INDICATION EXPANSION – the use of a product in a patient population beyond that for which it was originally approved – is almost universally employed by pharmaceutical companies as a sales-boosting lifecycle management technique designed to keep generics manufacturers at bay. However, where will this strategy be left by moves to limit the lifecycleextending benefits of product label expansions, and by heightened safety concerns surrounding the use of drugs off-label?

Regulatory changes in the USA and Europe

A new report from independent market analyst Datamonitor has found that of the 50 top-selling drug brands in 2004, 84% have had additional indications approved since their initial launch in the US, and a further 6% are known to have subsequent indications in development. Further analysis reveals that not all indication expansions are planned to maximise return on investment (ROI). With indication expansion being such an established part of the brand manager’s armoury, it is vital that companies do not lose sight of the need to evaluate the suitability and likely profitability of a strategy before implementation.

Recent regulatory changes on both sides of the Atlantic are altering the environment for indication expansion. The new data exclusivity provisions of the recent review of European pharmaceutical legislation offer the potential to gain an additional one-year market exclusivity for new indications filed during the first eight years on market, says Datamonitor analyst Adele Schulz. “This exclusivity would apply to the product as a whole; seemingly an incentive for companies to seek approval for new indication. On the downside though, the new regulations also include a provision for generics companies to exclude patented indications or dosage forms from their product information.

“This prevents pharmaceutical companies from employing the historically used strategy of filing for multiple new indications across different European markets as a means to delay the entry of generics.”

Meanwhile in the US, the Medicare Modernisation Act (MMA) of 2003 has removed the ability of companies to benefit from multiple 30-month stays of generic approval each time a generics company challenges a patent listed in the FDA’s Orange Book. Whereas patents filed for multiple indications previously resulted in multiple 30-month delays of generic approval, MMA restricts each company to one 30-month stay, triggered when the originator company sues a generics player for challenging any listed patent.

Safety concerns regarding off-label usage

“While regulatory developments have reduced the potential for on-label indication expansion to act as a lifecycle extension strategy,” Schultz says, “recent high-profile drug safety concerns are also threatening to reduce the potential for companies to profit from off-label use of their products in an expanded patient population.”

Some of the most successful forays of products into new indications in recent years have been driven by off-label usage. Genentech/Roche’s Rituxan, for example, is a blockbuster drug that only holds US approval for a niche oncology indication; much of its success is due to off-label use in a broader range of leukemia patients. Likewise, Pfizer’s Neurontin was initially approved for adjunct therapy in epilepsy, an indication that made up only 5.3% of the blockbuster drug’s US prescriptions in Q2 2004 (MIDAS medical data, IMS Health, October 2004).

However, a number of high-profile drug safety issues (including the withdrawal of Vioxx in late 2004 and the investigation of links between SSRIs and suicide) are changing the environment for pharmaceuticals (and pharmaceutical marketing in particular), and may reduce the potential for companies to profit from off-label use of their products.

Schulz comments: “During 2005, the FDA has come under much criticism for its drug safety monitoring process and has reacted by putting in place plans for a number of drug safety reforms.

“One of these reforms, the establishment of the Drug Watch website, may have particular implications for levels of off-label prescribing by bringing attention to adverse events experienced during off-label use of products. As the FDA tightens up on drug safety regulation, it may also become more active in enforcing penalties for breaching of its guidelines to the industry.”

In Europe, 2005 saw the publication of the UK Government Health Select Committee’s inquiry into the influence of pharma companies on prescribing practice, patient groups and regulatory bodies. Companies’ influence on physicians through journal publications – a key way in which off-label drug use is encouraged – was singled out for particular attention. One of the key recommendations made in the report is for the publication of trials in an independent register to avoid publication bias. This fits in with moves being made toward this aim in the US, and may reduce companies’ ability to leverage promising trial results to drive off-label prescriptions.

In deciding the optimum indication management program, companies will now have to weigh the increased scrutiny associated with off-label indication management strategies against the possibly reduced rewards of on-label strategies. New indications that require a significant raising of awareness will increasingly be best pursued with an on-label strategy.

Off-label use will continue to have a place in niche indications with high unmet need, or as a feasible strategy for second- and third-to-indication members of product classes experiencing off-label uptake in an indication. “However,” Schulz says, “companies must be aware that off-label promotion in commercially attractive populations will be subjected to increased scrutiny in future.”

From indication expansion to indication ‘targeting’

Given the increasingly challenging environment for indication expansion, companies should focus on early planning and implementation of such strategies. This will solidify indication expansion’s role as a mid-lifecycle ROI boosting strategy, rather than as a late-lifecycle generic defence strategy.

