In response to manufacturers’ co-pay assistance programs, insurers have become concerned that these programs will disrupt their formulary design and inappropriately encourage patients to receive, and physicians to prescribe, expensive therapies. It is not surprising then, that a study published this May has found a potential link between the availability of co-pay programs and positive clinical outcomes for patients, due to improved treatment persistence and adherence, across several diseases 1. Pharmaceutical patient assistance programs are intended to help patients afford expensive medications, often focusing on subsidizing patients’ insurance co-pay obligations that themselves can be quite substantial. State legislatures are beginning to take action, banning co-pay “accumulator” programs Congress may not be far behind.Another federal court has stricken down an HHS rule that would require manufacturers to “ensure” that patients get the benefits of co-pay assistance programs, or otherwise report such amounts as a discount in best price calculations.Co-pay programs remain unavailable to participants in federal government-funded health care insurance, with one federal court upholding HHS’ position that co-pay assistance for such patients is illegal.Patient outcomes studies suggest a clinical benefit of co-pay programs, and a negative impact of co-pay accumulator programs.
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