossible to turn around,” he told guests at a cardiology discussion forum, held by iRx Solutions in London last month.

It is this momentum that will, in all probability, see the formation of some 500 Clinical Commissioning Groups, formerly known as GP Consortia, replacing around 150 Primary Care Trusts, which are to be abolished.

Omar Ali (pictured above right, with Jayesh Shah and Victoria Overland), a formulary pharmacist in the NHS, and one of three directors at iRx Solutions, suggests that these commissioning groups will be crying out for support around medicines management and commissioning, and believes that pharmacists have the necessary talent to fill the gap. “We have experienced firsthand how much sway pharmacists have as decision-makers within the NHS. This cultural change has happened over a number of years but has resulted in our profession being in a prime position to help deliver a new outcomes-focused healthcare system, which needs our expertise – and needs it urgently,” he said.

Mr Ali and fellow iRx Solutions directors, Victoria Overland and Jayesh Shah, also NHS pharmacists, came together in 2010 to consider how they could facilitate sharing of ideas and good practice among such influential pharmacists. Their vision: a suite of medicines-related solutions, including specialist education and medicines commissioning support, delivered by expert pharmacists to colleagues in ‘payer’ roles. Their recent cardiology discussion forum was a refreshing mix of good food, sponsored and non-sponsored presentations, and debate – attended by prescribing advisers, heads of medicines management and other pharmacy leaders.

Victoria Overland, who comes from a background as a commissioning pharmacist in primary care, says that pharmacists are now among the key decision-makers and are well placed to influence both prescribing and commissioning in the new NHS. “Therapy choices made by GPs,” she explains, “are currently supported by PCTs, which have a wealth of commissioning experience – balancing effectiveness and outcomes with the costs to the health economy. When the PCTs disband, this requirement for high-quality medicines commissioning support will still exist. What will be different about it is that Clinical Commissioning Groups will be making decisions that they feel best suit the needs of highly localised populations. We know that pharmacists have a great deal of experience in reviewing the efficacy and safety of medicines, and, crucially, their impact on healthcare budgets.”

So what did participants hear about at the discussion forum? Cardiology content was served up alongside presentations from Stuart Saw, who described the challenges being faced with the NHS reconfiguration, and Omar Ali, who gave an express tour of how value-based pricing of medicines might work in the future.

Helen Williams, Consultant Pharmacist for cardiovascular disease in south London, outlined how appropriate changes in drug therapy could support the Government’s QIPP – quality, innovation, productivity and prevention – agenda. Conversely, she questioned the wisdom of switching patients from certain branded angiotensin-receptor blockers (ARBs) to generic losartan. Ms Williams argued that some of the branded ARBs are due to come off patent in the near future and that the healthcare costs associated with switching therapies – not to mention the potential disruption for patients – might not be justified.

“We had nine years between simvastatin patent expiry and atorvastatin patent expiry and, as a result, we’ve saved millions,” she told attendees. She pointed out that the losartan patent expired in March 2010, adding: “We’ve got valsartan [expiring] this year and we’ve got candesartan and irbesartan next year. So I think we’ve missed the boat. If we wanted to make savings . . . from generic losartan, specifically, we needed to plan for it in 2008–09.”

Stable angina was also on the menu, with the profile of the condition set to be lifted following the publication of a new clinical guideline by the National Institute for Health and Clinical Excellence. Making clear that the NICE guideline was only in its draft form (when the discussion forum took place), Sotiris Antoniou, Consultant Pharmacist CV Medicine NE London CV & Stroke Network Barts & London NHS Trust, described the place in therapy of the range of medicines available for treating stable angina patients in the UK. He emphasised the need for clinicians, when interpreting NICE guidance, to “think about the whole patient” and his or her quality of life.

This is something that Jayesh Shah understands all too well from working as a medicines management pharmacist, supporting GP consortia. “With so many changes since the White Paper was published last year, there is a lot of confusion among both clinicians and managers,” he says. “But something we are certain about is that healthcare professionals care a great deal about their patients and want the best outcomes for them. So that’s our passion and driver, and meeting the ambitious goals of the QIPP agenda is also an imperative.”

