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.

How well do you understand the various priorities of a key element of your customer-base: the payer? Omar Ali pens Part II of a typical day in the life of a Formulary Pharmacist.

10AM : GP REFUSED PRESCRIBING OF A PAIN DRUG/ACTION ASAP
OK, we have been here before – this product is non-formulary. It has never been applied for. The GP is well within rights to refuse prescribing. The consultant knows it is non-formulary and has ‘requested’ via a letter – actually stating it is non-formulary, so would the GP kindly prescribe it.

The GP is irate, and the patient is now confused and unhappy: “why wont you prescribe what the expert/consultant has asked for?” There is a stalemate. Not a great scenario – this call is backed up with emails going back with two PCT advisers, a commissioner, a GP and a pain nurse. This will mean going to see the consultant and being firm: these are the rules of engagement, this is the financial framework, this is how I can help you manage your patient.

Thoughts for pharma

We call this ‘lockdown’. It’s a process by which redundancy is built into the formulary processes to ensure compliance, limited loopholes and consequential policing. What’s crazy is I know the brand, and I know the rep. Every month she asks: “when is the next D&T?” I tell her – and nothing happens. Next month, she asks again. So what’s happening?

The representative knows she needs a consultant to bring her brand to the D&T but can’t/won’t affect it. The representative then considers ways around the D&T; KOL to find loopholes, write to the GP, prescribe on FP10(HP), do a non-formulary request, try IFR, etc. In fact, exhaust all opportunities except the one that is needed: D&T approval.

Sometimes the pharma company has a brand philosophy which doesn’t press the right buttons: they have representatives calling the wrong people, the quality of the representative is not good enough, the seniority/decision-making-abilities are lacking.

This ‘lockdown’ effect will usually mean that the company goes round in circles. It focuses on new materials and a wonderfully articulated campaign – usually around ‘Edith’, a 50-year-old patient who is suffering from constipation and can’t enjoy her grandchildren. “If only you would prescribe the brand for her. You would if it was your own grandmother”.

The ‘payer avoidance’ strategy will not work. Lockdown is getting tighter. With Clinical Commissioning Groups it will be even more so. The financial framework will be more akin to trying to prescribe a non-formulary drug whilst working for BUPA, who would neither tolerate nor reimburse because the formulary is under a financial restrictions.

Indeed, the pain market has also intensified. This means numerous brands shouting for a louder voice in an intense market. Neuropathy, Opioids, Fentanyl/breakthrough Ca pain – add these up and you have pharma running around competing for a slice of the pie. Given all the warnings we had with COX-IIs, now we have them with NSAIDS, and of course even the weak Opioids have ‘addictive warnings’ all over them.

It is not surprising we are caught in the headlights of where to go in the name of safety and analgesia. Please someone, be it a brand manager or someone with payer access, see the bigger picture. Help us with the whole pathway. See our needs and work in partnership with us.

11AM : MEETING WITH PHARMA BRAND MANAGER
It’s not often I get a visit from a brand manager! We have been struggling for some time attempting to commission a funding pathway for an osteoporosis product – see earlier Matrix Revolutions. However, we may have a solution now with a variety of process mapping models.

I have finally received a number of options and interestingly the applicable HRG codes for activity within this domain. This has been a headache, despite a NICE TAG within the context of this ongoing saga. A resolution is long overdue. After a lot of liaising and a lot of technical HRG work-up, we may end up up with a streamlined prescribing pathway which lines up the PCT, the GPC, the acute trust, and fracture liaison service.

Thoughts for pharma

There is an intriguing change of paradigm when I am sat having an adult conversation with a brand manager compared to a ‘rep-call’. I realise that brand managers can’t go and see all their customers face-to-face.

But the paradigm shift is palpable. Why? Here we have it: The representative is ‘detailing me’ – that is never going to compare with an adult conversation with a brand manager who gets the bigger picture.

But something else, potentially more devastating: the brand manager is able to vocalise the ‘brand story’ in a far more compelling way than the ‘local rep’. That’s interesting, because the local rep is trained in the ‘brand messages’.

Even if you put aside that the brand manager has a ‘big picture understanding’, the fact that the value of the brand was unbelievably clear means that somewhere along the factory chain of sales force effectiveness and tier upon tier of managers, the message is lost in Chinese whispers. Why? I don’t actually know.

The representatives that are sent to see me are not in the same locator of food chain as I am. In effect, pharma is sending people of a certain authority that doesn’t fit with where I am. Even with account management. Remember, I talk clinical, I talk financial, I do commissioning maps, I do total drug budgets – I still have a boss.

However, pharma send people to see me with the following authority: “I need to get my medic to answer that…I need to get my line-manager to answer that…I need to call in my health economics person to see you…I need to call my regional account manager to approve that…”

When will I see all these people? Why do I need to see them all? Is it all ABPI, is it internal compliance, or is it sales force design? I’m not all for it, but I do see where some industry leaders are coming from in proposing authorised account managers answerable to MDs with budgets run at their own liability and expertise.

I recently did a ‘Payer Process Mapping Day’ for a pharma company/team of Executive Healthcare Development Managers. It fascinated me. Pharma has spoon-fed even higher NHS teams to such a level, that if you clear the playing field and ask them to come up with solutions to landscapes, they go blank. at day, the summarising  suggestions was simply: “we need a toolkit from head-office”. It was worrying. My conclusion?

We need to innovate within the NHS. Pharma companies are stakeholders. We should be asking you to help us innovate, but the people you are sending me… while I’m wanting them to look at the traffic jams I have ahead of me, and help navigate local influencing factors, they are waiting for a tool-kit from head-office!

11.30AM : CARDIOLOGY CONSULTANTS FORUM
Cardiology prescribing has so many focal features right now, I’m struggling to keep up with payer issues. This is due to a mixture of NHS demands, D&T processes, a sizable shift in coronary intervention work – and the drugs required within such units) and recent launches of new products that are proving challenging to implement within our health economy.

The format takes place as follows: I basically ‘gatecrash’ the forum and hijack a section of the agenda to use the opportunity for both information flow – in both directions, buy-in – to various prescribing initiatives, D&T processes and budgetary issues, and input to a number of shared-care-prescribing guidelines.

The aim is to open GPC/CCG cluster prescribing. A lot of this is about supportive communications; managing up – to my Chief and Director of Finance, and managing down – to pharmacy team on formulary policing. I need to take the consultants from ‘one place to another place’ within each micro-managed sub therapy. It’s a give-and-take scenario.

Thoughts for pharma

Cardiology has never really left the ‘priorities’ list. Right now, although there are some exciting and challenging implementations, I foresee a rocky road ahead. Antiplatelets. With the onset of generic clopidogrel’s price suddenly dropping like a stone – Plavix was £40 pcm, generic clopidogrel is now £2.50pcm, the Director of Finance is looking at the cost savings that we have built into our financial planning.

