The Centers for Medicare and Medicaid Services (CMS) announced two policy changes that should improve access to chimeric antigen receptor (CAR) T-cell therapies: First, the agency issued a final rule that raises payments for new technologies, including CAR T-cell therapies, from 50% to 65%. Next, CMS Administrator Seema Verma said that CMS will now provide “consistent and predictable” nationwide access to the therapies.
The FDA has approved two CAR T-cell therapies: Novartis’s tisagenlecleucel and Gilead Science’s axicabtagene ciloleucel. Both are used to treat diffuse large B-cell lymphoma, while tisagenlecleucel can also be used to treat pediatric and adolescent and young adult patients with acute lymphocytic leukemia. Hospitals pay a list price upwards of $373,000 for a single infusion of these therapies; the costs can increase further to cover associated expenses and management of complications. The new rule will reimburse only $240,000 for cancer treatment for Medicare beneficiaries with lymphoma.
The new payment rule will go into effect for fiscal year 2020, which begins October 1.
Health care providers’ opinions of how this will affect providers and patients vary. Medical organizations such as the Leukemia & Lymphoma Society said that they are “very pleased” with the decision. Others, including the American Society of Hematology (ASH), noted that the increase may not provide enough relief. ASH President Roy Silverstein, MD, stated that, while it is a “positive step, … we are disappointed that CMS did not take additional steps to address the barriers faced by institutions in recouping the cost of the product as well as the cost of additional medical care these patients require.”
By announcing nationwide coverage of the revolutionary therapy, CMS also hopes to clarify coverage determinations. Previously, Medicare’s regional managers made such determinations, leading to confusion and inconsistencies.
The agency also said that hospitals will no longer be required to collect and report data on patient outcomes as part of the “coverage with evidence development” requirement, a move praised by ASH. ASH feared this requirement would prevent hospitals from providing CAR T-cell therapies. Instead, CMS will use information collected by the FDA and the National Cancer Institute (NCI).
CMS also said it will expand its coverage to CAR T-cell therapies administered at health care facilities enrolled in an FDA-mandated safety program that focuses on special training to manage side effects of these therapies, potentially allowing treatment to be provided at outpatient facilities.