Inconsistent NHS leadership questioned

The NHS has suffered due to inconsistent leadership over a prolonged period, peers in the House of Lords have been told.

Baroness Cumberlege, a Conservative peer, told the House the number of different health secretaries in recent times has led to a lack of trust and confusion by the health service.

Speaking during the committee stage of the Health Bill, Baroness Cumberlege compared the Sir Alex Ferguson’s 25-year reign at Manchester United and asked “what difference it might make to the NHS” had it had a leader for a similar tenure.

Since 1997, there have been seven different health secretaries – six of which under the previous Labour government.

“One of the real problems that we have, and it exists even if it is the same party in power for a length of time, we lack a consistency of leadership, because the Secretaries of State are here one minute and gone the next,” said Baroness Cumberlege.

“I think that contributes to an NHS that gets confused, that gets fed up and is mistrustful of its masters.”

In the UK joint working is being encouraged to develop innovative services and propagate best practice. But in France, new legislation is placing significant barriers between pharma and its clients. Jérôme Guermonprez explains the implications for market access strategies in the country.

Across Europe pharmaceutical companies have been looking to underpin market access strategies with strong links to healthcare professionals. And while most pharmaceutical companies admit there are significant national differences that demand specific market access strategies, there has been a push, where possible, to leverage expertise, messaging and strategy to drive economies of scale.

Many organisations are now actively embarking upon innovative, cooperative working with regional decision-making bodies – such as the Clinical Commissioning Groups (CCG) in the UK; whilst doctors and pharmacists are increasingly involved in research projects, from clinical research to patient care, patient outcomes and procedures. Indeed, the UK’s amended Health and Social Care Bill strongly encourages pharmaceutical research, innovation and the use of scientific evidence in decision-making.

In France, the forthcoming radical overhaul of the drug regulatory system will significantly change relations between pharmaceutical companies, healthcare professionals, patient associations and physician associations. The “Reforme du Medicament” legislation aims to crack down on health practitioner conflicts of interest, restructure the country’s drug regulator and tighten the process for licensing drugs and for monitoring their effects once in use.

The proposed bill creates compliance requirements that far outstrip the UK anti-bribery laws and includes a number of significant changes which will directly affect the way pharmaceutical companies interact with opinion leaders across the French health service.

To minimise the risk of conflict of interest, the new legislation mirrors the US Sunshine Act by requiring pharmaceutical companies to disclose all financial relationships with healthcare professionals, patient associations and scientific experts.

With an emphasis on patient safety, the bill also requires far more detailed information and discussions about indications – from the provision of a helpline number on every drug packet to enable patients to report problems, to the creation of a government watch list of drugs under review.

It also demands pharmaceutical companies no longer undertake direct physician training but instead provide the funding for training to the government, which will then oversee independent training programmes.

 

Restricted access

Critically, from a market access perspective, the bill will prohibit individual medical representative visits to physicians within a hospital; visits must be collective to avoid any one-to-one relationships and ensure discussions are open and transparent.

The impact of this legislation – which is currently being discussed and should be passed by the French government by the end of 2011 – will be significant for pharmaceutical market access policies and demand companies gain new insight into key opinion leaders (KOL).

Under this new model, the industry will have to be incredibly careful about the type of relationships that are put in place with stakeholders; indeed, at least one pharmaceutical company has already announced it will no longer pay physicians directly in the future or invest directly in physician grants to avoid any regulatory compliance issues.

Furthermore, with many physicians likely to back away from any interaction with the pharmaceutical industry, at least in the short term, patient and physician associations will have a far greater role to play. Pharmaceutical companies will have to rapidly assess the way these associations and individual physicians respond to the new legislation and amend market access strategies accordingly.

 

Regional structure

This new challenge comes at a time when pharmaceutical companies are still adjusting to the major overhaul of the French healthcare system – which has seen the creation of 26 Regional Health Authorities (RHA).

While drug reimbursement is still set nationally as in the UK, since 2009, each region has found the responsibility to adapt national objectives to local or regional health and demographic problematic. Over the past year, each region has had to sign multiple year contracts between the  state and the region to deploy the health strategy.