But here’s the catch – not only do we have branded prasugrel, we also now have branded ticagrelor, both pushing upward of £50pcm+. So how do we manage this? I have potential new pipleline antiplatelets which have offerings to interventional cardiology versus a savings plan that I will need to explain if I renege on. Tough. After much consternation, we’d put prasugrel onto our formulary, and now we have displaced this with ticagrelor.

We still have the generic clopidogrel as first line – but we always, always need a second line drug. Interestingly, neither company appears to have come forward with a QIPP line yet. One of them have thought about patient access schemes. NICE looks like it will be happy to support either. Cardiac networks play an important role – the cardiologists just want somewhere else to go after generic failure.

This was a learning curve for me. Whilst the clinical ‘story’ for either brand never really did magical wonders for the payers, the cardiac network is influential, and I think the companies are now maybe reconciling a ‘payer value story’.

There was a scary moment for one of the companies – a serious hospital discount nearly had us giving away one of the brands as a 12-month supply on the rucksack of a patient discharged from the angio suite – with a cost-saving share with the PCT. The company in question quickly made that disappear! It’s fascinating and like a game of chess sometimes…

Dronedarone. Even with a NICE TAG behind it, this has not been easy to implement. It really does take some serious ‘heads-together’ and I have never seen such fierce debate between clinicians and payers. Affordability and the increasing prevalence of AF makes for a great D&T discussion.

The next meeting I have with the directorate is to implement the use of this agent in young patients – outside NICE who recommended in 75yr+ – as the clinicians see greatest benefit here. This is where the payer’s approach needs serious consideration. All being well, I’ve managed to create an amber/shared care with PCT funding to keep all happy – let’s see what happens at the formalisation and authorisation meeting.

NICE chest pain implementation. There are significant stakeholders here with a number of large meetings across the PCT – payers, consultants, commissioners, coronary care units, etc. The implementation involves a number of small ‘mini-projects’, putting different drugs into the formulary for specific uses to help implement NICE.

That’s the way proper process mapping occurs. It’s more about the drug assisting the pathway, not about the drug per se. I see a lot of work to be done here. But I also expect to see consistency across the PCT.

Read Omar’s previous article in this series on Account Management in pharma.

Omar Ali is the Formulary Development Pharmacist for Surrey & Sussex Healthcare NHS Trust and sits on the External Reference Group for Cost Impact Modelling for NICE. He may be reached on omar.ali@sash.nhs.uk

The UK medical device market is one of the biggest in the world, with growth relying predominantly on imports. But it is also a significant exporter of medical technologies. In the second of two articles looking at the domestic market, Medtech Business in association with Espicom takes a look at the UK medtech export market.

The UK is a significant global exporter of medical devices (including medical equipment and medical supplies) and remains among the world’s top 10. But the sector has faltered in recent years. Exports peaked in 2006 at US$7,238.5 million, but have fallen every year since then. In 2009, exports dropped to US$5,394.4 million – roughly the same level seen in 2005. The orthopaedic sector was hit especially hard in 2009. (For more details, see Figures 1–3.)

Consumables

Medical consumables were the largest individual export area in 2009, valued at $1,140.0 million,* or 21.1% of total exports. This was a fall of 3.8% compared with 2008, with a 2005–09 Compound Annual Growth Rate (CAGR) of –1.8%.

Consumables are defined as wound care products (medical dressings, sutures, sterile, surgical and dental goods), syringes, needles and catheters. Within this category, catheters and cannulae amounted to $279.7 million, virtually unchanged from 2008, but significantly lower than the 2005 level of $410.6 million. Exports of medical dressings amounted to $503.7 million, a fall of 8.3% compared with 2008.

Diagnostic imaging

Diagnostic imaging is not historically one of the UK’s stronger sectors. In 2009, UK exports of diagnostic imaging apparatus amounted to $1,131.3 million – 21.0% of the country’s total export market. In recent years, the electrodiagnostic sector has been its biggest source of growth. The 2009 total showed a fall of 0.1% compared with 2008, with a CAGR for 2005–09 of 5.4%.

Electrodiagnostic imaging exports amounted to $575.1 million, a rise of 23.4% over 2008 due largely to a big rise in MRI exports. Radiation apparatus exports were far lower at $83.4 million, although this too represented a strong increase of 28.2% on 2008 figures. Exports of imaging parts and accessories fell sharply in 2009, by 21.4% to $472.9 million.

Orthopaedic products

Exports of orthopaedic and prosthetic products saw a sharp fall in 2009. Exports totaled $1,231.5 million in 2008, but fell by 46.7% the following year to reach $656.2 million. Artificial joints fell by 67.1% to $71.5 million, while other orthopaedic/fracture appliances fell by 49.8% to $445.2 million.

As outlined in Medtech Business’s first UK market article (July 2011), imports in this sector also saw a sharp fall in 2009. Espicom suspects that much of the reduction is due to a change or relocation of multinational manufacturing and repackaging activities.

Patient aids

Exports of patient aids amounted to $1,054.5 million in 2009, a fall of 5.2% compared with 2008.

Portable aids fell by 8.0% to $762.1 million, while therapeutic appliances rose by 2.9% to $292.4 million.

Dental products

Exports of dental products reached US$148.2 million in 2009 – 2.7% of the total. This is an increase of 4.1% over 2008; the total fell sharply in 2007, but has since recovered a little.

Dental cements amounted to US$70.2 million in 2009, a rise of 17.7% over 2008.

Leading destinations

In 2009, the single leading destination for UK exports was the US, with $768.1 million (4.2%) of total exports. The largest shipments to the US were diagnostic imaging products, which amounted to $188.8 million, 16.7% of exports in this sector. This was followed by consumables, which amounted to $136.5 million, 12.0% of exports in this product area. The US also received 31.7% of dental product exports, valued at $47.0 million. (See Figures 4 and 5 for more details.)

More than half of UK exports went to the EU-27 countries. Shipments totaling $3,016.7 million (55.9% of total exports) left the UK for the EU-27. The principal recipient within the EU was Germany, accounting for 13.4% of exports, valued at $720.6 million. Almost a quarter (22.3%) of diagnostic imaging apparatus exports went to Germany. Belgium was the single biggest importer of UK consumables (18.6%) and UK orthopaedic and prosthetic products (17.2%) – in both cases outstripping the US. Other leading destinations within the EU were France, Ireland and the Netherlands.

Next month, Medtech Business will look at the medical technologies market in France.

This article is based on information from Medical Market Outlook reports published quarterly by Espicom Business Intelligence.
*All figures are in US $. For further details of the 63 markets covered, please visit www.espicom.com/outlookm1

Keeping hold of key members of staff has always been an issue for successful organisations. To avoid head-hunters, Anton Franckeiss explains valuable measures to increase employee retention and satisfaction.

