The EACH/PIC Coalition submitted comments to the Washington PDAB providing input on the upcoming affordability determinations for Enbrel and Xtandi and urging for clear, data-driven and repeatable methodology for drug reviews.
The letter stated:
We appreciate the opportunity to provide comments as the board prepares to make affordability determinations for Enbrel and Xtandi. These first determinations will establish an important precedent for future reviews. We therefore encourage the board to establish a clear, data-driven, and repeatable methodology that focuses on the affordability challenges experienced by patients, identifies the source of those challenges, and considers whether a subsequent upper payment limit (UPL) would meaningfully address them.
As the board deliberates on each drug, we urge members to determine whether patients are actually experiencing affordability challenges, understand what is driving those challenges, and apply clear and consistent criteria across all drugs under review. Doing so will make the review process more transparent and provide a stronger foundation for determining which policy solutions are appropriate.
Importantly, much of the patient input collected during the board’s review of Enbrel and Xtandi points to insurance-related barriers. Patients identified loss of insurance, waiting periods, barriers to financial assistance, and other insurance restrictions as challenges affecting access to treatment.
These problems are unlikely to be resolved by a UPL. A UPL limits reimbursement for a medication, but does not directly reduce deductibles or coinsurance, eliminate coverage restrictions, or improve access to financial assistance. There is also no guarantee that changes in reimbursement will translate into lower out-of-pocket costs for patients.
The board should also carefully evaluate patients whose costs fall outside broader averages. Patients facing particularly high out-of-pocket costs clearly warrant attention, but their experiences should not automatically be interpreted as evidence that a UPL is the appropriate response. Depending on the source of the hardship, targeted policies such as out-of-pocket caps or improved access to financial assistance may provide more direct relief.
The board should also consider how a UPL could affect continued access to treatment. Implementation of a UPL could affect manufacturer participation in the market or prompt insurers and pharmacy benefit managers to change coverage, formularies, tiering, or utilization management. These responses could leave patients with fewer treatment options or result in non-medical switching.