MA S895

Pharmaceutical manufacturers must provide early notice to the Health Policy Commission within 30 days of FDA approval for pipeline drugs, generics, and biosimilars, and at least 60 days before implementing wholesale acquisition cost increases exceeding 15% for brand-name drugs in any 12-month period

The commission will review "eligible drugs" including brand-name drugs with launch costs of $50,000+ per year, biosimilars not priced at least 15% below their reference biologic, public health essential drugs costing $25,000+ per year, and diabetes-related drugs and devices

Manufacturers of eligible drugs must disclose pricing information including 5-year wholesale acquisition cost history, federal/state subsidies received over 10 years for R&D, and aggregate research and development expenditures

If drug pricing substantially exceeds the commission's proposed value, manufacturers may be required to file an access and affordability improvement plan within 45 days, with implementation timelines not exceeding 18 months

Civil penalties up to $1,000,000 per instance may be imposed on manufacturers who fail to comply with notice requirements, obstruct commission reviews, or fail to implement affordability plans in good faith, with penalties deposited into the Prescription Drug Cost Assistance Trust Fund