Global headquarters may get the strategic ball rolling for a new drug launch, but Lilly’s affiliates are responsible for bringing home the bacon, according to a Lilly global brand director.
The decentralized approach to product commercialization, which puts global headquarters in the role of “coach for the affiliate,” represents a corporate rethinking, although the pendulum tends to swing from centralized to decentralized (and back) over time, said S. Michael Harrill, Lilly’s global brand director, neuroscience, during a presentation yesterday. “We’re now in decentralized mode, which is a big difference from five years ago,” said Harrill.
As such, global headquarters and affiliates do their own market research prior to launch; the former does not necessarily guide the latter. Prior to a global launch, companies are understandably “working with incomplete data,” although Harrill says Lilly is “investing heavily in market research, and will do even more” in the future. But it’s important for affiliates to conduct their own research, rather than cribbing exclusively from headquarters’ intel, “so it’s not supposition on top of supposition,” said Harrill. Allowing affiliates a degree of independence lets them adapt to the situation more quickly, he said.
In pre-launch, Harrill emphasized the importance of ‘PRA,’ or pricing, reimbursement and access issues, and anticipating payers’ needs. “Ten years ago, we were creating a pricing value and access notebook too late, around phase 3, but now that happens much earlier,” he said. Other pre-launch activities include an understanding of the patient journey – a “new moniker” at Lilly – as well as key player segmentation, competitive activities assessment, tracking and influencing environmental issues (SWOT analyses, for example), creation of HCP and patient education materials and brand certification training.
In the peri-launch phase, Harrill said key roles include tracking and influencing an affiliate’s operating expenses, coordinating global manufacturing supplies, insuring PR and patient advocacy plans are in place, conducting launch preparedness assessments, and updating the global brand strategy.
In the post-launch phase, the old rule of thumb – at eight months, it’s possible to get a pretty good idea of a product’s trajectory – isn’t appropriate anymore, said Harrill. “Delays in access, REMS, and other issues have lengthened the front end of uptake…there are often six or 12-month delays in access.” Building on that thought, Harrill said the sales rep to PRA personnel ratio is “out of balance.” He cited the fact that Lilly has only four PRA managers in Italy, in neuroscience. “When you think about the number of accounts in Italy, that’s mind-boggling,” said Harrill. In Italy, marketers could end up “sitting there twiddling their thumbs while four PRAs get access in the 12 provinces you’re counting on.” Harrill also acknowledged rising commercialization costs and shorter net exclusivity periods, and faster uptake of generic products upon expiry, to underscore the need for organizations to “look for what the payer wants, early.”
Harrill’s comments were delivered at CBI’s 2nd Annual Commercialization and Market Access Congress, in Philadelphia, on December 6. CBI is a subsidiary of Advanstar, publisher of PharmExec.