StemCell Therapy

Johnson & Johnson and partner Legend Biotech are expecting an FDA decision for their first CAR-T product, cilta-cel, in November. To prepare for the upcoming launch of the personalized cell therapy, the Big Pharma company is planning a specialized patient support program, a dedicated sales team and more.

J&J intends to roll out a customized programto help cilta-cel-prescribed multiple myeloma patients navigate the treatment journey, Serge Messerlian, Janssens U.S. oncology president, said in a recent interview.

CAR-T therapies modify a patients own T cells to make them better weapons against cancer bearing a specific biomarker. For such a personalized medicine, one needs to be very thoughtful not just [about] the product, but theres a very important service component to that, Messerlian said.

RELATED:J&J, Legend Biotech's multiple myeloma CAR-T scores FDA priority review, setting up a clash with BMS' Abecma

Because of the complexity in production, CAR-T products can be pricey. Before cilta-cel, Bristol Myers Squibbrecently introduced a rival BCMA-targeted cell therapy, Abecma, at a list price of $419,500. Patients need to travel to designated treatment centers to have theirT cells drawn and later to receive the final product. They must also monitor for a potentially life-threatening side effect known as cytokine release syndrome after treatment.

For J&J'sprogram, each patient will get one-on-one assistancenavigating access challenges and help with the logistics associated withtreatment, Messerlian said. For the upcoming launch, J&J isworking on CAR-T site initiations and making sure the market is ready to receive the medicine. Although the company already has a popular multiple myeloma therapy, Darzalex, cilta-cel will have a separate sales team, he said.

J&J has a separate personalized patient assistance program for Darzalex, called Janssen Compass, which also covers prostate cancer med Erleada. The company is now rolling out Janssen Compass on a national scope after a limited run, Messerlian said.

Compass is a very patient-centric, patient-oriented platform; it almost serves like a shepherd, Messerlian explained. In Janssen Compass, a single point of contacta nurseis assigned to help bring the right resources to a patient to manage obstacles along the way, including access challenges and side effects.

RELATED:J&J cell therapy partner Legend carves out production foothold in Belgium as myeloma drug nears finish line

About half of the patients that get on any drug drop off within six months, Messerlian noted, and not all of them are related to costs.

Sometimes, patients dont understand what to expect on the treatment journey or fully acknowledge the benefits ofthe medicine, so they may not be committed to the therapy, Messerlian said. In Janssen Compass, a care navigator will help set expectations, educate each patient on how to manage potential obstacles and support them in developing a care plan to communicate with doctors.

In return, J&J is getting valuable insights. Janssen Compass allows the company to understand and analyze which patients will be most likely to drop off, and what are some interventions we can [use to] predict and prevent these types of patient drop-offs, Messerlian said.

Beyond patient support, J&J is also teaming up with healthcare facilities and specialty networks to help train doctors, especially in the community setting. The goal of such education is, as Messerlian put it, about bending the quality-of-life curve.

RELATED:Pharmas' return on $5B spent yearly on patient support programs? Only 3% are using them: survey

Working with its care partners, J&J is collecting and analyzing data to map out how various patients move through the treatment process, aiming to improve outcomes along the way.

It comes down to understanding, what are the inputs of this care process, what are the decisions along the process, and can you standardize to that, Messerlian said. [With] a standard set, you can then roll that out in partnership with other practices to ultimately elevate the standard of care.

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Johnson & Johnson preps for first CAR-T launch with a new patient support program, a dedicated sales team and more - FiercePharma

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