Although the pharmaceutical industry is one that consumers tend to depend on to provide instant cures or magical remedies to our all too human frailties, it actually operates to a longer timeframe. Any new treatment for our remedies may take only seconds to swallow, but will have been in development for many years, and possibly even decades. But despite its foundation in long-term projects, the industry also experiences higher than average staff turnover rates – a circumstance that the industry shares with IT and financial services. While the requirement for specialist knowledge and professional skills is a common factor across all three of these sectors that should not be ignored, human resource (HR) professionals within the industry should resist the temptation to believe that there is a single cure that can be prescribed and administered.

Although the analogy may be a simplistic one, especially in the industry context, adopting a holistic view that sees retention rates as one of the vital signs of the ‘patient’ (ie the workforce of each pharmaceutical company) may be helpful. Recent surveys, both by Pharmaceutical Field and by the Chartered Institute of Personnel and Development, have shown a slowing of staff turnover rates in the industry. Yet the reasons may be at least partly a reflection of the broader labour market and economy.

In an era of slow economic growth after a sharp recession, employees are seeing redundancies elsewhere – or even closer to home – and may have drawn the conclusion that the metaphorical frying pan might be a happier place to be for the medium-term than the unknown quantity of the metaphorical fire. There is, however, no room for complacency here. If the factors at play are limiting turnover rather than actively encouraging retention, the ‘condition’ could flare up again at short notice depending on movements in the broader economy: a chronic condition, after all, requires monitoring and management to ensure that any chances of it becoming acute are minimised.

Road to recovery

The analogy of a chronic condition, however, should be challenged. A continuing situation of poor retention does not imply that this either must simply be lived with or will inevitably get worse. There is no reason that the prognosis should be gloomy, although a combination therapy approach will be required and the regime will need to be maintained for some time before improvements in the underlying condition are secured. The key to success lies in the depth of understanding that the doctor – in this case the HR functions of companies in the industries – can acquire about their patient.

Without research, dialogue and communication, companies can too easily assume that they understand the retention factor priorities of their workforce, while the employees actually see the outlook rather differently. A 2006 survey by Talent Drain, for example, showed that employees rank ‘cooperation’ as the second most important factor, while employers listed this in ninth place.

Employers also typically overstate the impact of pay and financial rewards, while underestimating the importance to employees of opportunities for personal growth. What appears as a mission critical role contribution through one end of the telescope looks more like one component of an on-going personal biography from the other. In an industry that embraces great diversity of roles – from sales to scientific specialists – there is likely to be a similar diversity of outlook – the intelligent response is to seek understanding rather than to assume that a single remedy can be applied in all cases. Feedback to HR from line management in different operational areas could be helpful here, so keep lines of dialogue open.

The right prescription

Employee motivation and engagement requires similar treatment; although recent surveys say suggest turnover is reduced, they also suggest what an earlier Pharmaceutical Field article, called The Fear Factor, highlighted. Pro-actively seeking to increase engagement will enhance the chances of turning a cure into a preventative approach. The highly engaged will be less easily tempted away when external economic factors change. Again, an appreciation of potential complexity will be helpful. Scientific staff may be balancing a need to supervise and manage others and commercial encouragement from the organisation to develop their leadership skills with their personal commitment to their professional discipline. Acknowledging such a potential conflict of factors will be a far more productive way of identifying motivational approaches than failing to address it.

There are also industry-specific challenges to address, one of which was highlighted in an interview between the BBC’s Evan Davis and GSK Chief Executive Andrew Witty in the former’s recent book, Made in Britain: “One of the things we say to our scientists is that you have to be comfortable with failure. [There are] great scientists in this company who will never succeed in their entire career … Of 10,000 new molecules that we might synthesise, so that we might create 10,000 possible new drugs, probably one will be a drug.”

Strategies that promote innovation – the use of multi-disciplinary project teams where each can make their own distinct contribution and gain inspiration from other – can help here in other ways. But also allow staff with specialist skills to receive peer, as well as line management, feedback on the value of their contribution. It was a point by Alistair Flaister in a People Management article, Organisational learning: The social network, when he made the important point that: “The real engine of creativity and organisational success is to be found in internal networks of friendship and collaboration.”

Line managers have other contributions to make, not least in listening acutely and in building a supportive and encouraging team culture. It’s a point underlined in the 2010 Work Foundation report, Exceeding Expectations: the principles of outstanding leadership, which identified two elements common to the approaches of outstanding leaders in creating a working environment:

The first is the need to develop an open and supportive atmosphere to create the conditions for trust and respect, and the second is to ensure the workplace enabled success and satisfaction.

Part of the latter element may require support from HR in terms of fresh thinking. Depending on the severity of the case, HR might also ponder the benefits of making a referral to a specialist consultant. Helping specialist staff to make the transition to a leadership role is not simply a progression or promotion through a series of levels of leadership. It requires them to make a fundamental transition from development of a professional discipline to that of a broader organisational and commercial role. It also requires the transfer and application of new behaviours that challenge and enhance their performance and contribution. Two other factors that The Work Foundation found as common to outstanding leaders is a willingness to be flexible in their approach to process, and a willingness to adapt roles to give individuals the maximum opportunity to achieve personal growth and job satisfaction. An organisational willingness to be similarly flexible in role definition and organisational design can support good leaders within the company to deploy this approach successfully.

Never say no

Think of a talented individual that the company should seek to retain, and then imagine how they might feel if they heard the words “I’d love to be more flexible, but I’ve spoken to HR and they said …” It’s also helpful to remain mindful that disengagement is unlikely to be a proactive personal choice – employees are more likely to become disengaged as a reaction.

Ultimately, employee retention is not so much a condition as a symptom. An indicator that employee engagement is low, that opportunities to satisfy personal motivations are too limited, that opportunities for progression are overly limited or unclear, or that employees are not receiving positive feedback on their performance and/or contribution when praise is due. The answer is not to treat the isolated symptom, but to investigate the underlying condition and develop a comprehensive talent management strategy that will systematically improve organisational health. Even in an industry where specialist skills are a key requirement in many roles, an employee value proposition and a recruitment strategy that identifies employees with a strong cultural fit are still important requirements. Any industry dependent on innovation and intellectual property should appreciate that human resources are its critical input. And most employees – who will, after all, have chosen to make an application to join the organisation and done so in good faith – are ultimately looking for something relatively straightforward: regular reminders of several good reasons to stay. That, of course, is easy to say, but there’s something positive to be said for making it easy to do.

Anton Franckeiss is the Managing Director of ASK Europe.

The revised Health and Social Care Bill remains contentious, but appears likely to pass into legislation. Simone Carron-Peters of Frost & Sullivan analyses its probable impact on the UK healthcare market.

The Government’s contentious Health and Social Care Bill has raised many concerns among the various stakeholders. The eight-week NHS listening exercise conducted by the NHS Future Forum has resulted in the proposal of multiple changes to the Bill, whose passage towards legislation is summarised in Figure 1 below.

This article evaluates the planned NHS reforms for impact on the health system and the life science industry.

