Drugmakers may not be the only ones keeping less-expensive drugs off the market.
The Food along with Drug Administration has approved nine biosimilars, generic versions of biologic medicines, however only three are available inside U.S.
Manufacturers are using several schemes to “hamstring biosimilar competition,” FDA Commissioner Scott Gottlieb said at the Pharmaceutical Care Management Association’s PBM Policy Forum, according to a copy of his prepared remarks.
He added in which he worries pharmacy benefit managers have been “complacent participants” inside schemes.
Pharmacy benefit managers are companies in which control which drugs are covered along with negotiate discounts on branded drugs with manufacturers. In some cases, restrictive contracting, rebating along with distribution agreements deter biosimilars coming from being covered along with reimbursed, Gottlieb said Thursday in a speech to an audience of PBMs.
“While such schemes may hold the immediate impact of reducing the costs of these therapies, the net result will be a lopsided playing field in which disincentives biosimilar developers coming from producing the sizable investment in bringing such products to market. I am concerned in which will lead to reduced competition inside long-run along with unsustainable costs for these treatments,” Gottlieb said in his prepared remarks.
PBMs along with insurers may stick with branded biologics because they receive discounts coming from manufacturers on these treatments. in which can leave consumers paying for costly treatments when less-expensive ones are available while PBMs make more money on these discounts, known as rebates.
“Many of these practices persist because high list prices enable lucrative returns across the drug supply chain as the spread between list along with net cost will be carved up along with shared among participants,” Gottlieb said in his prepared remarks.
“the idea’s easier to log profits in which quarter than to think about what the market will look like in two years’ time or a few,” he said.
PBMs have become an increasingly common target for their role in rising drug costs. Manufacturers say these middlemen pocket rebates they give them instead of sharing them with customers along with reducing patients’ out-of-pocket costs. Critics blame the opaque system for preventing people coming from knowing much about how PBMs operate.
A PCMA spokesman responded to Gottlieb’s prepared remarks in a statement to CNBC:
Pharmacy benefit managers (PBMs) have long been strong supporters of bipartisan legislation in which would certainly prevent brand drug a new abuses of risk evaluation along with mitigation strategies (REMS) in which block generic competition. Allowing generic along with biosimilar drugs to get to market more quickly will reduce overall drug costs.
A broad group of different stakeholders support in which legislation, including the Association for Accessible Medicines, the Academy of Managed Care Pharmacy, Public Citizen, along with Blue Cross Blue Shield Association.
Gottlieb has not been shy about his thoughts on how different players inside health-care system are contributing to rising drug prices. His message last month to health insurers: You’re doing the idea wrong.
Thursday, he applauded insurers who have recently pledged to pass a new’s drug rebates directly on to some of their members. Both Aetna along with UnitedHealth Group said last month they would certainly do so for fully insured members.
“in which will be a bold action in which will help create a fairer, more transparent market,” Gottlieb said in his prepared remarks. “I desire in which different insurers, employers, along with manufacturers follow their lead. I also desire in which your industry will continue to innovate to make the idea more transparent to pass along these rebates.”