Health Secretary Jeremy Hunt answers the questions you weren’t afraid to ask.

After the clinical waste left by Andrew Lansley, Secretary of State for Health, Jeremy Hunt, is keen to restore public confidence, establish clarity and, generally, galvanise a flagging NHS reform bill. In a Pf exclusive he takes his place on our imitation-leather hot seat, as readers (and writers) don ominous white outfits for a bit of ‘ultra-questioning’.

Since you took over the role as the ‘guardian’ of people’s health in the UK, what has surprised you most about the functionality of the NHS? – Iain Bate (Writer)
I’m very proud to be the Secretary of State for Health, and I know that a lot of people are incredibly passionate about our health service. The NHS is one of our greatest assets; it is admired around the world and has a reputation for excellence, but I want it to be even better.

The coming year will be an important one for the health service and my priorities are to improve care and nursing in the NHS; promote technology to make care more straightforward; and help people to feel in control of their health, supporting them to lead longer, healthier lives.

Given the rapidly expanding role of the private sector in the NHS, how will transparency in contracting be achieved? After all, business to business transactions are confidential. – Joel Lane (Writer)
We have always been clear that, whenever services are procured in the NHS, it should be through a fair and transparent process, judged on the quality of the care. This helps improve healthcare and enables patients to access the best possible services.

The Health and Social Care Act was the first piece of legislation to create rules and regulations around this process, making it more straightforward. It prevents discrimination in favour of private health companies over the NHS, and helps protect patients’ interests.

But it is worth remembering that charities, social enterprises and independent providers have played an important part in providing NHS care for some time. They offer patients more choice about how they are treated by the health service, and every year, a significant number of patients choose to be treated in independent hospitals, ‘on the NHS’.

The NHS is moving into an era whereby it will need to make decommissioning decisions which are unpopular, such as delivering services that patients will have to pay for. How do you aim to integrate this into the wider healthcare bill implementation? – Omar Ali (Pharmacist)
Let me be absolutely clear on this – the NHS will always be free at the point of delivery and no one will be asked to pay for its services. Yes, in the future, services will be provided differently – public health services will be organised by local authorities, for example – but the founding principle of those NHS services being free, for those who need it, will never change.

To some extent, the NHS remains a 1950s animal trying to survive in 2013. What are the challenges when it comes to changing an institution’s post war philosophies and encouraging it to embrace modern practices, without altering the fundamental concept? – John Pinching (Writer)
Of course the NHS has evolved over its 64 year history, and it continues to improve the lives of people up and down the country, but we have to guarantee that the founding principles of the NHS are protected.
I would like to see the NHS using technology more, while continuing to improve care and experiences for patients. That would mean people being able to book their GP appointments online, or those with long-term conditions managing their situation from home, digitally; saving time for both them and their doctor. Technology in the NHS is rapidly developing, and I would urge local doctors and nurses to embrace it.

Recently the Government announced that it will cap individual payments for social care at twice the Dilnot-recommended level, i.e. at about £70k rather than £35k. Will NHS funding for the less wealthy be increased, or will their suffering and avoidable death be allowed to escalate? – Susan Ranch (Key Account Manager)
This is incorrect. The Government has not said this and no decision has been made. I want this country to become one of the best places in Europe to grow old and make sure people can live independent and healthier lives into old age. As part of the care reforms, we committed to taking action: ensuring people do not have to sell their homes to pay for care. While we have also agreed that Andrew Dilnot’s model of the cap on care costs is the right basis for any new funding model. Given the current economic situation, we need to look carefully at how we can pay for this. 

You have acknowledged the differences within the UK of cancer survival rates and compared to other European countries. How can the pharmaceutical industry work with the NHS to help address these inequities? – Leigh Saunders (Key Account Manager)
The pharmaceutical industry already plays a vital role in improving the health of people with cancer. I want to improve mortality rates, where the targeting and development of medicines is becoming ever more important. I am sure the pharmaceutical industry will want to build on its work in this area and help improve cancer care.

Are you still encouraging British hospitals to sell their services abroad and, if so, what future plans do you have to support this? – Valerie Nolan (Clinical Nurse Specialist)
The NHS has many valuable assets, including products, technologies and knowledge. It makes absolute sense that the NHS should be able to use those assets to earn money, which it can reinvest back into patient care at home.

Through Healthcare UK – a UK government initiative in collaboration with UK Trade and Investment and the Department of Health – we are working on several very promising commercial opportunities to support those parts of the health service that can earn income abroad. Any investment generated will be put back into the NHS for the benefit of patients. Importantly, no part of the NHS will be forced to do this, and NHS patients will always come first.

At the current time, David Nicholson is praising the NHS for achieving a major reduction in referral rates, Diabetes UK, however, has noted that reducing referral rates has led to an increase in premature deaths and amputations in people with type 1 diabetes. Is this a case of cost saving targets being achieved at the cost of human lives?  – Nick Dawes (Sales Manager)
Patients should always get the care they need from the health service, and rationing services on the basis of cost alone is wrong and compromises that patient care. Decisions on treatments, including suitability for surgery, should be made by clinical experts taking the needs of each individual into account. We have already written to the NHS to set out clearly, that access to services should not be restricted on the basis of cost.