According to Mr Shah, a healthy dialogue between pharmaceutical companies and pharmacists – “we need to think creatively about this relationship” – will help the industry to align its priorities with those of the evolving NHS. Omar Ali adds: “We are committed to working with the pharmaceutical industry to ensure all aspects of our educational events meet regulatory requirements. Moreover, iRx Solutions is committed to ensuring the quality of the content and speakers is exceptional. But we know that this kind of meeting is about more than the educational programme: both pharma and medicines management attendees see the value in time put aside for networking.”

Progress of the NHS reforms may have slowed, but it appears that momentum is building in at least one profession to tackle whatever the Government manages to push through Parliament. If the opinions of the team at iRx Solutions are anything to go by, pharmacists certainly have a bright future as decision-makers around medicines.

The directors are speaking on behalf of iRx Solutions not the NHS organisations by which they are currently employed. For more information on iRx Solutions, visit www.irxsolutions.co.uk.

Many doctors think the proposed NHS reforms will bring more risks than benefits, a survey for the BMA has shown.

An Ipsos MORI survey of BMA members has revealed that the majority of doctors are not convinced that the potential benefits of the government’s plans for the NHS in England outweigh the risks.

The reforms were laid out in the White Paper Equity and Excellence: Liberating the NHS in July 2010 and this year’s Health and Social Care Bill, which is currently going through its House of Commons committee stage.

A third (33%) of respondents said they are broadly opposed to the reforms, around a fifth (18%) are broadly supportive, and just over a third (36%) say they are waiting to see what happens. However, even within the ‘pro-reforms’ group, 67% agree that increased competition in the NHS will lead to a fragmentation of services.

Several statements had high levels of agreement among the 1,645 respondents, these were:

· Increased competition in the NHS will lead to a fragmentation of services (89% agree)

· Increased competition in the NHS will reduce the quality of patient care (65% agree)

· The move for all NHS providers to become, or be part of, foundation trusts will damage NHS values (66% agree)

· The proposed system of clinician-led commissioning will increase health inequalities (66% agree)

The survey also suggests that doctors believe the changes that are most likely to be achieved are those which are least welcome, such as increased competition between providers, and the changes that would be most beneficial are least likely to be achieved, i.e. closer working between general practice and hospitals.

Three fifths of respondents (61%) think it likely that the reforms will lead to them spending less time with patients, a change which only 1% would welcome.

Dr Hamish Meldrum, Chairman of Council at the BMA (pictured), said: “This survey shows that the government can no longer claim widespread support among doctors as justification for these flawed policies. The government simply cannot afford to dismiss this strength of feeling amongst the group they are expecting to lead much of the change.”

Many doctors think the proposed NHS reforms will bring more risks than benefits, a survey for the BMA has shown.

An Ipsos MORI survey of BMA members has revealed that the majority of doctors are not convinced that the potential benefits of the government’s plans for the NHS in England outweigh the risks.

The reforms were laid out in the White Paper Equity and Excellence: Liberating the NHS in July 2010 and this year’s Health and Social Care Bill, which is currently going through its House of Commons committee stage.

A third (33%) of respondents said they are broadly opposed to the reforms, around a fifth (18%) are broadly supportive, and just over a third (36%) say they are waiting to see what happens. However, even within the ‘pro-reforms’ group, 67% agree that increased competition in the NHS will lead to a fragmentation of services.

Several statements had high levels of agreement among the 1,645 respondents, these were:

· Increased competition in the NHS will lead to a fragmentation of services (89% agree)

· Increased competition in the NHS will reduce the quality of patient care (65% agree)

· The move for all NHS providers to become, or be part of, foundation trusts will damage NHS values (66% agree)

· The proposed system of clinician-led commissioning will increase health inequalities (66% agree)

The survey also suggests that doctors believe the changes that are most likely to be achieved are those which are least welcome, such as increased competition between providers, and the changes that would be most beneficial are least likely to be achieved, i.e. closer working between general practice and hospitals.

Three fifths of respondents (61%) think it likely that the reforms will lead to them spending less time with patients, a change which only 1% would welcome.

Dr Hamish Meldrum, Chairman of Council at the BMA (pictured), said: “This survey shows that the government can no longer claim widespread support among doctors as justification for these flawed policies. The government simply cannot afford to dismiss this strength of feeling amongst the group they are expecting to lead much of the change.”

