At a panel at the GRx+Biosims 2018, Molly Burich, MS, director of public policy for biosimilars and reimbursement at Boehringer Ingelheim, and Melissa Andel, MPP, vice president of health policy at Applied Policy, discussed the impact that US policy developments are having and will continue to have on the biosimilars market.
At a panel at the GRx+Biosims 2018, Molly Burich, MS, director of public policy for biosimilars and reimbursement at Boehringer Ingelheim (BI), and Melissa Andel, MPP, vice president of health policy at Applied Policy, discussed the impact that US policy developments are having and will continue to have on the biosimilars market.
According to Andel, CMS’ newly announced policy to allow Medicare Advantage (MA) plans to implement step therapy provides an opportunity for biosimilar uptake, especially since the popularity of MA plans continues to grow as more patients are “aging into Medicare.”
On the heels of that policy overhaul, said Andel, CMS announced that, in 2020, Part D plans will be able to use indication-based formulary design, contrary to the current landscape in which plans are required to cover all FDA-approved indications for a covered drug. How this new policy will impact biosimilars is not yet clear, but Andel said that it may offer opportunities related to contracting.
Andel added that in the commercial market, aggressive rebating strategies from reference product sponsors are limiting uptake of biosimilars, so biosimilars may need “coverage plus” (which she described as coverage with a larger add-on payment for physicians) or even value-based agreements, linked with patient outcomes, in order to see better uptake.
Burich explained that, from the manufacturer’s point of view, the past year has seen a number of positive changes related to reimbursement, including CMS’ announcement of separate billing codes for biosimilars and inclusion of biosimilars in the Medicare Part D coverage gap discount program. The Trump administration is serious about lowering drug prices, said Burich, and this is among the first times that she has seen such close alignment between CMS and FDA in terms of their goals.
A key question for Burich, however, is who or what will eventually drive the biosimilar market; and payers, patients, and automatic substitution, she said, all have a role to play.
Payers, she said, have begun to take steps to help biosimilar adoption; leading pharmacy benefit managers have begun to include biosimilars on their national formularies, though they have not yet excluded reference products as a means to drive biosimilar uptake, and “I think the rebate dynamics certainly play a role.”
On the patient side, whereas individual patients have felt the benefit of generic drugs in terms of their out-of-pocket expenses, they do not yet have a true incentive to use a biosimilar. “An esoteric benefit to the system,” she explained, is no match for a direct benefit to the patient.
Interchangeability—and Burich noted that BI is the only biosimilar developer to announce a study designed expressly to demonstrate interchangeability—is also an important because it will allow for automatic substitution at the pharmacy level, which was a key driver of generic uptake. Burich said that BI generally agrees with the FDA’s current draft guidance on interchangeability, as it sets an appropriately high bar for an interchangeable product. However, the time and resource investment necessary for such a study means that interchangeability can only be a catalyst, not the only enabler, of the market.
Burich also noted that most US states now have laws in place to eventually govern substitution of interchangeable biologics, but she raised the question of whether these laws should target interchangeability or a different standard, saying “did we base substitution on the right thing? Is interchangeability going to be something that many products pursue, or maybe just certain products?” She noted that FDA Commissioner Scott Gottlieb, MD, has said that the agency is considering whether more flexibility is warranted in the interchangeability guidance.