(1) [Editor's note: This version of the introductory portion to subsection (1) is effective until January 1, 2025.] The board may conduct affordability reviews of prescription drugs in accordance with this section. The board shall identify, for purposes of determining whether to conduct an affordability review, any prescription drug that is: (1) [Editor's note: This version of the introductory portion to subsection (1) is effective January 1, 2025.] The board may conduct affordability reviews of prescription drugs in accordance with this section. The board shall identify, for purposes of determining whether to conduct an affordability review: (a) [Editor's note: This version of subsection (1)(a) is effective until January 1, 2025.] A brand-name drug or biological product that, as adjusted annually for inflation, has: (I) An initial wholesale acquisition cost of thirty thousand dollars or more for a twelve- month supply or for a course of treatment that is less than twelve months in duration; or (II) An increase in the wholesale acquisition cost of ten percent or more during the immediately preceding twelve months for a twelve-month supply or for a course of treatment that is less than twelve months in duration; (a) [Editor's note: This version of subsection (1)(a) is effective January 1, 2025.] Any prescription drug that has: (I) A wholesale acquisition cost of three thousand dollars or more; (I.5) An increase of three hundred dollars or more above the wholesale acquisition cost for the prescription drug in the preceding twelve months; (II) An increase of two hundred percent or more above the wholesale acquisition cost for the prescription drug in the preceding twelve months; or (III) A current wholesale acquisition cost for an average course of treatment per person per year of thirty thousand dollars or more; and (b) [Editor's note: This version of subsection (1)(b) is effective until January 1, 2025.] A biosimilar drug that has an initial wholesale acquisition cost that is not at least fifteen percent lower than the corresponding biological product; or (b) [Editor's note: This version of subsection (1)(b) is effective January 1, 2025.] Any biosimilar drug that has an initial wholesale acquisition cost that is not at least fifteen percent lower than the wholesale acquisition cost of the corresponding biological product. (c) A generic drug: (I) That, as adjusted annually for inflation, has a wholesale acquisition cost of one hundred dollars or more for: (A) A thirty-day supply based on the recommended dosage approved for labeling by the FDA; (B) A supply that lasts less than thirty days based on the recommended dosage approved for labeling by the FDA; or (C) One dose of the generic drug if the labeling approved by the FDA does not recommend a finite dosage; and (II) For which the wholesale acquisition cost increased by two hundred percent or more during the immediately preceding twelve months, as determined by comparing the current wholesale acquisition cost to the average wholesale acquisition cost reported during the immediately preceding twelve months. (1.1) Subsection (1)(c) and this subsection (1.1) are repealed, effective January 1, 2025. (2) [Editor's note: This version of the introductory portion to subsection (2) is effective until January 1, 2025.] After identifying prescription drugs as described in subsection (1) of this section, the board shall determine whether to conduct an affordability review for each identified prescription drug by: (2) [Editor's note: This version of the introductory portion to subsection (2) is effective January 1, 2025.] After identifying prescription drugs as described in subsection (1) of this section, the board shall determine whether to conduct an affordability review for an identified prescription drug by: (a) Evaluating the class of the prescription drug and whether any therapeutically equivalent prescription drugs are available for sale; (b) Evaluating aggregated data; (c) Seeking and considering input from the advisory council about the prescription drug; (d) Considering the average patient's out-of-pocket cost for the prescription drug; and (e) Considering whether the drug has an approved orphan drug designation for one or more rare diseases and no other indications and, if so, considering input from consumers and the Colorado rare disease advisory council created in section 25-1-1503. (3) If the board conducts an affordability review of a prescription drug, the affordability review must determine whether use of the prescription drug consistent with the labeling approved for the prescription drug by the FDA or with standard medical practice is unaffordable for Colorado consumers. (4) In performing an affordability review, to the extent practicable, the board shall consider: (a) The wholesale acquisition cost of the prescription drug; (b) The cost and availability of therapeutic alternatives to the prescription drug in the state; (c) The effect of the price on Colorado consumers' access to the prescription drug; (d) The relative financial effects on health, medical, or social services costs, as the effects can be quantified and compared to baseline effects of existing therapeutic alternatives to the prescription drug; (e) The patient copayment or other cost sharing that is associated with the prescription drug and typically required pursuant to health benefit plans issued by carriers in the state; (f) The impact on safety net providers if the prescription drug is available through section 340B of the federal "Public Health Service Act", Pub.L. 78-410; (g) Orphan drug status; (h) Input from: (I) Patients and caregivers affected by the condition or disease that is treated by the prescription drug that is under review by the board; (II) Individuals who possess scientific or medical training with respect to a condition or disease treated by the prescription drug that is under review by the board; and (III) The Colorado rare disease advisory council created in section 25-1-1503; (i) Any other information that a manufacturer, carrier, pharmacy benefit management firm, or other entity chooses to provide; and (j) Any other factors as determined by rules promulgated by the board pursuant to section 10-16-1403 (5). (5) Trade-secret, confidential, or proprietary information obtained by the board pursuant to this section may be accessed only by board members and staff or by a qualified independent third party that has contracted with the division pursuant to section 10-16-1403 (3) and is subject to a nondisclosure agreement prohibiting disclosure of such information. Any person with access to such information shall protect the information from direct or indirect publication or release to any person. (6) In performing an affordability review of a prescription drug, the board may consider any documents and information relating to the manufacturer's selection of the introductory price or price increase of the prescription drug, including documents and information relating to: (a) Life-cycle management; (b) The average cost of the prescription drug in the state; (c) Market competition and context; (d) Projected revenue; (e) The estimated cost-effectiveness of the prescription drug; and (f) Off-label usage of the prescription drug. (7) (a) To the extent practicable, the board may access pricing information for prescription drugs by: (I) Accessing publicly available pricing information from a state to which manufacturers report pricing information; (II) Accessing available pricing information from the all-payer health claims database and from state entities; and (III) Accessing information that is available from other countries. (b) To the extent that there is no publicly available information with which to conduct an affordability review, the board may request that a manufacturer, carrier, or pharmacy benefit management firm provide pricing information for any prescription drug identified pursuant to subsection (1) of this section. The failure of an entity to provide pricing information to the board for an affordability review does not affect the authority of the board to conduct the affordability review, as described in this section. (8) [Editor's note: Subsection (8) is effective January 1, 2025.] The board shall issue a report summarizing, to the extent permitted by section 10-16-1404 (3), the data that the board considered in making the board's determination as to whether a prescription drug is unaffordable. The board shall make the report available on its public web page.
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