Lawmakers are contemplating a substantial range of reforms to make biologics more affordable for patients.
The Trump administration’s stated goal of repealing and replacing the Affordable Care Act (ACA) left many in the industry wondering what would become of the Biologics Price Competition and Innovation Act (BPCIA); however, the American Health Care Act (AHCA), narrowly passed by the House of Representatives, has not made any provisions that specifically affect biosimilar drugs.
Yet, as Erin Ator Thompson, counsel for Intellectual Property at Vinson & Elkins LLP, discussed at the 8th Annual Summit on Biosimilars, a number of newly proposed bills seek to reform the biologics marketplace. While none of the bills discussed have yet been passed out of committee, lawmakers are contemplating a substantial range of reforms to make biologics more affordable for patients. The proposed bills include the following:
If passed, these acts would impact federal law, yet biosimilar-related reform is also taking place at the state level—a level that, based upon this week’s Supreme Court ruling in the case of Sandoz v Amgen, seems to be increasingly important for biosimilars. Thompson pointed out that 43 states have considered legislation to stipulate when a pharmacy can substitute a biosimilar product for a reference product, and 32 states have enacted such legislation. The laws enacted by these states vary, but they do have common features, including leaving decision-making power in the hands of prescribers, requiring notes concerning substitution in patients’ medical records, and providing legal immunity to prescribers.
Many Summit attendees who commented on Thompson’s talk agreed that these legislative efforts reflect the mood of the public. Legislators, it seems, are finally taking seriously the blockades to patient access, and are making efforts, however aspirational, to rein in the rapidly increasing costs of these biologic treatments.