Datamonitor expects to see an evolution of the lifecycle management strategy from indication expansion to indication ‘targeting’ or ‘selection’, which implies a more focused, product-specific approach. Schulz says: “Growing use of pharmacogenomics will contribute to this shift, as initiatives to streamline the drug development process using biomarkers to identify patient populations in which a treatment will have an enhanced risk-benefit profile grow in prominence.”

Although it segments the patient population, indication targeting will result in numerous lifecycle benefits including:

• Lower development time and cost, extending the product lifecycle.

• Potential for earlier line use of therapy or even preventative treatment, significantly expanding the patient population.

• Potential for rapid expansion into new subgroups once identified by biomarker.

• Increased prescribing of the drug through benefits such as increased compliance (when prescribed to those patients most likely to benefit) and increased cost-effectiveness.

Adele Schulz, Datamonitor pharmaceutical industry analyst, is available for comment. Her Datamonitor report ‘Lifecycle Management: Accessing New Patient Populations – Maximising Return on Investment of Indication Management’ is a case study-based analysis targeting the creation of best practice recommendations for entering new patient populations in the US and Europe.

How female sales representatives can be safe and savvy when on the road.

“The aim of The Suzy Lamplugh Trust is to improve people’s personal safety and to reduce their fear of crime, and we are therefore delighted to be presenting these seminars with Driver Training Matters. Whilst personal safety when driving is an issue for everyone, we realise that women can feel particularly vulnerable and believe that the seminars will go a long way towards helping them to feel safer and more confident on the road.”

– Julie Smith, Training Manager for The Suzy Lamplugh Trust

RESEARCH SHOWS that the one of the things most women fear when out driving alone is ‘road rage’ or verbal abuse. Would you know what to do if you were carved up and had someone gesticulating at you angrily, shouting abuse? Have you ever thought through the strategies you would use to handle this situation? The answer, in all honesty, is probably No. If you were faced with this or another one of those dreaded ‘What if?’ scenarios – such as a breakdown, late at night when you were miles from home – how do you think you would react?

A new course is about to go nationwide to address these issues and more. In particular, it aims to increase women’s confidence when they are out and about and on the road. Designed by driver training specialists Driver Training Matters and The Suzy Lamplugh Trust, it aims to boost women’s confidence so that they can deal with any situation. The Suzy Lamplugh Trust is the UK’s leading authority on personal safety; by combining this with DTM’s driving expertise, the seminars will make women feel safer and able to avoid potential problems on the road.

Keeping your head

You would be well advised to use a mixture of psychology and common sense if you should be unlucky enough to find yourself involved in a road rage incident. It is, in reality, a smaller risk than the media would allow us to believe – but it does happen, and it is still a worry. It is important to stay calm yourself, avoid excessive eye contact and do not let yourself get drawn into a confrontation.

We are human and can sometimes make a mistake with our driving. It is far easier to accept that and apologise: a simple gesture to say you are sorry will usually defuse a situation immediately without letting it escalate out of all proportion. Think about what annoys you in other drivers, and don’t do things like tailgating and cutting in. Be aware of yellow box junctions and ‘keep clear’ areas: blocking these can so easily provoke an argument.

Statistically speaking, women are unlikely to be a victim of physical attack following an incident of road rage or a breakdown – but that doesn’t stop women feeling vulnerable. Fear can be a magnifier, and it can give women in particular a distorted view of their own risk levels. The ideal approach is to be aware of the dangers, but not to get them out of proportion.

PLAN and POWER

The key to driver and personal safety is fourfold: PLAN – Plan & Prepare, Look confident, Avoid risk and Never assume. It’s a fact that if you plan ahead and look confident, you will radiate nonvulnerability. If something should go wrong, don’t let yourself think like a victim.

Under the heading ‘Plan & Prepare’, for instance, how well do you normally check and prepare your vehicle before you get in? If you’re like most people, you probably just jump in and drive. It might seem boring, but spending a few minutes checking your vehicle every day could save you a lot of problems and stress. Quite simply, if you look after your vehicle it will look after you. Take a quick walk around your vehicle and check your tyres for any damage or flats. The course doesn’t specifically tell you how to change a tyre, but it advises you on how to prevent such a situation from arising in the first place.

Be aware of your fuel gauge, and don’t wait until it is nearly empty to refill it: this is very often a reason why breakdowns occur. If you get lost for any reason and you are low on fuel, it will only add to your stress levels.

