Leading by example

pharmafile | November 24, 2004 | Feature | |   

Selling medicines has always been a complicated business. The end user of the new product is ultimately the patient, but there are a number of hurdles to overcome before the drug reaches them. Along with the traditional prescribers, such as primary and secondary care doctors, firms now have to navigate the tricky waters of new policy making bodies such as the National Institute for Clinical Excellence (NICE) and the Scottish Medicines Consortium (SMC).

Not to mention the involvement of the 'new' prescribers of the 21st century – NHS pharmacists, nurses, formulary committees and local opinion leaders.

Despite the new look of the 'route to market' chain, the initial link has remained the same – if pharma companies are to successfully develop and spark the chain reaction they will need to have established and respected key opinion leaders (KOLs) on board as early as possible. These 'thought' leaders need to champion the product and ensure it gets the right kind of exposure, enabling it to withstand the rigorous tests it will have to undergo on the rocky road to a successful launch.

The process of finding the right, high profile advocates to kick-start a molecule is, however, no longer the fairly simple process it used to be. As little as ten years ago, the best method was considered to be to wine and dine the most prestigious hospital consultant, get him or her up on the platform at the relevant medical symposia and then watch a positive ripple effect cascade through the prescribing community. What is more, this process could actually be conducted after a drug had won regulatory approval.

Updating and revitalising the KOL model

Unfortunately for the  pharma industry, this model has become outdated and KOL development, like much of the current marketing mix, has had to move with the times. For a start, sourcing key opinion leaders (KOLs) is no longer a matter of tirelessly scouring the medical journals or simply networking with advocates you have successfully used in the past.

The more forward thinking companies are now leaving no stone unturned in their quest to find the right KOLs, taking an innovative and rigorous approach to selection. It is now not uncommon for marketing departments to use a comprehensive interactive KOL database to not only pick out the leaders of the past but also the up-and-coming stars of the future. This will help companies to explore all the obvious and not-so-obvious strands of KOL identification and is particularly useful if they are entering a new therapeutic area for the first time.

Recently appointed managing director at 4D Communications Kevin Mageean says it is not the model that has changed so much as the environment in which it has to be applied.

"The trick in dealing with this new environment is to create customised KOL programmes. Rather than have a traditional KOL (eg, the world renowned professor) address all the available audiences it is important to ensure that the most appropriate KOL develops a dialogue with the relevant target audience. For example, it can be more compelling for a GP to address other GPs. The professor will still have a role but many others need to be involved. This creates a more effective matrix for a KOL programme."

It is thus essential to analyse groups such as congress boards, scientific journal editorial committees and professional and patient group leaders in as much depth as possible to avoid missing out on the KOLs that could make all the difference to a product.

Chris Link, field physician for Seroquel at AstraZeneca says that opinion leaders are still very important in the area of psychiatry, saying: "Many of the initial prescribing decisions are made in secondary care, particularly for severe enduring mental illnesses so it is important that through a partnership of education and sharing of key data and messages that companies develop brand advocates who are influential in defining good clinical practice for the field as a whole."

But he accepts that changes are beginning to emerge, particularly at a local level.

"In psychiatry, local advocates are becoming increasingly important, for example, to ensure that D&T formularies endorse a given brand on the basis of the available clinical data," he says.

"A thorough understanding of the key trials and communication messages through an educational programme can equip an advocate with all the tools needed to provide convincing arguments to ensure acceptance on a local formulary and hence remove a key obstacle to prescribing."

David Garmon-Jones, head of sales at Merck Pharmaceuticals agrees that the KOL landscape has evolved and become more complex. He points to the fact that particularly within primary care, there are a lot of new influencers and also that many primary care formularies are separate and make their own decisions as opposed to following leads in secondary care.

"There are different policy makers around now, people such as NICE and the SMC," he states. "These organisations are making pretty big decisions – decisions that could kill your product if you fail to get them on-side." He does believe the traditional model of gaining access to certain top opinion leaders has not, in itself, changed very much: "Even though there's a bigger network of opinion leaders and policy makers at both a national and local level, if you're going to get anything substantial happening in terms of guidelines, you will need to source the top guys because ultimately it is them who put the guidelines together."

Past and present KOLs

In order to understand who are the key opinion leaders of the 21st century, it is necessary to look at how they have evolved over the years. Thirty years ago, they were the clinicians who had access to the patients in any therapeutic area, be it multiple sclerosis, arthritis or cancer, and were therefore the obvious choice of pharma companies needing a distinguished name to publish a study.

In the US it was not uncommon for opinion leaders to be directors of clinical research who resembled quasi-businessmen in that they resided on the advisory boards of ten pharma or biotech firms. In the UK, although there has not been such a pronounced link between the lab and the boardroom, the point is the same: opinion leaders worldwide have essentially been the clinicians at the cutting edge of science and very much involved in the randomised clinical trial process.

Opinion leaders are ultimately members of the medical community and are usually attracted to the innovative science behind a project, rather than any promotional campaign. They thrive on the research opportunities that allow them to increase their profile and in return, pharma companies can begin to create the necessary noise around their products.

Ultimately, today's KOLs no longer belong to a single group and Maggie Malpas-Spencer, managing director at Jango Communications, defines the KOL of today as: "Those most likely to influence best practice with the welcome benefit that this will bring the greatest return on investment for the product and the company concerned.

