Patient Assistance Programs: Are They Still Relevant?
Autor: Cristiana Barbosa | Publicado: 2012-03-13T22:52:00-03:00

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.


By William Looney | Original Published: March 12, 2012 (PharmExec.com) 

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