Spend a few minutes looking at the car handbook, and know what the warning lights mean. Red normally means Don’t drive the vehicle, and orange is a warning of a problem. If you notice any change in the way the vehicle is running or how your brakes function, get it looked at as soon as possible.

A few simple checking exercises that can easily become habitual will certainly make for less stressful driving, and knowing you have been proactive will make you feel more confident anyway. It all plays an important part in preventing the risk of a breakdown and avoiding trouble for yourself. An easy way to remember what items on your car need to be checked is POWER – Petrol, Oil, Water, Electricity, Rubber.

A driving force

The seminar course will cover many of the issues facing women on the road. It will raise women’s awareness of potential dangers and encourage strategies to recognise and reduce those risks. This, in turn, will help to give women the confidence and peace of mind necessary to drive safely and enjoy driving.

The day will include a number of interactive sessions in which women can discuss and address particular issues they may face or fear when driving. However, we will cover the following topics:

Women taking the course will receive a wealth of information on safe and sound driving – including practical advice on travelling with children, driving through busy towns at night and travelling abroad – to help them become safer women, safer drivers.

Every responsible company should be addressing the issue of personal safety and doing everything it can to safeguard its female employees, particularly when they are driving on company business.

In 2001 Ian Fogg, Sue Birch and Claire Frost founded The Vacancy Management Company, the first niche company to provide interim solutions to the pharmaceutical and healthcare industry for such projects as maternity leave and sickness cover. Five years on, VMC looks back at how ‘Vacancy Management’ has developed into a popular buzzword across the industry and service sector since the company’s inception.

Sue Birch
General Manager

Claire Frost
Resourcing Manager

Ian Fogg
Managing Director

WITHIN THE LAST FIVE YEARS, significant changes within the NHS have impacted on the pharma and healthcare industry. As a result of this, companies have had to respond to these changes and review the way in which they operate with regard to employing their sales teams. They have also had to make significant adaptations to people’s roles, and introduce new types of positions to ensure that they are targeting the appropriate customers in the right way. So now the concept ‘Vacancy Management’ is not only used by the industry to meet the requirements of traditional types of skill shortages, but is increasingly used for special projects and experimental organisational changes.

Sue Birch, General Manager of The Vacancy Management Company, explains how important it has been for the company’s growth and success that it has developed its business over the last five years in line with these changes.

Providing the best service

Claire Frost, Resourcing Manager, explains how essential it has been for VMC to listen carefully to the demands placed on its clients, and hence the changes in their requirements compared to five years ago.

“At VMC we will always strive to ensure that the interests of our clients are at the forefront of our minds at all times as the dynamics of the sales structure continues to evolve and set new challenges.

“We appreciate that for our clients to be successful in their long-term goals, we need to be continually adapting our service and offering the most flexible, open-minded approach to their requirements. To this end, we are always completely honest and open with all our clients, providing not only a ‘Vacancy Management’ solution but also a professional advice and support service. This is one of the reasons why many of the clients we started working with in 2001 are still utilising our services now. Many of the new clients whom we are continually developing have come from recommendations. This is also true of our employees and the candidates who use our services. We offer them exactly the same support, honesty and openness.”

Like the industry itself, the requirements of candidates have changed considerably in the last five years. They want far more flexibility in their working situation: it is necessary to have an individualistic approach to each person’s needs, rather than a blanket one whereby one candidate will suit all positions. This approach of being selective to our candidates’ requirements has enabled VMC to build a highly ethical professional standing in the service sector: our candidates know they will be treated fairly and as individuals.

The Vacancy Management Company can be contacted by calling  01420 82202  01420 82202 or via their website at

www.vacancymgt.com.

Meeting specific needs

Ian Fogg, Managing Director of VMC – and previous founder of RDL, one of the largest contract sales organisations in the UK – has seen extensive changes within the industry over the last five years, and certainly since the onset of RDL. Ian explains how pharmaceutical companies are now far more targeted in their approach:

“Whereas the traditional approach has been to employ a blanket cover of sales representatives across the whole of the country, the needs are now much more specific to a local level. Different territories often need different levels of coverage at different times, and it is in this way that we have been able to offer our clients the level of flexibility they need in order for them to achieve their forecasted budgets.”

Things have changed in this market sector, and will continue to change – as we have seen recently. Ian says: “I believe more and more companies will move closer to working with providers like ourselves, who can adapt their service and clearly tailor it to specific requirements.”

With this in mind, we have very consciously developed our service offering in the last five years. Sue Birch explains: “We like to be able to offer the all-encompassing ‘Vacancy Management’ solution to our clients, so that they feel they can develop a close and trusting working partnership with one provider that meets all their requirements.” To this end, the diversity of the services VMC can now provide, compared to when we started business in 2001, has greatly expanded.

