Senate Bill 783 (“S. 783”) was recently introduced before the Massachusetts General Assembly. As introduced, S. 783 would amend current law to require the Health Policy Commission (“Commission”) to review the impact of “eligible drug costs” on patient access. The term “eligible drug” is defined as a brand name drug or biologic with a launch wholesale acquisition cost (“WAC”) of $50,000 or more for a 1-year supply or full course of treatment; a biosimilar drug with a launch WAC that is not at least 15% lower than the referenced brand biologic at the time of launch; or, a public health essential drug with a significant price increase as determined by the Commission or a WAC of $25,000 or more for a 1-year supply or full course of treatment.
If the Commission determines that pricing for a reviewed drug does not exceed the proposed value substantially, it must notify the manufacturer in writing and evaluate other ways to improve patient access. If the Commission determines that a reviewed drug’s pricing significantly exceeds the proposed value, it must confidentially notify the manufacturer and require the manufacturer to enter an access improvement plan. S. 783 describes an access improvement plan to include specific, measurable strategies and action steps a manufacturer proposes to address the cost of the eligible drug and to improve patient access. An access improvement plan must be approved by the Commission and must remain confidential.
S. 783 would authorize the Commission to assess a civil penalty of up to $1,000,00 per occurrence if it determines that a manufacturer willfully neglected to file an access improvement plan, failed to file or implement an access improvement plan in good faith, or knowingly failed to provide or falsified information. The Commission would be required to promote compliance with the provisions of S. 783, and to impose a penalty only as a last resort.