Weekly Policy Blog: PDAB Selects Drugs for Affordability Reviews
By: Colorado BioScience Association Date: 08/07/2023
On Friday, August 4, the Colorado Prescription Drug Affordability Board (PDAB) selected five drugs for affordability reviews: Enbrel, Genvoya, Cosentyx, Stelara, and Trikafta. PDAB staff plan to begin conducting affordability reviews for the first three and let stakeholders know how to engage. After completing the affordability review for each drug, the PDAB may or may not decide to impose an upper payment limit (UPL) for the drug in Colorado. CBSA will continue to actively advocate for the life sciences ecosystem and for patients as this important process moves forward.
In 2021, the Colorado General Assembly passed SB21-175, which established the Prescription Drug Affordability Board (PDAB) “to evaluate and place upper price limits on the highest cost prescription drugs.” The five-member PDAB is charged with collecting prescription drug pricing information and determining which drugs should undergo an affordability review. If the PDAB determines that a drug is unaffordable for Colorado consumers, they have the authority to set a UPL on all payments and reimbursements for the drug in the state.
There is also a fifteen-member Prescription Drug Affordability Advisory Council (PDAAC), which is designed to provide stakeholder engagement and input to the PDAB with representation from manufacturers, employers, carriers, and patient advocates.
Then, in 2023, the Colorado General Assembly passed HB23-1225, which expanded the PDAB’s authority to conduct affordability reviews and to set UPLs for more drugs even though they had not yet completed a single affordability review or set a single UPL.
CBSA was part of the life sciences coalition that lobbied against SB21-175 and HB23-1225, fighting for and winning key amendments that mitigated some of the most harmful provisions threatening the availability of life-saving medications in Colorado.
Although CBSA shares the goal of improving the affordability of medicines for patients, we remain concerned that the PDAB will make it harder for patients to access medicines that have a state-mandated UPL and for companies in our life sciences ecosystem to raise the capital they need to support research, development, and commercialization of new therapies.
PDAB Selects Drugs for Affordability Reviews
On Friday, August 4th, the Colorado PDAB moved ahead with selecting five drugs for affordability reviews, which could result in the setting of UPLs, despite vocal opposition from rare disease patients and important questions about the data and methodology used to inform recommendations and guide prioritization.
CBSA is very concerned that this decision could have serious unintended consequences on patient access to medicines, on healthcare providers purchasing medicines, and on the market for innovative biopharmaceutical products.
- Highlight concerns about the impact of price control programs that create unpredictability for Colorado companies, negatively impacting companies’ ability to raise enough capital to advance early-stage therapeutic programs to patients.
- Urge the PDAB to gather state economic impact data to evaluate potential impact of pricing controls on investments and innovation and consider this at each stage of implementing UPLs—in the selection of products for review, in the determination to establish a UPL, and in setting a specific UPL, including:
- Number of therapies currently available today that would most likely not have come to market and therefore would not be available for patients and their providers, and
- Number of direct and indirect biopharma jobs in Colorado expected to be lost.
- Surface specific concerns with the PDAB and PDAAC’s work:
- A lack of clarity regarding the PDAB’s process and methodology,
- The accuracy and reliability of data sources informing the PDAB’s methodology,
- Concerns about material errors in calculations, and
- Public disclosure and handling of confidential information, among others.
- Urge strong caution against the PDAB selecting any drugs for affordability review until critical errors in the Prioritized List and individual ranked lists were corrected.
- Strongly urge the PDAB to slow down and methodically address stakeholder concerns expressed by numerous organizations and individuals from supply chain entities and patient groups.
- Suggest that when the PDAB does identify products for selection, a final vote on those selections should not occur until the meeting after they are identified and discussed so that stakeholders can provide input.
- Encourage the creation of an inquiry form or other process for manufacturers and other stakeholders to submit questions, comments, and/or objections to data on the dashboard and in other materials, with the option of remaining anonymous, and to ensure a timely response from the PDAB.
The recent comments CBSA has submitted can be found here:
- June 23rd letter from CBSA and BIO to the PDAB
- July 21st Dashboard Inquiry
- July 31st letter from CBSA and BIO to the PDAAC
- August 4th letter from CBSA and BIO to the PDAB
The PDAB also heard strong opposition from a variety of stakeholders, including the Colorado Women’s Alliance, a small business owner in western Colorado, the National Organization for Rare Disorders, the Rare Access Action Project, and a large showing from cystic fibrosis patients and advocates urging the PDAB not to select Trikafta or other drugs for rare diseases for an affordability review. Many of them, like Hannah Pfieffer, who was interviewed by KDVR, emphasized that their “concern is centered around making sure access to the drug does not go away as the process plays out.”
Before voting to select drugs for an affordability review, the PDAB discussed recommendations from the PDAAC, which included a list of twenty-five drugs not in priority order and some general guidance.
Despite important concerns about the data and methodology used by the PDAB, as well as vocal opposition from rare disease patients, the PDAB chose to move forward with selecting five drugs for affordability review and chose not to exclude drugs for rare diseases. However, they did categorically exempt all products with a therapeutic equivalent or biosimilar and all biosimilars. The PDAB selected:
- Enbrel (autoimmune diseases)
- Genvoya (HIV)
- Cosentyx (psoriasis and psoriatic arthritis)
- Stelara (psoriasis and psoriatic arthritis)
- Trikafta (cystic fibrosis)
In making their selections, the PDAB acknowledged that “the data [used to inform their selections] is not perfect.” For example, a Dashboard FAQs document posted by the Division of Insurance states that PDAB staff did not normalize the data prior to calculating the weights for the five prioritized metrics: Patient Count (25.888%), 5-year Change in WAC (22.961%), Patient OOP Cost (19.541%), Total Paid Amount (16.284%), and Avg Paid Per Person Per Year (PPPY) (15.326%), so the largest value (i.e., the Total Paid Amount) has an outsized impact on the rankings.
Per the PDAB’s direction, PDAB staff plan to begin conducting affordability reviews for the first three drugs selected and let stakeholders know how to engage in this next step in the process. The timeline and whether the reviews will be done sequentially or concurrently is not yet clear. The upcoming PDAB and PDAAC meetings are:
- PDAB – September 15, 10:00 a.m. – 2:00 p.m. MT (register here)
- PDAAC – October 12, 9:00 – 11:00 a.m. MT (register here)
- PDAB – October 27, 10:00 a.m. – 2:00 p.m. MT (register here)
- PDAB – December 8, 10:00 a.m. – 2:00 p.m. MT (register here)
After completing the affordability review for each drug, the PDAB may or may not decide to impose a UPL for the drug in Colorado. CBSA will continue to work closely with BIO, PhRMA, and member companies on next steps and is committed to opposing the creation and enforcement of UPLs that we believe will lead to negative unintended consequences on patient access to medicines, on healthcare providers purchasing medicines, and on the market for innovative biopharmaceutical products.