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136 STAT. 1847 PUBLIC LAW 117–169—AUG. 16, 2022 ‘‘(A) Research and development costs of the manufac- turer for the drug and the extent to which the manufacturer has recouped research and development costs. ‘‘(B) Current unit costs of production and distribution of the drug. ‘‘(C) Prior Federal financial support for novel thera- peutic discovery and development with respect to the drug. ‘‘(D) Data on pending and approved patent applications, exclusivities recognized by the Food and Drug Administra- tion, and applications and approvals under section 505(c) of the Federal Food, Drug, and Cosmetic Act or section 351(a) of the Public Health Service Act for the drug. ‘‘(E) Market data and revenue and sales volume data for the drug in the United States. ‘‘(2) EVIDENCE ABOUT ALTERNATIVE TREATMENTS.—The fol- lowing evidence, as available, with respect to such selected drug and therapeutic alternatives to such drug: ‘‘(A) The extent to which such drug represents a thera- peutic advance as compared to existing therapeutic alter- natives and the costs of such existing therapeutic alter- natives. ‘‘(B) Prescribing information approved by the Food and Drug Administration for such drug and therapeutic alter- natives to such drug. ‘‘(C) Comparative effectiveness of such drug and thera- peutic alternatives to such drug, taking into consideration the effects of such drug and therapeutic alternatives to such drug on specific populations, such as individuals with disabilities, the elderly, the terminally ill, children, and other patient populations. ‘‘(D) The extent to which such drug and therapeutic alternatives to such drug address unmet medical needs for a condition for which treatment or diagnosis is not addressed adequately by available therapy. In using evidence described in subparagraph (C), the Secretary shall not use evidence from comparative clinical effectiveness research in a manner that treats extending the life of an elderly, disabled, or terminally ill individual as of lower value than extending the life of an individual who is younger, non- disabled, or not terminally ill. ‘‘(f) RENEGOTIATION PROCESS.— ‘‘(1) IN GENERAL.—In the case of a renegotiation-eligible drug (as defined in paragraph (2)) that is selected under para- graph (3), the Secretary shall provide for a process of renegoti- ation (for years (beginning with 2028) during the price applica- bility period, with respect to such drug) of the maximum fair price for such drug consistent with paragraph (4). ‘‘(2) RENEGOTIATION-ELIGIBLE DRUG DEFINED.—In this sec- tion, the term ‘renegotiation-eligible drug’ means a selected drug that is any of the following: ‘‘(A) ADDITION OF NEW INDICATION.—A selected drug for which a new indication is added to the drug. ‘‘(B) CHANGE OF STATUS TO AN EXTENDED-MONOPOLY DRUG.—A selected drug that— ‘‘(i) is not an extended-monopoly or a long- monopoly drug; and Effective date. VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00031 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw