Amendment ID: S2499-2

Amendment 2

Biosimilar Manufacturers

Mr. Rush moves that the proposed new draft be amended by striking Section 21 and inserting in place thereof the following:-

SECTION 21. Said chapter 6D is hereby further amended by adding the following 3 sections:-

Section 21. (a) As used in this section, the following words shall have the following meanings unless the context clearly requires otherwise:

“Eligible drug”, (i) a brand name drug or biologic that has a launch wholesale acquisition cost of $50,000 or more for a 1-year supply or full course of treatment; (ii) a public health essential drug, as defined in subsection (f) of section 13 of chapter 17, with a significant price increase over a defined period of time as determined by the commission by regulation or with a wholesale acquisition cost of $25,000 or more for a 1-year supply or full course of treatment; (iii) all drugs selected pursuant to section 17T of chapter 32A, section 10R of chapter 118E, section 47UU of chapter 175, section 8VV of chapter 176A, section 4VV of chapter 176B and section 4NN of chapter 176G; or (iv) other prescription drug products that may have a direct and significant impact and create affordability challenges for the state’s health care system and patients, as determined by the commission; provided, however, that the commission shall promulgate regulations to establish the type of prescription drug products classified under clause (iv) prior to classification of any such prescription drug product under said clause (iv).