On May 15, ASBM submitted comments to the Colorado Prescription Drug Affordability Board urging it not to impose an upper payment limit (UPL) on Cosentyx unless the Board can demonstrate that the policy will directly reduce patient out-of-pocket costs without disrupting access to treatment. ASBM emphasized that a UPL would reduce the amount paid by […]
On May 11th, ASBM submitted comments on the FDA’s recently released draft guidance and Q&As aimed at “streamlining” biosimilar development by permitting the use of data from non-U.S.-licensed comparator products and foreign clinical studies in the U.S. biosimilar approval process. While efficiency is important, ASBM is concerned that these changes may lower evidentiary standards in […]
Congress is considering the Maintaining Investments in New Innovation Act (MINI Act) [HR 1672], legislation to protect patient access to genetically targeted therapies (GTTs)—innovative treatments designed to address the underlying genetic causes of serious diseases. Under current law, some of these therapies may face Medicare price controls earlier than similarly complex treatments, simply due to […]