Overview of the Bill

The Health and Social Care Bill proposes to create an independent NHS Board, promote patient choice and reduce NHS administration costs.
Its key focus areas are:

• To establish an independent NHS Board to allocate resources and provide commissioning guidance.
• To increase GPs’ powers to commission services on behalf of their patients.
• To strengthen the role of the Care Quality Commission.
• To develop Monitor, the body that currently regulates NHS Foundation Trusts, into an economic regulator to oversee aspects of access and competition in the NHS.
• To reduce the number of health bodies, including abolishing PCTs and SHAs, in order to help the Government cut NHS administration costs by one-third.

More power (and money) to the GPs

In its initial form, the reform aimed to improve the quality of service delivery by devolving NHS commissioning powers and responsibility into the hands of GPs. The GP consortia would receive budgetary allocations from the new NHS Commissioning Board, which would be responsible for managing and allocating about £80 billion of the health budget. The consortia would, in turn, devolve the funds to the various practices under them.

The new GP consortia would replace the 302 PCTs in England, which would be abolished by 2013. All NHS trusts were set to become Foundation Trusts by April 2014. It was anticipated that the consortia would require significant assistance, including support from the private sector, in exercising these new commissioning functions.

Medical organisations and NHS trusts were immediately sceptical about the implementation of this reform, saying that the changes could have negative effects on NHS services. Some trusts argued that it is risky to reduce the central grip on commissioning at a time where urgent savings are being made. Others agreed that GPs are well positioned to make decisions on the use of resources for their patients.

The BMA: a critical response

The reform plans have also not gone down well with the British Medical Association (BMA), who expressed concerns about the level of responsibility being bestowed on GPs. One of the BMA’s major concerns was the lack of clarity in the Bill with regard to the roles that the GP consortia would be expected to perform. The BMA also believes that it is important to ensure the funding for GP practices remains distinct from other budgets, as it would cause significant complications if GP consortia were to be made responsible for amalgamated budgets that included the management of standard GP contracts.

Currently there are about 177 GP ‘pathfinders’ (pilot groups of GPs testing the system’s concepts and functions) who are taking the lead in implementing the new commissioning roles.

In May 2011, the BMA’s Health Policy and Research unit conducted a national survey of GP opinion that received a response rate of 39%. The survey findings revealed an alarming 55.8% of the respondents citing NHS reforms as a reason for their intention to retire in the next two years. That figure was composed of 59.4% of the 688 principal or contracted GPs, 41.1% of the 30 employed salaried GPs and 35.8% of the 39 freelance GPs who participated in the survey.

The survey also asked GPs how confident they were that the GP commissioning consortia would be appropriately skilled and supported. 65.6% were ‘not confident’ that the consortia would be appropriately skilled, while only 15.8% were ‘confident’ that they would be. In addition, 70.9% of the respondents stated that they were ‘not confident’ that the consortia would be supported, while just 10.2% were ‘confident’ that they would be.

Amendments to the Bill

Based on the recommendations of the NHS Future Forum, the Health Secretary announced changes to the Health and Social Care Bill in June 2011. The Bill is due for its third reading on the 6th and 7th September 2011.

The role and functions of GP consortia are now better-defined. The consortia – now called Clinical Commissioning Groups (CCGs) – would be required to publish details on their constitution and how the allocated budgets have been used. They would also be required to follow guidelines from, and be accountable, to the NHS Commissioning Board. GPs are also bestowed with a responsibility to promote research and innovation.

The plan for all NHS trusts to become Foundation Trusts by April 2014 has been amended. NHS trusts would become Foundation Trusts by 2016, based on their clinical readiness for transition. They would be given the liberty to make use of private health treatments, and would compete among themselves for patients.

The role of the National Institute for Health and Clinical Effectiveness (NICE) would increasingly focus on giving authoritative advice to clinicians on when and how the most effective treatments can best be used, and also on the development of quality standards for the NHS to aim for in the treatment of certain conditions.

Value-based pricing (VBP) would replace the Pharmaceutical Price Regulation Scheme (PPRS), which has existed since 1957. The purpose of VBP is to improve NHS patients’ and clinicians’ access to effective and innovative drugs and medical technologies by ensuring they are available at a price that reflects their value, based on an assessment of the outcomes they can achieve.

Impact assessment of the health reforms

The implementation of the Health and Social Care Bill will witness an increase in private sector and voluntary involvement in the delivery of healthcare. GP commissioning will allow the use of private healthcare for NHS patients. Healthcare vendors and providers can capitalise on this shift by offering products and services best suited to patients’ needs in order to influence GP commissioning.

The aim of value-based pricing is not to achieve the lowest price possible, but to encourage the development of new therapies and promote innovation. The principle of linking the price of innovations to their value has already received support from a broad range of stakeholders.

The priorities of the health reforms are ambitious; if instituted, they will have far-reaching effects on the way the British public accesses the health system. It will also affect the role of the private sector in the UK healthcare system, increasing opportunities for private providers of both clinical and support services to become involved in providing healthcare to NHS patients.

According to the Government’s calculations, the reforms will bring about a huge cost saving for the NHS. However, negative consequences such as redundancy for administrative staff in the health authorities will pose a huge socio-economic threat.

How will the savings affect the prospects for innovative medical technologies? The adoption of such products has always been necessary for medical professionals, predominantly because new technology aims to provide healthcare at a quicker rate – minimally invasive technologies being a major example. The Government has vowed to ensure the system delivers effective and appropriate healthcare to all who need it. Moreover, GPs have a greater understanding of patients’ needs than the managers or PCTs who at present make funding decisions. Thus the demand for innovative devices will arise regardless of the allocated NHS budgets.

One of the main objectives of the reforms is to put patients and public first by implementing a ‘no decision about me without me’ policy. National standards and independent inspection will continue to assure patients that all NHS-funded services are safe and of a high quality. Patients will have much more information about individual services and their performance, enabling them to choose the services that best meet their needs.

The reforms will ensure that services are easier to access and more responsive. Shorter patient waiting times, one-stop clinics for diagnostics, and increased provision of healthcare in patients’ homes are some examples of services that are likely to develop in response to new incentives. Patients will be able to gain access to healthcare in new ways that are more flexible. This is likely to mean more services delivered in local communities, such as urgent, preventative and rehabilitative care, thus helping to avoid unnecessary hospital admissions. Better information will help patients to understand and make the best use of the options available.

The reforms will also support services to become more integrated. Improved information systems will play a key role, enabling healthcare providers to exchange clinical data more easily and so gain a complete view of the patient’s condition. Increasingly, there will be opportunities for patients to influence the pattern of services within their locality. Local practices will have incentives to provide locally-based health improvement and health protection services. Patients will be in a better position to manage their own health.

Financial goals

The Government is confident that the health reforms will allow it to save billions. Figures from the Impact Assessment published alongside the Health and Social Care Bill earlier this year claim that the structural reforms to the NHS will save £5 billion per year, though this is a gross rather than net figure. The Bill promises to reduce NHS administrative costs while promoting patient choice. However, time alone will tell whether these reforms prove to be economic.

