Key Opinion Leaders in Pharma

Key Opinion Leaders– “Highly respected medical experts within their domain, by which their thoughts and actions have a greater (asymmetric) effect on their peers with regards to adopting a new idea, product or service. In other words, KOLs have an impact on the diffusion of innovation”. (1)

Need of KOLs

KOLs have a place in both the development and marketing of a drug since companies seek guidance of experienced physicians during the development phase of a product and also later on, during marketing. In the development phase these doctors help design the protocols and run the research programme. Since they gain experience with the molecule before the others, during product launch, they can talk about their experiences to other doctors thus helping the molecule to gain acceptance.

In fact the relationship of the company with the KOLs is evolving. A senior figure with an academic background is needed during the development phase of a new drug. However once the drug is launched, other KOLs like primary care physicians, or senior general practitioners could also play the role.(2)

An ideal Pharma company and KOL relationship is synergistic. The company gains by improved dissemination of information about their latest product, and the KOL stays in the limelight and achieves an improved professional standing

Regulations

Traditionally pharma has been using the services of KOLs to promote their products, thinly veiled as CMEs , medical discussion groups etc. They were also remunerated handsomely in cash or kind. But of late, these associations have been restricted in many countries.

The Pharmaceutical Research and Manufacturers of America (PhRMA) released updates to its voluntary Code on Interactions with Healthcare Professionals. The new guidelines took effect from January 2009.

In addition to prohibiting small gifts and reminder items such as pens, notepads, staplers, clipboards, pill boxes, etc., the revised Code:

1. Prohibits company sales representatives from providing restaurant meals to healthcare professionals, but allows them to provide occasional meals in healthcare professionals’ offices in conjunction with informational presentations
2. Includes new provisions requiring companies to ensure their representatives are sufficiently trained about applicable laws, regulations, and industry codes of practice and ethics.
3. Provides that each company will state its intentions to abide by the Code and that company CEOs and compliance officers will certify each year that they have processes in place to comply.
4. Includes more detailed standards regarding the independence of continuing medical education.
5. Provides additional guidance and restrictions for speaking and consulting arrangements with healthcare professionals. (3)

The Physician Payments Sunshine Act in the US, lays down rules for providing honoraria to healthcare practitioners, as well as disclosure requirements.(2)

In the UK, the 2011 edition of the Association of the British Pharmaceutical Industry’s code of practice was updated to include a restriction on promotional giveaways (from May 2011) and requirements to declare payments to doctors and funding to attend medical congresses (in 2013).(2)

In India too, the Indian Medical Association (IMA) has laid down norms for gifting and remunerating medicos for educational services rendered

Identification of KOLs

Pharma companies spend huge resources to build and maintain a KOL network. There are various methods of identifing a KOL. The number of publications in a particular area is a major indicator. A new method being projected by KOL management firms is Social network Analysis (4)

Other methods used to shortlist candidates are recommendations from colleagues and opinion of marketing colleagues. The subliminal thought is always how many more prescriptions this association is going to generate for the company.

KOL management

Some methods of utilising a KOL are

• Seeking advise from time to time during development phase. This is often achieved by getting the KOL group together for a tete a tete with company research personnel
• Utilising their skills as investigators for faster patient recruitment during the trials
• Lecture tours of KOLs. Once the product is launched, these KOLs are the best and only agents who can talk passionately about their research.
• As mentioned above, during the marketing phase local KOLs also need to be developed. They need to be given complete product knowledge and sometimes even training on presentation skills
• An advisory board of these local KOLs can be created to generate new product development and marketing strategies
• Medical Science Liaisons, who are medicos by qualification can liaise with KOLs at an equal level and are often preferred by KOLs for academic discussions.

Until a few years back, KOLs were subtly pressured by companies to mention their product by name. But today KOLs sign a contract saying they will not under any circumstance mention the name of the product. They have now realised that they can impart information to fellow medicos much better than pharma companies. (2)

The KOL identification and nurturing process is still evolving, given the realisation by KOLs of their special utility to companies, complexity of medical knowledge due to developments in genomics, proteomics etc and stringent legal frameworks being designed world over.

References:

1. Topham P, Quantity Does Not Equal Quality in Evaluating a Scientist’s Real Importance as a Key Opinion Leader, Lnx Pharma White paper 2010
2. http://social.eyeforpharma.com/marketing/pharma-and-kols-how-create-transparent-collaborative-relationships, downloaded june 2014
3. http://en.wikipedia.org/wiki/Pharmaceutical_marketing, Downloaded June 2014
4. Topham P, Finding Key Opinion Leaders Using Large Scale Social Network Analysis,Lnx Pharma White paper 2007