Engaging with Physicians in an Era of Transparency
“It's no use going back to yesterday,” Alice said in Wonderland, “because I was a different person then.”
As Alice’s environment changed her, so, too, is an era of “looking glass” transparency changing the pharmaceutical industry, as tough new legislation forever alters physician-pharma relations.
Triggered by the widespread collapse of public trust for conflict-of-interest protection measures following several high profile cases in which health care professionals, medical schools, journals and continuing education establishments worked more in their own interest than the public’s, the industry and physicians alike now face new legislation that will throw open a revealing window onto engagement practices. And like Lewis Carroll’s heroine, the industry is struggling to navigate a way forward in a challenging, ever-changing landscape.
From the US Physician Payments Sunshine Act, which will compel pharmaceutical companies to disclose physician payments, to demands for greater transparency in clinical trial results, the authorship of medical papers, the regulatory process for licensing drugs as well as payments made to patient groups and medical schools, it is clear that the emerging “looking glass” transparency is not only changing the rules of engagement with physicians—it’s doing so contagiously.
The result? Considerable uncertainty for the industry and physicians alike—and some leadership by a few companies, like Merck and GlaxoSmithKline, as they attempt negotiate the tough new regulatory mood.
Key insights from expert sources
Engaging with Physicians in an Era of Transparency --FirstWord’s first report in its timely new “pharma transparency series”--offers critical insights in to what’s driving the new era of transparency, the legislation that is emerging and how the industry and physicians alike will have to alter their practices to suit. Containing compelling interviews with industry leaders, discussions of everything from marketing crackdowns to increasing compliance requirements, the report investigates the ground-zero impact of transparency legislation and how some industry leaders like Eli Lilly and GlaxoSmithKline are already determining their own strategies to change with voluntary disclosures and new engagement practices.
The report reviews the current transparency legislation to establish:
The report
Key quotes from opinion leaders
“We are moving from a culture of compliance to a culture of transparency. What we are seeing is a perfect storm of drivers pushing companies towards the need to be more transparent. This is a major shift that will require new ways of engaging with stakeholders.” Jonathon L. Kellerman, a partner in PricewaterhouseCoopers’ US Pharmaceutical and Life Sciences Practice.
“Industry is going to have to choose how it engages with professionals and how to defend those engagements as having a positive effect on clinical outcomes and are therefore beneficial to patients. You have to be comfortable with the money you are spending and it should be limited to areas both recipient and payer can defend.” Peter Claude, a partner in PWC’s US Pharmaceutical and Life Sciences Practice.
“The current go-to-market model focuses almost exclusively on initial prescription writing, largely ignoring other drivers of the market. To grow in the new healthcare environment, as product differentiation becomes harder to sustain, pharmaceutical companies need to go beyond promoting for first prescriptions (and banking on maximising price in payer negotiations) toward expanding the total size of the market and the resulting revenue potential.” Oliver Wyman report entitled ‘A prescription for change’.
“A KOL relationship should not be measured in a ‘reach-and-frequency’ paradigm. Rather, this relationship should be treated as a series of ‘tacit and collaborative interactions’, because of the nature of information exchange and development.” Sara Melo-Pereira of Skila, a KOL management software company
As Alice’s environment changed her, so, too, is an era of “looking glass” transparency changing the pharmaceutical industry, as tough new legislation forever alters physician-pharma relations.
Triggered by the widespread collapse of public trust for conflict-of-interest protection measures following several high profile cases in which health care professionals, medical schools, journals and continuing education establishments worked more in their own interest than the public’s, the industry and physicians alike now face new legislation that will throw open a revealing window onto engagement practices. And like Lewis Carroll’s heroine, the industry is struggling to navigate a way forward in a challenging, ever-changing landscape.
From the US Physician Payments Sunshine Act, which will compel pharmaceutical companies to disclose physician payments, to demands for greater transparency in clinical trial results, the authorship of medical papers, the regulatory process for licensing drugs as well as payments made to patient groups and medical schools, it is clear that the emerging “looking glass” transparency is not only changing the rules of engagement with physicians—it’s doing so contagiously.
The result? Considerable uncertainty for the industry and physicians alike—and some leadership by a few companies, like Merck and GlaxoSmithKline, as they attempt negotiate the tough new regulatory mood.
Key insights from expert sources
Engaging with Physicians in an Era of Transparency --FirstWord’s first report in its timely new “pharma transparency series”--offers critical insights in to what’s driving the new era of transparency, the legislation that is emerging and how the industry and physicians alike will have to alter their practices to suit. Containing compelling interviews with industry leaders, discussions of everything from marketing crackdowns to increasing compliance requirements, the report investigates the ground-zero impact of transparency legislation and how some industry leaders like Eli Lilly and GlaxoSmithKline are already determining their own strategies to change with voluntary disclosures and new engagement practices.