We can now offer:

Leading the field

During the last five years, The Vacancy Management Company has developed to become one of the leading resourcing companies within this market sector. Sue Birch would like to take this opportunity to thank both the clients and the candidates who have utilised VMC’s services over the last five years, and looks forward to working with you again in the future.

For those of you who have not yet had the opportunity of working with us, we would encourage you to either call us or visit our website in order to discover how we can help you be successful.

By Paul Midgley, The Healthcare Partnership

The amendments to the General Medical Services national contract for 2006–7 build on the recent work that practices have put in to develop services and improve their Chronic Disease Management via the Quality and Outcomes Framework (QOF). Paul Midgley looks at how you can help your customers maintain high QOF scores for the range of chronic diseases targeted in the new scheme.

IN DECEMBER, agreement was reached between the BMA and NHS Employers to develop the GMS national contract, following completion of the first part of a two-stage review. These changes will take effect from 1 April 2006. Negotiations for the second stage are set to follow the publication of the Government’s White Paper in England ‘Our health, our care, our say: a new direction for community services’ (published 30 January 2006, for implementation from 2007), which tells us more about the implications for primary care. These are far-reaching, and will be examined in future issues of Pf. Key elements of the new GMS contract revisions The new GMS contract that was introduced in April 2004 encouraged practices to improve the care of patients with long-term conditions by introducing incentives for systematic follow-up of patients on certain disease registers. The changes coming into force in April 2006 will build on this work, focusing on the existing and nine new disease areas to extend the benefit of improved care to new patient groups with long-term conditions. However, Quality and Outcomes Framework changes are not the only issues tackled by GMS 2006. The key features of the 2006 GMS agreement include:

• A freeze on the ‘basic pay’ element of the contract (the ‘global sum’), meaning that high QOF achievement is required to maintain or increase income (and to take on Directed Enhanced Services).

• QOF changes to incentivise improvements in care for a wider range of patients with long-term conditions:

  • 138 ‘recycled’ points allocated to new clinical areas
    
  • 28 points to strengthen existing indicators
    
  • higher qualifying thresholds for practices to start earning points.
  
  

• New ‘Directed Enhanced Services’ (DESs) to support practice implementation of key Government priorities for patient services. For England, this includes Practice-based Commissioning (PbC), offering choice to patients when referred (‘Choose & Book’) and adopting Connecting for Health’s IM&T programme. Details on country-specific DESs for Scotland, Wales and Northern Ireland are not yet agreed.

• In England, a new ‘Access DES’ will absorb the current DES and its 50 access points in QOF, and extend its scope.

• In England, a new independent patient experience survey will be developed that will trigger payments to general practice for access and choice.

• In England, £132m will be available for premises and IT (a drop in the ocean of what is actually needed . . . ).

• In England and Wales, a new system for paying dispensing doctors from 1 April 2006 will remove the link between pay and drug costs, based on one fee per item. This is coupled with improvements to the system for reimbursing VAT, with new incentives for dispensing doctors to maintain and improve standards in dispensing medicine.

• Across the UK, some changes to childhood MMR payment weightings will improve fairness for practices offering MMR, address those penalised by poor uptake rates following recent autism scares, and rebuild herd immunity.

The GMS Contract changes in more detail

1. Quality and Outcomes Framework (QOF).

A total of 166 points (out of a new total of 1000) is being reallocated to new or existing areas for 2006–07, resulting in a greater focus on:

• Clinical areas whose increased priority is supported by robust evidence. This should have a direct impact on the health of patients with long-term conditions.

• Areas where more detailed information is needed to tackle recognised health problems, such as obesity and depression.

Nine new areas – totalling 138 points – are being introduced within the three broad areas of mental health, end of life care and cardiovascular disease:

A further 28 points are being reallocated to existing areas, with higher thresholds for existing indicators to “encourage continuous improvement and to demonstrate value for money in quality patient care”. Details of these have yet to be announced. Points have been shifted to these new areas from the existing ‘holistic care’ bonus and certain ‘organisational’ indicators, as well as by reducing points for a number of disease registers and completely removing the ‘quality practice payment’.

2. New patient experience survey (England only).

A new, independent national patient survey is being introduced to capture patients’ experience of practice services, initially focusing on access and choice. The results will determine the level of practice awards for payments against the new DESs for access and choice (see below). Alongside this survey, practices will still have the opportunity to carry out an in-house survey and earn points through QOF (survey number 2), and will continue to take part in the primary care access survey (survey number 3). So the next time you visit the doctors, beware of people brandishing clipboards...

