by Samir Mistry, Pharm.D.
After working in the managed care pharmacy space for many years, I have both worked with and for many of the largest pharmaceutical manufacturers. There has always been a significant emphasis placed on having the support and endorsement of Key Opinion Leaders or KOLs. Generally, KOLs were practicing physicians who were either considered experts in their field of medical specialty where the company’s drug was indicated for use, or were regionally and or nationally influential on practice guidelines or the field of practice.
I have worked in the medical affairs department of one of the world’s largest pharmaceutical companies. As an educator of the company’s medications, I presented the company’s products to large national and regional health plans, and pharmacy benefit managers (PBMs). I trained with many of the product-specific medical science liaisons (MSLs), who constantly spoke about KOLs. New to the pharmaceutical industry, I inquired more and more about who the KOLs were and why they were important. I learned that the KOLs were the clinical experts in the medical field that aligned with their products. They either led clinical trials crucial for the drug or influenced the clinical practice guidelines. At the time, I never questioned or challenged the role and importance of KOLs. However, after leaving the pharmaceutical company and spending many years in the payer leadership space, I strongly believe that the KOL model should be revisited.
In today’s rapidly changing healthcare markets, a brand drug’s market share growth is significantly dependent on its preferable formulary status for large national and regional health plans and employers (payers). Based on this trend, consideration should be given to recognizing managed care leaders as the new KOLs of this growing industry. When considering who has the influence with respect to a pharmaceutical company’s drugs, it is important to consider a number of factors. Initially, what type of disease is the drug treating and how many competitors does it have. If the drug is unique, considered a “gold standard,” or indicated to treat severe diseases like cancer or HIV/AIDS, then there may not be any barriers to unrestricted access on drug formularies. But if the drug is used to treat a chronic condition such as hypertension or diabetes and there are multiple brand and generic competitors, then there should be a focus on formularies for both national and large regional health plans and large employers (payers). Following is a list of key questions that drive the discussion on the factors pharmaceutical companies may want to consider when developing KOL lists.
Who is the decision-maker?
Since regional and national health plan and employer formulary status can drive either success or failure on a potential drug’s sales targets, there should be some emphasis placed on who are the decision-makers for large health plans and employer formularies. Another factor to consider is the need for all formularies to be reviewed and approved by a Pharmacy and Therapeutics Committee (P&T). If the payer (health plan or employer) manages its own custom formulary, the P&T is managed internally within the payer. If the payer uses its PBM’s national formulary, then the PBM’s P&T committee is used. With all of these items considered, the true decision-makers are those who drive the P&T committees’ decisions on the formulary, usually the Chief Medical Officer or Vice President/Director of Pharmacy. These individuals usually chair the P&T committee, present topics and drive the decision on the formulary and how the drugs are placed on the formulary.
Who influences the decision-maker?
Those who have influence on the decision-maker include the following: health plan medical directors, clinical pharmacists, directors of quality, and finally the pharmacy benefit manager (PBM) that administers the pharmacy benefit. A key influencer for health plans and employers, which may be underestimated, is the PBM. Many plans and employers utilize a PBM’s national formularies for their members. Additionally, formularies are influenced by a PBM’s rebate contracts with pharmaceutical companies to drive certain branded drugs. Therefore, another influencer could be an account executive from a PBM who manages the drug benefits for large payers that contract with the PBM for drug benefit services.
How can you change your approach for KOLs?
In considering a new approach to defining KOLs and key influencers for a pharmaceutical company’s products, I suggest developing a baseline assessment for the payers that most utilize the product. For example, it the drug treats chronic conditions like hypertension or diabetes, it would be a good idea to focus on large regional and national payers with Medicare lines of business. If the drugs treat asthma, it would a good idea to focus on the Medicaid and Commercial payers. The second step would be to identify the decision-makers, such as chief medical officers and vice presidents of pharmacy for all of these payers and consider them the key focus. The next step consists in developing the list of influencers such as medical directors, clinical pharmacists and the PBM account executives for the payers. Another focal point to consider is to intensify the visits and discussions with the payers’ decision makers where there is an unfavorable formulary position for the company’s products. This is the best opportunity for growth.
In summary, recent developments in market behavior are challenging the old theory for defining the KOLs within pharmaceutical companies. I believe the true KOLs are the individuals who drive formulary decisions in payers. If a pharmaceutical company is able to influence formulary change from a non-preferred or restricted position to either a preferred or unrestricted formulary position, the ability for physicians to write prescriptions becomes a much easier task which can translate into significant drug market share growth.