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Clinical studies are increasingly designed to satisfy evidentiary needs.
Biopharma manufacturers struggle to communicate the clinical value of their medicines to payers for many reasons: payer drug evaluations are conducted in secrecy, promotional messaging to payer P&T committee members is largely prohibited, and rebate negotiations dominate manufacturer-payer engagements. These challenges are further compounded by the payer community’s legions of pharmacist drug evaluators declaring a therapy’s clinical profile to be undifferentiated after a meticulous review of its pivotal trials.
The solution? Pivotal trials that stand on their own and convey compelling value to their payer audiences. Trial designs have made significant advancements over the past two decades, driven primarily by technological innovations, regulatory changes, and the growing complexity of diseases and patient populations. However, despite having risen to the demands of higher scientific standards, numerous launches have failed to achieve the optimal patient access required for commercial success. Payers not compelled by clinical trials to do otherwise implement market access restrictions that limit patient access and result in poor commercial performance. This dynamic is playing out today as payers weigh the cardiovascular outcomes of obesity therapy trials against a range of access restriction scenarios.
Novel therapies can appear to demonstrate impressive Phase III results, but if payers do not discern sufficient value, they will seek to limit that product’s access to patients. A drug development program can meet all regulatory endpoints in record time, but if a study protocol suggests the intervention was not the first line of therapy, payers will consider step-therapy options. If, in an honest effort to avoid confounding data the trial population excludes patients with common comorbidities, payers may restrict the drug’s use for those populations. Trial designs can inadvertently overlook the very patients most in need of access to the new drug.
Rory Davies, the former chief pharmacy officer at Cigna, offered this perspective: “Payers have a responsibility to their clients to minimize waste and maximize the value of newly approved therapies. Often, we would look to clinical trials to identify the exclusion criteria that best support that responsibility. This, of course, can justify restrictions beyond what the manufacturer envisioned when embarking on the study.”
Incorporating payer insights into the design of pivotal clinical studies can not only inoculate drug launches from onerous patient access restrictions, but it can also bolster commercial success in unexpected ways.
The following are four ways to earn patient access through clinical trials:
Bridging the gap between clinical trials and payer expectations is essential for successful drug launches in today’s market. Disciplined market access research with today’s payer community enables the alignment needed for commercial success. By proactively incorporating payer insights into trial designs, manufacturers can strengthen promotional claims, better navigate the evolving landscape of reimbursement, and enhance patient access.