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

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

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

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

Foundation Trust status

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

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

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

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

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

Challenges for trusts

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Opportunities for trusts

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

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

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

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

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

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

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

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

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

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

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

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

Opportunities for pharma

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

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

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

Sony has acquired Washington-based Micronics for an undisclosed amount in plans to enter the portable medical devices market.

Sony said it was looking to move into producing point of care medical devices that can be easily used on patients, in addition to their portfolio of printers, cameras and data recorders designed for medical use.

A spokesman for the company said: “Sony has sold such peripheral devices to medical device manufacturers in the past, but it will be a new business to sell directly to customers such as hospitals.”

He said that Sony will market the medtech devices in the US primarily, once they have been approved by FDA regulations. No timeline has been set for launches of devices.

Micronics specialises in manufacturing in vitro diagnostic products for disease diagnosis, prognosis and treatment monitoring.

CHASE Recruitment has appointed Kirstie Justice as Recruitment Consultant, responsible for the East and West Midlands area.

Kirstie originally trained as a teacher before working for Eli Lilly as a Hospital Specialist. She has worked for CHASE previously in June 2010 to cover maternity leave.

CHASE provides specialist recruitment services and contract sales organisation (CSO) solutions to pharmaceutical, biotechnology and healthcare companies in the UK.

The diversity of wounds and the wounded means that the evidence base for wound care therapies is a complex issue. Professor Richard White of the University of Worcester and Wound Care Alliance UK looks at how companies can best establish the case for their products.

The current situation regarding issues of product evidence and product availability in wound care has been discussed in Medtech Business (May and June 2010). Therapies affected by these issues include silver and other modern wound treatments, such as moist wound healing dressings and topical negative pressure (TNP) devices, which have attracted the scrutiny of those who conduct systematic evidence reviews. Following those commentaries, this article offers some proposals for a way forward.

Therapies on trial

The modern age in wound care, dating from around 1970, has seen a variety of new medical devices come to market – many of which have achieved ‘standard of care’ status. For example, elastic and non-elastic compression bandaging; hydrocolloid, alginate, foam and film dressings; honey as a CE Marked product and many others have become established in the clinical armamentarium.

Countless clinicians, many of them acknowledged experts, have come to rely on these products, knowing that when they are correctly used they work well. This steady supply of products has come from an innovative, dynamic industry that works closely with the clinician.

However, the evidence gathered to support these products does not satisfy the various groups who insist on the Cochrane-style analysis of randomised clinical trials (RCTs). Recent publications have criticised the evidence for moist wound healing, antiseptic dressings and TNP. This criticism, published in the medical literature and the national press, has led to restrictions on product availability.

The key priority, in my view, should be to maintain a regular flow of safe and effective innovations, supported by sufficient evidence for regulatory purposes and for informing the clinician. The introduction of such products should, of necessity, be followed by the ongoing collection and publication of clinical evidence.

Innovation is vital to wound care, as the steady flow of new and improved products leads directly to better patient care. The discipline is still in its infancy – a stage when developments are frequent. The industry is populated by a broad mix of large, established companies and smaller companies, many of them start-up ventures. This affects the level of investment available for expensive RCTs.

Should trials be left to the wealthy companies alone? Or can other, more economical forms of clinical evidence be gathered instead? That would offer the smaller, less affluent companies greater opportunity to develop products, gather evidence and take their treatments to market – and in the past, that has been a significant feature of wound care in the UK.

There is no doubt that evidence in one form or another is essential for the development of wound care – so open discussion of the issues around what makes for effective evidence is needed. In addition, some proactive action on the part of the wound care sector is also essential: companies must, to my mind, take action before further restrictions in product availability are foisted upon them.

Finding the facts

There is a strong case for looking more carefully at what evidence is already available in the public domain. Cochrane analyses have been justly criticised for not taking all of the available evidence into consideration. A preferable method of analysis, with recommendations, is the GRADE system. This well-known and respected system, in my opinion, should be employed to assess the evidence for a number of existing products.

With regard to the ‘quality’ of different types of evidence, the European Wound Management Association (EWMA) has published guidelines for the conduct of RCTs in the May 2011 issue of the Journal of Wound Care.

If a company decides that an RCT is the most appropriate means of gathering clinical evidence, it is important that they avoid the pitfalls which have blighted many previous trials. The Cochrane reviews list the numerous shortcomings in trials, mainly methodological errors, which form grounds for disqualification. These can be avoided!

• At the planning stage, trials should be configured with purchasers in mind: as well as gathering clinical information, the trial should take account of economic factors and quality of life instruments.
• Once the data are published, these should enhance the chances of product uptake or changes in clinical practice. Quality data will make counter-arguments difficult and merit publication in quality journals, and so garner support from opinion leaders.

Case studies are frequently used to provide support for products. However, it is an unfortunate fact that many, probably most, of these studies are of very little value. This is due to their planning and objectives, as well as the information provided. When case study posters and journal reports make products appear to be panaceas, it is no wonder that the whole exercise becomes devalued.

