As the incidence of diabetes in the UK soars, the austerity NHS is increasingly unable to meet the needs of patients with this complex and lethal disease. How can the pharmaceutical industry help the situation?

Blindness. Foot and leg amputation. Kidney failure. These are among the complications of diabetes, a complex metabolic disorder that is now the leading health challenge facing western society.
In diabetes the absorption of glucose (sugar) from the blood fails, causing it to accumulate in the circulatory system. This occurs either because the pancreas stops producing the hormone insulin (type 1 diabetes) or because insulin production is inadequate or the body’s response to it is poor (type 2 diabetes).
Both types of diabetes have genetic risk factors, but type 2 or ‘mature onset’ diabetes has other risk factors such as age, obesity and lack of exercise. Type 1 or ‘juvenile onset’ diabetes is fatal unless the missing insulin is replaced by injection. In type 2 diabetes, a range of medications such as metformin can be used to improve glucose uptake.

The number of people diagnosed with diabetes in the UK has increased from 1.4 million in 1996 to 2.9 million in 2012, and continues to rise, with type 1 diabetes now accounting for only 10% of the total. The prevalence of type 2 diabetes has risen sharply, due to the ageing population and the trend towards obesity.

There is no cure for diabetes. A range of medications exist to treat it, but establishing the correct dosage levels is not easy: only an estimated 6% of diabetes patients get the balance right. Since no medication can make diabetes go away, the condition demands constant monitoring and medication adjustment, as well as checks for complications.

And at a time of deepening austerity in NHS funding, that level of attention to patient needs is getting harder to afford. All the signs are that people with diabetes (especially the more high-maintenance type 1) in the UK are at increasing risk of disabling or fatal complications. Sugar is killing more of us all the time.

High and dry
In November 2012, the Public Accounts Committee observed that diabetes care in England was “depressingly poor”, with 24,000 preventable deaths from the disease happening each year. The report pointed to a lack of clinical leadership and a ‘postcode lottery’ in diabetes care.

Barabara Young, Chief Executive of charity Diabetes UK, commented: “Given all the increasingly strong evidence of inadequate care, we simply cannot understand why the NHS has sleepwalked into this situation.”

During 2012, Diabetes UK drew attention to the need for better access to diagnostics, more referrals to specialist care, and wider awareness of the role of healthy lifestyle in preventing and controlling diabetes.
In April 2012, Young noted that 80% of NHS spending on diabetes care went on treating preventable complications. In May 2012, Diabetes UK stated that diabetes care in England was in a “state of crisis” with fewer than half of patients receiving adequate care.

Yet the medicines and diagnostics exist to reduce the incidence of diabetes, manage the condition and avoid complications. It’s not rocket science. What has gone wrong – and what is the solution?

A preventable crisis
Tracy Kelly, Head of Care at Diabetes UK, spoke to Pf about the problems of diabetes care. For the patient, she said, “Optimal diabetes control requires dedication and motivation from the individual to test, inject or take medication, adjust their dietary intake, potentially make lifestyle changes, monitor their condition and ensure they are receiving their health checks.”

This puts the patient under intense pressure, especially if they have other chronic conditions. How can the pharmaceutical industry help? In three ways, Kelly said: “Better provision of information and education for people with diabetes and for the healthcare professionals; commitment to research into new and improved treatments and monitoring approaches; and bridging the gap in healthcare services by supporting specialist nurses and dieticians in hospitals, for example with pump training and starting on insulin.”
Importantly, Kelly noted, the agendas of drug treatment and lifestyle change are not opposed: “There should always be a dual approach.” In treating both types of diabetes, clinicians need to look for the optimum blend of medication and lifestyle factors for each patient. The NHS needs to deliver programmes of risk assessment and early diagnosis; offer effective education in self-care for all patients; and ensure that they receive the nine regular checks recommended by NICE.

Working together
Successful diabetes care depends on integrating primary and specialist care, Kelly emphasised. “Effective diabetes care can only be achieved through integration. There must be clear referral plans in place and transparency about who does what and where specialist diabetes care is required. Specialist teams also have a key role to play in educating and supporting primary care.”