As in the UK, over the past two years, pharmaceutical companies have realigned resources to create a regional approach based on a key account management (KAM) model. The regional structure has significantly broadened the number of stakeholders involved in decision-making, both financial and medical.

Furthermore, each RHA has a different demographic breakdown and health issues, creating very diverse goals for each region. This change has required a far greater insight into decision-makers and regional objectives; it has also demanded pharmaceutical companies use the KAM approach and strong CRM tools to drive synergies between teams at local, regional and national level.

Pharmaceutical companies in both France and the UK are now actively seeking in-depth insight into the KOLs within new regional structures. Information from the structure of the new organisations, including the multiple drug, technical and price commissions, to identifying specific members, roles and drivers is proving key to create the right regional messaging.

And with this regional, KAM-based model still in its infancy in France, pharmaceutical companies face a tough challenge to ensure the implications of the new medical reform legislation are incorporated.

Messaging, for example, must now be amended to include product safety, as well as quality and efficacy; while companies must ensure information is up to date to ensure changes in physician attitude to the pharmaceutical industry as a result of the new regulations are flagged to remove the chance of inappropriate or unwanted contact. CRM tools will also be essential to coordinate group visits to physicians to avoid any chance of the forbidden one-to-one interaction.

As in the US following the introduction of the Physician Payment Sunshine Act in 2009, pharmaceutical companies will also need help to meet their obligations to declare all activity with physicians.

 

What next?

It is tough to predict how the health service in France will respond to the new legislation over the next 12 months. For pharmaceutical companies there is no doubt that direct physician contact will decline and organisations will have to refocus efforts towards the increasingly influential patient associations and physician associations.

But for those organisations operating across Europe, the changes must demand very different approaches towards health service co-operation. As the UK market looks to drive service innovation and close ties with practitioners at every level, counterparts in France are being compelled to be transparent and improve patient safety. The concept of the global, or even pan–European, market access strategy looks ever less practical.

Jérôme Guermonprez is the Vice President and General Manager, France, Cegedim Relationship Management.

Despite the ongoing criticism of the Health Bill as it passes through the House of Lords, structural changes are still happening at ground level. Dr Thoreya Swage outlines the timescale for changes as PCT clusters switch responsibilities to CCGs.

The momentum of reform of the National Health Service in England continues to gather pace. Following a four month hiatus while the wise and the good of the NHS Future Forum pondered and produced recommendations for the adjustment of the Bill, the DH published further guidance on the developing role of the Primary Care Trust (PCT) clusters.

Although the 151 PCTs have been squeezed into fifty-one PCT clusters in preparation for their demise in April 2013, it seems that they have a vital part to play in the development of the emerging Clinical Commissioning Groups (CCGs).

This guidance or ‘shared operating model for PCT clusters’ has been produced by the mandarins at the DH to ensure that the commissioning landscape is as consistent and smooth as possible in time for the takeover by the CCGs. This is so that the nascent NHS Commissioning Board inherits a robust enough system to take account of further developments and improvements in healthcare in early 2013.

 

A shared model

There are six main functions or ways of working for the shared operating model for the clusters. These have been identified where consistency of approach is considered to be of importance and they are listed as commissioning development, financial and operational issues, ensuring quality, emergency planning, development of providers as Foundation Trusts and communications.

 

CCG development

The most important function is the preparation of CCGs for authorisation as soon as possible following the successful passage of the Health Bill through Parliament. The process of authorisation to become fully fledged commissioners is due to begin in the second half of 2012.

Although this is a year away, CCGs can commence their preparations now using a self diagnostic tool – an interactive computer-based assessment that helps them to determine their capability in six domains and identify their development needs.

The areas covered include:

• A clear clinical focus of the CCG commissioning plans to include tackling health inequalities and improving primary care
• Demonstration of meaningful involvement of patients and the wider community
• A plan for development that is clear and credible which, in particular, delivers the QIPP (quality, innovation, productivity and prevention) agenda
• Capacity and capability of the CCG, i.e. robust constitutional and governance arrangements which enable the CCG to commission care effectively and ensure financial control
• Collaborative arrangements for working with other CCGs, local authorities and the NHS Commissioning Board
• Capacity and capability of the CCG leadership which ensures effective working.