3. Directed Enhanced Services (England).

Three new Directed Enhanced Services (DESs) and a revised Access Scheme DES are being introduced in England, and will be available to practices that want to expand or enhance the range of services they offer in return for extra payments. Being ‘Directed’, these Enhanced Services must be made available to practices by every PCT, regardless of its financial plight.

4. Choice and booking (‘Choose & Book’) DES.

This DES will reimburse practices for the additional workload involved in discussing all the choices on offer with patients in secondary care when they are referred for their first consultant outpatient appointment, as well as securing a booked appointment for them. The retrospective DES payment, worth 95p per registered patient, will be based on two measurables:

• feedback from the new patient experience survey on whether patients recall a conversation about choices

• the percentage of patient consultant referrals that are made using the new booking arrangements.

5. Taking on Practice-based Commissioning (PbC) DES.

A one-year DES with a two-part payment is designed to encourage practices that are not yet engaged to get involved in PbC. These practices will receive 95p per registered patient in recognition of the time taken by practice managers, doctors and nurses to develop and manage PbC in their practice. The practices must draft a PbC plan with specific objectives focusing on, for example, demand and referral management. Payment will be awarded to the practices following agreement of the plan with their PCTs.

The second part of the payment enables PCTs to offer an award of approximately 95p per patient if the practice delivers against its plan. This is paid as an alternative, not in addition to any savings made. It is assumed that full PbC will take over after this first year, and any PbC ‘income’ will have to come from savings against budget rather than DES payments.

6. Information management and technology (IM&T) DES.

A one-off DES worth £70m nationally supports practices adopting Connecting for Health’s programme of IM&T reform. These include the electronic prescription service (ETP), electronic transfer of GP records, Choose & Book, and the NHS Care Records Service. The timing for implementation and one-off payments will vary according to the national rollout of these systems.

7. Access DES (England).

A new DES worth £108m combines the 50 access/money points in QOF and the current 24–48hrs DES. This new package focuses on four key areas:

• being able to consult with a GP within 48 hours

• being able to book appointments in advance

• ease of telephone access (this will be interesting!)

• being able to wait for a practitioner of preference (no time limit).

Payment of the DES will be based on two components:

• an upfront payment with a firm commitment from practices to deliver on the first three access areas (48 hours, advance booking and telephone access) as well as continuing to participate in the existing primary care access survey (PCAS)

• retrospective payment based on results from the new patient experience survey on local access.

8. Childhood vaccination and immunisation (UK-wide).

The GMS contract also introduces improved weightings for the current childhood MMR immunisation payments, as follows:

• pentavalent vaccine – 50%

• measles/mumps/rubella – 25%

• meningitis C – 25%.

9. Dispensing doctors (England and Wales).

A new ‘fee per item’ pay system will be introduced from 1 April. This will remove the link between pay and the cost of drugs, and bring improvements to the system of reimbursement for VAT costs on drugs. It will ensure that the reimbursement for VAT incurred is equal to the actual amount of VAT paid. The VAT changes will only apply to dispensing GPs, who will need to consider registering for VAT from 1 April 2006. The ‘container cost allowance’ for dispensing doctors is being abolished. Dispensing doctors will be subject to new proposals to maintain and improve standards in dispensing medicine, in line with the standards for community pharmacists. Guidance will be published shortly on the need to avoid excessive or inappropriate prescribing; this may have major implications for representatives in rural territories, where prescribing may be influenced by good dispensing deals offered on certain products less favoured by the Prescribing Advisors/PCT formularies.

Where are we now and how can you help?

The General Practitioners Committee issued implementation guidance to GPs in late January 2006. Our next article in Pf will provide you with more details about the changes to QOF and how you can prepare your key customers to develop systems for improving registers and management in the new disease areas before and beyond 1 April, and to develop their business plans for managing Practice-based Commissioning within their practice.

Given the wide range of changes facing General Practice this year (all of the above plus new PCTs/SHAs, Revalidation, PbC and the White Paper), you will need to be sensitive to GPs’ busy schedules and sensitivities around change. Understand that communication of these changes and (practicebased) training on implementation by the primary care team will be high on their agenda. Offer any assistance you can to support their practice training needs and provide speakers for QOF-related meetings, using in-house Protected Learning Time where possible to maximise the learning time available and include the whole practice team.

Identify which changes will benefit your products, and prioritise these in terms of educational support. If your product is not in a relevant QOF disease area, look out for opportunities to piggy-back meetings being organised by others to discuss these changes, as there will be a great many meetings around this topic in 2006.

