|53 Charts and Diagrams|
In response to recently enacted reporting-based legislation such as the Sunshine Act in the United States and rate-based legislation in other countries, life science companies have formalized their internal FMV processes. This formalization focuses on three main areas: standardized rate cards, clear KOL scoring systems and regular access to reliable FMV rates.
The primary research collected for this study is aggregated from surveys from industry professionals across the life sciences industry. Cutting Edge Information gathered data from more than 120 pharmaceutical, biotech, diagnostics and medical device companies. This study features aggregate FMV benchmarks across 4 KOL tiers, 6 company types, 11 regions and 6 activity categories for specialists as well as primary care physicians and non-MD providers. FMV data also include base hourly rates for specialists in 25 specialty areas.
Industry executives working in pharmaceutical compliance, legal, medical affairs, commercialization, and clinical teams will get the following benefits from this report:
Key Questions That This Study Answers
Top Reasons to Read This Report
Create detailed rate cards to standardize fee schedules, facilitate KOL negotiations and avoid regulatory scrutiny: Formalized payment rates help companies to track their interactions with healthcare experts and reduce the time spent negotiating KOL contracts. This report will help you understand the factors used to determine FMV rates. It also provides comparisons of rates across a wide range of thought leaders, including specialists, primary care physicians and non-MD providers. Benchmark your FMV rates and maintain regulatory compliance.
Review and formalize your KOL scoring system: Payment structures based on a KOL’s geographic influence are fairly common. A majority of rate cards indicate different payment rates depending on the type of activity KOLs perform. KOL selection data in this report are broken down by company type (top 10, top 50, small pharma, device/diagnostic and other), therapeutic area and geography. Data also include average ratings of KOL criteria broken down by therapeutic area and region.
Set accurate fee schedules and benchmark your FMV rates to stay compliant: Despite the wide variances in processes, FMV payments are cohering into more consistent and defensible fee schedules that will withstand scrutiny from compliance teams and regulators. This report presents FMV rates based on company size, KOL tiering, geography and specialty areas. Data also show the impact of travel expenses and honoraria on FMV compensation.
6 infographics detailing the evolution of the US Physician Payment Sunshine Act and thought leader payment reporting requirements and restrictions for individual states. This chapter also examines the Sunshine Act’s influence on other countries’ transparency laws. As an example, a chart explaining the French Sunshine Act is also highlighted in Chapter 1.
11 charts and tables showing companies’ base hourly payment rates across KOL tier, specialty, company size/type, geography and activity category. KOLs are segmented into four tiers in this report based on companies’ perceptions of the thought leader’s influence. An Exceptional KOL is a global-level thought leader; Tier 1, national-level; Tier 2, regional-level; and Tier 3, local-level. When data are segmented by company type, “other” encompasses academia, contract research organizations and consulting firms.
36 charts and tables detailing key opinion leader selection criteria and FMV rate card analysis. Charts include ratings of a number of factors companies use to select KOLs and designate them to specific tiers of influence. Throughout the chapter, KOL selection data are broken down by company type (top 10, top 50, small pharma, device and other), therapeutic area and geography. When data are segmented by company type, “other” encompasses academia, contract research organizations and consulting firms.
These data are broken down by therapeutic area:
And by region:
The following excerpt is from Chapter 1, “The Future of FMV: A Review of the US Sunshine Act and Other Physician Payment Regulations.”
PHYSICIAN AND INDUSTRY REACTIONS TO THE US SUNSHINE ACT
Following the release of the Sunshine Act, healthcare audiences’ reactions have been divided. Some view the Act as long overdue, whereas others are less supportive. One small company pharmaceutical executive noted that the Sunshine Act may help to mitigate some of what he considers “the ugly side of speaker programs,” for instance. He noted one conference in which a speaker refused to take the stage because the individual wanted to renegotiate fees. In his opinion, increased payment data transparency will encourage companies to develop standardized rates — if they have not already — and, subsequently, expedite salary negotiations between pharma and medical experts.
Other medical audiences are less enthusiastic about the Sunshine Act. For example, in response to recent CMS updates, some physicians noted that there are larger healthcare drivers than physician payments — such as patient non-adherence — that should be addressed first. Some opponents of the legislation claim that the Sunshine Act undermines the scientific value that pharma-sponsored events may yield. Even the original proponents of transparency legislation view the Sunshine Act negatively, saying that it needs to eliminate payments to physicians altogether. They believe that while company-paid physicians’ scientific contributions remain valuable, it is unreasonable to expect them to deliver unbiased accounts.
