Before marketing authorization and eventual negotiations commence, an affiliate's market access, government affairs, and commercial
and medical colleagues usually create a stakeholder plan or "influencers map" to identify key players, their motivations,
orbits of influence, and discretionary decision-making authority. This step proved invaluable for this author when his former
company prepared simultaneous access plans for an expensive biotech product for auto-immune diseases and a novel infant vaccine,
the price of which set a dramatically high bar for the class. Developing a comprehensive stakeholder approach was derived
from the need to improve communications between affiliates and head office personnel, as well as from the need to provide
a clear platform general managers could embrace, regardless of team size. Stakeholder plans proved essential in setting the
stage for eventual negotiation strategies.
Many companies have refined their stakeholder plan process, incorporating it into market access strategies to ensure core
value dossiers remain the linchpin for payer and KOL advocacy. The approach we developed through a multinational team of general
managers, government affairs managers, market access directors, and health economists centered on a straightforward seven-step
process, with five steps performed annually and two reviewed at the general manager's monthly meeting. Success hinged upon
strong general manager orchestration accompanied by affiliate staff "owning" specific relationships.
The Access Debate
While stakeholder plans emerge as a basic affiliate requirement, the access environment and payer demands to "show us the
real value" of products require even higher skills for today's affiliate managers: To negotiate well, be better than your
competitors. Payers are asking: Is it worth it (value for money)? Can we afford it (budget impact)? Can we avoid funding it
(political impact)? Potential budget impact often outweighs available funds requiring tradeoffs of price versus patient access
(subpopulations coverage) and other negotiable factors finding their way into the payer toolkit; eventual risk-share agreements
often provide the entry ticket into reimbursement. Understanding payers' interests (e.g., predictable budget, good political
image, patient care) as differentiated from their positions (e.g., desire for higher political station, public perception
of not "caving in" to multinational drug firms) becomes a critical factor as affiliates prepare for negotiations.
Preparing affiliate managers to negotiate with a shifting payer environment requires comprehending payers' interests and judging
the company's offer from the funders' perspective. Moreover, the shift toward more decentralized decision-makers (e.g., Swedish
county councils, Spanish autonomias, Italian provincial formularies, Dutch hospital pharmacists) requires company negotiators
to conduct multiple discussions simultaneously. Meanwhile, these payers talk with one another to share lessons and outcomes;
only time separates emerging markets such as Brazil, India, Russia, China, and Turkey from learning new tricks from industrialized
cousins with long heritages of socialized medicine. Affiliate managers face the firing line daily. Helping them develop solid
negotiating skills makes practical sense.
Informed and battle-tested industry veterans understand these challenges. For my former company, systematic stakeholder plans
replaced a potpourri of affiliate access plans that often delayed decisions. That stakeholder foundation led to systematically
analyzing, simulating, and rehearsing actual reimbursement negotiations, enabling affiliate managers to reconcile various
potential outcomes with head office global pricing committee policies. These processes streamlined consultation, provoking
better decisions and ultimately stronger, more realistic proposals to payers. The commercial performance of the biotech product
and the childhood vaccine benefitted from these applications in most markets.
The pharmaceutical reimbursement scene challenges affiliate managers in ever more creative ways. New drugs appear on the market
today less often than they did a decade ago. Unmet medical needs in diseases such as oncology, MS, Alzheimer's, and others
still offer significant opportunity, especially for biotech entrants. Meanwhile, biosimilars have begun to appear on the horizon,
and over the next few years will touch some significant therapy classes, such as rheumatoid arthritis. Payers continue to
see lower tax bases supporting growing, older populations with years of builtup expectations to have their old age conditions
handled by the government or its proxy. Against this scenario, pharma companies' affiliate operations will require discreet
skills to gain trust with multiple payers. Having a solid stakeholder management plan seems a no-brainer as long as affiliate
managers take clear ownership of relationships under the guiding hand of the general manager.
The skill set of the future—competently and carefully negotiating with payers—will continue to grow. Those who excel at this
may watch their competitors from the rearview mirror as they pass them in the marketplace.