By Joan Barnard, Medical Consultant to the Pharmaceutical Industry

An essential guide to the new ABPI Code and how it will affect your working life.

The new ABPI Code of Practice came into effect from 1 January 2006. It is the result of the first major review of the Code for ten years, so there are some significant changes. Some of these will affect you directly, others only indirectly, but it is important that all representatives know what the changes are and have some idea of the background to them.

Some of the changes were required because of changes to European and UK legislation, and some because of changes to the EFPIA Code (the European equivalent of the ABPI Code). Other changes were made to address criticisms of the industry in the Health Select Committee report. All of the changes are intended to ensure that all promotional activity is of a high standard and not likely to bring the industry into disrepute.

General changes

The Code has always required that all promotion – whether it is printed material or a spoken detail – be accurate, balanced and not misleading. There is increased emphasis on these requirements, and a strong focus on patient safety. This can probably best be summed up by saying that promotion must encourage ‘informed prescribing decisions’, i.e. give prescribers enough good information to allow them to make the correct decision for each patient.

There has been criticism about the amount of promotion targeted at health professionals. There is now, therefore, a limit on the frequency of mailings: no more than four mailings per health professional for new products in the first six months, and no more than eight for any product per year. There is no change to the limits on representative call frequency – no more than three on average per prescriber per year – but recent cases have shown that the pattern of calling is important, in that it is not acceptable to use up all the call allowance in a short period of time.

You may notice a difference in the promotional aids your company is providing, as the Code has toughened up on what is and is not acceptable. So no more clocks, lamps or umbrellas, and nothing that is for use in the home or the car. Also, competitions, quizzes and prizes are now considered unacceptable methods of promotion.

There is a major change in relation to communication with the general public, patients and patient groups: it is now possible for companies to make much more information about products available, particularly on the Internet. This is not in any way DTCA (direct to consumer advertising) and does NOT mean that you can now talk freely to people who are not health professionals, but it does mean that the public will have access to more information about medicines.

Meetings

Excessive and inappropriate hospitality by pharmaceutical companies has been criticised in the media and by the Health Select Committee, and the new Code responds to this with much tighter control.

The main requirement is unchanged: education must be the main purpose of any meeting. Any hospitality must therefore be secondary, and be appropriate to the occasion – this is further defined as “subsistence only”, i.e. only what is necessary in relation to the educational objectives of the meeting. ‘Subsistence’ probably implies something more basic than you (and perhaps your doctors) are currently used to.

The cost should still be no more than the attendees would pay for themselves, but lavish or deluxe venues and venues famous for their entertainment facilities must not be used. This means that, regardless of who is attending a meeting, expensive or renowned hotels and restaurants cannot be used. Delegates attend- ing meetings can only be provided with economy class air travel (whatever the destination or journey length).

These requirements are based on the EFPIA Code, so all meetings throughout Europe will now have to meet these standards. Your company will no doubt issue guidelines as to how you should organise meetings given these new requirements.

Clinical audits, therapeutic reviews and ‘switches’

There have been a lot of complaints about these activities over the past year or so, and the Code requirements have been tightened up significantly as a result.

‘Switches’ (arrangements where patients on one drug or group of drugs are simply switched over to another drug, without any clinical assessment) can no longer by funded by companies, either directly or through a third party. This is because funding a ‘switch’ effectively means that the company is buying prescriptions.

Clinical audits and therapeutic reviews (e.g. nurse-led review clinics) are still possible, as long as they meet the requirements of the Code. One key requirement is that any such service must be completely non-promotional. As a representative you are considered inherently promotional, so you cannot have any involvement in these services as part of your regular activities. You can briefly introduce a service, or deliver materials, during a promotional call; but if you need to discuss the service at all, you must arrange a separate call to do this.

And remember, you must never come into contact with patients or patient data, as this would represent a breach of patient confidentiality.

Representative training

All representatives must now be entered for the ABPI Medical Representatives Examination during their first year of employment as representatives, and must pass it within two years. There are now no exemptions to the exam – so if you are a representative of some years’ standing and have not previously had to pass the exam, you will need to sit it by the end of 2006 and pass it before the end of 2007 if you want to continue working as a sales representative. This applies to contract staff as well as company staff.

Complaints

The charges associated with breaching the Code have been substantially increased. These charges are not intended to be fines, but they will nevertheless be significant sanctions – particularly for smaller companies.

Details of complaints will now be made available on the PMCPA website, as well as in the quarterly Code of Practice Review. Serious complaints will be publicised in the medical press at the expense of the offending company.

