By Karin Rives
June 5, 2009 – Each month, Jefferson Regional Medical Center administers between 20 and 40 doses of Retavase, a drug used to treat acute heart attack. An injection dose can cost as much as $2,000, so uninsured patients who don’t qualify for Medicaid were well-served by the patient assistance program that New Jersey-based EKR Therapeutics, the manufacturer of Retavase, offered. That is, until the program suddenly ceased this spring and the option of free drugs disappeared.
“We had a couple of applications pending with them at the time and I called to follow up on Medicaid denial paperwork I had faxed over when they told me,” said Lelan Stice, the Pine Bluff, Ark.-based hospital’s administrative director of pharmaceutical and materials management. “There was no prior warning. So now, for those patients that can’t get Medicaid, the hospital just has to write the bill off as charity care and take a loss.”
So it goes with patient assistance programs, or PAPs. They come and go as drugs lose their patent or – as was apparently the case with EKR – when budget constraints force drug makers to scale back. And at a time when many drug companies are expanding their PAPs to meet the growing needs of uninsured Americans and the country gears up for healthcare reform, a debate is emerging over what role such programs do, and should, play.
Drug companies spreading word of PAPs
According to PhRMA, the trade organization representing large, brand-name manufacturers, more than 5.7 million patients have received drug assistance since the group formed its high-profile Partnership for Prescription Assistance program four years ago to provide easier access to free drugs. Television stars Montel Williams, the partnership’s spokesman, and Mayte Prida of the Hispanic network Telemundo are marketing the initiative nationwide, as is the group’s “Help is Here Express” bus criss-crossing the 50 states.
Pfizer also made a splash when it recently rolled out a free-drug program tailored to the newly unemployed. The initiative earned the company accolades nationwide, although some cynics suggested that Pfizer was simply pushing free drugs to steer people to brand-name medications with sagging sales. Pfizer says the program was initiated by company employees who were witnessing friends and family struggle to pay for medicines after losing their jobs.
Manufacturers “have done a great job raising awareness of patient assistance programs, and lots of people are using them now. So it’s fair to begin to ask what role these programs play,” said Dr. Niteesh Choudhry, an assistant professor at Harvard Medical School and associate physician at Brigham and Women’s Hospital in Boston. He recently co-authored an article inHealth Affairs titled “Drug Company-Sponsored Patient Assistance Programs: A Viable Safety Net?,” which argued that more transparency in PAP programs should be a national health policy priority.
Government has a stake, some say
Clinics and hospitals today spend considerable time and public resources helping patients access a patchwork of patient assistance programs. Working with patients with multiple chronic conditions who need several different drugs from different programs can be especially time-consuming, Choudhry said. PAPs also encourage patients to use brand-name drugs that can have direct financial implications for Medicaid or employer-sponsored health plans, he noted.
With the Obama administration focusing its domestic agenda on healthcare reform, “it’s very natural to begin asking questions,” Choudhry said. “What role do these programs play, and are they a solution for healthcare reform? Wouldn’t it be good to work together to better target these programs so they reach patients more effectively?”
But the Health Affairs article did not go over very well with the drug industry, which rejected the idea of having government snoop around their free drug programs. If drug makers are subjected to more administration and regulation it’s “quite possible” that many will just drop their programs, warned Myrl Weinberg, president of the National Health Council, a Washington, D.C.-based patient advocacy group funded in part by the drug industry.
Regulations can backfire, industry warns
Ken Johnson, PhRMA’s senior vice president, echoed her concerns in another Health Affairsarticle. Demands for more transparency “during these uncertain economic times could cast a chill nationwide on other philanthropic efforts,” he wrote.
Such words of caution notwithstanding, California law makers passed legislation in 2006 requiring pharmaceutical manufacturers to report some of the data that Dr. Choudhry and his co-authors called for.
Section 130530 of the California Health and Safety Code says that in order to verify that California residents benefit from patient assistance programs, manufacturers must share annually with the state “the total value of the manufacturer’s drugs provided at no or very low cost to California residents during the previous year.” They must also document “the total number of prescriptions or 30-day supplies of the manufacturer’s drugs provided” during the same period.
Uncertain future for PAPs – and the healthcare world
What the final healthcare legislation that Congress is working on will look like is anybody’s guess at this point. Will there be universal healthcare coverage, and if so, what will be the definition of “universal”? Will there even be a need still for charity prescription drugs?
“There absolutely will be and should be,” said John Doster, senior vice president and managing director of the Franklin Group, which administers traditional and institutional patient assistance programs along with reimbursement programs for large manufacturers.
“In any scenario that looks reasonable at this point, there will be many products that will not be easily accessible through formularies under healthcare reform, and no drugs works for everybody,” he said. “There may be different business rules going forward and these programs may evolve, but there will always be valuable services that patient assistance programs provide.”
In an ideal world, patient assistance programs would become obsolete, said Marc Steinberg, deputy director of health policy for Families USA, a Washington, D.C.-based group pushing for healthcare reform.
“We would like to see high-quality prescription drug coverage for everybody, but we also know there will be a transition period of several years when these programs will be phased in,” he said. “So I could definitely see a role for patient assistance programs, but it would have to be a different model than we have today. And if everybody has healthcare coverage, the manufacturers would have to rethink who their target audience is.”