Identification of a Proposed Value

(1) Based on all available information, including information the Commission receives from MassHealth under M.G.L. c. 118E, § 12A, from the Referred Manufacturer under 958 CMR 12.04, and from any other interested stakeholders, the Commission may identify a proposed value for the Drug. (2) In identifying a proposed value for a Drug, the Commission shall consider the Drug's benefits to the Commonwealth and its residents and may consider factors including, but not limited to: (a) information regarding the clinical efficacy, effectiveness and outcomes of the Drug; (b) information relating to the pricing of the Drug including, but not limited to, information relating to prices paid by other countries; (c) the Drug's net price as compared to its therapeutic benefits including, but not limited to, the seriousness and prevalence of the disease or condition that is treated by the Drug, and the extent to which the Drug addresses an unmet medical need or impacts affected patient subpopulations; (d) the extent of utilization of the Drug or expected utilization of the Drug; (e) the likelihood that the use of the Drug will reduce the need for other care or reduce caregiver burden, or enhance quality of life; (f) whether there are therapeutic equivalents of the Drug, and the number of such equivalents available; (g) characteristics of the Drug, including means and setting of administration, dosing frequency, duration of therapy, side effects, interactions and contraindications, and potential for misuse or abuse; (h) analyses by independent third parties, provided that the Commission shall consider the methodologies and models underlying such analyses, any assumptions or limitations of research findings in the context of the results, and any outcomes for affected subpopulations that utilize the Drug, if applicable; and (i) any other factors that the Commission considers relevant.