If an item is ruled in breach of the Code, it will have to be withdrawn from use within five working days (rather than ten as previously). Your company will have a procedure for ensuring that this can happen, and it will be essential that you comply with all instructions precisely and promptly.

Your company is likely to have to revise at least some of its procedures and guidance to stay in line with the new Code. Make sure you are familiar with the new requirements, so that you can keep on the right side of the Code in 2006.

How long have you worked for Sanofi Pasteur MSD? What were your previous roles?

I initially worked for 10 years for Ortho (which became Janssen-Cilag), where I went from Sales Representative to Regional Manager to Key Account Manager. I have been with my current company for ten years and worked on the same territory all that time.

What is your average day like?

Busy. Unlike other medical sales roles, I can see customers at any time of the day, and will visit possibly up to 10 people. Customers are always keen to meet me, so there aren’t the same restraints in seeing people. Currently my business is mainly with the Practice Manager, and with the Practice Nurse and key GPs to discuss the clinical aspects of a vaccine.

What is the most challenging part of your job?

Organisation and preparation demand an awful lot of my time, so I have to be good at time management. It is also important that I am accurate. I may have to place orders for many thousands of pounds with many deliveries to a number of sites. This has to be done in a timely fashion, as patients are waiting to be immunised.

What do you find most rewarding?

Vaccine sales are rewarding financially and there is also the satisfaction in knowing that we are selling products that protect people against a wide range of disease areas, e.g. flu, tetanus, hepatitis A etc. I enjoy the fact that I am not under pressure to move up the career ladder; I’m free to concentrate on my job and develop my own business for the long term. I can make my own decisions for my future, and this may involve working hard in my present role whilst enjoying a good quality of life.

What advice would you give to someone hoping to develop a career in vaccines?

Research the role in detail. It is a completely different role to other medical sales jobs, with a whole different set of pressures. In the past I’ve had 62 phone calls in one day! Vaccine sales isn’t just about easy access, there’s a lot more to it than that, but if you’re organised and on top of your work it’s the best job in the world!

Lucy Randle provides some insight into making the transition from traditional pharma to direct (vaccine) sales:

We are blessed to operate in an industry where our work has bearing on the health of our nation, but the difficulties of making the link between cause and effect can be incredibly frustrating and demotivating. Within the Medical Sales arena there are, however, a number of unique opportunities available beyond the traditional GP/hospital rep role. ‘Vaccine sales’ provides one such option, offering medical sales professionals the opportunity to really have their cake and eat it. Due to the unique way in which the NHS ‘purchases’ vaccines, you can benefit from knowing that your products reduce healthcare costs and save lives AS WELL AS the satisfaction of knowing exactly what you’ve sold, to whom and when.

This is a privileged position to be in, and these roles are few and far between. As such they are fiercely fought and hard-earned. Here are a few questions to ask yourself if you choose to move your career in this direction:

1. Is it for you?

It is vital that you do your research and truly understand the similarities and differences versus a traditional pharma role. Once you have understood the anomalies, you must be really honest with yourself and establish whether you are truly suited to the role. Will you not only cope, but thrive, in this fast-paced, highpressure environment? Will you really enjoy having absolute visibility around your results, and consequently being held directly accountable for your sales?

2. Are you good enough?

Not only do you have to be motivated by the right things to succeed in this role, you also need to be highly competitive, skilled, capable and competent. Are you well-organised and tenacious, with an unusual ability to forge and develop relationships? Are you a strong negotiator, able to think on your feet, with exceptionally strong business acumen and commercial awareness?

3. Can you prove you are good enough?

Vaccine sales specialist roles are rare, so you need to stand out from the crowd. You must be able to demonstrate clearly how and why you are right for such a role. You will need to show (with supporting evidence) how YOU have directly impacted on your sales. This is particularly important for those of you working in a large and/or synchronised sales team where several individuals may contribute to the end result. Think carefully, too, when answering competency-based interview questions, to distinguish between ‘what we did’ versus ‘what I achieved’.

If your skills, attitude and motivators are right, vaccine sales could provide you with a unique opportunity to know the true cause and effect of your actions whilst reaping all the benefits of working in medical sales.

Sponsored by STAR Medical

In order to target the right customers, medical sales and marketing professionals need a dynamic approach to the market information.

OVER THE PAST 20 years, the concept of being able to target elected doctors who are more likely to give you trade has become prevalent in the pharmaceutical industry. Different data sets and different methods of analysing and profiling data have allowed ever more complex lists of target customers to be generated – each iteration further from logic as the sales person sees it, yet all scientifically valid.