The report reviews the current transparency legislation to establish:
- How the new era of conflict-of-interest legislation is unfolding
- How the legislation is affecting specific groups from sales representatives to the continuing medical education sector
The report
- Examines how demands for transparency have evolved as a result of public mistrust
- Deconstructs the tone and content of legislation as it affects key sectors within the industry and medical profession
- Offers guideline solutions being dynamically developed by industry leaders—as the environment changes
- Notes possible positives emerging from transparency demands, such as opportunities to set the record straight on healthcare market expectations
- Contextualizes emerging legislation—and it’s likelihood of success
Key quotes from opinion leaders
“We are moving from a culture of compliance to a culture of transparency. What we are seeing is a perfect storm of drivers pushing companies towards the need to be more transparent. This is a major shift that will require new ways of engaging with stakeholders.” Jonathon L. Kellerman, a partner in PricewaterhouseCoopers’ US Pharmaceutical and Life Sciences Practice.
“Industry is going to have to choose how it engages with professionals and how to defend those engagements as having a positive effect on clinical outcomes and are therefore beneficial to patients. You have to be comfortable with the money you are spending and it should be limited to areas both recipient and payer can defend.” Peter Claude, a partner in PWC’s US Pharmaceutical and Life Sciences Practice.
“The current go-to-market model focuses almost exclusively on initial prescription writing, largely ignoring other drivers of the market. To grow in the new healthcare environment, as product differentiation becomes harder to sustain, pharmaceutical companies need to go beyond promoting for first prescriptions (and banking on maximising price in payer negotiations) toward expanding the total size of the market and the resulting revenue potential.” Oliver Wyman report entitled ‘A prescription for change’.
“A KOL relationship should not be measured in a ‘reach-and-frequency’ paradigm. Rather, this relationship should be treated as a series of ‘tacit and collaborative interactions’, because of the nature of information exchange and development.” Sara Melo-Pereira of Skila, a KOL management software company
EXECUTIVE SUMMARY
INTRODUCTION
Transparency and reputation
Transparency is contagious
SIDEBAR ON PHYSICIAN PAYMENTS SUNSHINE ACT
Rewriting conflict-of-interest policies
From banning gifts to exposing payments
SHIFTING SANDS
Reporting from the frontline states
Vermont
Minnesota
Pioneering pharma
Eli Lilly
Merck
GlaxoSmithKline
Cephalon
Evidence from physicians
Table 1: Frequency of physician–industry relationships according to benefit received
NEW RULES OF ENGAGEMENT
Marketing crackdown
Sales representatives
Corporate Integrity Agreements
Data-mining restrictions
Direct-to-consumer (DTC) advertising
Continuing medical education (CME)
Increasing compliance requirements
Competition for thought leaders
Managing the thought leaders
Evaluating the value of thought leaders
Figure 1: The reporting structure of medical science liaison officers
A question of money
Figure 2: Average hourly rate ranges across all therapeutic areas and company sizes by thought leader category
Table 2: Hourly rates to thought leaders by company size across all therapeutic areas
Table 3: Flat-rate fees paid to thought leaders for specific functions across all therapeutic areas
Annual capitation caps
Figure 3: Average annual compensation limits for thought leaders engaged by small, mid-sized and large companies
Going global
THE WAY FORWARD
The prescribing decision
Table 4: Factors considered by physicians when prescribing
Collaborative working
New media
Table 5: Distribution of physicians signed up to Sermo.com
REFERENCES
ABBREVIATIONS/ACRONYMS
APPENDIX
Useful links
INDEX
INTRODUCTION
Transparency and reputation
Transparency is contagious
SIDEBAR ON PHYSICIAN PAYMENTS SUNSHINE ACT
Rewriting conflict-of-interest policies
From banning gifts to exposing payments
SHIFTING SANDS
Reporting from the frontline states
Vermont
Minnesota
Pioneering pharma
Eli Lilly
Merck
GlaxoSmithKline
Cephalon
Evidence from physicians
Table 1: Frequency of physician–industry relationships according to benefit received
NEW RULES OF ENGAGEMENT
Marketing crackdown
Sales representatives
Corporate Integrity Agreements
Data-mining restrictions
Direct-to-consumer (DTC) advertising
Continuing medical education (CME)
Increasing compliance requirements
Competition for thought leaders
Managing the thought leaders
Evaluating the value of thought leaders
Figure 1: The reporting structure of medical science liaison officers
A question of money
Figure 2: Average hourly rate ranges across all therapeutic areas and company sizes by thought leader category
Table 2: Hourly rates to thought leaders by company size across all therapeutic areas
Table 3: Flat-rate fees paid to thought leaders for specific functions across all therapeutic areas
Annual capitation caps
Figure 3: Average annual compensation limits for thought leaders engaged by small, mid-sized and large companies
Going global
THE WAY FORWARD
The prescribing decision
Table 4: Factors considered by physicians when prescribing
Collaborative working
New media
Table 5: Distribution of physicians signed up to Sermo.com
REFERENCES
ABBREVIATIONS/ACRONYMS
APPENDIX
Useful links
INDEX