Cohort studies, when properly conducted, can be valuable in many ways. Their merit has been extolled by many influential figures. The GRADE system of analysis gives reasonable weighting to such studies, whereas Cochrane analyses ignore them completely. Their format is less clear than that of RCTs – but when they are conducted in a multicentre setting, with clear objectives and endpoints such as clinical goals, economic factors and quality of life issues, they provide useful data.

Post-marketing surveillance studies, conducted long-term in the ‘real world’ of routine clinical practice, are under-used and under-estimated in wound care. As far as I am aware, they are mandatory in Germany and some quality data have been published from these studies.

Audit of clinical practice is as ‘real world’ as we can get when it comes to clinical (and hopefully financial) data. Efficient clinical settings can audit their practice for long-term outcomes in treatment of wounds. Such studies can provide the most meaningful evidence.

Value and cost

Cost-effectiveness, or health economics, has been a high priority in healthcare for many years, yet it does not figure in enough wound studies. Rather naively, claims of ‘cost-effective’ based on the unit price of a product still appear.

Health economics is a defined and refined science and must be recognised, and used, as such. In this respect there is vast room for improvement in company-sponsored wound treatment studies.

For the future, it is important that the evidence for wound care therapies is of better quality than it generally has been over recent decades. This is achievable through awareness of the literature and close liaison with experts – it does not necessarily need to incur substantially greater costs!

The whole dynamic of selling has changed over the past twenty years. No longer is it sufficient to demonstrate the product to a nurse or doctor and wait for the orders to flow in. Other key groups are now involved, and liaison with them to facilitate product uptake has become essential.

Everyone involved in wound care in the UK must now be aware of, and recognise the important role of, pharmacists, medicines management, formulary committees etc. Companies must do more to involve these groups.

The transition or evolution of standards for medical devices from the days of the first modern ‘moist wound dressings’ is remarkable. Following the enactment of the Medical Device Directives in the mid-1990s, the system has become more ordered and bureaucratic.

However, this process is far from complete. The recent furore over failing hip implants has shown that the current regulations are not adequate to prevent major clinical catastrophes involving medical devices. In the USA, the FDA is taking a very close look at device regulation.

As the standards for evidence become more sophisticated, better reflecting the realities of clinical practice, the medical device industry – and in particular, the sector supplying wound dressings and associated products – has the opportunity to address the need for change and adapt accordingly.

 

 

Richard White is Professor of Tissue Viability at the University of Worcester.

The FDA has approved Roche’s new generation of Accu-Chek Aviva Plus test strips to monitor blood glucose levels in diabetes patients.

The new self-monitoring strips are designed to prevent the interference of maltose on blood sugar readings which occurs rarely when a patient takes medication metabolising to maltose.

Daniel O’ Day, Chief Operating Officer at Roche Diagnostics, said: “With its advanced technology and chemistry it is designed to support patients to manage their condition more effectively.”

More than 25 million people live with diabetes in the US, of which seven million are currently undiagnosed.

Roche’s Accu-Chek portfolio manufactures blood glucose readers, insulin delivery systems and lancing devices.

Being in the early months of my new job having come through a recent recruitment process, I almost religiously searched for advice on how to write the perfect CV.

There’s a lot of information online, and if you’re anything like me, you’ll divulge the whole mass and end up biting off more than you can chew, becoming more confused than when you started. But here is what I learned.

First of all, no matter how much advice you try to follow, the key point to remember is that your CV is your CV. Nothing’s more personal than how you spend your 40 hours per week, so make sure you sell yourself, not entirely copy a generic layout and writing style. Don’t get me wrong, you need to cover all bases, but your personal qualities and skills need to stand out in a way that is unique for you to get the job.

For sales jobs, recruiters are looking for candidates who are motivated by financial targets, are resilient against setbacks and show initiative when faced with complicated challenges.

If you already have a sales background, then you’re already one step up from the wide-eyed graduates. Sales experience opens doors to management roles, so beef up your CV with examples of your experience in sales. There are less of these positions available thanks to the recession, but it doesn’t mean they’re non-existent. You’ve just got to want it more and prove it in your CV.

Having good communication skills will be your saviour through your cold calls, and listening is just as important.

Putting across a genuine personality helps you connect with a client, and in turn they’ll respect your expertise and honesty. If you’re able to make a connection with your potential manager at your interview, they’ll know that this will be transferable when dealing with clientele.

But how can you put this across in a CV? Here are a few basic tips that will help you go far in the recruitment process:

A list of achievements where you've interacted with a variety of people is clear evidence to the employer that you are comfortable working with others. These activities could include work experience, voluntary work, or gap years. Experience in hospitality and retail are also great examples of proving to the employer that you can work under pressure as well as sustain interaction and customer service.

