Drawing that Full House
So how can the US really achieve a win-win? Sidore believes it's by keeping patients on medicine. "Using innovative contracts
to lower and eliminate copays for certain focus medications is an area with win-win potential," he explains. "In many specialty
cases, and even chronic disease retail classes, both the plan and the manufacturer are better served by having lower copays—as
the patient stays adherent and manages his condition better. Contracting to provide copay offsets directly to patients, in
return for favorable or exclusive formulary status, is a promising win-win area." Step therapy is another path that is friendly
to the diverse and clinically heterogeneous US environment. It can be defined as "creative contracting," which is basically
putting some modest limits on the choices that providers have in prescribing, rather than simply telling providers what they
can or cannot use in treating individual patients.
For Schoonveld, the US's goal should not be risk sharing at all. "It should be bringing the best treatment to patients." He
cites comparative effectiveness research (CER) as a worthy trend, "but we need to make sure we don't simply use it as an excuse
to block out innovation." Gathering that kind of data takes time, so it could easily become an excuse for payers to say that
a treatment has not been proven. But, he says, CER is where alternative pricing schemes could prove helpful.
An offshoot of CER that tallies more closely with some of the risk sharing deals mentioned above is coverage with evidence
development (CED). CED allows for reimbursement of a product at a price determined by the manufacturer, but only for a set
period of one or two years. After this period, a price review takes place based on real-time evidence to assess how the product
has showed value against agreed outcomes. If the product has failed to show any value, the payer withdraws the price and sets
it lower against existing standard of treatment.
CED seems to have gained some traction among major managed care payers in US, such as the Blue Cross and Blue Shield (BCBS)
companies. Dr. Allan Korn, the BCBS Association's senior vice president and chief medical officer, currently chairs the Technology
Evaluation Center (TEC), which has developed scientific criteria for assessing medical technologies through reviews of clinical
evidence; TEC now averages 20 to 25 assessments a year. Korn has also led the creation and implementation of "Blue Distinction,"
a portfolio of initiatives to "acknowledge clinical excellence and foster quality improvement in collaboration with providers."
These initiatives notwithstanding, whether a robust form of risk sharing takes hold in the US, or just fizzles out as it did
in the late '90s, is open to question. It is certainly never going to become, according to Bob Carlson in Biotechnology Healthcare, a panacea for pharmaceutical and biotechnology companies. "It's not even a preferred option, but a last resort," he says.
But it could mean the difference "between getting reimbursement and good access or not." And, as Bruce Pyenson asserts, the
US is now at a point where doing business in "the usual way" is unsustainable.
It seems, however, that we'll need a few more convincing examples of effective risk-sharing deals, both from Europe and the
US, for it to enter the US mindset, let alone the market, as a practical solution for the future—whether as a necessary stop-gap
or a whole new way of doing business.
Benefit from industry updates and case studies related to this article
CBI's 3rd Annual Risk-Sharing and Innovative Contracting Models for Bio/Pharmaceuticals
Pay-for-Performance | Outcomes-Based Agreements Pricing | Reimbursement Approaches
March 22-23, 2012