The tool helps the CCGs identify priority development areas which form the basis of the developmental plan paving the way to full authorisation.

To support all this work CCGs will receive £2 per head from the PCT clusters as well as extra management resource to help the groups hone their commissioning skills and capability.

CCGs experiencing difficulty in defining their boundaries will have guidance from PCT clusters on how to resolve this. PCT clusters also have the unenviable task of engaging the reluctant practices that so far have not participated in their local CCG discussions, with the aim of being part of a viable commissioning group by October.

 

Separating commissioning functions

All through the last quarter of this year a very detailed exercise is being carried out by PCT clusters to identify and segregate the service areas that CCGs and the NHS Commissioning Board will be responsible for. Although CCGs will be commissioning acute, mental health, community and ambulance care there are other services that PCTs currently commission which will need to be transferred to the Board.

Services such as GP and other primary care contractor groups – primary dental care, pharmacy and optical services – secondary dental care, prison, specialised and military health services are set to go under the umbrella of the NHS Commissioning Board. Even though the contracts for GP services are held by another body, the CCGs are expected to have an input into primary care development and improvement.

 

Quality assurance

A vital component of the commissioning process is ensuring the quality of healthcare. Practices may have been involved to a greater or lesser degree in various quality assurance processes in the past. However, CCGs are required to take on board these responsibilities seriously.

There is a whole raft of procedures and measures including delivery of better health outcomes for patients, meeting the Care Quality Commission (CQC) requirements for safety and quality of services, standard contracts, the NHS Operating Framework, professional guidance and other relevant requirements that CCGs need to get to grips with.

This could potentially be a vulnerable time for the development of the CCGs if attention wanders and serious patient safety incidents are not acted on promptly. Clinical governance processes must therefore be extra secure.

 

Budgets and responsibilities

Over the next year or so there will be a period of dual functioning and handover as the CCGs mature and the PCT clusters delegate more and more responsibilities until April 2013. The handing over of the baton has started now with PCT clusters having identified a “clear percentage of budgets” to CCG pioneers or pathfinders in August and plans for future delegation of budgets set by October.

Sandwiched in between will be the agreement on which mental health and community services will be subject to ‘Any Qualified Provider’ (AQP). This policy is set to be implemented from April next year when GPs can refer to providers of certain services eligible for AQP from a list of approved organisations, including the private sector, drawn up by the DH.

A review of commissioning support required by CCGs has already been undertaken in July with clear arrangements agreed by the end of the year.

In March next year, CCGs will be required to enable the development of the local health and wellbeing boards supported by their PCT clusters – health and wellbeing boards being the mechanism for joint health and social care planning and commissioning locally.

Meanwhile, individual PCTs will continue to carry out their statutory functions through the clusters until their abolition in April 2013. The statutory functions include contract monitoring, ensuring that providers meet their QIPP obligations and other statutory requirements, for example, safeguarding children and vulnerable adults.

The big challenge for CCGs will begin when they will be required to lead the next planning round for 2012/13. This begins in the latter part of this year and is a function previously undertaken by the PCTs.

This will involve doing a needs analysis, identifying local inequalities, understanding demand and activity for local services, negotiating and setting priorities with partners and developing the local strategic vision. Handover of commissioning functions will continue with CCGs being an active participant in the subsequent contract negotiations and agreement.

 

The outside world

It is apparent that despite the pause for reflection on the proposed changes in the NHS earlier this year, the momentum for restructuring and dissolving healthcare organisations continues. The picture remains a little confusing however, as CCGs are in varying stages of development and maturity and it is not clear that all will be truly viable by the tight deadline set for October.

What is clear is that that work of commissioning and delivering healthcare has to go on and now is a good time to find out who the key movers are within the CCGs.

