California Health and Safety Code 127677 – (a) A manufacturer of a prescription drug with a wholesale …
(a) A manufacturer of a prescription drug with a wholesale acquisition cost of more than forty dollars ($40) for a course of therapy shall notify each purchaser described in Section 127675 if the increase in the wholesale acquisition cost of a prescription drug is more than 16 percent, including the proposed increase and the cumulative increases that occurred within the previous two calendar years prior to the current year. For purposes of this section, a “course of therapy” is defined as either of the following:
(1) The recommended daily dosage units of a prescription drug pursuant to its prescribing label as approved by the federal Food and Drug Administration for 30 days.
Terms Used In California Health and Safety Code 127677
- department: means State Department of Health Services. See California Health and Safety Code 20
- State: means the State of California, unless applied to the different parts of the United States. See California Health and Safety Code 23
(2) The recommended daily dosage units of a prescription drug pursuant to its prescribing label as approved by the federal Food and Drug Administration for a normal course of treatment that is less than 30 days.
(b) The notice required by subdivision (a) shall be provided in writing at least 60 days prior to the planned effective date of the increase.
(c) (1) The notice required by subdivision (a) shall include the date of the increase, the current wholesale acquisition cost of the prescription drug, and the dollar amount of the future increase in the wholesale acquisition cost of the prescription drug.
(2) The notice required by subdivision (a) shall include a statement regarding whether a change or improvement in the drug necessitates the price increase. If so, the manufacturer shall describe the change or improvement.
(d) The notice required by subdivision (a) shall be provided to each state purchaser and other purchasers described in paragraphs (2) to (4), inclusive, of subdivision (a) of Section 127675 if a purchaser registers with the department for the purpose of this notification. The department shall make available to manufacturers a list of registered purchasers for the purpose of this notification.
(e) If a pharmacy benefit manager receives a notice of an increase in wholesale acquisition cost consistent with subdivision (a), it shall notify its large contracting public and private purchasers of the increase. For the purposes of this section, a “large purchaser” means a purchaser that provides coverage to more than 500 covered lives.
(Amended by Stats. 2021, Ch. 143, Sec. 110. (AB 133) Effective July 27, 2021.)