On October 21, 2021 Johnson & Johnson and partner Legend Biotech reported that they are expecting an FDA decision for their first CAR-T product, cilta-cel, in November (Press release, Johnson & Johnson, OCT 21, 2021, View Source [SID1234591823]). 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.
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J&J intends to roll out a customized program to help cilta-cel-prescribed multiple myeloma patients navigate the treatment journey, Serge Messerlian, Janssen’s U.S. oncology president, said in a recent interview.
CAR-T therapies modify a patient’s 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 there’s a very important service component to that," Messerlian said.
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Because of the complexity in production, CAR-T products can be pricey. Before cilta-cel, Bristol Myers Squibb recently 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 their T 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’s program, each patient will get one-on-one assistance navigating access challenges and help with the logistics associated with treatment, Messerlian said. For the upcoming launch, J&J is working 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.
Building personalized cancer drug support programs
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 contact—a nurse—is 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 don’t understand what to expect on the treatment journey or fully acknowledge the benefits of the 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.
Gaining treatment insights to develop better care
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."
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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."