It is at this point in time when the developmental needs of CCGs will be uppermost and it is here that pharma can provide some input. Skills and knowledge in leadership development and highlighting therapeutic areas where evidence-based care really works are two such possibilities.

CCGs will be keen to smooth patient pathways across primary and secondary care and nowhere is this more pertinent than in prescribing effectively. Delegated prescribing budgets are now very real for CCGs and they will be keen to ensure value for money and improvements in care for their patients. This provides a good opportunity for pharma companies to demonstrate the effectiveness of their drugs in specific disease areas.

On the commissioning front, by December of this year, CCGs and PCT clusters will have had to agree what commissioning support they need to carry out this function. Given the requirement to reduce costs, commissioning skills and expertise may actually be thin on the ground within CCGs.

Bearing in mind that effective commissioning will be judged by outcomes achieved as outlined in the NHS Outcomes Framework, pharma is well placed to demonstrate how their products can meet the requirements of domain 1: preventing premature deaths, domain 2: enhancing the quality of life of people with long-term conditions and domain 3: aiding the recovery of people who have an acute illness or injury.

The next few months will be busy while the NHS sorts itself out structurally. Once the picture begins to clear, pharma will need to engage with the new clinically skilled commissioners who now have the financial responsibility for making decisions about healthcare.

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

Andrew Lansley has insisted he and his successors as Health Secretary will have a duty to provide a comprehensive health service via the NHS Commissioning Board and CCGs.

The Secretary of State for Health has said it will remain incumbent for those in the position to ensure services currently provided by the NHS.

Speaking at the National Association of Primary Care conference, Mr Lansley said “that is in law, in essence, what is described as a comprehensive health service.”

Changes to the duty of the Secretary of State to provide a comprehensive health service have been one of the most controversial aspects of the Health Bill since its release and its debate in the House of Commons and the House of Lords.

“It’s the duty that has been placed on me and my predecessors for more than 60 years and it will be incumbent on you to discharge that duty in the future - and it will remain incumbent on me and my successors to ensure that through the NHS Commissioning Board and through your CCGs that service is provided,” Mr Lansley told delegates.

The Health Secretary also emphasised the freedoms CCGs would have under the NHS reforms. But he outlined the opportunity would only come with the responsibility to ensure patients have “access to the NHS services” they require.

“You will have the freedom to choose who should support you in taking charge of local health services,” he said. “Clinical senates and clinical networks will be there to advise you, not to tell you what to do.

“You will have the freedom to structure yourselves to meet the needs of your population, providing you involve members of the public, with nursing and secondary care experience on board.”

The BMA has set out eleven areas of continuing concern with the Health and Social Care Bill.

The Association says that a series of further amendments to the Bill are necessary in “order to mitigate damage” to the NHS.

Its recommendations include giving Clinical Commissioning Groups (CCGs) the freedom to commission the most appropriate services, and ensuring the Secretary of State retains ultimate responsibility for the NHS.

Dr Hamish Meldrum, BMA Chairman, says although the Association would prefer the Bill to be withdrawn, “there is scope for further significant change to be made” during its passage through the House of Lords.

In its latest briefing paper, the BMA also calls for an amendment which makes it explicit that patient choice will not be given priority over fair access for all. It also wants further safeguards which prevent providers of care or services ‘cherry-picking’ more profitable services.

On incentives for commissioning, the Association “continues to have serious concerns” about conflicts of interest with the link of financial incentives to the performance of CCGs.

Dr Meldrum hopes that peers in Lords will agree with the suggested amendments and change the controversial legislation before it progresses any further.

“Because so much of the detail won’t appear on the face of the Bill and will instead be left to secondary legislation and guidance, it is essential to have firm assurances now about the government’s implementation plans, for example, we continue to have serious concerns about the ethics of the current proposal to incentivise commissioners,” he said.

“Other areas where the BMA is seeking amendments relate to public health; the private patient income cap; the foundation trust failure regime; increasing bureaucracy and complexity, and information and confidentiality.”

Members of the BMA have previously expressed “major concerns” about the Health Bill on various occasions, calling for the Government to amend the plans back in June 2011.

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.