All told, responses to the Sunshine Act from the healthcare industry have focused on accepting the Act’s inevitability and settling down to meet the challenges of implementation. Doctors’ reactions have been more intensely against the Act. Overall, physicians express frustration in three areas:
The following excerpt is taken from Chapter 5, “Analysis of Aggregate FMV Payment Data.” The full chapter examines the aggregated FMV benchmarks for Top 25, Top 50 and Top 100 drug manufacturers, as well as device and diagnostic companies. It details average, median, minimum and maximum hourly rates and flat fees paid for consulting, advisory and speaking services.
The values in this excerpt have been intentionally blinded. The full study provides detailed FMV benchmark analysis.
Although a smaller percentage of companies pay their KOLs by hourly rate, those that do tend to be Top 25 or Top 50 drug manufacturers. These companies develop products in across a number of specialty areas — a fact that leads to a significant amount of hourly rate data. When aggregated, the data show a familiar pattern: the more experience and specialization that a KOL has, the higher the mean payment and compensation range.
The data show that specialists earn an average base hourly rate of $XXX; those specialists with a subspecialty earn XX% more at $XXX per hour. Among survey respondent companies, the maximum hourly rate for both of these KOL categories is $XX per hour, though the subspecialist range starts at $XXX per hour rather than $XXX for specialists.
The ranges for primary care physicians, mid-level providers and allied health professionals are much smaller compared to those of specialists and subspecialists. The hourly rate range for primary care physicians, for example, is $XXX to $XXX, with an average payment of $XXX per hour. From that point, the ranges drop: mid-level providers receive an average payment of $XXX per hour in a range between $XXX and $XXX per hour; and allied health professionals are paid in a range between $XXX and $XXX, with a mean payment of $XXX per hour.
The following excerpt is taken from Chapter 1, “Trends Impacting KOL Compensation.” The full chapter examines the impact of the Sunshine Act and other regulatory and policy changes. Italso includes data that illustrates the extent of the shrinking KOL pool. Other topics explored in this chapter include the increasing restrictions placed on KOLs by academic institutions and medical publications, as well as KOLs’ reactions to greater transparency and regulations.
Cutting Edge Information’s research shows that the shrinking KOL pool is a consistent trend over the past five years. The environment is changing for both companies and KOLs. The pharmaceutical industry is working to address compliance concerns in the face of expanded government regulations. For their part, physicians are also dealing with restrictions from their employing academic and research institutions. Because each party is coping with change, both sides look to strengthen the relationships that are already in place.
Pharmaceutical companies cannot offer the lucrative honoraria they had in the past, forced to draw the line at fair-market value. Meanwhile, academic physicians are only able to work a pre-specified number of industry events. Surveyed pharmaceutical executives do not refute that times have changed; they simply reject the notion that thought leader management is more difficult because of it.
For thought leader management teams, any roadblocks to working with physicians decrease the overall opinion leader pool. Pharmaceutical companies unfortunately bear the consequences of a smaller thought leader pool. Companies struggling to launch novel medicines now face the prospect of filing for approval without advice from the most expert medical professionals. As more KOLs decline to work with pharmaceutical companies, clinical and marketing teams inevitably will lack knowledge of specific patient needs and other information that help develop a better product. Furthermore, the smaller thought leader pool creates a political nightmare for thought leader management executives whose goals are based on the successful relationships that they develop. It also causes development teams to turn repeatedly to those relationships already established, exacerbating the very situation causing the current problem.
Data show the rapid decline in specialist relationships with the average pharmaceutical company. Between 2006 and 2011, the number of specialist relationships has fallen by 76%. 2011 is the first year of in which Cutting Edge Information’s research found that none of the companies surveyed reported more than 1,000 specialist relationships. In 2006 and 2007, four companies reported relationships with over 1,000 specialists.
Many of the executives interviewed for this study agreed that the public reporting of physician payments is having an effect on the available pool of KOLs. The general consensus is that physicians are not excited about having their names appear on list after list of industry ties.