Cutting down on GP referrals is a growing NHS trend, praised by David Nicholson in his 2012 NHS review and promised in many CCG commissioning plans. Does this pose a threat to diabetes care? Kelly’s response was clear: “Cutting down referrals to specialist care may increase the risk of complications and could result in increasing costs to the health system. Diabetes is complex and any blanket rules to cut referrals could put lives at risk over the long term.”

For patients with type 1 diabetes, in particular, referral management is a recipe for trouble: “We know it is important for people with type 1 to have access to a team of specialists such as a dietician, podiatrist and counsellor. But often their access to this kind of support only comes once complications have developed.”
In short, drug manufacturers and healthcare providers can work together to support patients in avoiding complications – but clumsy cost-driven applications of QIPP are tending to disable care.

The hidden disease
As Louis MacNeice said, the North begins inside. Danish pharmaceutical company Novo Nordisk has specialised in diabetes care since its launch in 1923. Its insulin products (used by many type 2 as well as type 1 patients) are the standard of care in the UK. The company’s CEO, Lars Sorensen, recently observed: “What we are good at, all of a sudden becomes the biggest public health problem we have ever seen.”
Peter Meeus, Vice President, Novo Nordisk UK and Ireland, spoke to Pf about the company’s role in meeting the diabetes challenge. He noted that according to the National Diabetes Audit, only half of diagnosed patients in the UK are achieving treatment targets, while fewer than half of all people with diabetes receive all nine recommended healthcare checks.

Too often, Meeus noted, diabetes is only detected when secondary complications arise such as retinopathy and foot ulcers. Insulin can be the most effective treatment, but fear of injecting is sometimes a barrier to its adoption. As a result, “many patients start on insulin too late and are therefore at risk for developing serious late complications”. This is unfortunate, as the needles used today are much thinner and less painful.

Shot in the dark
According to Meeus, the pharmaceutical industry can help the NHS meet the challenge of diabetes by helping to identify the high proportion of diabetes patients who are poorly controlled, and to ensure these patients achieve control within the national guidelines.

He added: “Novo Nordisk is working with the DH and local health economies, together with physicians, to deliver agreed diabetes health outcomes at both national and local level, using appropriate innovative medicinal interventions as well as service design and support.” Specifically, the company provides Diabetes Education Nurse Facilitators to primary and secondary care organisations where needed, and its local Diabetes Outcomes Directors work to assist the redesign of diabetes services.

The company may owe its current growth in part to the growing incidence of diabetes, Meeus said, but its depth of experience in this therapy area has enabled it to take advantage of the opportunities: “Innovation and science have always been at the core of Novo Nordisk’s business, and as a result we today have the broadest portfolio of R&D diabetes projects. At a time when others in the pharmaceutical industry are cutting R&D budgets, we’re increasing our investment.”

“The challenge going forward,” he concluded, “is the fact that diabetes today is the biggest problem for healthcare systems, but at the same time the healthcare budgets are under increased pressure.” Diabetes UK and millions of patients would agree. But where there’s a will, there’s (sometimes) a way.

Pharma giant Pfizer insists it followed all appropriate guidelines after it was revealed the company didn’t pay any tax to the Government last year.

A Public Accounts Committee (PAC) investigation into tax affairs found that despite a turnover of £1.8bn on its UK sales last year the company reported operating losses – allowing it to avoid paying corporation tax.

A statement by Pfizer said the company “complies with the appropriate rules and regulations” in the UK and in all other countries it operates within.

Globally the company made $12.7bn last year. In the UK, it has offices in Surrey, Maidenhead and Berkshire. It also has manufacturing and distributing plants in Hampshire, as well as an R&D centre in Cambridge and Kent. It is one of the major suppliers to the NHS and has the best selling drug on the UK market in Lipitor.

But the company said it made operating losses of £46m in 2010 and of £59m last year. “Due to a number of factors including the level of investment Pfizer makes into the UK and restructuring costs, Pfizer actually generated losses in the UK in 2011,” a spokesperson said. “Under UK tax law, corporation tax is calculated on profits not turnover.”

Pfizer has previously been quizzed over its tax affairs in the US and in Germany. Regulators in the US wrote to the company earlier this year asking how it recorded profits overseas yet losses in America when 40% of its sales were in the States.