 

Simone Carron-Peters is a Research Analyst for growth consultants Frost & Sullivan.

Finding the best employer is like playing the dating game. No-one wants to be married to their job, but tying the knot with an employer is an important commitment. The strongest relationships can last a lifetime, while playing the field may not look quite so good on your CV. So what is it that attracts us to our employers? Do we marry for money, or is long-term fulfillment enough? And is a good sense of humour essential? Pf’s Emma Campbell-Kelly outlines some of the key criteria in identifying ‘The One’.

The summer months, particularly the holiday season, are often the time when most of us pause and reflect on where we are in life. That two-week break in the Maldives, or even just the back garden, can invariably provide the catalyst for some killer questions: Am I in the right job? Does my employer appreciate me? Do I appreciate my employer? Is it time for me to move on? For many, this period of reflection provides little more than confirmation that they are happy where they are. In the current climate, where job security is king and fear of moving jobs has bred a ‘better the devil you know’ approach, many workers are staying put rather than risking change. But for some, a ‘grass is always greener’ philosophy drives them towards the pursuit of new employment. But what do you look for in a new employer? What defines the perfect job and, indeed, an employer of choice? Where do you begin in the pursuit of professional happiness?

Searching for a new job can be a daunting endeavour. Whether it’s your decision to enter the vacancy abyss or not, the task can be arduous and time-consuming. Slim pickings are expected in such a precarious economic climate, but there’s still a world of decisions to make: location, role, salary and even whether you are looking in the right industry are all key considerations.

The experience is similar to becoming newly single, in the market for a new partner. Job sites and recruitment companies could be metaphors for dating agencies in this case, or a friend who’s trying to set you up, or a speed dating session.

And you must select employers from this pool of availability in a similar way to how you would approach someone to ask them out. Like a relationship, a job is an investment, and will define you for the period you choose to stay committed to it. You want the whole package: ‘The One’. It will stay on your record, your personal history, or rather your CV. No pressure then.

What do you look for? Materialistic features (financial details) are number one priority for most. Your interest in a job or person is sparked by judging at face value. It’s not necessarily shallow, because what else can you base your judgement on in the first instance? Being objective with your search is key to obtaining a job that will tick all the boxes for you.

So once you’ve landed your first ‘date’ with the desired employer, aka job interview, first impressions are too important to disregard. You dress to impress, revise your CV, and prepare answers to every question under the sun. Both parties want to impress, without coming across as too keen. But at the end of the day, you want this job, you wouldn’t have applied otherwise. And the employer wants the best they can get (which is you, obviously). After all, as Ray Kroc, founder of McDonald’s, said: “You’re only as good as the people you hire.” So it’s potentially a win-win situation, as long as you both get what you want.

Job satisfaction has always come top of surveys questioning motivation at work. Until now. It seems that such an insecure and volatile economy is making us tighten our belts (as if they weren’t tight enough already). Living costs are continuing to rise, a unanimous, desperate ‘Yes please’ is given in response to money. The prospect of a double-dip recession has hit us while we’re down, just as we were getting our hopes up.

With this in mind, it’s no surprise when perusing the Chartered Institute of Personnel and Development’s (CIPD) recent quarterly Employee Outlook survey. The review showed that increased salary and benefit packages have overtaken job satisfaction as the number one reason why employees are looking to change jobs.

Out of 2,000 questioned employees, 54% rated higher salary and benefits as their top reason for wanting to change jobs, while 42% said that job satisfaction drove their career move choices. This is a sharp reversal compared to last year’s 61% voting job satisfaction over 48% monetary reasons to look for alternative employment. A shocking revelation from the survey showed that almost a fifth (18%) of employees completely run out of money before they’re paid, either always or most of the time. So the financial pressure is on, it seems.

But are finances what get us out of bed in the morning? We recall how the carrot beat the stick regarding the donkey’s motivation. But what does the carrot mean to you?

Is it salary, benefits, a fancy company car? For some people, especially those who are struggling financially at the moment, the answer would be a giant nod of the head. But what about the 42% who voted job satisfaction as their motivation to work hard?

For this group, an employer’s treatment of its workers and management skills really makes a difference. It’s the little things that contribute to their career happiness. A friend you can confide in, belief in your product, respect for your manager; the buzz of adrenaline when you know you’ve done a good job.

Company culture has always been a vital aspect of work life. Your co-workers are with you for a significant portion of the day, so team dynamics are important. Henry Ford of Ford Motor Company had the right thinking: “Our employees are like extended members of our family.” The company should run like a well-oiled machine at all levels, complementing and developing each other’s roles and responsibilities. Confidence and trust glue the team together and make everyday errands pass by effortlessly.

There’s no doubt about it, your happiness at a company is largely directed by what you do for at least 40 hours a week. And let’s face it – your working life is a long one, so it’s best to do something you enjoy. It’s been proven time after time that you’re more likely to work harder if you’re passionate about your job. Happy people are more energetic, proactive, creative and optimistic, and quicker to learn. In which case it’s in your employer’s interest to make you happy.

This is largely down to how you’re managed. Management and guidance at work largely affect your work ethic and the company’s dynamics. “Management is nothing more than motivating other people,” stated Lee Iacocca, Chairman for Chrysler Motors. Management is a crucial role to play, because your workforce implicitly relies on your motivation to work. Donald Trump once said, “Good people = good management and good management = good people.”

Money can only promise a limited amount of will-power from an individual; pride in their work will give them the edge and a hunger for success. Belief in your product, trust, loyalty and commitment to the employer are also invaluable attributes for an employee to embody, and are recognised by good employers. As Mary Kay Ash, Head of Mary Kay cosmetics, stated: “People are definitely a company’s greatest asset. A company is only as good as the people it keeps.”

So perhaps, most of all, we just need to feel loved. Being treated well, as in a committed relationship, ensures that we’re in it for the long haul.

In July, the Office for National Statistics (ONS) published a report on what makes Brits happy. Not money, as it turns out. Health, family and friends topped the list when around 34,000 people were asked “What is wellbeing?” and “What in life matters to you?”

The survey was commissioned by David Cameron to help him develop future policies, but ironically critics have since complained that the £2 million to conduct the survey was a waste of money as the results are quite obvious. We’re never happy, are we?

But at the end of the day, as much as money is a necessity to live, happiness in yourself and at work increases quality of life, and helps boost your company at the same time. A happy workforce is a productive workforce after all.

From an employer, you want to be pushed to your full potential, appreciated for your effort, made responsible for important decisions, making you believe in your product and employer.

Working life is most enjoyable if you’re lucky enough to be in the position of not worrying about money. To have an enthralling occupation puts a spring in your step.

And as much as looking for a new job can be tiresome and sometimes feels like a dead end, just remember, it’s all in aid of finding ‘The One’, your soulmate that offers the whole package: an invigorating role with great prospects. And if the money’s good at the same time, all the better. So make it a good one with good people.