By Chris Ross, Pf Editor

Debate around the virtues and implementation of the Health and Social Care Bill continues to dominate the news. Sir David Nicholson’s frank and informative contribution to the recent Public Health Committee’s discussion of the Bill offered some fascinating insights into what is uniformly agreed to be vast change for the NHS. Indeed, its own Chief Executive says the reforms, alongside the quality and efficiency challenges facing the health service, are “so large you can see them from space”.

The recent Government announcements of 141 Pathfinder groups is already courting controversy. Analysis of the groups has revealed that NHS South West has allowed different consortia to cover the same geographical area. The Government’s draft legislation states consortia must not coincide or overlap when they are formally established in 2013. NHS South West has said the current overlap is temporary and designed to assess the suitability of different models for GP commissioning.

This appears a fair response, given the gravity of ensuring that the new system works. Nicholson says that GPs need to engage with the changes that are happening now and provide leadership and input to make them happen. One of the criteria for becoming a Pathfinder, he says, is that they engage in the QIPP process. He has warned that if they do not work through the important issues now, they will not have budgets in 2013 because all the money will have been spent.

In an economic environment pointing ever more towards demonstrating value, the industry has a great opportunity to show how investment in its products can help GP commissioners to improve services, benefit patient health and meet challenges that are so big, they can be seen from space.

 

Contact the author: chris.ross@healthpublishing.co.uk

Liberating the NHS sets out a blueprint for a new healthcare system. This begins in 2011/12, but as can be seen in the Operating Framework, a very tight grip will be maintained by the centre. Alan Jones reports.

With the New Year now upon us it is that time again to examine what the Department of Health expects of the NHS in the year ahead. However, The Operating Framework for the NHS in England 2011/12 is not a normal list of things for the NHS to do. These are unprecedented times and this is an unprecedented Operating Framework – essentially an implementation plan for year one of the new world order and a very busy document. This is key need-to-know information for a future world of industry account managers with the priorities for all their present and future NHS customers set out for the next 12 months. Planning for transition is at the heart of this year’s Framework and it is thus a more important document than ever.

Different this year is the brand new NHS superstructure proposed and all the new players and payers. The 2011/12 Operating Framework also needs to be read alongside Liberating the NHS: Legislative Framework and Next Steps, published at the same time. This is the response to all the consultations but also sets out in much more detail what is likely to be in the Health and Social Care Bill – which has just started its passage through Parliament – and the long document plots a four year roadmap to 2015.

An accompanying letter from Sir David Nicholson, Chief Executive, NHS, completes this trio of related documents for the coming NHS year. For a flavour of what the NHS can expect, Sir David explains in the Framework’s foreword how 2011/12 will be a demanding year for the NHS during the transition to the new system.

There is much in The Operating Framework on the Quality, Innovation, Prevention and Productivity (QIPP) Programme. 2011/12 will be the first year of delivery of the QIPP savings, so performance monitoring and management of the successful delivery of local QIPP plans will intensify. National QIPP products are now coming out and if you have not seen the NHS Atlas of Variation from the QIPP Right Care work stream, for example, you must. Primary care trust (PCT) QIPP savings projections will be disaggregated to the level of consortia, who will then be expected to take on delivery. Very tight financial control and central ‘grip’ in 2011/12 are also emphasised in the document.

The year ahead

April 1st 2011 marks the start of a four year building process for a new health, social and public health care system in England. It is the first full year of the transition to the new system blueprint. It is intended to be a year of learning and planning for further roll-out in 2012/13 as a new landscape of organisations, accountabilities and relationships starts to emerge. The phrases “foundation stones” and “building blocks” are being used a lot! Much of this was all lightly sketched out in Liberating the NHS, but much more details are now available. Amongst the new bodies being introduced in shadow form include the NHS Commissioning Board (NHSCB) at the national level and a growing number of GP Commissioning Consortia (GPCC) coalescing at the local level. Although more of the GP Pathfinders are expected to be announced in March, they will not necessarily evolve into GPCCs as expect these new organisations to wax and wane over the shorter term – growing, shrinking, dissolving. On the hospital side, there will be a rush beginning to foundation status or merger with other trusts and a Provider Development Authority created to oversee this. Downward pressure on hospital costs continue through reductions in tariff prices and a renewed focus on reducing length of stays and keeping patients out of hospital.

