Weekly Policy Blog: PDAB Bill Advances, Plus CBSA Advocates on Federal Issues
By: Colorado BioScience Association Date: 03/13/2023
On March 10, CBSA testified in the House Health and Insurance Committee in opposition to HB23-1225, Extend And Modify Prescription Drug Affordability Board (PDAB). While CBSA shares the bill sponsors’ goal of improving the affordability of medicines for patients, we are concerned the uncertainty and unpredictability created by this bill will make it harder for the companies in our life sciences ecosystem to raise the capital they need to support research, development, and commercialization of new therapies. We also fear this bill will make it harder for patients to access medicines that have a state-mandated upper payment limit (UPL).
CBSA opposed SB21-175, the original PDAB bill, because of the concern that, by limiting reimbursement for the few new drugs that do get approved, the flow of capital that fuels biomedical innovation will stall.
CBSA is now concerned that HB23-1225 would prematurely expand the PDAB’s authority to conduct affordability reviews for more drugs when they have yet to complete an affordability review and expand the Board’s authority to set UPLs for an unlimited number of drugs when the Board has yet to set a UPL. We have not yet seen how the impact of the PDAB will play out for both patients and the life sciences ecosystem.
There is already significant fear around how the PDAB’s imposition of price controls will create regulatory uncertainty and unpredictability for investors and devastate companies’ ability to raise money to begin these ventures. The expansion of the eligibility criteria for an affordability review, including a wide-open catch-all provision that would permit any drug to be referred to the Board, along with the removal of the guardrails around how many UPLs the Board can set, just exacerbate those concerns.
It doesn’t make sense to remove important guardrails when we haven’t yet had a chance to gather any data on the potential issues that necessitated those guardrails in the first place. This added unpredictability will make it so potential life science investors will be even more unsure they’ll be able to recoup their investment.
Despite testimony from various stakeholders requesting that legislators reconsider extending and expanding this unproven program that could result in unintended consequences for patients and the life sciences ecosystem, HB23-1225 passed out of the House Health & Insurance Committee on a party line vote of 8-3. The bill now moves to the House Floor.
Also, this past week, CBSA President & CEO, Elyse Blazevich, and Vice President and Counsel for Policy + Advocacy, Amy Goodman, conducted virtual Hill visits in coordination with AdvaMed’s State Medical Technology Alliance Fly-In. They addressed some of the top concerns and priorities of CBSA members, and shared details on the growth and health of the life sciences ecosystem in Colorado with members of Colorado’s delegation.
The topics CBSA discussed included:
- Ongoing concerns with the Inflation Reduction Act (IRA),
- Improving access to emerging technologies through the Transitional Coverage for Emerging Technologies (TCET) rule and the Ensuring Patient Access to Critical Breakthrough Products Act,
- Research & development expensing,
- Modernizing regulation of diagnostic tests through the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, and
- The potential expansion of the Trade-Relations Aspects of Intellectual Property Rights (TRIPS) waiver.
CBSA’s Advocacy Efforts
The CBSA Policy + Advocacy team collaborates with members, partners, and policymakers to advocate for policies that protect patient access to needed therapies and technologies and support a pro-innovation environment for life sciences in Colorado (see CBSA’s Policy Priorities).
To get involved with CBSA’s advocacy efforts or talk about your concerns, perspective, or position on a bill, please contact CBSA’s Vice President and Counsel for Policy + Advocacy, Amy Goodman.