Should there be incentives in place for the private healthcare sector to expand and take on some of the load from the NHS, such as removing income tax on insurance payments? – Barry Rose (Independent Market Consultant)
The most important thing is ensuring everyone has access to the very best NHS care available and that those services are designed and provided to best meet the needs of the people who use them. This is why we are giving doctors, nurses and other health professionals more power to make decisions. They are the ones who know their patients best and will make sure that services meet the needs of their local communities.

Under this Government the NHS is performing well: waiting times are down, mixed sex accommodation has nearly been eliminated, we have the best ever record on hospital infections and access to dentistry has increased.

The end to the ‘postcode lottery’ will have to wait a little longer. Hopes were raised earlier this year when the Department of Health unveiled plans to introduce an ‘innovation scorecard’. The scheme would prevent hospitals blacklisting expensive drugs recommended by NICE. Patients, regardless of their location, would be able to receive the latest treatments without delay.

The DH initially planned to have the scorecard “fully implemented by the Autumn.” But, after discussions with the NHS and the pharmaceutical industry, it now looks likely that the scorecard will not be in place until the end of the year.

Speaking exclusively to Pharmaceutical Field, a DH spokesperson said talks were still ongoing between the health service and pharma to “collect all the data and information needed to ensure the scheme is accurate and effective. It will be launched in the coming months.”

The new scheme is expected to work in three different ways:

1. The innovation scorecard will allow patients and the public to see which NHS organisations have adopted the latest NICE guidance on recommended drugs and treatments.
2. The NHS will no longer have an excuse not to provide patients with NICE recommended products. Treatments recommended by the Institute will now be automatically added on to local formularies, allowing doctors to prescribe more expensive treatments if they wish.
3. A new group will be established to help the NHS overcome any barriers when implementing NICE guidance. The introduction of new medication or treatment may mean big changes in the
   way services are delivered. The group aims to spread best practice across the health service.

The DH added that NHS Trusts receive funding for each new NICE appraisal, so financial issues should not be used as a barrier to the uptake of innovative new treatments.

Speaking when the details were first announced in late August, then Health Minister Paul Burstow said the “new regime” would be a “catalyst for change”. He added that the DH is “determined to eradicate variation” across the uptake of NICE approved drugs. “NHS organisations must make sure the latest NICE approved treatments are available in their area, and if they are not, then they will now be responsible for explaining why not,” he said. “Being transparent with data like this is the hallmark of a 21st century NHS. It is
a fundamental tool to help healthcare professionals improve patient care.”

The introduction of the scorecard has been backed by the ABPI. Stephen Whitehead, ABPI Chief Executive, said it would be a “valuable tool” to support the latest NICE recommendations. “There is still a great deal of variation across the country on which treatments patients are able to access and so I am hopeful the scorecard will help highlight discrepancies which can then be addressed,” he said.

Whitehead called the scorecard a “definite step forward” in ensuring patients receive the latest treatments as quickly as their European counterparts. He said the existing system was bad news for the health of the nation which resulted in a lost opportunity to “drive efficiency savings through the use of medicines”.

The NHS Confederation was equally receptive to the introduction of the scorecard. But former Deputy Chief
Executive David Stout warned its implementation may cause “unnecessary bureaucracy” and stretch NHS finances even further. “It is also important to remember that the NHS is facing an unprecedented financial challenge and organisations must live within their means while providing high quality care,” he said. “The reality is we can only afford to provide new drugs or treatments where they are cost effective and demonstrably add real patient benefits. In a health system with no financial growth, any new costs have to be offset by savings elsewhere.”

Stout added that the introduction of the scorecard will only be a success if the NHS engages with local communities and clinicians to decide what local priorities are.

Incivo, Victrelis and Mepact win recognition at the 2012 UK Prix Galien Awards.

Two new medicines for the treatment of Hepatitis C have won the 2012 UK Prix Galien Innovative Product
Award. Incivo (Janssen) and Victrelis (MSD) fought of stiff competition to win the prestigious prize at London’s House of Commons. The chairman of the judging panel, Professor Sir Michael Rawlins, said the treatments provided a perfect example of how the pharmaceutical industry can “demonstrate and justify its place in healthcare by innovating for change and showing real gains to the world.”

The ceremony also saw Takeda become only the third winners of a Prix Galien Award for orphan drug development. Mepact – for the treatment of osteosarcoma, a rare malignant bone tumour – won the Orphan Drug Award.

UK Prix Galien 2012
The UK Prix Galien, organised and managed by the specialist market access consultancy WG Consulting – which owns the UK franchise – is held every two years. The 2012 awards were hosted by former shadow Minister for Health Kevin Barron MP, who was the event’s Parliamentary Sponsor. Barron, who is currently co-Chair of the Associate Parliamentary Health Group, said: “It’s a privilege to be able to witness, at first hand, just a glimpse of the deep volumes of medical innovations being developed here in the UK. As an MP, I’ve had a long-standing professional acquaintance with UK pharma. I know and recognise the many
benefits UK medicines have brought – and continue to bring – to patients all over the world. The sector’s continued commitment to the development of medicines to tackle disease, improve health outcomes and extend life is both remarkable and humbling.”

