The programs can also encourage patients to seek expensive brand-name drugs instead of less-expensive alternatives.

“That certainly contributes to health care costs,” Fugh-Berman said. Physicians should consider not only their patients’ co-pays, but the “true cost” of a drug to society and the health care system, she believes.

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Dana Kuhn, founder and president of Patient Services Inc. (PSI), who pioneered the nonprofit foundation model of patient assistance, noted, however, that PSI was created to help patients for whom generic alternatives to expensive brand-name drugs were unavailable.

Most of the patients to whom PSI offers assistance “do not have generic alternatives,” he said. “When generic alternatives are available or when they become available, PSI covers those treatments equally, as prescribed by the patient’s physician. If there were no charitable non-profit patient assistance programs to help afford treatment, many patients would be forced to discontinue treatment altogether.”

The drug price-inflation controversy came to a head in August 2015, when Turing Pharmaceuticals made headlines—and attracted the attention of congress and federal investigators, including the Federal Trade Commission—over its abrupt 5000% price hike for pyrimethamine (Daraprim) soon after securing rights to the antimalarial drug. Pyrimethamine is also used to treat Toxoplasma gondii infections in immune-compromised patients, including those undergoing chemotherapy.

Facing public outrage, Turing pointed to PAPs as evidence that the price hike would not present a barrier to care. The company paid PAP charities to offer drug discounts to patients.

Drug companies are not legally permitted to coordinate with the PAP charities, however, to earmark donations for their own medications.

But a whistleblower, former Celgene sales representative Beverly Brown, claims that Celgene and 2 PAP charities colluded to do just that, coordinating co-pay assistance to boost Medicare reimbursements for Celgene’s multiple myeloma drugs, lenalidomide (Revlimid) and thalidomide (Thalomid).4

Celgene publicly rejected Brown’s allegations as “baseless,” but did not respond to a request for comment for this story. The allegations caught the attention of the United States Justice Department, which issued a subpoena regarding Celgene’s relationships with the PAPs.4

That subpoena follows others issued over the past year to Valeant Pharmaceuticals, Gilead Sciences, Biogen, Jazz Pharmaceuticals, and Horizon Pharmaceuticals.

Drug companies point to insurers’ high co-pays as the real problem, and argue that PAPs are the best way to help ensure patients’ access to vital medications.