All community services will have completely separated from PCTs and so pharma will have a brand new customer group, although some have been backed into acute and mental healthcare trusts. It’s also an important transition year for local government too as the new arrangements for health and wellbeing boards, and the new public health service are ‘tested’. Shadow health and wellbeing boards will form and there will be early adopters here too. The joint strategic (health) needs assessment process will be the key vehicle by which councils will lead on integrated working and commissioning across the NHS, public health and social care – and this will perhaps be a key document to add to your reading list. Local government’s role has been further strengthened following the consultation on the White Paper and further new incentives will be introduced to drive the integration of health and social care.

Developing a new commissioning system

It is also important to understand that the ten Strategic Health Authorities (SHA) are not going just yet, they will have a key role in 2011/12 in being ‘transition managers’, amongst other things closely monitoring progress against key QIPP performance indicators. PCTs are not going just yet either, but the document signposts very different plans for them with a ‘managed consolidation of PCT capacity’ to create PCT clusters across all regions by June 2011. The numbers are expected to be nearer 50 than 75. They are to be ‘transition vehicles’, helping to close down the old system and build the new. Each cluster will have a single executive team and will oversee management and implementation of medium term QIPP plans as well as nurturing GP commissioning consortia growth. PCT staff will increasingly be ‘assigned’ to emerging GP consortia to support their development, although some GPs might actually not want this!

Buried deep in the text is comment that PCT clusters will be creating a comprehensive commissioning support offering and the DH will support staff working in these ‘commissioning support units’ to survive by forming social enterprises or joint ventures with private sector or ‘civil society’ organisations by April 2013; and that these commissioning support organisations may then hold contracts with the NHSCB! So, PCT rumps are to live on after all. The document was expected to quote what the management costs might be for the GPCCs but rather confusingly and unhelpfully it only talks about ‘running costs’. More is expected to be revealed this month in the 2011/12 financial planning guidance.

Other highlights

It’s also important to mention some other business critical areas relevant at both local and national company level in the Framework. First off, note that some 31 new Quality Standards have been announced to come from NICE in 2010/11 and these are very much linked to the 2011/12 NHS Outcomes Framework. Like in many areas this year, this will be a ‘shadow’ framework with no teeth until 2012/13. Thereafter the NHSCB will hold GPCCs to account for improving outcomes through a new Commissioning Outcomes Framework (COF) and there will be a new legal duty for commissioners to have regard for continuous quality improvement.

Quality accounts roll out to community services though the year and those published by acute trusts will now be expected to reflect the new outcomes world. These will be published in June and should be a ‘collector’s item’. The Operating Framework also has much reference to the new public health strategy outlined in Healthy lives, Healthy people and the setting up of Public Health England. But although public health responsibility will move to local authorities, the document is keen to point out that the NHS will continue to play a crucial role. The disease areas focused on this year include dementia, diabetes, COPD, mental health, stroke and cancer care. Also, look out for the forthcoming new Mental Health Strategy and Improving Outcomes Strategy for Cancer.

Wrapping up

So there we are – another sketch of the key annual NHS business planning document, plus the year ahead. Interestingly, more than anything though, one gets a real sense that the complexity and scale of the changes ahead is causing some concern at the centre. It could all go horribly wrong and managing the risks is also in the document. This is why the National Quality Board is developing some early warning system indicators as the NHS moves from the transition (Phase 1) to the new system architecture (Phase 2). That is why in 2011/12 there actually will be no ‘liberation’ at all but in fact more ‘occupation’ as power is taken back into the centre. So the coming year will be filled with various local shadows lit by penetrating central searchlights. It’s QIPP, outcomes, transition and mainly grip for the year ahead. Liberation has been put off until 2012/13 and beyond!

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, he can be contacted at alan.jones28@virgin.net.

A recent survey by MGP and Brainsell reveals pharmaceutical advisers and senior medicines management pharmacists believe the transition to the planned NHS reforms may not be a smooth one.

The White Paper Equity and Excellence: Liberating the NHS sets out the new Government’s strategy for the Health Service. The intention is to create an NHS which is more responsive to patients, and achieves better outcomes, with increased autonomy and clear accountability.