Barron said there was political consensus that driving improvements in health outcomes across all major diseases is a key priority for the NHS – and this focus had been reflected in the 2012 finalists. “It’s interesting to note that the shortlisted entrants for the 2012 UK Prix Galien show that pharmaceutical innovation is aligned with many of the priority needs identified in the NHS Outcomes Framework. Finalists include innovations for the treatment of diseases in cardiovascular, hepatology, mental health, neurology, gastroenterology and oncology. In addition, Prix Galien’s recognition of the industry’s attempts to treat rare, orphan diseases, once again underlines the very human value of R&D.”

Value-based message
The architect of the NHS Outcomes Framework, former Health Secretary Andrew Lansley, also addressed the audience. Attending his fourth consecutive UK Prix Galien, Lansley said: “Every time I come to this event I hear about fascinating innovations that I know are going to be at the heart of the health service for years to come. I’ve met – and continue to meet – patients that have benefited directly from innovations that I’ve previously heard about at Prix Galien. The HPV vaccination programme we have been able to roll out is just one example of that. So it’s a privilege to be here.”

Lansley said that recognising and rewarding innovation is a key Government priority – and that the publication of Innovation Health and Wealth last December was part of a consistent value-based message
it wanted to send to the NHS. “That message is that as you, the pharmaceutical industry, bring forward new treatments that will clearly add value and improve the quality of healthcare for patients then the NHS should be at the forefront, internationally, of demonstrating that value. Our health service can be an exemplar and inspiration to people around the world because of its capacity to demonstrate the effectiveness of new treatments when they are used within the NHS.”

Lansley praised the UK pharma industry, highlighting the value its innovations bring both to the economy and to patients worldwide. “What you are doing is part of how this country will pay its way in the future,” he said. “And it has the added value of knowing that, in the process, we can give patients in this country access to the very best healthcare anywhere in the world.”

The recognition of innovation that can lead to improved health outcomes is a core aim of Prix Galien, as outlined by Professor Sir Michael Rawlins, who announced the winners. “Prix Galien is about honouring excellence in pharmaceutical research and development,” said Professor Sir Michael. “It is about recognising the contribution that new medicines can make to the lives of people with life-threatening conditions. It is about celebrating the achievements of all those individuals – working as teams – upon whom we rely for the discovery and development of new medicines. Most will be unknown to us – but we all owe them a huge debt of gratitude.”

Innovative Product Award
The prestigious Prix Galien medal for innovation was jointly awarded to Janssen and MSD for their respective hepatitis C treatments Incivo and Victrelis. In the UK, it is estimated that there are between 200,000 and 400,000 people chronically infected with hepatitis C virus. This may lead to liver cancer as well as other serious liver diseases. Infection with the hepatitis C virus poses a substantial global health burden, and is responsible for 40% of all cases of end-stage cirrhosis, 60% of hepatocellular carcinoma and 30% of liver transplants.

Professor Sir Michael Rawlins said: “Hepatitis C virus has become an enormous area of need globally, with many patients unaware that they are infected. The consequences of this virus are considerable and burdensome to both patients and the healthcare system; current treatments remain ineffective in a significant number of cases whilst being unpleasant and poorly tolerated by patients themselves.

“Hepatitis C infection is a perfect example of where the pharmaceutical industry can demonstrate and justify its place in healthcare by innovating for change and showing real gains to the world. It is for this reason that the panel felt that both Janssen and MSD should be celebrated and congratulated for their part in addressing the ongoing challenge in managing HCV and its associated complications.”

Brilique (AZ) and Resolor (Shire) both received commendations. Gilenya (Novartis), Xarelto (Bayer), Xeplion (Janssen), Xgeva (Amgen), Yervoy (Bristol-Myers Squibb), Zelboraf (Roche) and Zytiga (Janssen) were all shortlisted.

Orphan Drug Award
The Orphan Drug Award was introduced as a dedicated category at 2008 UK Prix Galien. There had previously been a special award for orphan products in 2006. The term ‘orphan condition’ is used to describe conditions that affect a very small number of patients in a given population – many of which are either untreatable or treated very inadequately. It is estimated that there are 6,000 orphan diseases – which, in total, affect about 30 million EU citizens.

“For orphan diseases that are potentially treatable with medicines, pharmaceutical manufacturers face a number of hurdles – including concerns about the size of the market and difficulties because of the small numbers of patients – in their development,” said Professor Sir Michael.

The 2012 Orphan Drug Award was won by Mepact from Takeda. Mepact (mifamurtide) is for the treatment of osteosarcoma, a rare malignant bone tumour – mainly of children and adolescents – that affects fewer than 1 per 10,000 individuals in the EU. This is equivalent to 150 children and young adults each year in the UK. Tumours most frequently occur in the long bones and are highly aggressive with a propensity to metastasise, particularly to the lung. If left untreated, the primary tumour will undergo local and systemic progression, leading to death within months.

“To investigate the role of this immune modulator in osteosarcoma required extensive and complex trial design with careful implementation of the study programme,” said Professor Sir Michael. “Apart from its novel mechanism of action – and clear evidence of its clinical effectiveness – the jury were also extremely impressed that such an advance in the management of osteosarcoma represents the first significant change in outcomes in 10–20 years of managing this disease. That Takeda managed to undertake the clinical development of this product – in such a niche indication – is hugely to their credit.”

