On August 26, CBSA and our partners participated in the state Prescription Drug Affordability Review Board (PDAB) meeting, which was open to the public. The PDAB was created in 2021 when the state legislature passed Senate Bill 175. CBSA’s Policy + Advocacy team worked closely with our members and partners to advocate for changes to the bill to mitigate the understood harm having a PDAB in Colorado would have on our state’s life sciences ecosystem.    

In accordance with Senate Bill 175, the PDAB holds regular meetings every six weeks, which began on November 12, 2021. In these first regular meetings, the board focuses on developing the rulemaking structure, which will enable them to set upper payment limits (UPLs) on up to 12 drugs.

The August PDAB meeting included a regulatory hearing on some of the rulemakings/regulations, including:

1. Proposed Rule Part 1 – General Provisions
2. Proposed Rule Part 5 – Reporting Requirements for Use of Savings
3. Proposed Rule Part 3 – Affordability Review

The meeting also covered approval to file additional regulations, including upper payment limit for drugs deemed unaffordable by an affordability review.

Prior to this board meeting, CBSA and BIO jointly submitted written comments. It is important to CBSA that the PDAB understands that CBSA has long been supportive of a more rational and transparent system of rebates – and specifically ensuring that patient cost sharing is based on the net cost of the drug to the payor. However,

• We are concerned that the increasingly complex and opaque rebate dynamics, paired with the market power PBMs now yield, have created an environment in which patients are harmed and competition is stifled. Simply put, patients who take medicines are not benefiting from the significant discounts manufacturers provide to PBMs and the savings from manufacturer assistance programs are not always being passed along to the patient at the pharmacy counter.
• We encourage the board to be clear that it must first identify drugs eligible for an affordability review by assessing drugs in accordance with the statutory criteria.
• Then, the board must select drugs from the list of those that are eligible. We encourage the board to be consistent with the legislative findings related to out-of-pocket costs for Coloradans focus on data that analyzes out-of-pocket dynamics for different patient segments.
• The board’s selection should then seek to understand where patients are potentially not benefiting from the rebate dynamics described above. Therefore, we continue to advocate for lowering patients’ out-of-pocket (OOP) costs.

Comments taken at the meeting were summarized and discussed, and a redlined version of the proposed changes will be released on September 9. At that time, the public will have additional comment opportunities through the end of September in advance of the “second reading” and potential final approval, which will take place at the board’s October 7^th meeting.