Weekly Policy Blog: PDAB Releases Stakeholder Engagement Guide on Affordability Review Process
By: Colorado BioScience Association Date: 08/14/2023
As the Colorado Prescription Drug Affordability Board (PDAB) begins affordability reviews of the five prescription drugs selected earlier this month, it is reaching out to stakeholders to request their engagement in the affordability review process via their Stakeholder Engagement Guide. Specifically, the PDAB is seeking input from patients and caregivers, individuals with scientific and medical training, drug manufacturers, insurance carriers, and Pharmacy Benefit Managers (PBMs). Stakeholders can engage through weekly office hours with staff, stakeholder meetings, and submission of written or verbal public comment, or voluntary written information.
CBSA is Advocating for Our Community
CBSA shares the goal of improving the affordability of medicines for patients. However, we remain concerned that any future decision to deem a drug unaffordable or to set a state-mandated upper payment limit (UPL), could have serious unintended consequences on patients’ access to life-saving and life-changing medicines and on the feasibility of bringing new innovative biopharmaceutical therapies to patients with unmet medical needs. CBSA is advocating for our life sciences community.
The Facts Matter
When assessing affordability and determining whether to impose an upper payment limit (UPL) for each drug, the board must consider many factors set forth in rule including:
- The price the manufacturer sells the drug for
- The cost to produce the drug
- Price reductions such as rebates and discounts
- Cost sharing through copayments, coinsurance, deductibles etc.
- How much patients pay out of pocket
- The effect of price on consumer access
During the PDAB’s process to select drugs for affordability review, CBSA, through joint letters with BIO, expressed concerns about the accuracy and reliability of data sources, material errors in calculations and problematic process, and methodologies leading to critical errors in the data for specific drugs, as well as, the prioritized list of drugs in the Colorado PDAB 2023 Eligible Drug Dashboard. We also urged 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 determining whether to set a UPL, including the 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 the number of direct and indirect biopharma jobs in Colorado expected to be lost.
The PDAB’s failure to consider all the important information risks patients’ access to their current medicines and to the next generation of innovative therapies that are being developed to improve and extend patients’ quality of life. As the PDAB engages stakeholders in the coming weeks and months, CBSA is committed to addressing the spread of misinformation and will continue to support our members in ensuring that the Board has access to all relevant and accurate information to inform their evaluation of whether the drugs it has selected are unaffordable, and if an upper payment limit should be set.
The Problem is Complex
Any intervention intended to control drug prices should:
- Be informed by complete accurate data and analyzed using correct proven methodologies
- Be based on a clear and accurate understanding of the complex chain of factors that determines what consumers pay for prescription drugs, and
- Address the health care system as a whole, considering every player in the complex multi-directional flow of funds through the pharmaceutical distribution system, which includes, manufacturers, wholesalers, pharmacies, PBMs, health plans, plan sponsors, and patients.
The PDAB’s determination of whether each drug is unaffordable and whether an upper payment limit will be set threatens to narrowly impose controls directly on manufacturers of medicines that prevent, treat and cure disease, without adequate regard to true transparency across the entire healthcare system.
At the same time, the national conversation on drug pricing reform has broadened bipartisan discussion on other drug pricing reforms that we believe are crucial for making medications more affordable for patients.
CBSA is committed to continued collaboration with members, industry partners and a broader coalition of organizations to educate the PDAB, the Prescription Drug Affordability Advisory Council (PDAAC) and the public about the complexity of the flow of funds through the pharmaceutical distribution system, how drug prices are determined, and what actually impacts the price patients pay at the counter. CBSA will also emphasize the innovative medical therapies being developed in our state to benefit patients suffering from diseases lacking treatment or cures, which are at risk of advancement to the clinic if upper payment limits stifle investment in R&D. If you are interested in helping CBSA convey the message about how Colorado companies are being impacted by the PDAB’s work, please contact Amy Goodman, CBSA Vice President & Counsel for Policy & Advocacy.
Opportunities for Stakeholders to Engage
During the PDAB meeting on August 4, Lila Cummings, Prescription Drug Affordability Director, said the division will be “over-inclusive in reaching out to stakeholders”. Since then, the Stakeholder Engagement Guide was released outlining all the ways stakeholders can engage in the PDAB’s affordability review process.
CBSA has been working closely with our members and our national partners at BIO and PhRMA to proactively engage and advocate every step of the way. To learn more, visit our Weekly Policy Blog on August 7, PDAB Selects Drugs for Affordability Reviews.
The opportunities for drug manufacturers, individuals with scientific and medical training, and for patients and caregivers to provide the PDAB input are summarized below.
Voluntarily Submitted Information from Manufacturers or Other Entities
The deadline for drug manufacturers or other entities to submit written information for the PDAB to consider is October 3, 2023. The method for these submissions will be sent by the PDAB in upcoming listserv emails. CBSA will watch closely for this information to be released and follow-up with more details once we learn more.
Scientific & Medical Training Expertise Stakeholder Meetings
PDAB staff will facilitate stakeholder meetings September 19-27 for individuals with scientific and medical training with respect to a condition or disease treated by the prescription drug that is under review by the Board including autoimmune diseases, HIV, psoriasis and psoriatic arthritis, and cystic fibrosis.
Separate virtual meetings will be held for each of the five drugs selected for an affordability review. Specific meeting times, meeting registration links and methods to submit information will be sent by the PDAB in upcoming listserv emails. If you are developing a therapeutic that treats one of these conditions or are a scientist or medical professional with expertise in one of these conditions and would like to engage in the stakeholder input process, please contact Amy Goodman, CBSA Vice President & Counsel for Policy & Advocacy.
Patients & Caregivers Stakeholder Meetings
PDAB staff will also facilitate stakeholder meetings September 19-27 for patients and caregivers affected by a condition or disease that is treated by the prescription drug under review by the Board including autoimmune diseases, HIV, psoriasis and psoriatic arthritis, and cystic fibrosis.
Separate virtual meetings will be held for each of the five drugs selected for an affordability review. Specific meeting times, meeting registration links and methods to submit information will be sent by the PDAB in upcoming listserv emails. If you are a patient or caregiver and would like to engage in the stakeholder input process, please contact Amy Goodman, CBSA Vice President & Counsel for Policy & Advocacy.
Upcoming PDAB and PDAAC meetings:
- 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. We oppose the creation and enforcement of UPLs that we believe will lead to negative unintended consequences on patient access to medicines, on healthcare providers prescribing medicines, and on the market for innovative biopharmaceutical products.