The Hidden Advantages of PAPs for Their Providers
The concern is that pharmaceutical companies “can charge prices as high as they want,” because PAPs reduce public demand for lower prices, Dr Zafar said.
Robert Carlson, MD, CEO of the National Comprehensive Cancer Network (NCCN) in Fort Washington, Pennsylvania, shared this concern.
“It’s a 2-edged sword,” Dr Carlson said of PAPs. “They do help patients who would not otherwise access a medication, but the other side of the equation is it’s an artificial way that drug companies can support the high costs of drugs. It’s good for an individual patient, though perhaps not so good for society.”
Dr Zafar and colleagues studied 24 drug manufacturers’ PAP program websites (and called patient-assistance hotlines) to assess what information is readily available to patients.3 Those 24 manufacturer PAPs cover 87% of FDA-approved cancer drugs. One in 5 PAPs reviewed failed to describe eligibility criteria, and none of the PAPs contacted would share participation statistics with the researchers. Thirty-nine percent of PAPs required patients to re-apply annually to maintain enrollment.
PAP eligibility criteria vary from program to program, but most are available to uninsured patients earning less than 200% of the federal poverty level ($11,880 a year for an individual, or $24,300 for a family of 4).
Some free-drug programs, however, allow patients with much higher incomes to participate.
“Among those willing to disclose limits, average maximum annual income for patients applying to free drug programs was $86,279,” with a range of $51,183 to $125,000, the researchers reported.
It is unclear how many patients apply for PAP assistance nationwide each year.
“Most patients who apply for [PAP] assistance are approved,” believes Dr Vlastelica, based on her institution’s experience. “At Duke, approximately 5% are denied, mainly due to the applicant being over the income limit.”
Even outpatient medications that are covered by insurance can involve high out-of-pocket costs for patients.
“Patients often don’t let their providers know what they actually have to pay at the pharmacy,” she said. “This is true not only for their chemotherapy medications, but other supportive-care medications, like those for pain and nausea.”
With growing awareness of patient costs among oncologists and the proliferation of patient-navigation services, PAP enrollment has probably climbed over recent years, Dr Vlastelica told Cancer Therapy Advisor. Exact figures are difficult to confirm, however, since no government agency tracks PAP enrollment.
“I think this may be more likely for the intravenous medications, because the practice is more likely to see the billing than for a prescription sent to an outside pharmacy,” noted Dr Vlastelica. “Most drug companies and their representatives are very proactive in providing information about, and discussing, their programs.”
Regulatory oversight of PAPs is scant. PAPs are not regulated by the FDA, partly because PAPs ensure access to drugs that have been already been approved. Under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), however, insurance providers must coordinate with PAPs.4
Rules for Medicare beneficiaries’ participation in PAPs, however, can be dauntingly complex for patients.