One of the central features of the proposals in Liberating the NHS is to devolve commissioning responsibilities and budgets as far as possible to those who are considered best placed to act as patients’ advocates and support them in their healthcare choices. The aim is to empower GP practices to come together in wider groupings or ‘consortia’ to commission care on their patients’ behalf and manage NHS resources.

PAMMtrak is a bi-annual survey that gathers the views of, and highlights the key issues facing, pharmaceutical advisers and senior medicines management pharmacists. In October 2010, healthcare publisher MGP and specialist market research company Brainsell carried out a specific survey of this PAMMtrak audience to assess how they see the future in the light of the Government’s White Paper.

The results of this online survey are based upon the first 100 responses and make very interesting reading for those working in the pharmaceutical industry.

The new NHS

Only 17% of pharmaceutical advisers and senior medicines management pharmacists who responded to the questionnaire are positive about the future under the new commissioning arrangements; whilst 58% are either quite or extremely negative. Indeed, more than 80% believe that their colleagues feel either quite or extremely negative about the proposed changes.

When asked about their greatest concerns over the new arrangements, typical comments included:

“The destruction of the PCT and SHA organisation and expertise, the loss of their functions particularly in regard to quality and patient safety.”

“The proposals to completely remove PCTs. I agree there is potential opportunity to make some savings in management costs but the many functions and benefits that PCTs bring to the NHS are I’m afraid going to be thrown out with the bath water and we will have a system in total chaos.”

“The disintegration of medicine management services and rising prescribing costs.”

“Fragmentation, particularly with respect to medicines management.”

“Medicines management teams can be quite large in some areas, if we are to be directly employed by GP consortia, how are they expected to pay for the whole team? Will they want to? Therefore, jobs may be lost.”

“The lack of pharmacy networks if pharmacy moves to consortiums.”

“That GPs will not sufficiently comprehend the value of our offering and choose not to use our medicines management services but go elsewhere for them.”

“Uncertainty as to where we will be. Will there be a role for us and will this be within the NHS umbrella?”

“Losing my job.”

Respondents were also asked: “What do you consider will be the major changes to medicines management under the proposed new NHS commissioning arrangements?” Typical responses included:

“The drug budget being passed to GP consortiums.”

“It may become fragmented with individual consortia each taking their own focus. This may have benefits if benchmarking and sharing across consortia are developed.”

“Prescribing teams having to create their own limited companies and therefore not being NHS staff. Working for GP consortia and, again, not being an NHS employee.”

“Loss of capacity, expertise and leadership within medicines management, particularly in primary care, where the majority of the QIPP changes (major cost savings) will be delivered.”

“Greater focus on direct work for GP practices, budget management, formulary management, working on GP agenda rather than PCT agenda. Employed directly by consortia? More outsourcing/industry involvement.”

“It will be positive as working with doctors more closely.”

Assumed responsibilities

When asked to think about which organisations under the proposed new NHS commissioning arrangements will have prescribing formularies, clinical guidelines/care pathways, and provide medicines management advice the results point largely to foundation trusts and GP consortia/consortia federations.

It is interesting to see that under the new arrangements roughly 50% of pharmaceutical advisers and senior medicines management pharmacists consider that they will be employed directly by GP consortia and 28% by GP consortia federations. Additionally, roughly a fifth considers that they will be employed by either a social enterprise spun out from a PCT or a private provider company.

The majority of respondents consider that they will be working in a salaried post. Although interestingly over 16% think that they will be working on a ‘fee per project’ basis, over 10% on a fee related to target achievement and over 8% on a percentage of drug savings basis.

From the list of medicines management activities that they consider that they will be involved in it would seem that these will be in managing the prescribing budget, formulary management, cost minimisation, prescribing reviews and formulary development. More than half also consider that they will be involved in care pathway design and implementing national guidance.

The link with pharma

The respondents were also asked how likely they would be under the new commissioning arrangements to engage in joint working with the pharmaceutical industry in a range of activities.

The responses were largely positive with the leading areas where they would be likely or very likely to engage with the industry being training, patient education, project staff support, economic analysis and guideline implementation. Roughly a third stated that they would be unlikely to engage with pharma in this way, meaning that two thirds may be happy to do so.