The effects of NICE and evidence-based medicine

Tom Kass, head of healthcare and biotech investment services at EFG Private Bank argues that with the birth of organisations such as NICE and the publication of journals such as Clinical Evidence (sent out by the NHS and the BMJ and proclaiming itself to be: 'the international source of best available evidence for effective healthcare') the true opinion leaders are in danger of being left on the sidelines.

"What currently exists in the UK is a desire to get away from opinion leaders by gathering clinical evidence and insisting on evidence-based medicine," he says.

Garmon-Jones agrees that the emphasis on evidence is real and palpable, saying:

'I suspect in the old days, it was possible to kick-start a launch by conducting your KOL development after you gained marketing authorisation. Nowadays, you just can't do that, you have to have the evidence before things start. There's now quite a large emphasis on our medical and clinical programmes to make sure we possess the data that people need."

However, Kass insists that access to key opinion leaders has not been totally impeded by the new emphasis on evidence.

"If companies want clinical trials done, there is already a fully fledged commercial network underneath the NHS that grants you access to the various professors," he explains. "It's not a problem to get opinion leaders on board. The struggle is based on how NICE and evidence-based medicine are trying to change the concept of opinion leaders. Evidence-based medicine is based upon best practice as published in peer-review journals. The problems come when opinion leaders are too busy working on patients to publish their ideas!"

When to conduct KOL development?

For Kass, the crux of the issue is that if effective KOL development is to be successful, it needs to be conducted earlier in the process, at the phase III or IV stage.

"Opinion leaders are crucial around the phase IV stage and therefore it's the clinical staff rather than the marketing people who have to sign them up," he says. "From pharma's point of view, it would love to get a new treatment into the hands of the best practitioners at a top hospital. An even better way to do it would be to get it into that top hospital as well as twenty other centres in the form of multi-centre trials."

Of course, there are also advocates of the theory that KOL development should really start at phase I, despite the obvious risks of expending effort so early in the process that it becomes wasted when a product is pulled. Despite this, the advantages are obvious: by displaying forward planning, companies are already moulding a profile for a product which will help it when it is exposed to the prescribing community.

For Janine Hogan, executive director at Jango Communications, the ideal time to start thinking about KOLs is once the product has cleared phase II development.

"At this stage crucial bridging is needed between scientists and clinicians. I would deploy a top scientist to influence my next most relevant tier of KOLs. I would then evolve the profile of the KOL to be most relevant to the product as it develops," she says.

The local factor

The question of how much companies should take the local factor into consideration is a contentious issue. Undoubtedly, if a product launch is to be successful, the marketing team have to gauge local priorities and understand what are the implications of new players and leads such as supplementary prescribers and primary care trusts (PCTs).

Local formularies are also gaining in influence and have been known to make decisions unpopular with the industry. Kass contends that last winter's flu epidemic could have been countered more effectively if drugs such as Cetek and Zithromax had been prescribed instead of the cheaper options.

"Many local microbiologists snubbed these brilliant products, even though the global 'thought' leaders had said they should be in use," he says.

AstraZeneca's Link believes that other clinical disciplines such as nurses and pharmacists have an important role to play in the prescribing decision within the context of the diversified team.

"AstraZeneca has recently begun to work with these professional bodies to ensure a common understanding of the brand in all key stakeholders," he says. Although the NHS has been keen to stress the importance of nurses and pharmacists in the new environment, Kass is less convinced that they can really be considered 'opinion leaders' in the true sense of the meaning.

"At the end of the day, a nurse or pharmacist is not going to be able to prescribe a drug like Cetek – they're going to make sure you stay on something like Ventolin at a fraction of the price," he says.

"This kind of scenario shows the conservative bias of the NHS to pull everything back and prevent people from having the newest and latest innovative treatments. Nurses and pharmacists are not opinion leaders, although they do influence prescribing. I suppose that's the difference between a 'thought leader' and today's 'opinion leaders' – a true thought leader is somebody at the cutting edge, advancing practice that can be quantified as being an improvement."

Kass thinks that the UK is starting to drag its heels in the uptake of new medicines: "Thought leaders are the people doing the latest clinical trials with the latest treatments, modalities and medications. They are the ones who should be influencing our best practice as opposed to GPs looking backwards at the last twenty years of the Cochrane database."

Appropriate boundaries for KOLs

With an ever-increasing spotlight on the relationship between the pharma industry and the medical professions, it is almost inevitable that certain sceptics will see partnerships between the two as a cosy arrangement more geared towards drug promotion rather than clinical advancement.

Garmon-Jones accepts that if opinion leaders are overused this can give rise to suspicions. "There was one opinion leader who we used and he had also been used by a lot of other companies. I suspect that other opinion leaders may have slightly perceived him as being in the pocket of the industry and responded differently to approaches."

The opinion leaders themselves are keen to maintain their credibility and sometimes distance themselves from pharma companies as an initial prerequisite to possible advocacy. It is crucial that companies respect sentiments such as these if they are to effectively drum up the awareness they need for their brands.

Kass has little time for the sceptics and believes that with NICE-style fourth hurdles cropping up in a whole swathe of countries, the pressure is on companies more than ever to get their products into the hands of the major opinion leaders.

"When people make this negative connection between the industry and opinion leaders, it represents a type of cynicism that makes the accusation that doctors are not really interested in providing the best treatment," he says.

"GPs have a habit of prescribing the drugs they learnt about in medical school. If pharma is to get them on board with a new product, they need to have the best data and that is only going to come from the top opinion leaders from the leading centres."