A major breakthrough in Immunotherapy drug coverage was announced last week. Medicare will now cover high-priced blood cancer cell therapies nationwide. The news, announced by officials at the Centers for Medicare and Medicaid Services (CMS), comes two years after the FDA approved the first CAR-T therapy in 2017, Novartis’ Kymriah®, a treatment for acute lymphoblastic leukemia. This long sought-after coverage decision will now ensure patients have consistent and predictable access to potentially life-saving therapies.
The primary struggle has been figuring out how to pay for these emerging CAR T-cell therapy therapies where costs can range from $375,000 to $475,000 depending on the type of cancer. These treatments typically involve hospital stays which add hundreds of thousands of dollars to the cost of care. Cell therapy treatment is typically reserved for patients who have failed to improve with more traditional treatments like chemotherapy and radiation. Cell therapies have eliminated cancer cells in many patients, but it’s too soon to know if they will deliver long term cures.
CMS’ final decision on coverage dropped the requirement to have hospitals collect and report data on the patient due to concerns it would be overly burdensome for hospital staff. The FDA is requiring the two manufacturers of the therapy — Novartis and Gilead Sciences — to follow patients for years and report on outcomes. Such data will be put in a registry supported by the National Cancer Institute.  The American Society of Hematology praised the decision to eliminate “coverage with evidence development” because it would have made hospitals unable to provide treatment.
The decision by CMS is another positive step taken to bolster CAR T-cell therapy. The agency also announced last Friday that it would increase the reimbursement amount for CAR T-cell therapy. On the market currently is Kymriah® (Novartis), a therapy for certain types of lymphoma and childhood B-cell acute lymphoblastic leukemia, and Yescarta® (Kite Pharma, a Gilead Company), used to treat adult patients with certain types of non-Hodgkin’s lymphoma. The treatments are both autologous which involves extracting and genetically altering the patient’s T cells to attack a protein on the surface of cancer cells. After cell manipulation, the product is infused back into the patient. Medicare will also pay for CAR-T even when it's used to treat conditions that aren't FDA-approved but recommended in CMS-approved compendiums.
CAR T therapy has largely been used to treat blood cancers, but clinical trials are underway to treat solid tumors in patients with breast, colon, and lung cancers. These new Medicare coverage developments will help accelerate efforts to expand access to Yescarta and Kymriah and potentially open the door for new cell therapies that are currently in development. As long-time supporters of all CAR-T developers, HemaCare is very excited about this positive movement forward. Click here to learn how HemaCare supports cell therapy from product and process development through commercialization.
McGinley, Laurie. Medicare will cover pioneering cancer treatment nationwide. Washington Post. 7 August 2019.