Amgen, Astellas pay nearly $125 million to settle US claims of paying kickbacks through copay assistance foundations

The US Department of Justice (DOJ) announced that Amgen and Astellas agreed to pay nearly $125 million to resolve allegations that the companies used charities that help cover Medicare patients' out-of-pocket drug costs as a way to pay kickbacks aimed at encouraging the use of their medications. The claims relate to Amgen's Kyprolis (carfilzomib) and Sensipar (cinacalcet), as well as Astellas' Xtandi (enzalutamide).  

"According to the allegations…Astellas and Amgen conspired with two copay foundations to create funds that functioned almost exclusively to benefit patients taking Astellas and Amgen drugs," remarked US attorney Andrew Lelling. "As a result, the companies' payments to the foundations were not 'donations,' but rather were kickbacks that undermined the structure of the Medicare programme and illegally subsidised the high costs of the companies' drugs at the expense of American taxpayers," Lelling added.  

Specifically, the government contended that Amgen halted support of one charity providing financial support to patients taking any of a number of secondary hyperparathyroidism drugs and approached a second foundation with the goal of creating a fund to specifically support patients using Sensipar. Additionally, the DOJ stated that Onyx Pharmaceuticals, which Amgen acquired in 2013, asked a charity to create a fund to cover healthcare-related travel expenses for patients taking any multiple myeloma drug, but the fund was primarily used to cover such expenses for patients using Kyprolis.  

Meanwhile, Astellas was accused of asking two charities to create funds to provide copay assistance to Medicare patients using androgen receptor inhibitors, such as Xtandi, but not for other types of prostate cancer drugs. The government said that when the fuds were formed, Astellas was the sole donor, claiming that the company knew that Xtandi would likely account for the vast majority of utilisation from the funds.

As part of the settlement terms, both Amgen and Astellas have agreed to five-year corporate integrity agreements with the Office of the Inspector that will require the drugmakers to implement measures, controls and monitoring ensuring independence from any patient assistance programmes that they financially support. The companies have also agreed to create risk assessment programmes and obtain compliance-related certifications from company executives and board members.

The settlement comes after Alexion Pharmaceuticals, Jazz Pharmaceuticals and Lundbeck agreed earlier this month to pay a combined $122.6 million to resolve allegations that they used copay assistance programmes to increase sales of their products.

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