CMS Cancels Agreement With Novartis to Pay for CAR T-Cell Treatment

The U.S. Centers for Medicare and Medicaid Services (CMS) has ended a proposed “outcomes-based” agreement to pay for tisagenlecleucel, a chimeric antigen receptor (CAR) T-cell therapy for the treatment of acute lymphocytic leukemia and diffuse large B-cell lymphoma.

The agency entered the arrangement to mitigate concerns over the drug’s $475,000 list price. The model noted that CMS would not pay for tisagenlecleucel unless patients responded to treatment within a one-month timeframe. CMS has not commented on its reasons for scrapping the plan.

The proposed agreement would have been the first instance of CMS paying for treatments based on patient outcomes, a key point in President Donald Trump’s plan to lower prescription drug costs. Because these plans ensure that drug manufacturers only get reimbursed when patients experience positive outcomes, pharmaceutical companies are incentivized to create and sell only the most effective treatments, according to the administration’s plan.

However, the plan has drawn scrutiny from CMS and members of Congress, who contend that the model was too favorable to Novartis, tisagenlecleucel’s manufacturer. Critics claimed that the one-month timeframe, in particular, could not be used to judge the success rate of a therapy; many patients treated with CAR T-cell therapies experience relapse up to one year or more after appearing to respond to treatment.

Though CMS pulled out of the plan, the agency is not giving up on its quest to lower drug prices through new models of payment, according to CMS Administrator Seema Verma, MPH. In a letter to Congress, she wrote that the agency is still “exploring the design of an innovative payment model that would involve value-based payment for prescription drugs.”

Source: Politico, July 9, 2018.