When the feds first kicked off a look at patient assistance programs, the company names that were surfacing were some of those known for hinky sales practices in a number of areas, Valeant Pharmaceutical and Horizon, for example. But as it has picked up steam, it also has rolled up some of the bigger players, like Gilead Sciences, Celgene and now Biogen.
The Boston-area biotech in an SEC filing Thursday said that it received a subpoena from the federal government in December for documents relating to government price reporting, rebate payments and Biogen's copay assistance programs for Avonex, Tecfidera, Tysabri and Plegridy.
It also got a civil investigative demand from the federal government for documents and information relating to relationships with groups that provide clinical education and reimbursement support services. It said it is cooperating in both cases.
These kinds of programs have come under increasing scrutiny as allegations have surfaced that some drugmakers are using them to juice sales. While government regulations prohibit drugmakers from tying charitable donations to specific support for their own drugs, a whistleblower lawsuit against Celgene has contended that it “gamed the system” so that charities would prefer its drugs when helping cancer patients needing help paying for treatment.
Celgene, which also received a subpoena, has denied seeking any special treatment from charities for its contributions of $50 million to $100 million a year. “Celgene donates money to fund these charitable organizations because, without this service, many cancer patients would be denied access to essential medical care simply because they cannot afford the treatment,” the company’s lawyers have said in court documents.
Drugmakers often fund their own direct assistance programs to help patients cover their share of the cost of expensive brand-name drugs. Biogen not only helps with copayments on its blockbuster Tecfidera, but even provides the drug for free for patients who are having trouble winning insurance reimbursement. Tecfidera, launched in 2013, now holds half the market share for multiple sclerosis treatments.
Others have also been subpoenaed for information about patient-assistance programs, including Gilead, which was asked for info about payment programs for its highly successful hepatitis C drugs.