Update on Legislation, Notification Rules Concerning the Substitution of Interchangeable Biologic Drugs

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Although the FDA has not yet awarded the title of interchangeable to any biosimilar, legislation that governs their substitution will continue to be a dominant state issue in 2017. Since 2013, 24 states and Puerto Rico have passed legislation regarding interchangeable biologics.

As many as 15 states will have biosimilar-related legislation introduced by coalitions in 2017. The ACR has been working with various coalitions across the country to ensure appropriate safeguards are put in place to protect prescriber authority and the patient–provider relationship.

Notification of Substitution

Biosimilar legislation is almost uniform across the country. If a patient is prescribed a biologic and a less expensive biologic is available that the FDA has deemed interchangeable, each state requires that the pharmacist must dispense the less expensive alternative.

Notification for prescribers has been a point of contention nationwide. Each state varies in its policy regarding prescriber notification of substitution. The national average is five business days, with exceptions being: Oregon (five calendar days), Pennsylvania (72 hours), Georgia (48 hours) and North Dakota (24 hours).¹ Florida is the only state where pharmacists do not have to notify the prescriber if a substitution has been made.

ACR policy on the notification of substitution of interchangeable biologics states that if a biologic is substituted, then the pharmacist must notify the prescriber prior to, or within 24 hours of, the substitution.²

How Rheumatologists Can Affect State Policy

Due to the frequent prescribing of biologics by rheumatologists for treatment of rheumatic disease, no other specialty has more insight to offer when it comes to these state policies. Rheumatologists who make themselves available to educate policymakers and stakeholders are a critical component of success required for a strong patient-centered notification policy.

Most legislators look to state medical societies when it comes to health policy. That is why it is incumbent on rheumatologists to become members of their state medical society and also to participate in the state society’s government affairs committee. If rheumatologists can help their state medical society develop a strong policy for prescriber notification, then the state medical society will work for this policy to be put into law at the state capital, ensuring patients are better protected when biosimilar drugs come to market.

References

1. Cauchi R. State laws and legislation related to biologic medications and substitution of biosimilars. National Conference of State Legislatures. 2016 Sep 15.
2. Position Statement: Biosimilars. American College of Rheumatology. 2016 May 12.