What does the Public Health Outcomes Framework reveal about the DH’s vision?

Public health is no longer the sole responsibility of one single organisation. Government reform through the Health and Social Care Act outlines how local authorities, the NHS, clinical commissioning groups (CCGs) and, more importantly, Public Health England (PHE) have now been tasked with improving the health of the nation. So how will it work?

PHE is the new, integrated and professional health system designed by the Government to be more effective and to give clear accountability for the improvement and protection of health within the community. The main function of PHE – along with its partners in the health service and in wider society – is to deliver support and enable improvements in health and wellbeing and to design and maintain systems to protect the population against existing and future threats to public health.  The new body brings together experts from a range of organisations, such as the Health Protection Agency, under one umbrella and gives local authorities and CCGs control over the public health budget – believed to be in the region of around £5.2bn – to improve regional requirements.

Public Health Outcomes Framework
For the first time public health will be measured against a devised framework allowing councils and the Government to track improvements and to take action where systems are failing.  From April next year, councils will be given access to a ring-fenced budget to tackle public health inequalities in the local population and meet Government targets. Councils who make the most improvements against desired outcomes will be rewarded with a cash incentive. 

Former Health Secretary Andrew Lansley said that the decision to move the public health budget away from Whitehall to local authorities was “absolutely right”.  He said: “We are giving local councils the money, the power, the right expertise and information to build healthier communities. Every area of the country is different so councils will be able to decide what the most important public health concern is for them and spend the money appropriately.”

A public health outcomes framework for England, 2013–2016 sets the context for the revised system from local to national level with one simple vision: “to improve and protect the nation’s health and wellbeing, and improve the health of the poorest fastest”.

It builds on the white paper Healthy Lives, Healthy People – published at the same time that PHE was established in December 2010 – and reveals that outcomes will be measured by a broad range of 66 indicators chosen by experts and grouped into four domains. The framework has two high-level targets: increasing healthy life expectancy, and reducing differences in life expectancy and healthy life expectancy between communities.

The Department of Health said the main outcomes “reflect the focus we wish to take, not only on how long we live – our life expectancy – but on how well we live – our healthy life expectancy, at all stages of the life course.”

Domains, objectives and indicators
The domains, which each have individual objectives, are:

• Domain 1: Improving the wider determinants of health
• Domain 2: Health improvement
• Domain 3: Health protection
• Domain 4: Healthcare public health and preventing premature mortality.

The framework makes it clear that although responsibilities have been moved away from central Government to local authorities, the NHS will still “remain critical to protecting and improving the population’s health” and “NHS clinical contribution is therefore central” to driving improvements.

In order to do this, the framework aligns with the Adult and Social Care Framework and the NHS Outcomes Framework through a series of shared or complementary indicators. The DH says that it intends to create an alignment with the outcomes framework through a series of set shared indicators that straddle domain 4 of its framework and the first domain in the NHS alternative. The shared indicators will be on premature mortality from specific areas of cancer, cardiovascular disease and liver disease.

The first domain in the public health framework has the objective to make “improvements against wider factors that affect health and wellbeing and health inequalities”. There are 19 indicators included, ranging from children in poverty to employment for those with long-term health conditions, including those with a learning difficulty/disability or mental illness and people with a mental illness or disability in settled accommodation.

Yet it is possibly in the other three domains where the pharmaceutical industry can exert greater influence and offer support. The objective of Domain 2 is to ensure “people are helped to live healthy lifestyles, make healthy choices and reduce health inequalities.” The 24 indicators here include a number that are relevant to pharma. These range from successful completion of drug treatment to cancer screening coverage and recorded diabetes- and alcohol-related admissions to hospital.

Improvements in these indicators will, in the main, be led locally by clinical commissioning groups through schemes devised or introduced to drive standards of public health.

Domain 3 has just seven indicators – although the framework says these are “critical” to protect the public’s health. Its target is to ensure “the population’s health is protected from major incidents and other threats, while reducing health inequalities.” Indicators that focus on Chlamydia diagnosis, vaccination coverage for the population, people presenting with HIV at a late stage of infection and treatment completion for tuberculosis are of clear significance for the pharmaceutical industry.

Domain 4 aims to reduce the “numbers of people living with preventable ill health and people dying prematurely, while reducing the gap between communities.” Several indicators stand out as far as Key Account Managers should be concerned. Indicators including mortality from causes considered preventable, mortality from all cardiovascular diseases, and mortality from cancer, liver disease and respiratory disease call out for pharma’s expertise in creating innovative pathways of care, and of course its products.

The DH makes it clear in the framework that it is the responsibility of all healthcare providers to deliver improvements in indicators in this domain. 

Other uses
As well as driving standards of public health, the framework also supports health improvement and protection at all stages and across the life course of the population, especially in the early years. A further purpose is to provide a mechanism for transparency and accountability across the public health system. “As governance and accountability for Public Health England, local government and the NHS differ from each other, so will their relationship to demonstrating performance towards improving public health outcomes,” the document says.

