A long-awaited decision on coverage of CAR-T cell therapies in cancer under Medicare has finally arrived.
The Centers for Medicare and Medicaid Services said Wednesday evening that it had issued its decision for CAR-Ts, making the immunotherapy treatments available to Medicare beneficiaries nationwide. It addresses a longstanding dilemma, whereby CAR-Ts were covered under Medicare in a more haphazard way, without a consistent policy in place, while also broadening coverage.
“Today’s coverage decision provides consistent and predictable patient access nationwide,” CMS Administrator Seema Verma said in a statement. “CMS will work closely with our sister agencies to monitor outcomes for Medicare patients receiving this innovative therapy going forward.”
Currently, two Food and Drug Administration-approved CAR-Ts are on the market: Novartis’ Kymriah (tisagenlecleucel), for acute lymphoblastic leukemia in children and young adults and adult diffuse large B-cell lymphoma; and Gilead Sciences’ Yescarta (axicabtagene ciloleucel), for adult DLBCL only.
Ensuring a consistent coverage regime for CAR-Ts is crucial, given the therapies’ high price tags: Both carry list prices of $373,000 for DLBCL and, in the case of Kymriah, $475,000 for ALL, on top of high supportive care costs for conditioning prior to therapy, hospitalization and treatment of side effects. And those costs to the healthcare system will balloon as more CAR-Ts and other cell therapies enter the market in the coming years.
“I’m thrilled to see that CMS listened to commenters and backed away from things it had proposed such as coverage with evidence development, collection of patient-reported outcomes data, among others,” wrote Jugna Shah, president of Nimitt Consulting, in an email. “This is definitely a win for patients and providers. Now we just have to continue working on getting hospitals appropriately reimbursed for this therapy.”
Notably, the finalized decision takes a liberal approach to the way CAR-Ts can be used and monitored.
For one, Medicare will cover off-label use of CAR-Ts as long as they are recommended by CMS-approved compendia, such as the National Comprehensive Cancer Network Guidelines. Compendia like the NCCN Guidelines contain recommended uses for drugs based on clinical data that may not have FDA approval and are used by payers to determine coverage for off-label uses of drugs.
In addition, whereas CMS had initially intended to only cover CAR-Ts if they were administered under registries or clinical trials that include two years of monitoring post-treatment – known as Coverage with Evidence Development, or CED – it will instead cover their administration in any healthcare facility enrolled in the FDA’s Risk Evaluation and Mitigation Strategies, or REMS program.
That also means that CAR-Ts do not necessarily have to be administered in a hospital setting, a limitation many experts had feared, as it would cut off access to patients who live far away from hospitals. Previously, the plan was to only cover the therapies if patients received them at facilities accredited by the Foundation for the Accreditation of Cellular Therapy. “Per the FDA, hospitals and their associated clinics may administer CAR T if the facilities are enrolled in with the REMS requirements,” the decision memo issued Wednesday read.
“Hospitals and their associated clinics” is consistent with the language used in the FDA-approved REMS for Kymriah and Yescarta.
The decision follows an unusually drawn-out delay by CMS. After publishing a proposed decision memo in February, the agency posted a short press release on May 17 stating that the National Coverage Determination had been delayed, but would be “forthcoming.” Nevertheless, until Wednesday it remained mum, and even drugmakers said they had not been given any update or timeline for when the decision would be reached.
Photo: nopparit, Getty Images
