Under heavy lobbying by the pharmaceuticals industry, the Kentucky General Assembly has passed a bill that would allow pharmacists to switch patients to cheaper variations of expensive biologic drugs.
Biologics, so-called because they are derived from human tissue, account for about 27 percent of new federal drug approvals and are used to treat a wide range of conditions, including arthritis, cancer and psoriasis. Kentucky, like dozens of other states, is amending its law for the day that less expensive substitutes hit the market.
Pharmaceutical companies and groups took extraordinary steps to ensure the bill’s passage. They hired a record number of lobbyists for the 2016 session and were coming off a year in which they spent a record $824,196 on lobbyists in 2015. Many listed the biosimilars bill as the reason for hiring lobbyists. (Read " Drug Company Lobbying Has Doubled In Kentucky In Recent Years")
The amended bill was unanimously passed by the House last week and by the Senate on Tuesday. It now goes to Gov. Matt Bevin for enactment.
So far, the U.S. Food & Drug Administration has approved only one biosimilar drug, Zarxio, for certain cancer patients. Meantime, the drug industry has forged ahead to promote model legislation in states throughout the country. One sought-after provision, which legalizes only biosimilars that are “interchangeable,” is included in the Kentucky bill.
Another provision sought by the industry -- that pharmacists communicate with prescribing doctors before switching patients to substitutes -- was altered. An amendment by Rep. Jody Richards, D-Bowling Green, allows pharmacists to call, e-mail or fax doctors -- or their staff.
Kentucky pharmacists had objected to the communication requirement as a deterrent to dispensing cheaper alternatives.
"Studies have shown that notification requirements increase brand dispensing and negatively impact anticipated savings," Bob McFalls, executive director of the Kentucky Pharmacists Association, said in a released statement. "As a result, we remain concerned about the cost implications by including notification requirements for biosimilars going forward."
Reporter James McNair can be reached at jmcnair@kycir.org and (502) 814.6543.