Patient Assistance Programs: Are They Still Relevant?

One of the key reputational assets of Big Pharma is the patient assistance program [PAP], which provides patented innovative medicines to needy patients for free or at a nominal charge – it’s the industry’s own branded version of the social safety net. But a shifting landscape of government fiscal pressures, economic decline and the erratic pace of health reform is putting the PAP model under intense scrutiny. Using the old rubric that no good deed should go unpunished, a growing list of stakeholders is posing the pregnant question: are PAPs still relevant?

Pharm Exec’s sister organization CBI held its 13th annual state-of-play conference on PAP programs last week in Baltimore, attracting a sellout crowd of more than 400, all of whom displayed the angst, curiosity and earnestness of a Big Pharma specialty in flux. Helpings of “more of the same” was not on the menu; instead the crowd’s appetite centered on the nouvelle cuisine of Obamacare, where the industry can expect benefits in very small portions, served up at high expense. Most of the speakers and panelists emphasized how the Patient Protection and Affordable Care Act might force major adjustments in how PAPs are financed, organized and accessed. The affordability gaps such programs are designed to fill is likely to change, with the underinsured population becoming more prominent as a source of demand. And the numbers of patients classified as underinsured will rise as high cost specialty medicines claim a larger share of the drugs bill. Meanwhile, more of the low income patients that are currently the focus of many PAPs are supposed to qualify for expanded Medicaid coverage. Overall, the practical effect will be to require drug-makers to consider transforming these programs into co-pay, cost-sharing or discount schemes, which raises in turn a host of issues, the most important of which is the loss of a charitable orientation to something more overtly commercial.

Co-pay schemes are a competitive minefield, as evidenced by the furor unleashed by Pfizer’s low ball $4 per prescription offer to keep Lipitor patients on board in a post-patent world. Whatever the merits, no one associates that offer with the “safety net” premise rooted in the PAP model. It is likely to accentuate criticism that PAPs can actually increase cost to payers by discouraging patients from moving to lower cost alternative therapies. So if the pressure is to adapt and opt for the co-pay approach, will good will and reputational enhancement take a bigger hit?

In fact, Big Pharma may have the worst of both worlds: uncertainty on how best to organize to respond to reform’s impact on the way health services are financed and distributed – some panelists suggested turning PAPs into step-aside foundations to win favor with an invigorated HHS Office of Inspector General [OIG] – combined with expectations to fill the breach caused by a yawning deficit of funds on the government side. Said one speaker: “it’s not well known, but under reform we face in 2017 and beyond a transfer of responsibility for funding all this increased access to care to the states; without some fundamental restructuring prior to then, the whole system is likely to collapse – and all eyes will turn to industry’s big pockets.”

As a sign of the times, when attendees were asked in an instant on-site poll what aspects of their company’s PAP program was most likely to face pressure for change, the largest response was the non-financial elements of the eligibility criteria for participation. In essence, it means no one today really knows what in the future will define which patients get support or not, and who will do the defining. The bottom line? Charity must find a metric. And the Big Pharma’s must lead, or government will set that metric for them.