Crucially, it will be for local authorities, in partnership with health and wellbeing boards, to demonstrate improvements in public health outcomes through progress against the indicators included in the framework that best reflect local needs, included in Joint Strategic Needs Assessments (JSNAs) and reflected in Joint Health and Wellbeing Strategies (JHWSs), to achieve cash incentives. Here, the DH expects specific progress against measures in the framework being “built into” JSNAs and JHWSs. These documents should be easily obtainable and accessible for KAMs, allowing an insight into local priorities which can then be targeted.

Although the framework has been planned for a three year period until 2016, the DH has confirmed that it will be refreshed annually “as data improves, technical capability across the public health system develops” and as it maintains an “aligned approach” across the NHS and local authorities.

Indicators will also be developed in order to create a complete set of baselines to support local service planning within the coming weeks by public health observatories, local authorities, the NHS and the Department of Health.

The DH accepts that “public health is such that the improvements in these outcomes will take years – sometimes even decades – to see marked changes”. But with budgets already in place to help tackle regional issues, pharma is perfectly placed to assist in driving public health outcomes in the short, medium and long term.   

Sir David Nicholson has predicted “big changes” on the day the NHS Commissioning Board (NHSCB) takes over its new responsibilities.

The NHS Commissioning Board Chief Executive said Monday 1 October 2012 was a “landmark” day in the history of the NHS as the NHSCB takes full control of its budget.

Writing in The Guardian, Sir David outlined how the Board plans to split the health service’s £85m budget.

He explained how around £60m will be allocated to clinical commissioning groups to “plan and pay” for local health needs.

The remaining £25m will then be used by the Board on “community services” and on more “specialist services” for conditions that are more complex and rarer.

Sir David said that patients “won’t notice a difference” immediately as a result of the changes, but was confident “they will start to experience real improvements” soon.

The Board’s CEO outlined how it had recruited experienced healthcare professionals to “key positions” so it can make the correct decisions “made on the best clinical advice.”

However, Nicholson said the “most significant shift” in emphasis is the way “we underpin all that we do” with a single focus on “improving the quality of care for our patients”.

Nicholson added that there are “no better words” to explain the work of the NHSCB than the principles and values set out in the opening paragraph of its constitution. The four short sentences describe how the NHS “belongs to the people”, how the health service aims to support patients “mentally and physically well”, to work at the “limits of science”, and to touch the lives of individuals at “times of basic human need, when care and compassion are what matter most.”

New organisations formed as a result of the NHS reforms may cause conflicting policies and bundles of red-tape for the health service, Mike Farrar, NHS Confederation CEO, has warned.

Mr Farrar said the reforms would lead to several new bodies interfering with the day to day operation of the health service and result in a “tsunami of new bureaucracy”.

He added that new organisations will need to “minimise the burdens their policies place” on the NHS in order for it to “stay focused on patient care” and not on “repeatedly providing information in different formats to multiple bodies.”

Writing in an editorial for the Health Service Journal, the NHS Confed chief executive was responding to a survey of NHS chairs and CEOs. The survey found widespread concerns by NHS leaders as a result of the reforms.

Managers warned that widespread structural changes will result in a lack of senior experience and that savings targets are causing serious financial pressures.

Mr Farrar argued that the reforms are not a magic wand to improve performance and that expectations must be realistic. “Performance in many parts of the system will be patchy at first,” he said.

“Those leading the change need to be open-minded and flexible to improve policy and practice as we go. We are losing many experienced leaders.

“We need to ensure that as new ones emerge, taking on these challenges, they are given the support and cover they need to succeed, even if that means tolerating some difficulty along the way.”

The former SHA leader added that for new organisations to be successful they must listen to NHS leaders and focus on “critical overarching concerns that will matter most in the end”.

“It’s essential that national bodies ensure they are driving towards the same goals, not subjecting the NHS to a myriad of conflicting policies,” he said. “Otherwise the NHS will be pulled in different directions and unable to make progress.”

Health Minister Simon Burns insists the reforms remove layers of administration and will actually result in less bureaucracy for the NHS. “Our reforms mean that doctors and nurses will be in charge of the NHS, not managers,” he said. “It makes sense for the people that know their patients best, doctors and nurses, to take responsibility for driving up standards in their local NHS, free from bureaucratic interference.

“Careful work is underway now to ensure that new NHS bodies are prepared, but this is not affecting patient care. Waiting times are low, infection rates are down and patient satisfaction remains high.”

What priorities does Andrew Lansley’s draft mandate for the NHS Commissioning Board reveal?

The draft mandate for the NHS Commissioning Board (NHSCB), published on 5 July 2012, is a manifesto for the new NHS: the first clear public statement of the anticipated course of NHS reform since the Health and Social Care Act became law. It offers a snapshot of the emerging structure for local commissioning, and highlights the Government’s key priorities for an NHS reform that is now a reality.

Introducing Our NHS Care Objectives: A Draft Mandate to the NHS Commissioning Board to Parliament, Health Secretary Andrew Lansley said: “Today we will be laying the foundations of the new, more independent NHS.” By this, he explained, he meant an NHS “free from constant political interference” and “tasked with continuously improving the care that patients receive”.