Critics have pointed towards similar operating losses by other multi-national organisations that allow them to legally avoid paying tax by paying in high tax jurisdictions, whilst reporting profits in low tax ‘havens’.

Charlie Elphicke, a former tax lawyer and now a Conservative MP, called for HMRC to be more firm in its approach to tax-avoiding companies. “What concerns me is that you have a company like Pfizer which has such a large presence in the UK not paying any tax at all,” he said. “That raises serious questions. We need to have an aggressive approach to tax like they have in America where those that evade taxes are prosecuted and those that avoid it face heavy scrutiny.”

Diabetes care in England is “depressingly poor”, with 24,000 preventable deaths from the disease each year, according to the Public Accounts Committee.

The report from the parliamentary group follows similar critical studies by the National Audit Office and Diabetes UK, emphasising the variations in access to checks for risk factors and complications.

However, the Department of Health denied the report’s validity and asserted that the new CCG commissioning regime would ensure better-integrated services.

Margaret Hodge, chairwoman of the committee, commented: “There is no strong leadership and no effective accountability. Variation in the level of progress across the NHS also means that there is an unacceptable ‘postcode lottery’ of care.”

Echoing her own previous comments, Barbara Young, Chief Executive of Diabetes UK, said: "Given all the increasingly strong evidence of inadequate care, we simply cannot understand why the NHS has sleep walked into this situation."

However, a DH spokesman said recent improvements in access to checks for people with diabetes meant the report’s conclusions were false – but the variations in access to tests across England needed to be addressed.

In addition, he said, giving control of commissioning budgets to CCGs would ensure that more diabetes checks were carried out.

The NHS is not using high-value diagnostic imaging and radiotherapy equipment to its full capacity and is failing to meet patient needs as a result, according to a report from the Government’s Public Accounts Committee.

The report, ‘Managing high value equipment in the NHS in England’, stated that poor co-operation between trusts is leading to a “scandalous” shortfall in provision of vital services such as post-stroke scans.

NHS Supply Chain has said it is working with the DH to address the issues raised by the report and the “significant challenge” of procuring costly but much-needed equipment.

The NHS in England spends approximately £50m per year on MRI and CT scanners and linear accelerators for radiotherapy. However, the Committee said, the use of this equipment to provide services is “fragmented and uncoordinated”.

The number of CT scans carried out per machine in a year was found to vary between 7,800 and 22,000, with availability ranging from 40–100 hours per week.

Shockingly, the report found that only 50% of stroke patients received a CT scan within 24 hours – an essential service for determining immediate treatment.

Margaret Hodge, Chair of the Committee, said the way high-value equipment is bought and used by the NHS “is not providing value for money”. She described the shortfall in post-stroke CT scans as “scandalous” and the inequalities in usage between regions as “unacceptable”.

“The Department of Health has got to look at how machines can be used more efficiently to make the best use of scarce resources,” she concluded.

The report highlights the challenge for the new NHS Commissioning Board to ensure that Foundation Trusts work together to ensure access to capital equipment.

Health Minister Simon Burns commented that more streamlined procurement of scanners had already begun: “The NHS has saved up to 15% on scanners by working with NHS Supply Chain to co-ordinate large orders over time with other trusts. This is the NHS working smarter.”

“We are currently working with the Department of Health to consider the recommendations in the report,” said Andy Brown, NHS Supply Chain’s Managing Director for Diagnostics. “Buying and maintaining equipment during times of budgetary restraint will provide a significant challenge for NHS trusts and our range of frameworks to plan, aggregate, purchase or lease and maintain high-end equipment will be invaluable to the NHS.”

Government responds on procurement of consumables

As the Houses of Parliament slipped into the summer recess dominated by the phone hacking scandal, much of industry will have missed the Government’s response to the Public Accounts Committee (PAC) report on the Procurement of Consumables by the NHS, published in May. The remit of the PAC is to scrutinise Government spending, focusing on “value-for-money criteria which are based on economy, effectiveness and efficiency”.

The May report highlighted that £4.6bn is spent by the NHS on ‘medical supplies and other types of consumable goods’ and that each trust had control of its own purchasing. There was acknowledgement that the Department of Health (DH) is engaged in its procurement strategy, but there were also questions about how close the DH’s theoretical model of a ‘pyramid’ structure for procurement (procurement at national, regional and local levels depending on the product) is to the ‘current complex reality’, which has a ‘profusion’ of bodies involved in the procurement process.