Thinking laterally and being flexible with your initiative is key to solving challenges at work. Thinking on your feet will save a lot of time, as we all know: time = money!

In terms of CV layout, it depends on your personality and the specific job application, but basic content is similar throughout:

• Name, contact details, website
• Language qualifications, sporting achievements, academic awards
• Education, include educational experiences that contribute to your personal skills ie public speaking, group presentations

GSK’s Benlysta (belimumab) has not been recommended in draft guidance for treating systemic lupus erythematosus (SLE).

Questions were raised by NICE’s independent Appraisal Committee over concerns about the medication’s cost and clinical effectiveness against standard treatment options.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, says evidence “did not persuade the Committee that belimumab was good value for money”.

A Patient Access Scheme had been agreed between GSK and the DH for the treatment, although details of the agreement have been kept confidential at the request of Glaxo.

SLE is an incurable autoimmune condition, which mainly affects women. There are believed to be around 15,000 people in England and Wales with SLE, nine-out-of-ten are female.

The whole body is affected by SLE as the immune system attacks healthy parts of tissue and organs which may lead to serious internal damage.

It is a complex, poorly-understood condition and may be difficult to diagnose as symptoms are often similar to more common conditions.

“Systemic lupus erythematosus (SLE) is a debilitating condition which severely affects an individual’s quality of life,” said Professor Longson. “NICE’s independent appraisal committee has looked very carefully at the evidence provided on the use of belimumab for treating SLE, including the views of people with the condition, those who represent them, and clinical specialists.”

Although it is not licensed, certain patients with severe cases of the disease are treated with MabThera (rituximab). The Committee considered it relevant to compare Benlysta with MabThera, however NICE says there is no reliable data to show the relative efficacy between the two.

“Whilst recognising the severity of the disease, the Committee concluded that based on this evidence, belimumab could not be considered a good use of NHS resources,” added Professor Longson.

The decision is now open for consultation.

A new, hi-tech retinal imaging system that could help millions of diabetes patients from going blind has been launched in Europe.

EasyScan, developed by eye diagnostics specialist, i-Optics, is easy-to-use and more portable than systems currently used in retinal imaging.

The device aims to diagnose and treat diabetes patients quicker to prevent blindness earlier.

As pupil dilation is not required for diagnosis, the device reduces patients’ waiting times by at least 30 minutes. Patients can also drive immediately after examination.

Jereon Cammeraat, CEO at iOptics, said: “With aging populations and growing obesity, countries everywhere face a rapid increase in diabetic retinopathy, age-related macular degeneration, glaucoma, and other retinal diseases.”

He said that the current technology featuring fundus cameras are “large, exclusive, and expensive, as well as being slow and difficult to use”.

EasyScan’s non-invasive technology consumes little energy and can connect to a PC or laptop via a USB port. Using Scanning Laser Ophthalmoscope (SLO) technology, the device can identify clinical features in the retina in the earliest stages, provide better contrast than traditional fundus cameras, and can better penetrate media opacities such as cataract and corneal opacities.

i-Optics is a worldwide eye imaging developer, aiming to develop affordable, quick retinal diagnosis solutions.

Anti-bee or wasp venom treatment Pharmalgen has been recommended in preliminary draft guidance by NICE.

It has been recommended as a treatment option for those who have had a severe systemic reaction to being stung or a moderate reaction with additional complications.

Professor Peter Littlejohns, Clinical and Public Health Director at NICE, says Pharmalgen is an “effective, preventative treatment”.

Less than 0.5% of the population in the UK who are stung by a bee or wasp experience a severe reaction, known as anaphylaxis. Each year in the UK, up to nine people die as a result of anaphylaxis.

Pharmalgen works by gradually increasing doses of the allergen by injection, which over a period of time, desensitises a person with the allergy by altering their immune system. It is carried out in two phases: the first initial phase after a sting and the maintenance phase which last for three years.

“The reactions that some people experience to stings from bees and wasps can be distressing, frightening and sometimes life-threatening,” said Professor Littlejohns. “People who have had a serious reaction to a sting can often experience extreme anxiety about possible future stings, and this can affect their daily lives.”

Final guidance is now expected to be issued to the NHS in February next year.

Jazz Pharmaceuticals has appointed Jeffrey Tobias as their new Senior Vice President of Research and Development and also as Chief Medical Officer.

Dr Tobias brings twenty years of experience in the biopharmaceutical industry and has also served for a decade in clinical and academic medicine.

Bruce Cozadd, Chairman and Chief Executive Officer of Jazz Pharmaceuticals, says that Dr Tobias has a “unique combination” of drug development skills and broad medical knowledge.

“His breadth of experience, business acumen, strong intellect and focus on patients will serve us well as we build a targeted pipeline of important new medical treatments that will complement our growing commercial products,” added Bruce Cozadd.

The new R&D head will start his position from October 17.

Jazz Pharmaceuticals recently merged with Ireland-based Azur Pharma Limited.