State legislators in Nebraska have unanimously approved a biosimilar substitution bill in the first round of debate and plan to advance it through the legislature after revisions.
According to State Senator John Kuehn, who introduced the bill, “LB 481 is a critical piece of legislation for Nebraska to provide guidance for clinicians and dispensers as biosimilar products pass through the FDA approval process.” It would amend the Nebraska Drug Product Selection Act to allow pharmacists to substitute interchangeable biosimilar products in place of branded drugs.
Similar to the biosimilar substitution laws enacted in 28 other states, the proposed addition to Nebraska’s law requires pharmacists to notify patients if they dispense a biosimilar and must notify the prescribing provider of the switch via electronic health records. The text of the law specifies that providers can prevent biosimilar substitution by writing on the prescription that they do not wish the pharmacist to select another drug. Patients and their caregivers may also indicate they want the product written on the prescription with no substitutions, if desired.
To help consumers become more educated about biosimilars, LB 481 also includes a requirement that Nebraska’s Department of Health and Human Services website must publish and update a list of all biological products deemed interchangeable by the FDA.
“Transparent communication between the patient, physician, and pharmacist is the hallmark of high quality patient care,” said Kuehn on his website. “Proactively establishing the communication framework for use of interchangeable biologics is a common sense step for promoting patient understanding of their own health care and communication among all members of the health care team.”
A press release about the proposed legislation included an account from Jackie Newman, whose young daughter has juvenile rheumatoid arthritis (RA). According to Newman, her daughter Zoe struggled with her painful condition before trying a biosimilar drug, which “relieved much of Zoe’s pain and drastically improved her quality of life.”
Newman now hopes that LB 481 will expand access to biosimilars for other patients and families seeking relief. The bill’s passage, she said, “will dramatically affect not only children like Zoe, but also the thousands of Nebraska patients who stand to benefit from the innovative new treatments biosimilars have to offer.”
The proposed legislation has also received support from the Coalition of State Rheumatology Organizations (CSRO), as some biosimilars are used to treat conditions like RA. The group said in a statement that the bill “provides important pathways for access to these unique medications” while ensuring they are used with proper supervision. “CSRO supports the safe introduction of interchangeable biologic drugs into the practice of medicine in Nebraska and urges the passage of LB 481,” it concluded.
The bill was designated a priority by Jim Scheer, the Speaker of the Nebraska legislature. It is currently in the Enrollment & Review stage of the legislative process and will next move to the Final Reading, where a majority vote will determine whether it will proceed to Governor Pete Ricketts to be signed.
For more information on state biosimilar substitution laws as of March 2017, see the infographic here.