With a nod for CAR-T Abecma finally in hand, Bristol Myers Squibb now faces an almost equally difficult challenge—launching the complex multiple myeloma treatment.
Its first priority? Getting treatment centers online, training doctors and staff and working with payers to cover the $419,500 treatment.
The good news is with no treatments and few options available for Abecma's approved myeloma patient population, doctors are expressing "real excitement," Krishnan Viswanadhan, BMS’ global cell therapy franchise lead, said.
Abecma nabbed the historic green light Friday as the first CAR-T med approved in multiple myeloma and the first CAR-T in the B-cell maturation antigen-targeted (BCMA) class. It's approved for adults whose multiple myeloma has progressed after at least four previous rounds of treatment.
CAR-T meds are created using a patient’s own T cells, which are extracted, genetically modified and then infused back into patients to help the body kill disease. BMS is co-marketing Abecma with its partner bluebird bio, and the partners are sharing profits in the U.S.
BMS now has two cell therapies in two different diseases, and it plans to leverage its Breyanzi launch efforts—which got underway in February after the drug's approval in certain lymphomas—with the Abecma rollout, Viswanadhan said.
For both launches, the company is using a digital platform called Cell Therapy 360 to walk patients through the CAR-T "journey,” Viswanadhan said. The program helps patients and doctors to schedule apheresis and treatment, and it offers patients digital wearables after treatment to watch for cytokine release syndrome, a dangerous side effect.
The digital platform grew from interactions with patients and doctors during clinical trials. The company sought to "really understand where are there gaps today in the journey for patients,” Viswanadhan said.
Meanwhile, the company is pitching the med, which carries a $419,500 list price, to payers. The cost “reflects its value” as a one-time treatment that offers “deep and durable remissions with a manageable and predictable safety profile,” Viswanadhan said.
While BMS has plenty of enthusiasm about its Abecma rollout, analysts say the label could hand a forthcoming entrant from Johnson & Johnson an advantage. One multiple myeloma expert at a "leading academic center" had expected the drug to win an approval after two prior treatments, RBC Capital Markets analysts wrote to clients in mid-March.
Aside from bringing treatment centers on board, BMS is working with doctors to help them understand the drug’s clinical profile, Viswanadhan said. Meanwhile, the manufacturing team is set up and ready to begin producing individualized treatments.
In the long run, BMS is aiming to bring its CAR-T meds into earlier lines of treatment and is advancing a next-gen lineup of cell therapies. With its next-gen offerings, the company is aiming to improve turnaround times and lower cost of treatment, the exec said.