Transfer of powers
A key background document to the draft mandate is Lansley’s letter to the new Chair of the NHS Commissioning Board Authority, Malcolm Grant, in April. The letter stated his primary objective as being
“to design the Board so it transfers power to local organisations”. Other priorities included integrating health and social care and promoting patient choice.

Another important background document is the NHS Outcomes Framework, published in December 2010 and updated a year later. This defines the patient outcomes the NHS has to work towards – a counterpart to the business processes defined by the reform agenda.

The draft mandate has been issued for consultation. The final NHSCB mandate will be published in October and will guide the Board when it assumes its full statutory authority in April 2013.

Improving healthcare outcomes
The draft mandate begins by setting the context: the NHS is facing “one of the tightest funding settlements in its history”, while elderly care, long-term conditions and mental health are growing priorities. It outlines 22 objectives for the NHSCB for the two years from April 2013, as well as ‘ambitions’ for the coming decade.

The first major section lists 11 objectives for improving outcomes. The first six relate to the NHS Outcomes Framework – one for each of the five domains and one for the whole – setting concrete targets in QALY and similar terms, but leaving the actual numbers to the final version.

While there are no objectives for specific conditions, this section refers to dementia and mental illness and notes the need for better integration of general healthcare with treatment of these conditions. The NHS should work towards treating mental health as “on a par with physical health,” it states. There are objectives for reducing health inequalities, including life expectancy at birth. However, the reference to “greater improvement in more disadvantaged communities” should be seen in the context of the planned shift of public health funding from the NHS to local government. Finally, there are objectives relating to service performance standards and support for patient self-care.

Patient choice and local control
While the first 11 outcomes are related to the agenda for NHS improvement defined by Lord Darzi in 2008, the last 11 belong wholly to the new reform agenda. One crucial objective relates to patient choice. The Board must ensure that people are “involved in decisions about their care and treatment”; that personal health budgets are available “to anyone who might benefit”; and that a patient who has waited 18 weeks for treatment is entitled to choose another provider.

The Board is required to develop integrated care through joint commissioning and other methods, particularly for “people with dementia or other complex long-term needs”. It should also improve the quality of NHS information, using IT to make the NHS “transparent” to patients and carers.

The Government’s innovation agenda is highlighted by an objective requiring the Board to “promote access to clinically appropriate drugs and technologies recommended by NICE”, as well as supporting the participation of NHS clinicians and patients in life science research.

The section on commissioning states that the Board should fully authorise “as many CCGs as are willing and able” by April 2013, and allow the CCGs “full control over where they source their commissioning support”. The new clinical senates and networks will provide advice, with CCGs “free to make their own arrangements”.

The Board must have a “transparent, principle-based system” for managing “poor performance” or “financial risk” by CCGs. It must “support a fair playing field between providers” and “ensure that financial incentives for commissioners and providers support better outcomes and value for money”. The latter objective includes the controversial Quality Premium, a bonus payment rewarding CCGs who achieve a surplus on their annual budget. This will be funded from within “the overall administration costs” available to CCGs.

Crucially for industry, there is an objective to support “changes in services that lead to improved outcomes for patients”. These must meet four criteria: support from clinical commissioners; strong patient engagement; a clear clinical evidence base; and consistency with patient choice.

On the critical issue of cost savings, the mandate says only that the Board must ensure that QIPP savings are made “in a sustainable manner” as dictated by the Treasury, but without reducing service quality.

Between the lines
Responses to the draft mandate have focused on its open-ended nature. Mike Farrar, Chief Executive of the NHS Confederation, commented: “Unlike documents that have gone before it, the mandate does not seek to develop an ever-growing ‘wish list’ of objectives. It rightly encourages commissioners to exercise their knowledge of the needs of their local communities to plan and deliver the best care.”

Shadow Health Secretary Andy Burnham argued that Lansley had missed an important opportunity to highlight the issue of healthcare rationing – which the Health Secretary had recently stated to be
“unacceptable”. The delegation of control to local commissioners, Burnham argued, was “a mandate for privatisation.”

Dr Richard Vautrey, Deputy Chairman of the BMA’s GP Committee, praised the mandate for not placing too many restrictions on GP-led commissioning. However, he was strongly critical of the Quality Premium, which he claimed would encourage rationing and increase health inequalities.

Whatever the consultation period delivers, the draft mandate for the NHSCB is a clear statement of the NHS reform agenda: to deliver improved patient outcomes through CCG autonomy and provider competition.

What does the ‘single operating model’ for primary care commissioning mean for GPs?

The NHS Commissioning Board Authority’s ‘single operating model’ for primary care commissioning represents a major step in defining the relationship between GPs and the new NHS. As such, it is essential reading for anyone with a stake in prescribing behaviours and, more widely, in patient pathways.

A major question posed by the Lansley reforms is: who should commission the commissioners? If GP-led groups are responsible for commissioning secondary care, who can commission primary care? The answer, the NHS Commissioning Board, was greeted with mistrust by many GPs who asked why they needed some Big Brother watching over the job they had always done.

In addition, the passage of the Health and Social Care Act left a lot of broken glass scattered through primary care. The relationship between clinical outcomes and money, the involvement of the private sector in the NHS and the apparent fragmentation of the health service are issues that divided
the GP profession.

