The EACH/PIC Coalition submitted comments to the Maryland PDAB on the proposed rule on the cost review study process.
The letter stated:
As the board undertakes this effort, we encourage it to ensure that affordability determinations remain focused on patient affordability. While healthcare spending is an important consideration for policymakers, spending metrics alone do not demonstrate that patients are experiencing affordability challenges. Affordability reviews should therefore be grounded primarily in evidence that patients are struggling to afford treatment.
Spending Metrics Alone Do Not Demonstrate Patient Affordability Challenges
The proposed regulation allows a drug to be deemed an affordability challenge based on factors such as spending levels, spending growth, value assessments, and market competition concerns.
These metrics may provide insight into healthcare system spending, but they do not necessarily demonstrate that patients are experiencing affordability hardships. Spending measures do not reveal whether patients can afford their medications, whether they are delaying or abandoning treatment due to cost, or whether they face barriers that make treatment unaffordable.
The purpose of an affordability review should be to identify and address affordability challenges experienced by patients. A finding that spending is high does not demonstrate that patients are struggling to afford a medication.
Evidence of Patient Affordability Challenges Should Be Required Before a UPL May Be Considered
As drafted, the regulation permits affordability challenge determinations based entirely on system spending metrics without evidence that patients are experiencing affordability challenges.
The board’s reviews of Ozempic and Trulicity illustrate this concern. In both cases, the affordability challenge determination was driven primarily by healthcare system spending metrics rather than evidence that patients were experiencing affordability hardships associated with those therapies.
At the same time, upper payment limits (UPLs) have the potential to affect the patients who rely on these medications. As a result, patients may ultimately bear the consequences of affordability determinations that were not based on evidence of patient affordability challenges in the first place.
For that reason, we encourage the board to require that at least one patient affordability criterion be satisfied before a drug may advance to consideration of a UPL or other affordability intervention. If a policy is being pursued in the name of improving affordability, there should first be evidence that patients are experiencing affordability challenges associated with that drug.
Establishing this safeguard would help ensure that affordability reviews remain focused on improving patient affordability rather than solely reducing healthcare system spending.