Ernest Waaser, new CEO of global wound care company Systagenix, talks to Medtech Business about the importance of helping clinicians to address the challenge of wound healing across a range of care environments.

Ernest Waaser is the recently appointed CEO of wound care company Systagenix, based in the UK. Formed in 2008 through a buyout of Johnson & Johnson’s advanced wound care business, Systagenix supplies wound dressings to over 100 countries. The recent launch of its ‘Let’s Heal’ brand shows the company addressing the wound management and healing process proactively across primary, secondary and home-based care environments.

What prompted the launch of Systagenix in 2008: what opportunity did the company’s founders identify?
When our investors looked at the business back in 2008 they saw a strong existing business that, with the right focus and strategic investments, had a terrific opportunity to grow. The business had a 75-year heritage, a world-class R&D capability, and a strong reputation in wound care – a clinical area that’s continuing to grow with the ageing population and the increase in diabetes and obesity. It was part of a very large diversified company where it had to fight for investment and resources against other businesses. So by creating a stand-alone company that’s solely focused on wound care, we can be much more responsive to the needs of the market, make those strategic investments and bring real innovation to the world of wound care.

What is the thinking behind the ‘Let’s Heal’ brand?
What has it achieved for the company and for the industry? There are two basic beliefs behind the brand. First, we believe passionately that the goal is wound healing, not wound management. And in today’s practice, too often companies focus on managing individual symptoms in isolation from each other, rather than tackling the whole wound healing process as a continuum. Second, we recognise that there’s no single product or device that will heal every wound. Each patient and each wound is different, and there may be many reasons why a wound is not healing: the patient may have an infection or a high protease level, or a venous insufficiency, or any one of several other underlying illnesses or complications.

So our objective is to take a more holistic approach, to put a system in place, starting with diagnostic tools and leading on to the proper treatment for that wound in that patient. ‘Let’s Heal’ is our approach to providing a range of treatment options and a systematic approach to when to use each product. The huge innovation here is to start that whole process with point of care diagnostics that will provide immediate feedback on the status of the wound, which the clinician then uses to help select the appropriate treatment. ‘Let’s Test’ is our Systagenix umbrella for future wound diagnostics and assessment products, and that’s the entry point for our overall system of care.

Systagenix has particularly focused on treating hard to heal acute and chronic wounds. How are you trying to change the way these wounds are perceived?
The first perception we’re trying to change is that some patients must live with a wound. Our objective is that every wound should be healed, and we think every patient deserves that. Managing life with a wound is not in our vocabulary.

The second thing we’re trying to bring visibility to is that hard to heal wounds are not only affecting the patient’s quality of life, but are very expensive for the healthcare system. In many countries wound care is done partly in hospital, partly in an outpatient setting and partly at home, so the costs are spread around and the total cost tends not to be visible to healthcare administrators. The product that’s used to treat the wound is a small part of the cost: there’s hospitalisation, physician time, multiple home nurse visits, and the very real cost of complications ranging from infections to amputation.

There haven’t been many large-scale economic studies, but the evidence is pretty clear that the faster you get a wound healed, the lower the overall cost to the health system. That really is the focus of our ‘Let’s Heal’ approach: to eliminate trial and error, using point of care diagnostics to get the right treatment started immediately and shorten the overall healing time and cost.

How does that strategy work at the sales and marketing level?
Wound care is a clinical process that is spread not only across different care settings –  hospital, home, clinic – but also across a number of clinical specialties that treat wounds: vascular surgeons, podiatrists, general surgeons and others. One leading international clinician told me that wound care is a team sport. So part of what we do from a sales and marketing point of view is to try and bring these various clinical specialties and different types of clinicians together, to take a look at how the overall care process can be improved.

For example, we recently brought an international group of key opinion leaders together who issued an international consensus document on the use of a diagnostic in wound care to detect high protease levels, which are a known inhibitor to wound healing. They are putting the ground work in place to establish the need for that diagnostic test and determine how it should be used in clinical practice. This element of bringing the clinical community together to look holistically at how we can help them and provide them with the right tools to diagnose and heal wounds is an important part of the marketing effort for us.

How are current changes in the NHS landscape affecting the UK market for wound care companies?
We really haven’t seen the major impacts just yet. Obviously the NHS will be incredibly focused on delivering high-quality care at the lowest possible cost. I think our challenge as a sector is to demonstrate very clearly that our products and services can materially lower the cost of wound care: faster healing, fewer visits and fewer complications. I think as we go forward and the landscape continues to change, we’ll monitor that carefully and adjust as we need to.

What are the major business challenges facing UK wound care companies seeking to export to global markets?
I’d point out three challenges. The first is regulatory. Our products are covered under medical device and/or pharmaceutical regulations in every country they’re sold in, and once you get outside the EU they’re all different. The second is reimbursement. Just because you have regulatory approval doesn’t necessarily mean you can get paid for the product. The reimbursement systems are different in literally every country in the word. So those two issues, regulatory and reimbursement, require the combination of a fairly sophisticated infrastructure with the right skills and expertise and good local partners in your export markets. And finally, you really have to tailor your offering to local needs, taking into account local clinical practice and pricing expectations.

What do wound care companies need to do to address the clinical and commercial challenges of healthcare in the 21st century?
21st-century healthcare is all about finding more cost-effective ways to deliver high-quality care to a growing population of patients. As an industry we need to help clinicians in wound care get the right treatment to the right patient quickly and avoid much of the costly trial and error process that exists today. That requires thinking about innovation in a different way, looking not only at your product but at the overall process for treating a patient.

Pharma’s Account Management model is built on the principle that frontline professionals develop and deliver brand value propositions that align with the key priorities of key customers. But in a changing market where new customers are emerging, how well do you understand those priorities? Omar Ali pens Part I of a typical day in the life of a Formulary Pharmacist.

Despite consumers’ apparent lust for TV medical dramas and gruesome surgical documentaries, it’s unlikely that the viewing public would find a biopic centring on the work of a Formulary Pharmacist particularly enticing. But, for an audience of pharmaceutical sales professionals charged with understanding its customer-base, gaining an insight into the breadth and depth – and far-reaching implications – of a typical week in the life of NHS prescribing advisers, medicines management and formulary pharmacists should provide much food for thought.

Pharma appears desperate to establish the ‘key priorities’ of its many customers. This article, based on typical encounters with medical sales professionals, is a genuine attempt to outline mine.

A MONDAY MORNING, SOMEWHERE IN SURREY
8.10am: GI CONSULTANT / IBD.
(Discussion in the corridor)
Arrived at my NHS base camp. Stopped in the corridor by one of the GI Consultants who wants to set up a GPC/CCG commissioning group on GI Inflammatory Disease with one of the local Consortia - we ran one with Rheumatology framed around an osteoporosis brand. We put a date in the diary to discuss. I will be coordinating an IBD lunch event to facilitate joined-up working. Bringing in the GPCs is easy - I can text most of the GPs on the Commissioning Board of our local clusters, such is the relationship required for joined-up thinking. He’s very committed to his cause – and has very recently impressed significant knowledge and application of commissioning processes involved. Needless to say, many of his choice agents are either off-license or difficult to source from community pharmacies. He also has a whole stack of biologics he’s keen to use – but without some PCT discussions (and now outreaching to GPCs) he won’t get very far.