The report goes on to question how effective this landscape will be following the NHS reforms, which will give Foundation Trusts increased autonomy and less incentive to co-operate. Also highlighted are the problems faced by the DH as, despite being responsible for procurement across the NHS, it “has no control over the actions of the individual trusts”. This situation is described as having “produced a great deal of waste”.

The report concludes that there has not been an efficient process for procurement in the NHS and that boards have lacked the data to challenge managers. There is a danger, it states, that trusts will fail to get to grips with this situation and waste money through poor procurement while making cuts to treatment of patients.

The Government responded to this report in July, and was broadly supportive of the recommendations made by the PAC. Following the PAC report the Government:

• Intends to “strengthen trusts’ accountability to their boards” and “strengthen the way hospital procurement is supported at national and regional levels”.

• Has proposed the establishment of a set of Key Performance Indicators to judge the improvements made by trusts.

• Has highlighted a new, joint DH and NHS procurement strategy that is due to be launched in April 2012 – there is little detail on this, however.

• Has highlighted the role of the National Procurement Council in helping trusts to effectively utilise the support offered by regional and national procurement organisations.

• Supports the move for procurement savings to be included in KPIs as a way of persuading trusts to monitor this area of saving better.

• Has agreed that better information on what trusts buy and the prices they pay is necessary.

• Refers to the announcement by Ministers in June that GS1 coding would be adopted as the standard product coding system for the NHS.

• Refers to the establishment of a Foundation Trust Network ‘price benchmarking club’ and the exploration of potential web-based solutions.

The Government does not, however, agree that NHS Supply Chain is not demonstrating value. Its response states that the DH has invested considerable time making the offer more attractive, but needs to do more to improve value. It goes further and argues that simply looking at the prices NHS Supply Chain charges does not give a true picture of the total cost of the service it provides. The Government makes a series of recommendations around publishing better evidence of areas where NHS Supply Chain represents best value.

The final part of the response deals with ‘regional purchasing structures’, describing them as confused and lacking transparency. The Department of Health agrees with the PAC that it should work with Foundation Trusts to ensure that they are “used wisely, adding value and avoiding duplication”.

While scrutiny of the procurement system is welcomed by ABHI, the Association is disappointed by the Government’s response to the PAC report. There is widespread acknowledgement of the failings of the system, describing it as “fragmented” and suggesting it that has led to a “great deal of waste” with trusts “ordering in inefficient ways” and recognition that there has been “limited progress towards more efficient procurement”. However, the report does not offer a clear view of how the system should work, referring only to a new strategy in spring 2012. Readers may recall the launch of Necessity not Nicety in 2009 as a previous such strategy, following a similarly critical review of DH procurement capability by the Office for Government Commerce.

Coming through the Department of Health’s response is a message that there will be more emphasis in future on NHS providers being able to demonstrate that they have taken the necessary steps to get better value for money from their supply chains. The DH “will explore with Monitor, National Audit Office and any emerging NHS Provider support functions in the system, ways in which this can be achieved... include the drafting and agreement of Key Performance Indicators which can successfully measure improvements made by trusts in the management of their non-pay spend, by April 2012.” All this will mean more emphasis on providing data to the NHS about available products and prices – which are currently highly obscured by the various intermediaries, and different trusts have highly varied contractual requirements. In this regard, the Department acknowledges a potential “market for software and web-based solutions for NHS procurement to increase penetration of tools and technologies which improve transparency of spend and price information.”

However, the response fails to explore fully the role of intermediaries and their related practices, such as NHS Supply Chain’s ‘Direct from Manufacturer’ programme or the increasing frequency of Activity Based Income charges that are levied by regionally based purchasing organisations which are increasingly competing with each other. These are key issues for industry, and only result in additional cost to serve.

