Fitzgerald: Guidelines have to adapt to a world where the financing and delivery of healthcare is changing. Industry too must do more
to understand what the decision-makers driving system reforms really want. Accountable Care Organizations [ACOs], an alternative
to traditional fee for service payment, are being incentivized under the new health reform law. In this new structure, the
ACO chief financial officer may be the person who is key to assessing evidence and deciding that therapies end up on formulary.
Stein: The mindset of the industry is already moving in this direction. Celebrating approval has shifted to celebrating reimbursement,
because that is what gives our medicines access to the market. Our registration work has to begin with an understanding what
it will take to obtain a positive nod from the CMS, and quickly, as time to market is a competitive differentiator. The bad
news is all the additional tradeoffs we have to invest in to get to this decision. Such tradeoffs must be incorporated into
the drafting of guidelines or pathways, because without including the perspective of the payer these texts will not survive
in the real world.
Is it time for the industry to embrace a multi-stage approach to registration, what the European Medicines Agency [EMA] calls
"adaptive licensing," that requires a medicine to demonstrate its value in the clinical setting, after the initial licensing
Stein: Novartis is intrigued by the idea. If you can get a product on to the market earlier, and then accumulate evidence that we
can agree on to demonstrate the creation of value for the health system, it has the potential to be a "win win" for us and
for the regulator. It is certainly a trend that is building, so we will need to consider it seriously.
Creighton: I am concerned about the impact that adaptive licensing might have on the integrity of the physician-patient relationship,
which is at the center of the pathways model we are discussing today. Industry is likely to have little control over what
a regulatory authority sets as ground rules for re-examining the status of an approved medicine. What would the criteria be
for deciding if a therapy is effective, especially relative to other medicines? What would be the comparator? I think that
for any system to be personalized around the patient, the physician must manage the process. This is what the pathways are
for. Why do we need the regulator to come in once again and make a judgment about value? The market will decide.
Geipel: The Affordable Care Act [ACA] poses a challenge to patient access in its own right. The new insurance exchanges and the delineation
of "essential health benefits" may mean that enrollees will have little discretion in obtaining services not prescribed in
a plan or the list of benefits. It could make this discussion of physician-led pathways an academic exercise.