So the single operating model has the task not only of outlining new clinical and business relationships, but of building professional bridges. The Board tackles this challenge by saying up front that it seeks to
achieve “the right balance between national consistency and local decision making”.

Unlike earlier documents describing the infrastructure of the new NHS, Securing excellence in commissioning primary care does not list concrete developments to be in place by April 2013. Rather, it outlines a pattern of relationships that will develop from that date, when the new single operating model
for primary care commissioning becomes operative. It represents the parts of the new
NHS working together with a clear goal of outcome improvement.

The commissioning challenge
According to Dame Barbara Hakin, National Director for Commissioning Development, the new system aims to “tackle unwarranted variation and take positive steps towards raising the overall standard of primary care”. The document notes that primary care, while accounting for only 15% of the NHS budget, has a
profound role in making “preventative interventions” and influencing all the care patients receive.

The challenge of replacing “many different systems” for primary care commissioning with “a single national
operating model” without losing “vital local responsiveness”, the Board says, depends on “establishing relationships and arrangements across the new organisations” – including CCGs, whose health strategies
will set the context for primary care.

The NHSCB will be responsible for planning, securing and monitoring primary care services. Its local area teams will manage the performance of GPs and other primary care providers (dentists, community pharmacists and opticians), and will help to support providers in difficulty and deal with major emergencies.

The local area teams will support patient “choice and control in designing services that respond to their needs”, focusing on “the basic service offer” (such as early diagnosis) to reduce variations and health inequalities. Likewise, they will support the development of “local area clinical leadership teams” that draw on the expertise of all types of primary care clinicians. Finally, their focus on patient outcomes means they will look for “improvement strategies” at all times.

All together now
Most primary care commissioning will take place through the Board’s local area teams working with CCGs, local authorities and health and wellbeing boards. The Board as a central authority will “ensure consistency” and provide the framework for performance management and quality assurance. Crucially, this system involves “fewer managerial resources” and “larger geographical footprints” than the previous system. It does not remove local initiative: it just removes the SHA and PCT management layer.

At the heart of the model are the common operating procedures for local area teams, of which the most important is “to standardise the performance management frameworks and processes at practice, provider and individual levels”. Managing variability and the healthcare market are also key priorities.

Commissioning support services may also assist local area teams: emphasis is placed on the value of
business intelligence in providing “a single flow of standardised information”, and the potential for CCGs to share support for primary care development and redesign with local area teams.

Micro commissioning
CCGs themselves will work closely with the NHSCB to review the “micro commissioning decisions” made by
GPs in “each referral and prescription”. The Board says that its work with CCGs has shown they can progress effectively together towards “quality improvement” through benchmarking, data sharing and peer review. It notes further that CCGs will be able to commission integrated “wrap-around” community-based services in which GP practices can participate, with care taken to manage conflicts of interest.

The local area teams will establish relationships with a range of partners, including CCGs, Local Healthwatch, health and wellbeing boards, local authorities, Public Health England local units and the CQC. Clinical networks will feed into the primary care system “with a particular focus on early diagnosis and timely treatment”. Public health commissioners will advise local area teams on priorities for the local
population, and work with them to develop health improvement initiatives that may include primary care.

The Board concludes: “During the next three to six months, we will fully explore all the interdependent relationships critical for the operating model and take any action necessary to ensure that they will work effectively.” It encourages discussion of the model within PCT clusters and feedback on
potential improvements.

A business network
The single operating model for primary care commissioning is not so much a ‘one size fits all’ as an ‘all things to all people’. It shows the old hierarchical NHS giving way to something much closer to a business network, with shared rules and goals but different cultures. The imprecision of the arrangements described displays the will to promote clinical innovation and business
development.

The emerging structure is designed to give GPs more confidence that they will be neither isolated nor controlled. Those who need guidance and support will receive it, while others will have the freedom to change treatment pathways and business models. This will help to defuse opposition to reform in the
profession, while setting the stage for further changes.

For pharma, the new model points to the development of a complex and flexible customer network with many points of contact. Key account managers are much concerned with how primary care operates and the factors influencing it. This model shows primary care in a dynamic field of NHS and other stakeholders, responding to ideas from all sides: an exciting prospect for suppliers.

Roche’s Tarceva (erlotinib) has been recommended in final draft guidance as a first-line option for people with EGFR mutation-positive non-small-cell lung cancer (NSCLC).

The decision comes after Roche provided NICE with additional data on the clinical and cost effectiveness of Tarceva when supplied under an agreed Patient Access Scheme (PAS).

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, said the health regulator is “pleased to recommend another treatment” for NSCLC.

NICE recently recommended Iressa (gefitinib) as a first-line treatment for NSCLC. Roche were unable to provide any clinical data comparing Tarceva with Iressa, but specialists confirmed the two were similar and equally effective.

Tarceva and Iressa work differently to chemotherapy. The oral treatments are known as “target agents” due to the way they block certain processes in the cancer cells.

Data supplied by Roche showed Tarceva showed longer progression-free survival and similar overall survival compared with current treatment options. It expects that NICE’s recommendation will benefit approximately 11% of patients with NSCLC.