ABHI will continue to work with Government and with NHS leaders. The aim must be a commercial landscape that allows the NHS to get the best that medtech can offer for patients at the best value, with a reduced cost to serve. This is a big challenge, given the complexity of logistics and support and the ‘just in time’ nature of much NHS activity. While the PAC report highlighted many of the issues we deal with every day, it is not yet clear from the Government’s response how the key elements of NHS procurement will work together in future and how the various trusts and intermediaries should interact. Through our involvement in the National Procurement Council and our contact with Government and the NHS, ABHI will continue to lobby for a more efficient procurement system in the NHS.

For more from ABHI visit: www.abhi.org.uk.

The national programme for electronic patient records within the NHS is “unworkable” and should be abandoned, the Government’s Public Accounts Committee has said.

This verdict follows the decision to make the NHS IT programme dependent on multiple providers, with contracts negotiated locally, and the opting out of London GPs and hospitals from the scheme.

The Committee cited ongoing delays, lack of value from suppliers and existing problems with implementation as reasons for their view. It argued that having spent £2.7bn on developing an e-records system, the DH should invest the remainder of the £7bn budget elsewhere.

The aim of e-records was to make patient information more readily transferable between clinical centres and to facilitate the development and implementation of healthcare IT systems.

The £11.4bn NHS IT programme was launched in 2002 with the aim of improving the use of technology within the NHS. It has achieved the uptake of digital imaging (PACS) systems across the UK.

The e-records scheme, which aimed to give every patient an electronic file for use whenever they were treated in the NHS, was described the Committee as “a worthwhile aim” that was “beyond the capacity” of the NHS.

The Committee identified three problems: lack of value obtained from suppliers (e.g. BT charging £9m per site for services that NHS sites outside the scheme were obtaining for £2m); delays (the scheme is currently six years behind schedule) and problems with e-records currently in use.

Committee chairman Margaret Hodge concluded that “trying to create a one-size-fits-all system in the NHS has proven to be unworkable,” but that ending the national scheme might enable local NHS organisations to purchase more effective systems.

Electronic patient records will certainly play a part in the NHS of the near future – but the prospect of an integrated national system is in doubt.

The Government still has to resolve a series of critical issues over its NHS reform plans, a new cross-party Commons Health Committee report says.

The National Health Service Landscape Review outlines a lack of accountability and, more importantly, found the DH has not yet devised a framework should the reforms fail.

Margaret Hodge MP, Chair of the Committee of Public Accounts, says that “key questions have yet to be addressed” and believes it is vital the DH “creates robust accountability structures”.

Evidence from the report was obtained from the DH and four expert witnesses, including Professor Chris Ham of The King’s Fund and Dr Clare Gerada, Chair of the Royal College of General Practitioners.

During the structural changes proposed in the Health and Social Care Bill to clinician led commissioning, the DH is taking steps to integrate a £20 billion efficiency savings plan with the transition to the new NHS model. The report found that one-off costs and the disruption of reorganisation is providing an “additional challenge to the NHS”.

There is also a “natural tension” between the challenge and the decentralisation of key funding and spending decisions closer to the ‘front line’ which needs to be addressed, the report adds.

The move to make all health service provider trusts into Foundation Trusts by 2014 that will compete with non-NHS providers for the first time will provide “serious implications” for less competitive NHS hospitals, it warns. The report advises that it is “imperative” the DH develops a “clear and transparent” policy for managing the failures of commissioners or provides to ensure patients are protected and value for money is assured.

Also, the report states, that “high quality risk management” is essential if the programme of change is to be delivered on schedule and budget, and to realise its intended benefits, especially during the transitional stage.

It is unusual for the Public Accounts Committee to analyse the progress of reforms at such an early stage, but Chair Margaret Hodge said there were a number or areas which raised concerns which needed to be examined.

“The Department of Health acknowledged the risks associated with this radical shake-up of the NHS,” she said.

“Whilst the reforms could complement the imperative of achieving £20 billion efficiency gains by 2014/15, the reorganisation might also distract those responsible for making the savings while safeguarding standards of patient care.

“We were also concerned that the DH has not yet developed a high quality risk management protocol for either the commissioning or providing bodies. The DH acknowledged that some health trusts and some GP practices had some way to go to achieve foundation trust status or become commissioning consortia.

“The DH must have effective systems in place to deal with failure so that whatever happens, the interests of both patients and taxpayers are protected.”

