January brings a surge to new patient assistance programs (PAPs) which are charitable functions (with substantial pharma industry funding) to provide copay and other assistance to needy patients. Among some of the more prominent charity efforts, the Good Days / Chronic Disease Fund, Inc. has opened a fund for HIV/AIDS patients, including infection-prevention methods; The Patient Access Network (PAN) Foundation opened a PAP for bladder cancer patients; and the Healthwell Foundation open a fund for patients living with migraine and, in November, one for a condition known as Congenital Sucrase-Isomaltase Deficiency (CSID). Each of these 501(c)3 organizations also support dozens of other disease-specific funds.
There’s a seasonality to these funds: in general, they provide several thousand dollars’ worth of assistance for copays, premiums and other costs associated with drug therapy, to patients that meet various levels of neediness. But the funds perform, in a given year, for as long as the money is available, and then run out until the next year, or renewal (none of the companies provide a figure for the funds’ available monies, nor for their sources). PAP programs run by charities are obligated to provide assistance to qualified patients on a first-come, first-served basis, and pharma companies can have no say in what drugs get supported. Nevertheless, it’s worth noting that CSID had a treatment, Sucraid (sacrosidase), approved for QOL Medical, a Florida drug developer, in October; migraine has had a treatment approval of Lilly’s Emgality (galcanezumab-gnlm) in September, and the bladder cancer drug arena has become hotly competitive among several recent biologics, including Merck’s Keytruda (pembrolizumab) and Genentech’s Tecentriq (atezolizumab). The only FDA-approved treatment for HIV infection prevention is Gilead’s Truvada (emtricitabine and tenofovir disoproxil fumarate).
Last June, and again in August, HHS initiated what it calls the “Regulatory Sprint to Coordinated Care,” which is intended to touch on multiple aspects of how the Anti-Kickback Statute and Stark law (which pertains to physician self-referring) might be modified going forward. PAP charities were among those providing commentary to the HHS requests for information. According to Claire Turcotte, a partner at the law firm Bricker & Eckler, “CMS and OIG are currently reviewing comments and are expected to issue proposed rules in 2019 that could relax or create new exceptions and safe harbors,” which could serve to loosen some aspects of how PAPs operate.