Weekly Policy Update: Prescription Drug Affordability Review Board Members Appointed
By: Colorado BioScience Association Date: 10/08/2021
This week, Governor Polis announced the appointment of the inaugural five members of the Prescription Drug Affordability Review Board (PDAB). The PDAB was created through the legislature’s passage and Governor’s signature of Senate Bill 175 during this past session. 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.
CBSA led the way working to negotiate the inclusion of amendments to the legislation, of which five made it into the final version. These amendments represent important policy wins for our life sciences community. As introduced, the legislation would have allowed upper payment limits on any drug when the price rose more than $3,000 per year. However, that was changed to only allow such an action when a price goes up more than 10 percent in a year. These changes, along with protecting a five-year sunset for the board, were significant changes to protect health innovation in Colorado. All changes include:
- Amending the trigger threshold from $3,000 to 10%
- Asking for additional input to the PDAB from patients, caregivers, providers, and scientists
- Requesting additional input to the PDAB from manufacturers
Housed within the Division of Insurance, the PDAB is charged with collecting prescription drug pricing information and determining which drugs must undergo an affordability review. If the board determines that a drug is unaffordable for Colorado consumers, they have the authority to set an upper payment limit (UPL) on all payments and reimbursements for the drug in the state.
In accordance with Senate Bill 175, the PDAB will hold regular meetings every six weeks beginning on November 12, 2021. It is expected that during these first regular meetings the board will focus on developing the rulemaking structure which will enable them to set UPLs on up to 12 drugs starting in April 2022. The PDAB must also appoint members to a fifteen-member Advisory Council by January 1, 2022. The Council is designed to provide stakeholder engagement and input to the Board with representation from manufacturers, employers, carriers, and patient advocates.
As outlined within the law, the five members of the PDAB must have both an advanced degree and experience or expertise in either health economics or clinical medicine. Members may not be employees, board members, or consultants to drug manufacturers, carriers, or pharmacy benefit managers, or their respective trade associations. It is important to note that while the Governor has made appointments to the PDAB, these appointments must still be confirmed by the Senate during next session.
Background on appointed Board Members:
Term expiring September 27, 2022:
James Justin VandenBerg, Pharm.D., BCPS of Denver
VandenBerg is currently the Pharmacy Business Services Manager at Denver Health and started at Denver Health five years ago as the Drug Policy and Formulary Management Pharmacist. Before his time at Denver Health, he worked as a pharmacist in Phoenix, Arizona with the following organizations: Target, Banner Health- University Medical Center, and Cardinal Health. He graduated from the University of Arizona, College of Pharmacy in 2012 and completed his residency at Tucson Medical Center.
Terms expiring September 27, 2023:
Catherine Harshbarger of Holyoke
Harshbarger is the President and CEO of Melissa Memorial Hospital which is a small critical access hospital located in Holyoke. She has been with the Hospital for over two years where is initially worked in a dual role of CEO and Chief Clinical Officer. Prior to coming to Colorado, she previously worked as Chief Nursing Officer, interim CEO, and then CEO of Banner Health- Lassen Medical Center in Susanville, California.
Amarylis “Amy” Gutierrez, Pharm.D. of Aurora
Gutierrez joined UCHealth as Vice President and Chief Pharmacy Officer for the system. Additionally, she is a Clinical Associate Professor at the University of Colorado Skaggs School of Pharmacy. Before joining UCHealth, she served as the Senior Vice President and Chief Pharmacy Officer for Kaiser Permanente’s national pharmacy program and was the Chief Pharmacy Officer for the Los Angeles County Department of Health Services. Amy is the former President of the California Board of Pharmacy and is a graduate of the University of Southern California.
for terms expiring September 27, 2024:
Sami Diab, M.D. of Greenwood Village
Diab is the Immediate Past President of the Colorado Medical Society. He is a provider within Centura health’s network and is affiliated with Rocky Mountain Cancer Centers where he specializes in medical oncology/hematology and integrative oncology. He attended medical school at Damascus University, in Syria, and completed his residency at Wayne State University followed by fellowships in medical oncology at the University of Texas and in integrative Medicine, at the University of Arizona.
Gail Mizner, M.D., FACP, AAHIVS of Snowmass Village (Board Chair)
Mizner is the internal medicine consultant for Mountain Family Health Center working in the Basalt clinic, in her role she focuses on autoimmune diseases, endocrinology, and HIV care. She is a former faculty member in internal medicine at the University of Colorado Health Sciences Center, as well as former head of physician education for UCHSC’s AIDS Education and Training Center. And before returning to Colorado in 2010 she practiced in Prescott, Arizona, and in Ely, Nevada along with Northern Chile. She attended medical school at Yale University and completed her residency at the University of Colorado Health Sciences Center.
CBSA remains committed to advancing affordability solutions that correct market failures, increase competition, and lower costs for patients. We look forward to reengaging the strong life sciences coalition that worked tirelessly this past session on Senate Bill 175 now that the PDAB is moving forward in the implementation phase. And while there is still much to learn about how the PDAB will operate, based on its mission, we know the work to protect Colorado’s pro-innovation environment from the devastating effects of pricing setting policies has entered a new phase.