With the emphasis for commissioning shifting to GP consortia it seems that those involved in delivering medicines management have an uncertain future. However, this survey suggests that it is important that companies build strong relationships with the emerging GP commissioners and their medicines management teams and that there is a strong opportunity to do so.

  After the various reforms in the White Paper to healthcare and how new outcomes will be measured, Jean-Francois Delas discusses how pharma has been presented with the perfect opportunity to introduce new strategies and systems.

It is now widely recognised that pharma’s new commercial models will rely on the principles of account management, working collaboratively across key functions to navigate an increasingly complex stakeholder environment involving payers, providers, patients and other influencers and decision-makers. The basis of the relationship with customers will also change from transactional to one based on ‘value’. Even though the exact definition of value in this context is still evolving, one thing is clear: there will be the need to demonstrate ‘outcomes’.

The triggers of behaviours, measurements, rewards and incentives will therefore have to be re-aligned from the current focus on an individual sales person’s hard earned results to integrate softer elements highlighting intended teamwork to deliver benefits to customers.

GSK US signalled a re-engineering of its whole incentive system earlier in the summer, removing sales-based bonuses for customer satisfaction targets and measures. Other companies in Europe, such as Novo Nordisk, are following suit. But this re-engineering is easier said than done. Moving away from factual data and information is likely to involve some degree of subjectivity and a lack of robustness and reliability in measurements.

We believe that looking at payer-driven countries such as the UK, Germany and Sweden will provide the necessary insights and structure to develop the new wave of KPIs and compensation systems for new commercial models. National authorities and HTAs are pioneering measurement frameworks for an outcome based healthcare environment. Successful pharma companies should use these frameworks to inform their own measurement frameworks, ensuring alignment. This will enable joint working towards common goals and objectives and facilitate win-win relationships between the national authorities, HTAs and pharma companies.

This article draws upon information within the recently published consultation paper Transparency in outcomes – a framework for the NHS to provide example payer frameworks and discuss possible implications for the pharmaceutical industry.

The NHS Outcomes Framework

A cornerstone of the NHS White Paper, Equity and Excellence: Liberating the NHS, is a new Outcomes Framework, which is being designed to hold authorities and providers accountable for improving healthcare outcomes. It will also be linked to payment. This will be developed jointly with clinicians, patients, carers and representative groups with a view to implementation in 2011/12.

This provides pharma companies with a great opportunity to redesign their own measurement, rewards and incentives systems.

Its principles

In essence, the Framework will measure benefits and outcomes, delivered around three key areas:

· the effectiveness of the treatment and care provided to patients

· the safety of the treatment and care provided to patients

· the broader experience patients and their carers have of the treatment and care they receive

This will guarantee a balanced view of outcomes, looking not only at safety and efficacy of treatments but also at patient experience.

Its structure

Measuring outcomes within each of the above dimensions will happen at three levels:

· Overarching indicators will define overall outcomes goals that will provide an indication of the overall performance of the NHS against each of the five domains (see Figure 1).

· These indicators will then be associated with specific improvement measures – approximately five for each overarching indicator.

· Finally, a set of quality standards will be published by NICE describing how best to deliver improvements against the selected outcomes by working with providers. They will set out the structures and processes of care that the evidence suggests would be most likely to deliver improved outcomes for the overall domain as well as the specific improvements areas within the domain. In the UK over the next five years, NICE is expected to produce a library of approximately 150 quality standards covering the majority of NHS activity.

Overarching indicators and improvement areas outcome indicators will primarily be the focus for national level authorities, whilst supporting quality standards will be targeted towards providers explaining how best to deliver expected outcomes and benefits.

Embedded in the structure of these three layers is a cause and effect relationship, assuming that providing quality standards will ultimately deliver expected improvements and outcomes.

New relationships

For pharmaceutical companies, the NHS Outcomes Framework will provide clear structure and focus for the different discussions with stakeholders at national, regional and local level as it provides clarity on accountability for outcomes and standards.

Whilst conversation with national and regional authorities is likely to be centred around outcomes and benefits – as defined by overarching indicators and improvement opportunities – interactions with providers and local bodies will also include structure and processes for the provision of care – as defined by the NICE’s quality standards.