Nigel Edwards, acting Chief Executive, NHS Confederation, agrees with the need for greater accountability and says the success or failure of the Government’s health reforms will be judged on how effectively the NHS manages the structural overhaul and the required savings plan.

“The PAC rightly raises the need for adequate governance and accountability to ensure that public money is safeguarded,” he said. 

“The Government will also need to spell out how it will deal with those GP consortia and providers that fail. It will need to ensure the rewards of success and the consequences of failure are significant enough to have an impact on organisational behaviour and financial management.”

The Health Committee says it now intends to review the progress of the reforms at regular intervals to focus on the issues found in the report.

NHS hospitals in England are not providing value for money, a Public Accounts Committee (PAC) report has concluded.

Figures from the Office for National Statistics (ONS) estimate that productivity has fallen by an average of 1.4% each year since 2000, despite an increase in Government spending of 70%.

Productivity is defined as the ratio of the volume of resources (inputs) to the quantity of healthcare provided (outputs), adjusted to reflect their relative costs and quality.

Government spending on the NHS increased from £60 billion in 2000-01 to £102 billion in 2010-11. The increased funding has enabled hospitals to invest in better paid staff and improve buildings and equipment.

There has been a significant improvement in the performance of the NHS since 2000, the report notes, particularly in waiting times and outcomes for patients with cancer and coronary heart disease - areas targeted by the DH.

However, productivity has not matched the increased resources, as hospitals have mainly focused their efforts on meeting national targets.

“The Department of Health will now have to work to reverse the trend of falling productivity if it is to meet its ambitious revised target of achieving, by the end of 2014-15, savings of up to £20 billion each year,” said Margaret Hodge MP, Chair, PAC.

In 2002, the DH promised that it would deliver productivity improvements of between 1% and 2% in exchange for increased funding.

It promotes efficiency and productivity improvements in hospitals primarily through national pay contracts and by a setting a ‘tariff’ for individual hospital procedures. The report says this method has resulted in certain improvements, but as the system only covers 60% of hospital activity, there is a “substantial variation” in costs and activity.

The DH is now introducing ‘best practice tariffs’ to promote greater hospital efficiency, but the report warns this may “prioritise price over quality”.

“A key problem is that national pay contracts have not so far been used to manage the performance of staff effectively. It is indicative of this that consultants’ productivity has fallen at the same time as they have had significant pay rises,” Hodge added.

NHS hospitals in England are not providing value for money, a Public Accounts Committee (PAC) report on hospital productivity says.

Despite Government spending increasing by 70% in the last decade, figures from the Office for National Statistics (ONS) estimates that productivity has fallen by an average of 1.4% per year since 2000.

Margaret Hodge MP, Chair, PAC, said that NHS productivity “has been in almost continuous decline” in the last ten years and that taxpayers have been “getting less for each pound spent”.

Productivity is defined as the ratio of the volume of resources (inputs) to the quantity of healthcare provided (outputs), adjusted to reflect their relative costs and quality.

Government spending on the NHS has increased from £60 billion in 2000-01 to £102 billion in 2010-11. The increased funding has enabled hospitals to invest in better paid staff and improve buildings and equipment.

The report notes that there has been a significant improvement in the performance of the NHS since 2000, particularly in areas targeted by the DH, such as waiting times and outcomes for patients with cancer and coronary heart disease.

But the level of hospital activity has not matched the increased resources as hospitals have focused on meeting national targets and not improving productivity.

“The Department of Health will now have to work to reverse the trend of falling productivity if it is to meet its ambitious revised target of achieving, by the end of 2014-15, savings of up to £20 billion each year,” said Margaret Hodge.

“A key problem is that national pay contracts have not so far been used to manage the performance of staff effectively. It is indicative of this that consultants’ productivity has fallen at the same time as they have had significant pay rises.”

In 2002, the DH promised that it would deliver productivity improvements of between 1% and 2% in exchange for increased funding.

It promotes efficiency and productivity improvements in hospitals primarily through national pay contracts and by a setting a ‘tariff’ for individual hospital procedures. The report says this method has resulted in certain improvements, but as the system only covers 60% of hospital activity, there is a “substantial variation” in costs and activity.

The DH is now introducing ‘best practice tariffs’ to promote greater hospital efficiency, but the report warns this may “prioritise price over quality”.