The Importance of KOLs

Much is written about the importance of key opinion leaders (KOLs) for the pharmaceutical industry. These independent medical and scientific experts advise pharma companies on a broad range of activities, from the initial drug discovery research and pre-clinical stages, through clinical trials, to approval and market entry. Pharma companies seek out KOLs with expertise and experience in a specific therapeutic field to offer support in interpreting data and patient recruitment for clinical trials. Educating physician peers about how a drug acts in the body and which patient populations benefit the most, as well as treatment regimens and their own experience as early adopters with the drug are also areas in which a KOL may be helpful.

KOLs have played an increasingly important role for drug companies: their influence and importance has increased as the role of pharma reps has decreased.

Are KOLs Worth the Investment?

Measuring influence is a hard thing to do accurately and quantitatively, so it is difficult to establish the ROI of a KOL. A recent cautionary tale, however, suggests that the value KOLs add is real and working with KOLs is a necessity in the world of drug development and sales:

GlaxoSmithKline stopped engaging KOLs in 2013 after pleading guilty to bribing doctors, among other things. None of the other large drug manufacturers followed suit and in 2018, GSK decided to abandon its “No KOL” policy and start using these external experts again to educate medical professionals about the science behind GSK’s drugs.

This story demonstrates the importance of KOLs. One of the main reasons GSK reversed the ban was that not working with KOLs decreased the availability of educational materials and programs about their drugs among physicians. As a result, physicians had a reduced understanding of the benefits of GSK’s drugs for their patients and were less comfortable using them. In short, physicians did not prescribe the drugs, because they did not have enough information about them.

This story also highlights a second important point of KOL engagement: it has to start early, long before the drug is approved and available for physicians to prescribe to their patients. The scientific and clinical community needs to be educated about the drug, how different patient populations benefit, the drug mechanisms of action, as well as possible adverse side effects and interactions with other drugs the patients are likely to take. Conveying this information to physicians, as well as other healthcare professionals with prescriptive authority, such as nurse practitioners, takes time. Starting that process too late means the company is losing valuable time building the profile of the new drug among the clinical community and as a consequence, the adoption of a new drug will be slowed down.

A similar argument can be made for engaging KOLs early in the drug discovery and development process. Early on, KOLs can still bring their experience and expertise to critical issues such as the evaluation of unmet clinical needs, advise on discover platforms, and support clinical trial design and recruitment as well a product labeling.

Getting KOLs involved early also means that they are given the opportunity to develop a sense of ownership through the ups and downs of the drug development process.

Not All Therapeutic Areas Are Created Equal

Early involvement of KOLs in educating the marketplace is critical – in some therapeutic areas more so than in others. In oncology, for example, companies tend to share mechanism of action and safety information earlier that in other therapeutic areas. The reason for this is simple: oncology is a very rapidly advancing field. New treatment approaches, e.g., immuno-oncology, are resulting in drugs, large amounts of clinical trial data are published continuously, novel biomakers are discovered and validated: there is simply too much information for any physicians to be an expert on all. Trusted peers who provide background, education, and can relay their own experience treating patients with a new drug are especially necessary and welcome in such an environment.

Early involvement of KOLs is becoming the rule across all therapeutic fields but especially in areas, such as oncology, that are quickly advancing and require a lot of support and explanation. Identifying the perfect KOLs to embark with on this long-term journey is therefore even more vital than before.

At H1, we are here to help you with this critically important process. Please contact us to learn how we can work with you to identify the best KOLs.