Prescription Drug Affordability Board Activity, April 17 - April 30, 2025

PDAB Chair Gail Mizner gave an update to the PDAAC: Amgen brought a suit against the board and the court ruled that the case was dismissed because Amgen lacked standing to bring the case. They are going to refile in federal court. Embrel rule cost analysis has been published on the PDAC website. Rulemaking did not happen at the April 11 meeting. Instead, the board discussed a PBM’s miscategorization of data in the all claims database, switching commercial and Medicare claims. The board asked for corrected tables and will decide at the next meeting if they will consider UPL rulemaking for three drugs (Enbrel, Cosentyx and Stelara). The board also asked for increased input from stakeholders with scientific and medical training and has received a lot of input from patient organizations. The board wants input from individuals with health issues, and scientists and doctors who are not affiliated with pharmaceutical companies. The board is concerned that patient groups providing comments are associated with pharmaceutical companies. 

The PDAAC made suggestions for patient and doctor recruitment, including posting notices in medical group newsletters, doctors offices and—to reach uninsured patients—ERs

Dr. Brett McQueen suggested using this article to improvement patient engagement: https://pubmed.ncbi.nlm.nih.gov/38241282/

Leah Lindahl, Healthcare Distribution Alliance representative, complained that the PDAB misrepresents industry, which hasn’t been well utilized for information. She also complained that the board dismissed comments from patient groups as “not the right patient groups.” Misner responded that the groups need to provide sources of funding for transparency.

 

Sophie Thomas introduced herself. Previously the PBM enforcement director, she is now also the PDAB director. She stated that the PDAB is forming a time-limited stakeholder workgroup to identify best practices for gathering sensitive consumer experience information and determining preferred methods to gather info from consumers. They are requesting voluntary disclosure of conflicts of interest. She highlighted centering stakeholders as part of the PDAB’s values.

Stakeholders the PDAB is attempting to reach:

• PDAAC
• Patients & caregivers affected by a condition or disease treated by prescription drugs
• Advocacy organizations
• Providers with prescription authority including 340b clinics
• Manufacturers of the drugs selected for affordability review

PDAAC member Ingrid Pan pointed out that pharmacists are not included in this list and that social workers and other members of patient care teams are also missing.

PDAAC member Dr. Richard Miranda asked why insurers were not on the list, including, Dr. Pan pointed out, case managers at insurance companies.

Methods for gathering information from consumers:

1. Surveys
2. Group meetings
3. Written and verbal comment
4. Listserv

The council made suggestions about other methods to reach them:

McQueen asked that they pay close attention to survey language. Pan asked that they have more funding for promotion and utilizing existing patient and medical organizations’ regular meetings to engage with groups.

The PDAB will request voluntary disclosure of conflicts of interest from those with science and medical training. 

The council asked whether they’re going to do this for consumers and patients as well. Katelin Lucariello and Ingrid Pan pointed out that experts in the field are often in multiple roles, and that disclosures may cause PDAB to dismiss their concerns because they have consultancies with industry. Brett McQueen and Leah Lindahl agreed. Conflicts of interest should be clearly defined in contrast to bias.

The PDAB is seeking info from stakeholders specifically on best practices for:

1. Gathering sensitive consumer experience information
2. Determining preferred methods to gather information from consumers
3. Requesting voluntarily conflicts of interest

McQueen pointed out that #1 sounds like personal health information (PHI), and it needs to be clarified that it’s not. 

Future steps:

1. Board staff will hold the stakeholder workgroup in fall 2025
2. PDAAC members are  invited to participate 
3. Staff will deliver recommendations to PDAB in December 2025

PDAAC recommended that the Upper Payment Limit data submission guide (DSG) include a glossary of terms, verify exclusion of QALY data and clarify that confidentiality is insured.

Section changes:

1. Impact to older adults and persons with disabilities
   • Clarify language: “what is meant by the impacts on older adults and persons with disabilities”?
   • Add section requesting information on patient assistance programs
   • Clarify that submission can be written or oral
2. Research and methods that employ a dollars-per-QALY
   • Staff will review submissions for QALYs before information is shared with the board
   • QALYS will not be used during UPL rulemaking
3. Manufacturer submissions
   • Add average price changes to the data points requested from manufacturers
4. Wholesaler submissions
   • Rebates and discounts do not accurately reflect the relationship between manufacturers and wholesaler so the description was changed to “chargebacks”
5. Pharmacy/provider submission
   • Is the drug purchased from a manufacturer or distributor?
   • Do out of network prescriptions need to be transferred?
6. Separate document provides guidance to submit confidential information

Rainier Simons, CANN opined that cost benefit analysis on Enbrel is not substantive and needs greater detail. 

Amanda Boone repeated Lindhal’s comment that patients, including her, get insulted and attacked during meetings. She complained that there is no transparency in PDAB funding and that the program isn’t saving money and is concerned that program will impede access to medicine

Bridget Dandar-Seritt repeated concerns that patients are dismissed and called “bad actors” or “fear mongers” and wants the discriminatory nature of how the board speaks about patients changed. 

Emily Zadvorny commented that PBMS and vertically integrated healthcare system are the cause of price issues. She hopes the PDAB and PDAAC will continue to look at all of the drivers of cost.

Vanessa Lathan (EACH/PIC): UPLS do not guarantee patients will receive savings. She is concerned that patients will have limited access to medicine. 

Candace DeMatteis, PFCD: Avalere research states that UPLS are not likely to lower patient costs, UPLS are likely to harm access.