; or (V) on or after January 1, 2024, of at least 15 percent in the preceding 12 months or of at least 50 percent in the preceding 60 months. (C) High launch price for new drugs In the case of a drug that is marketed for the first time on or after January 1, 2020, and for which the manufacturer has established the first wholesale acquisition cost on or after such date, such wholesale acquisition cost for a year's supply or a course of treatment for such drug exceeds the gross spending for covered part D drugs at which the annual out-of-pocket threshold under section 1860D–2(b)(4)(B) would be met for the year. (2) Special Rules (A) Authority of Secretary to substitute percentages within a de minimis range For purposes of applying paragraph (1), the Secretary may substitute for each percentage described in subparagraph (A) or (B) of such paragraph (other than the percentile described subparagraph (B)(i) of such paragraph) a percentage within a de minimis range specified by the Secretary below the percentage so described. (B) Drugs with high launch prices annually report until a therapeutic equivalent is available In the case of a drug that the Secretary determines is an applicable drug described in subparagraph (C) of paragraph (1), such drug shall remain described in such subparagraph (C) (and the manufacturer of such drug shall annually report the justification under subsection (c)(2)) until the Secretary determines that there is a therapeutic equivalent (as defined in section 314.3 of title 21, Code of Federal Regulations, or any successor regulation) for such drug. (3) Dose For purposes of applying paragraph (1), the Secretary shall establish a definition of the term dose . (c) Justification described (1) Increase in WAC In the case of a drug that the Secretary determines is an applicable drug described in subparagraph (A) or (B) of subsection (b)(1), the justification described in this subsection is all relevant, truthful, and nonmisleading information and supporting documentation necessary to justify the