Thoughts for pharma

GI/IBD has become very noisy and in certain areas very controversial. Biologics are testing the very essence of ‘affordability’ in the NHS. We also know that by using them correctly, we can prevent signi­cant morbidity – surgery/admissions/etc. However, joined-up thinking doesn’t occur by magic – and you have a signifi­cant role in making this happen. When we coordinate this GPC/Hospital IBD lunch event, I am certain I will be discussing with various stakeholders, including pharma. NICE in principle supports a number of products but there are complexities. For example, bringing patients in for an IV infusion will generate income for the Trust – which funds a nurse who provides additional services. Patients treated at home may be a preferred option – there is no VAT. Home healthcare is not without its headaches around delivery, months’ supply ordered and administrative burden.

I am still disappointed at the level of pharma support I have seen here. There is far more that can be done to bring a clinical context into a financial framework. I call this the ‘Mortgage Principle’ – translating falling in love with a house into a financial framework with a defined loan: value and %APR with monthly repayments – see previous Matrix Revolutions. There seems to be a vast gap in understanding NHS processes – not just from pharma, but also from consultants – so improved process mapping from chronic disease to A&E through to post-discharge is essential. It also brings out the ‘true-cost’ of the disease in IBD – not just the ‘drug’s cost’. If our consultant doesn’t move ahead and advance his prescribing base, he will end up referring more patients to tertiary centres (which will only increase PCT costs) – so it’s important to put things into context here. Process Map the patient and the money will follow. If this is not tackled by pharma, I foresee the future of managed care entering here very neatly. Looking after the whole pathway and pushing pharma out to bystanders – look at companies like IHP, United Healthcare & Medco, it’s happening.

8.40am: Pharmacy Base.
(Discussion with the boss)
Arrived to my desk – finally. This time it’s the Chief waiting with an IFR/one-off-request that needs sorting. It’s the usual story: this time it’s a urology product that a GP is refusing to prescribe. We are having to push through the IFR/one-off-request – and also liaise with the GP for a medium-term solution (the patient is travelling significant distances to obtain this). This means some research, PCT discussions, GP emails and a phone call to the patient. I will also try and perch on the urology consultant’s shoulders (he runs a clinic this afternoon) and coordinate future D&T processes. Most of all, we need to ensure that the patient is central to this whole system – which is easier said than done. It’s good timing though – I have been in discussions with urology, working through the top-ten spend on the drug list to see where we have efficiency savings (something which is occurring across the whole trust in conjunction with PCTs & GPCs). This product initially came up as ‘not-on-the-radar’ but clearly needs some attention. I have our medicines information pharmacist conducting background research – I have emailed the specialist commissioning pharmacist at the PCT and CCd the prescribing adviser who has just evaluated a recent APC paper on overactive bladder prescribing (which we are discussing at our next D&T).

Thoughts for pharma

Urology is big on the radar. Many prescribing items are specialist, while there are significant prescribing efficiency savings aimed at ‘overactive bladder’ and linked into a more encompassing discussion with endocrinologists, and the ongoing story behind testosterone. I am sure I am sitting on a business card of a testosterone brand, but which company it was I cannot recall. Thumbing through my cards – the stack waiting for a call back is big – I can’t really see through the thick fog of various companies/pharma/sub-companies/take-overs. Note to self: request all staff to ensure reps write their brands on their business cards when they call at the pharmacy. Key priorities around urology that are high on the radar across primary/secondary care are as follows:

• Urinary retention/BPH
  Is it just me or has Combodart lost its way? I remember some very exciting joined up thinking on preventing unnecessary referrals and bringing consultants out to primary care. Given urology consultants admit themselves that DREs to exclude prostate Ca is not easy, liability and governance for getting GPs to this was always heading into a cul-de-sac. I think there is a ‘new campaign’, though I’m not sure what it is. We have both finasteride and dutasteride on our joint formulary – but I’m not seeing the right financial framework on the ground. I can see NHS PCOs moving backwards, lifting finasteride back on the pedestal and not even considering the Combodart story. If there is a value proposition around this brand someone better get this moving within commissioning circles fast. To add to this, tamsulosin’s patent expiry further hastens the need for the value story here. If the last D&T rejection we had is anything to go by this is either off the radar or must be a third drop-down detail on someone’s bonus scheme.
• Urinary incontinence
  We have NICE, LUTS and SMC. HTA is all important. Most of pharma focuses on product differentiation. They need to, NICE is an open forum for prescribing. But I don’t see a commissioning story or a decent value proposition for payers. Please don’t state you want to run me through a cost model – that is not a ‘value proposition’. I have yet to see a company come to me and talk about QIPP. Where are you guys? Please don’t moan at the NHS for using generic oxybuytnin first-line – we get the opposition, what we don’t get is a Payer ‘QIPP Value Proposition’ around your brand. Too much n=1 for my liking. The only brand working the NHS has to some extent are the solifenacin crowd – they certainly have significant clinician/KOL buy-in if the Payers are left somewhat ‘wanting’. I’m unsure where exactly duloxetine & fesoteradine are heading, or what their value story is – despite SMC approval. Maybe it’s just me.
• Bladder instillation
  This is hotting up big time. Why? Because there are costs to both primary and secondary care – and furthermore, despite numerous products – some without a license – for conditions such as interstitial cystitis there is significant unmet need on cure rates, relapse rates and hospitalisations. Someone, somewhere will win big when they map out to us what already suspect – hospitalisation costs here are huge, and process mapping will show how these are sectored into various health economies. At the moment, everyone is walking and talking product – bag of saline/infuse like this/lovely twisty connector/etc. Just waiting for someone like United or Medco to come and show us the path to the land of milk and honey. It appears no-one else will.
• Testosterone
  It’s back! The story has become interesting all over again, and all credit to pharma. The link with diabetes is moving this higher and higher up the agenda. It is fraught with issues. Everything from best mode of delivery to patient/compliance and desired effect, through to overlap with specialties – is this endocrine or urology or both, same pathway or different pathway? The pharmaceutical arguments in testosterone are worthy but having no coat hanger to hang your outcomes on makes for difficulty in pulling out the cheque book. There is a ‘gap-effect’ in situ – from academic niceties to clinical practice. I’m not sure the pull is there yet – and again, I return to my translation into a financial argument. Furthermore, there are cost savings and efficiencies to be had and this is where a product-matrix weighted with Payer Related Priorities would assist a brand in its Payer Value Proposition – if it indeed cares to invest in one.

It goes a bit like this:

1. What’s important to payers with a view to testosterone replacement?
2. Rank this list in a weighted manner so that they all add up to 100% (ie they may say evidence w%, compliance x%, safety y%, cost z% – w+x+y+z must all add up to 100%
3. Now you have your weighting, get the payers to allocate the numbers for each of the testosterone brands
4. Now you have not just who is the winner, but also how and why
5. So if, for instance, compliance is 25% weighting of the whole game, then if you spend 80% of your time talking about compliance, this may not be effecting your exposure time with payers to maximum benefit –remember the clinicians will have a different matrix. You may have the best compliance story – well done, that’s 25/25 but you will never score higher than this. There is another 75 points in this exam that you haven’t answered yet. You need to find out ‘what is the % weight that formulary/prescribing advisers give to the ‘testosterone story’ – once you have this value, you know how important it is.

9.30am: Meeting with Obs & Gynae Consultant / re: Formulary Application
This should be quick. We’ve recently put on some pessaries to our formulary. Obs and gynae want to use them in difficult/pre-specified labour/delivery situations. Now the company has whipped over a freezer to their unit. Yes, they are stored in the freezer, and no, before you ask, I don’t know whether we defrost before use or just pop them into our patients freezing cold. Have had a discussion about this with my wife over dinner, she is also a pharmacist – not a good move. Anyway, I’ve been firm but clear. The pharmacy doesn’t have a freezer, we need to discuss with the company about a freezer. There will be no prescribing of this new product within the Trust until we resolve the ‘freezer’ issue. All credit to the company, supportive they are, quick to respond they have been and, as I write, and you read, one of my staff is coordinating logistics around this. This is a classic example of simple supportive strategy. I looked back at the minutes of our D&T Form and smiled to myself… “accepted onto formulary, pending freezer.”

Omar Ali is the Formulary Development Pharmacist for Surrey & Sussex Healthcare NHS Trust & sits on the External Reference Group for Cost Impact Modelling for NICE. He may be reached on omar.ali@sash.nhs.uk

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.

It’s long been said that men are from Mars and women from Venus. Iain Bate explores the findings from the latest Pf survey to establish if, in pharma at least, the sexes really are worlds apart.

For decades studies have been evaluating whether men or women make the better boss or employee. Questions have also been asked time and again about who works harder or more efficiently with the resulting arguments commonplace in boardrooms, bedrooms and everywhere else in between. And, like every other industry, the world of pharma has not been immune from the debate. Now in its tenth year, Pf’s annual Company Perception, Motivation and Satisfaction Survey provides a confidential way for medical sales professionals to express what they really think of working within the UK pharmaceutical industry, and provides a useful benchmark of field-force remuneration. Once again, this year’s survey shows that the difference between men and women is not as clear as the X and Y chromosomes that separate us.

In 2007, Total Work, Gender and Social Norms, a study from the US National Bureau of economic Research, by Michael Burda, Dan Hamermesh and Philippe Weil, aimed to put an end to the age-old argument of who actually works harder. Although on the surface the majority of respondents claimed that women work harder than men, the survey found that across northern Europe and America the total workload – combining activity at work and at home – is now shared almost equally.

There are reportedly just 78 genes that separate men from women. But the feedback from the Pf survey would suggest masculine and feminine thinking is far closer together. Women slightly outnumber men in the survey accounting for 53% of respondents. They also outnumber male counterparts in almost every age group as well – a surprising statistic considering it’s usually females who sacrifice, or at least put their careers on hold, when starting a family. This social norm is reflected with the only age category in the survey where men outnumber female counterparts by almost 2:1 is those aged 55 or over.

The pay gap

Pay discrimination has always been a major issue and one which campaigners have tried to balance for decades. On the 1st October 2010, the Equality Act 2010 came into force. The brainchild of Harriet Harman and one of the Labour Party’s 2005 manifesto commitments it was supposed to finally bridge the gap in salaries between men and women. Forging together nine different laws, including the Equal Pay Act, the legislation gives the Government the power to require large private sector companies with more than 250 staff to establish whether there is a pay gap and to publish their findings.

But so-called ‘gagging clauses’, which stopped people from discussing their salary with colleagues, remained and several other provisions were left out of the Act, including the gender pay audit.

The Act was supposed to finally end the years of discrimination women have faced – particularly in respect to pay. However, if anything, the survey reveals the pay gap is actually increasing. In last year’s survey, the pay difference between the combined median salaries of medical representatives, hospital specialists, NHS liaison officers and first-line managers was £1,539. But that figure has now leaped to £4,000 in the space of 12 months See figure 1).

Despite the pay gap increasing, women are again more satisfied with their salary than men with more than half (51%) of female respondents admitting to being happy with their remuneration. Needless to say the amount of men who said they were satisfied with their annual remuneration increased from 46% to 49%. But more surprisingly is that 61% of women believe they are on an appropriate salary, compared with 57% of men – maybe the Government’s ‘gagging’ clauses remained for a reason…

Experience and expectations

Although there are more men within the medical sales industry aged 55 and over than women, it is the fairer sex that has more experience within the industry in the early stages of their careers (see figure 2). More than double the amount of women (14%) have up to four years experience in the trade. Women who have worked within the sector for between four and eight years also marginally outnumber men. But more than three-quarters of male respondents said they have eight years of more total experience, compared with 67% of women.

When analysing the amount of time in a person’s current role, it would suggest that the Equality Act is bridging any divide or favouritism towards a certain sex. Exactly a quarter of men have been with their current employer for less than a year with women only one per cent behind. Results also found that employers would now seem to favour an evenly balanced workforce of men and women. In fact, more than a third of both men and women (37%;35%) have been in their current role for between two and eight years. Over that, 17% of men and 14% of women say they have been employed for nearly a decade by the same company.

Often accused by women as having commitment issues, it would seem men do have itchy feet after all with 40% admitting to wanting to move company or position within the next 12 months (see figure 3). More than a third (35%) of women also admit to considering a change of employer or role by this time next year. But a higher number of women (59%)compared to men (53%) said they were happy to stay with their employer and within their existing role.

What really matters

In the current economic state it’s no surprise that both men and women claimed that their salary was the main motivational factor whilst at work (see figure 4). With pharma companies still content on cutting budgets and wielding the axe on sales teams it’s also of little shock that job security is now the second most important factor for employees within the industry. Interesting when you consider in the 2009 survey job security just managed to make the top-twenty motivational factors. The number of redundancies has obviously taken its toll on all respondents within the last twelve months with more people than ever keen to hold on to their job.

Women put a greater emphasis on work-life balance than men who said the relationship with their immediate manager was of more importance. This opinion again may reflect a more maternal instinct and a willingness to find the right balance between time spent with the family at home and at work. Men also said that company culture was of more importance than women with females having a greater belief in products than male counterparts.

Where satisfaction within the workplace is concerned there is no separating men and women. Both sexes said that a belief in products, relationship with manager, accountability, autonomy and pension scheme were the top-five satisfying factors. As the survey suggests, men and women have never been more similar…