Success seeds from the top
Bertsch: People who do market access tend to be mid-level executives. There is much less expertise and awareness the further up you
go in the chain of command. The absence of people with real clout can make it harder to compel others to collaborate.
What options exist to address these challenges? Might opening your doors to payers raise the level of engagement internally?
McLellan: In the United States, we can talk with the payers and have a fairly open exchange of views, including with people at the
top of the decision chain. Outside the United States, this kind of dialogue is difficult, often for cultural reasons. The
only way to really understand the payer environment is to sit across the negotiation table with payers in a price control
country. It is unfortunate that few in the organization will ever get that chance.
Shah: Successful market access programs make a commitment to cross-organization pollination of talent to codify the market access
mindset throughout (e.g., through rotational assignments for promising staff in related areas). For example, managers who
are designated "fast track" for advancement must include a stint on market access work in their career development and progression
plan. Obviously, this will take time for us to see a CEO with day-to-day exposure to payers in his resume. Contact with payers
has not been rewarded among those who follow the traditional routes to the "c suite."
What about the patient perspective? Is it firmly embedded in the market access mindset of your companies?
Stefanacci: Some of the larger patient advocacy groups are increasingly active partners of the industry in early- and mid-stage drug development.
These groups are actually funding some of this work, so as a result patients are signaling their value proposition right at
the very start. This assures their voice in the treatment development process.
McLellan: We say that the work we do must benefit the patient. Nevertheless, patients factor too infrequently into a decision to reimburse
a new drug. Patients—and their families—have a clear stake in our efforts to develop new treatments. They want to see and
understand our data. If the data shows an advance in the standard of care, patient groups are likely to become a factor in
the payer decision to budget for a new drug or to speak out when a benefit assessment decision lacks a strong medical rationale.
Sharma: To achieve that objective, industry has to move beyond the intellectual level and engage on the basis of a direct, emotional
connection with the patient. This is a tactic that industry handles relatively well on the promotional side. But we are less
proactive in making that real-world connection to the patient when it comes to negotiating a price or a position on the formulary.
Defining the best in Market Access
Can we come to a consensus on what factors are likely to determine success in an era that we all agree is going to pose more
challenges to market access?
Parks: One issue facing the industry is the gap between patients with drug coverage and those without it. There is a real ethical
divide. Some patients will get the cutting edge therapies that can cure or extend life; others may not and suffer the consequences.
What if society no longer supports the incremental innovations required to fund the next generation of breakthroughs? We can
say that industry's task is simply to develop medicines that pay for research and deliver returns to shareholders. But some
very powerful forces in society don't see it this way. Resolving this is going to require some difficult conversations. One
cannot be confident that the politicians will step up to lead in building a new consensus on P&R. What I fear more is the
"kick the can down the road" mindset that gives industry little clarity in managing all this uncertainty.
Shah: We must press for a better definition of what constitutes value in pharmaceuticals. The dialogue must shift from cost to
value. If a product shows it has value, then intrinsically the cost is aligned with the definition of benefits and outcomes
desired, which is what value is. A good start toward moving the debate away from being exclusively about cost is contesting
the idea that an incremental advance has no value. Drugs carry a high variability in the individual response, which shows
how important having a choice of therapy is when a clinician treats a patient.
Clinton: The days of approaching market access and cost cutting with an "Us vs. Them" philosophy are numbered. We need to focus the
discussion on how to help the patient with his disease instead of a limited focus on what happens when he receives our drug.
If we can think through the entire disease from diagnosis through resolution, we can identify other, creative ways to optimize
outcomes and control costs.
Bertsch: There is a contradiction at the heart of market access that poses more difficulty in the years ahead. While everyone lauds
the idea of closer partnerships with payers, no one wants to assume any risk in that relationship. Contracting deals are a
good example. Payers demand a payback when outcome goals are not achieved, while manufacturers fret that performance metrics
are unrealistic because the data on their product is flawed or unavailable. So both sides hesitate because there is too much
Shah: Data is reflective of a fragmented delivery system. It cannot demonstrate cross-sector impacts because the process by which
that data is generated, managed, and accessed is siloed. Our greatest contribution to value, which is how the drugs budget
impacts the cost of healthcare overall, is virtually impossible to prove with the data we can compile today.
Smeeding: This is a bit of an exaggeration. I have been fortunate to work with a specialized employer database whose model is integrated
across the full range of health services and encompasses a relatively stable survey population tracked over a long period
of time. We have been able to draw out some very interesting data that links pharmaceutical access to health outcomes.
Clinton: My challenge is whether our market access capabilities are able to address the complexity of the new insurance models that
are part of health reform. The industry is well prepared to assist patients without insurance through direct patient assistance
programs. There is less guidance for us on how to assist people who are under-insured, with minimal coverage but are not indigent.
Under the new reform law, I suspect we will see large numbers of people who opt for less than adequate coverage, with high
deductibles and co-pays for drugs. We will face an interesting situation—more insured people who will be seeking sources to
help pay for their medicines.