Beyond application for commercial operations, outcomes measures could also be used in the development process in the design of clinical trials studies, helping to define end points

Looking at the scope of each of the five domains, pharma companies have the ability to influence all of them, either directly or in partnership with other bodies. This will foster joint working between the NHS and the industry which is widely recognised as a core priority and feature of the future ‘commercial model’.

Beyond a most-effective use of resources, partnerships have the ability to bring innovation to the way care is and will be delivered, and to ultimately provide better outcomes and experience. Mutual trust is a pre-condition to effective joint working. As such, common objectives and goals will have to be supported via joint measurements.

Opportunities for the organised

The structure of the proposed Outcomes Framework indicators should also be replicated in companies’ dashboard and measurements systems to enable alignment with customers and similar thinking in terms of ‘outcomes dynamics’: which standards lead to what improvement/outcomes?

As these indicators are being measured and reported on a regular basis within the NHS, pharma companies should at least keep abreast of those measures which are relevant to their business and which they can influence. As relevant measures for customers, they should be integrated into respective conversations and supportive materials.

The detailed quality standards give great clarity on expectations for structure and processes of care and the relative expectations of different stakeholders. Whilst most of the standards are not directly related to the use of medicine, it provides great guidance to pharma companies to design services and value proposition beyond the product itself.

The way forward

As we are witnessing a change in the healthcare environment to become outcome driven, some countries have taken the lead to specify and codify frameworks and processes required to provide necessary accountability and transparency.

As key stakeholders in the delivery of care, this is a great opportunity for life sciences companies to ‘piggy back’ on these frameworks to develop their own measurements system. By doing so, this will provide the necessary focus, alignment with customers, and more importantly drive the development of required behaviours for new commercial models. As the development of such outcomes frameworks is at early stage, there is a great opportunity to engage in conversations with payers and decision-makers.

Finally, beyond the actual use for measurements systems for commercial organisations, outcomes indicators could also be used to guide the development process and the design of clinical trials.

Jean-Francois Delas is a Vice President at Kinapse Ltd. and leads the Marketing & Sales Consulting Practice. Kinapse provides consulting and outsourcing services to the life sciences industries, globally. More information is available online at www.kinapse.com or by contacting jean-francois.delas@kinapse.com.

Powers will be switched from central Government to Local Authorities under new plans to reform the public health service in the White Paper, Healthy Lives, Healthy People.

A new core service, Public Health England (PHE), is to be created to offer individuals more choice and power over their health, whilst keeping a firm national grip on crucial population-wide issues.

Nearly £4bn has been ring-fenced from the NHS’s budget for PHE’s areas of responsibility with Health Secretary Andrew Lansley saying the nation will “start seeing significant improvements” in its health.

PHE will combine experts from public health bodies such as the Health Protection Agency and the National Treatment Agency as part of the Department of Health. This will integrate leading expertise, advice and influence into one organisation with the aim for people to make healthier choices.

The majority of public health services will now be commissioned by Local Authorities from their ring-fenced budget instead of central Government.

Directors of Public Health will be employed by Local Authorities and will become the ambassadors of health issues for the local population leading discussions on how best to use budgets with the goal to enhance health and well-being.

To make sure that progress is made on key health issues, PHE will set a series of outcomes to measure whether people’s health actually improves. Local Authorities will also work towards a new health premium which will take into account health inequalities and reward progress on specific outcomes yet to be set.

The new plans follow the Nuffield Council of Bioethics Ladder of Interventions model in which the Government plans to take a less intrusive approach. This will mean that instead of reaching for choice-limiting regulations at every opportunity, the Government will employ a range of evidence based approaches to improve health.

Professor Lindsey Davies, President of the UK Faculty of Public Health, says the new approach is a “tremendous opportunity” to improve public health.

“We see the Public Health White Paper as a significant opportunity to deliver an effective local public health system, which has at its heart people’s health and wellbeing,” said the Professor.

“Government’s recognition of the central role of the Director of Public Health in realising this vision is welcomed. We recognise that there is still further work to be done during this critical period of transition and look forward to working with government to ensure that a quality public health workforce is in place to deliver lasting improvements to the health of the public.”

Alongside Healthy Lives, Healthy People, the DH is also to publishing a review of the regulation of public health professionals.