Vermont and Connecticut have recently signed laws providing a pathway for and regulations around the substitution of interchangeable biosimilars for the reference biologic product at the pharmacy level.
A number of states have recently been considering legislation around interchangeable biosimilar substitution at the pharmacy level. Vermont and Connecticut are among the 2 latest states to enact such regulation.
On May 30, 2018, Vermont Governor Phil Scott signed bill S.92 into law as Act No. 193. The Act instructs pharmacists to dispense the lowest-price interchangeable biological product to the patient, as well as notify the prescriber of which biological product has been dispensed.
Specifically, within 5 days of the biological product being dispensed, the pharmacist must communicate to the prescriber electronically through either an interoperable electronic medical records system, an electronic prescribing technology, a pharmacy benefit management system, or a pharmacy record.
In Connecticut, Governor Dannel Malloy signed S. Bill No. 197 into law as Public Act No. 18-74 on June 4, 2018. The Act allows a pharmacist to substitute an interchangeable biological product for a prescribed biological product if it provides a cost saving to the patient. In addition, the Act also includes provisions stipulating the notification to the patient purchasing the drug that there may be a cheaper interchangeable biological product available.
The Act also requires the dispensing physician to make an entry documenting the substitution, as well as inform the prescribing practitioner by facsimile, telephone, or electronic transmission of the substitution.
With the implementation of these laws, Vermont and Connecticut have joined 43 other states and Puerto Rico that have authorized legislation around the substitution of interchangeable biosimilars, despite the FDA having not approved such a product to date.
New Hampshire and Alaska are currently considering similar legislation.