By: DAN MARGOLIES
KU has been a pioneer in using the treatment, known as CAR T-cell therapy, which involves removing a patient’s T cells (a type of white blood cell) and genetically engineering them to recognize and attack the patient’s tumors. The cells are then put back into the patient’s body.
The Food and Drug Administration has approved two CAR-T drugs: Kymriah, which is made by Novartis and carries a list price of $475,000, and Yescarta, which is made by Gilead Sciences Inc. and lists for $373,000.
On Wednesday, Seema Verma, the administrator of the Centers for Medicare and Medicaid Services, said that Medicare will cover at least 65% of the drugs’ costs and associated costs such as overnight hospital stays. That’s short of what hospitals offering the treatment had sought, but more than Medicare had been paying.
“It still leaves a significant gap,” said Joseph McGuirk, director of the division of hematologic malignancies and cellular therapeutics at KU Cancer Center. “I do think that it potentially increases access for patients to this therapy.”
In April, McGuirk and fellow members of The American Society of Hematology met with representatives in Congress to advocate for a reimbursement rate of 80%. Medicare had been covering $186,500 of the cost of the therapy, but McGuirk called that “woefully inadequate.”
The American Society of Hematology called CMS’ coverage decision “a positive step” but said it didn’t go far enough. In a statement, Verma said it would give patients “consistent and predictable access” to a treatment that, for some, has proved life saving.
KU is the only hospital in the region to administer CAR T-cell therapy to adults, which it began doing about four years ago. (Children’s Mercy Hospital has used it on pediatric patients.) KU has since treated about 50 patients and achieved some remarkable results, although long-term data on remissions remains limited.
Half of Non-Hodgkin’s lymphoma patients have experienced complete remissions, according to McGuirk, compared to 7% who receive standard chemotherapy treatments. And 85% of patients with acute lymphoblastic leukemia, whose prognoses are typically bleak, have realized complete remissions.
Most CAR T patients experience severe side effects – what McGuirk described as “like the flu times 10” as well as neurological toxicity – but the complications eventually subside.
So far, 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.
“There are many challenges to be worked through, but it’s really a remarkable time in cancer therapeutics,” McGuirk said.
McGuirk, who has been practicing for 30 years, predicted that traditional chemotherapy treatments will become a thing of the past, replaced by the more targeted therapies typified by CAR-T.
“This train is going to keep going down the tracks and to the benefit of thousands and, God-willing, tens of thousands of patients with a more broad spectrum of cancers in the near future,” McGuirk said. “So from my perspective as an oncologist, this is actually the most promising time of my career. I’ve always been enthusiastic and optimistic about the future for our patients, but never more so than I am now.”
Dan Margolies is a senior reporter and editor for KCUR. You can reach him on Twitter @DanMargolies.
(Kansas News Service)