The PAS agreed between Roche and the DH may mean that Tarceva is supplied to the NHS free of charge in certain circumstances. Tarceva will be made available at a single cost of £12,200 per patient irrespective of the duration of treatment. However, Roche will only invoice the health service after the third monthly pack of Tarceva is supplied. Any patients who receive only one or two months of treatment will receive the drug without the NHS being charged.

Information, and more importantly access to it, has been identified as being key to delivering better care, better outcomes and improved efficiencies in the NHS. Health informatics systems have a major role to play in making the transition towards an era of ‘shared decision-making’. But success will not be achieved by technology alone. Michael Thick looks at the journey ahead.

When plans for the vision of the future of healthcare in the UK were recently announced, one of the central aims would be to bring NHS resources and decision-making ‘as close to the patient as possible’. The phrase “No decision about me, without me” not only provided a neat sound-bite to encapsulate the message, but it also casually condensed a multitude of major challenges into just six words. Moreover, it threw down the gauntlet to stakeholders across the marketplace that those responsible for designing and implementing health informatics systems needed to raise their game.

And though IT itself cannot lead change, its suppliers can show leadership and influence others to drive cultural change. The most effective suppliers will add true value to the dialogue. They will have an
intrinsic understanding of the NHS and how it operates at senior levels – and will be able to contribute meaningfully to discussions around service design because of it. There are savvy suppliers out there already working with the NHS – and patients – to enable healthcare to be provided in new and innovative
ways.

The challenges ahead are significant. The White Paper identifies information, combined with the right support, as being the key to better care, better outcomes and reduced costs. It speaks of an environment where patients have sufficient data on all aspects of healthcare to enable them to share in decisions made about their care. Moreover, it promises to correct an ‘imbalance in who knows what’, to give patients access to their own records, and, furthermore, to enable them to communicate with clinicians online. These are all worthy goals. But, as we move towards 2012, UK healthcare is some way off from achieving them.

The emerging customer
Against this backdrop of radical and ambitious reform, much of the current architecture for health
informatics in the UK is not yet in place. Improving it is a collective responsibility; for clinicians, for
NHS management, for back office suppliers, and, most of all, for patients.

The emergence of the patient as being central in the development and delivery of health care services is no longer rhetoric. But until the market as a whole recognises this and takes a holistic approach to the development of services to support the White Paper’s ambitions by engaging all key stakeholders and
influencers, the potential for success is reduced.

It is time for a shift in our cultural mindset. Clinicians, administrators, informatics experts, suppliers and patients must all work together to make the information revolution – and indeed the patient revolution – happen. This is about changing attitudes as much as it is about changing technology. The development process must be consultative and inclusive.

Technology in the revolution
IT can play a major role in driving, facilitating and delivering change, but plans for any new architecture
must capture input from all stakeholders right at the outset. And that must include the patient. For too long, informatics has had the clinician as its primary customer, but as patients begin to take more responsibility for their health and shared decision-making becomes the norm, it is clearly time for a rethink. In tomorrow’s world, the end-user is as much the patient as it is the doctor. To correct the imbalance, the tools being used must change to reflect this.

Making the patient’s needs central to the process – and building that patient’s needs into every stage of the development of a service – its design, implementation and evaluation, has to be the way forward.

The teaching of medicine and nursing has traditionally been focused on relieving the burden of care from the patient, but there is strong argument to suggest that increasing the involvement of the patient in their own care will bring better outcomes. Medical and nursing education does not currently teach people how to use health tools with patients, partner with patients or empower them using health information and this will need to change moving forward.

It is here where technology suppliers can play a valuable role. They understand patients’ perspectives and how their use of health IT is likely to grow in the future. Supplier expertise in providing packages for patient care is there to be exploited. Those who best understand patient needs should be involved at the earliest possible stages in the development of any service, rather than simply brought in at the compliance end of things.

The key voice
The approach is perhaps best exempli­fied by developments at NICE, which, as we know, has been appointed the arbiter of effectiveness, usefulness and quality. Charged with responsibility for designing around 150 Quality Standards in the next five years, NICE has identi­fied the patient experience as being central to this work. It requests that when new systems are being implemented, patients are consulted to establish the relevance and value of any changes. This is a fundamental requirement of the implementation of NICE guidelines – and the same approach should be taken in the development and implementation of health informatics systems to support them. This is certainly the case at those technology suppliers who are already aware of the role they have to play and routinely consult the patient in all plans for the implementation of NICE guidance. It’s a commitment to the spirit of “nothing about me, without me.”

And so as the health sector approaches the NHS Information Revolution mandated by its government, it’s clear that consultation phases engaging all stakeholders involved in the design and delivery of health services is paramount. Key voices, not least those belonging to patients and technology suppliers, must no longer be excluded from the process.

Conclusion
Success will not be won by technology alone. For real change to take place, collective buy-in to the wider principles of the empowered patient must be achieved. Clinicians, suppliers and patients must engage and collaborate to identify the most effective and efficient ways to improve health outcomes. A clear roadmap must be agreed up front before beginning the process of supporting it with an implementation. If we do things the other way around – as has often been the case in the past – we will not succeed.

“Nothing about me, without me.” It makes sense on every level.

Michael Thick is VP Clinical Strategy and Governance, McKesson.