But what is targeting in reality, and why do companies spend so much money undertaking these ever more complex exercises – and are they indeed relevant to today’s changing NHS? Let’s start by defining segmentation and targeting:

• Segmentation: The identification of key features in the customer base and the grouping of like members into common strategy groups.

• Targeting: The application of a promotional strategy to the identified groups from the segmentation analysis in order to achieve a marketing effect.

Segmenting the group of customers into discrete cohorts is not targeting. Targeting is the strategy that makes a cohort work for you, and relies on your ability to define a strategy that will maximise the potential for the cohort you have identified. As such, it is very realistic to have a multiple targeting strategy within a single customer base – though in the main, the UK pharma industry tends to simplify this to a single or dual strategy. This differs from more consumer-based strategies (eg in finance and publishing), where there may be true 1:1 marketing.

The adopter curve

Most targeting strategy is based on the premise of Rogers and Moore that different people accept or adopt an idea at different rates. ‘Adopter curves’ are usually segmented into five groupings: Innovators, Opinion leaders, Early majority, Late majority and Traditionalists (or Laggards). Where a person is on the adopter curve for your product proposition will determine the strategy you should use to convince them of its benefits. Over time they will naturally move along the curve, and so will come to need a different strategy. Most sales people see this as obvious and adopt it subconsciously as a matter of course. (See diagram)

However, a person’s position on this curve is dependent on the product you are talking about, their experiences and other environmental factors. Segmentation thus becomes very complex and three-dimensional, and the need for CRM becomes obvious. The pharmaceutical industry tries to simplify this complexity by combining segmentation cohorts using a series of ‘black box’ initiatives, so that most sales people are given one, two or three cohorts to focus on per cycle. Assuming the analysis is right, and ignoring environmental factors, targeting should have a positive effect on the sales proposition. The implementation of this usually takes the form ‘Focus on target and ignore non-target doctors’ – which given the complexity of the segmentation does appear to be illogical, though easier to manage.

Defining the segments is not enough. The ability to transfer the message will depend on the recipient’s ability to absorb that message, which is often ignored. Your strategy may be to focus on selected cohorts as defined by a complex 3-D analysis, but the recipient’s ability to respond will depend on whether (a) it is the first time they have heard the message (Level 1 on the Rainbow™ method); (b) they already have a little experience (Level 3 on Rainbow); or (c) they are well versed in the product and have lots of experience in its usage. In addition, their influencer network will have an impact beyond the confines of the segmentation model.

A good sales professional will instinctively recognise many of the customer traits necessary for the sale, and this underlines the value to an organisation of capable and experienced career sales people.

Access

Defining the segments and the targeting strategy is only part of the equation. If the sales person is going to gain access to the customer, accessibility is a very important issue. Currently (not allowing for some recent downsizing) there are over 14,000 sales representatives in the UK pharma industry. This equates to one representative for every 7 doctors. In primary care, the ratio is even lower: an average GP territory has around 200 sales representatives trying to visit around 110 practices, of which about 50 are usually target practices.

Up to a third of the practices in some parts of the UK will not see representatives – so the remaining practices see relatively high numbers of representatives, thus compounding the problem. Access to GPs has dropped by 25% in the last four years, yet the number of representatives has stayed roughly the same.

To make matters worse, Practice-based Commissioning means that a new approach needs to be taken in terms of the information needed and the methodology used to engage the NHS. Some companies, notably Takeda, have taken the bold step of totally refocusing their method of access to the NHS; others have high-level teams at work in PCTs, SHAs and higher levels.

Data sets

The use of new data set libraries such as NHIS (www.nhis.info), where much of the new NHS information resides, will support these steps. The more traditional data sets such as sales data need to be reassessed: with more than one company selling sales data, and each company processing the same data in different ways, various different pictures of the outcomes can be presented. This makes measuring the effectiveness of traditional targeting strategies very difficult, since the different data sets will give different measures of outcome.

The analysis of sales outcome against target doctor lists has not changed fundamentally in 10 years, and in many respects this is holding back companies from being creative. The NHS has changed, and continues to do so. Thus the measurement methods need to change too. Many other types of data are now available that, viewed holistically, can give the sales representative a very good picture of the mechanics of their territory – as long as they understand the source data and how it is processed. Transparency in data and data processing is the key to progress.

Reassessing the future

The age of the traditional representative is not over, however. The sales roles may change, but change is good. Given the incredible range of data available, the ability to move from the linear and 2-D targeting models of the 80s and 90s to 3-D models whereby all the influencer facets are considered, and where the sales representative is truly a business person, could at last be upon us. The future needs reassessing, but so does the now.