The results of a recent feasibility study on the outpatient administration of cell therapies is creating growing interest in whether home-based management may be possible in the future.
CAR-T therapy and bispecific antibodies are some of the most complicated cancer treatments. But speakers at a session at the Academy of Managed Care Pharmacy (AMCP) Nexus meeting said that a future of delivering them at home is not so farfetched and might help rein in the expense of the high-cost treatments.
There are currently six CAR-T cell agents on the market that are approved to treat advanced blood cancers such as lymphoma and multiple myeloma. CAR-T is a type of immunotherapy that uses a patient's own T cells, which are cultured to manufacture larger numbers of CD4 helper T cells and then re-engineered to engage the immune system. They are then infused back into the patient.
There are currently eight bispecific T cell engager antibodies on the market. These are off-the-shelf therapies are developed to harness the immune system and don’t require extraction of patients’ cells. Available therapies treat blood cancers. One of is these therapies — Kimmtrak — is approved to treat patients with uveal melanoma, which occurs in the eye and is consider a solid tumor.
These are high-cost therapies. The available CAR T’s have wholesale acquisition costs between $427,000 and just under $500,000. The bispecific antibodies have list prices of between $180,000 and $975,000.
Adding to costs for treatment patients with these cancers is the need for inpatient administration and monitoring, Simone Ndujiuba, Pharm.D., director, clinical strategy and innovation, oncology at Magellan Rx Management, said in her presentation. “There is the desire to move these therapies to outpatient because of cost but also to manage volume,” she said.
Outpatient administration may be possible, according to a feasibility study published earlier this year in the Journal of Clinical Oncology. Researchers at Mayo Clinic assessed the outcomes of a hospital-based outpatient program to manage patients with lymphoma or multiple myeloma who had received a CAR T or a bispecific antibody. Researchers included patient treated with the CAR T therapies Yescarta (axicabtagene ciloleucel or axi-cel), Tecartus (brexucabtagene autoleucel or brexu-cel), Abecma (idecabtagene vicleucel or ide-cel) and Carvykti (ciltacabtagene autoleucel or cilta-cel), as well as the bispecific antibody Tecvayli (teclistamab). Patients were assessed between March 2021 and January 2023 and were monitored by the inpatient clinical team.
Researchers found that of the 80 patients treated on an outpatient basis with a CAR T therapy, 21 were never hospitalized. Of those who were hospitalized, almost one-third were admitted three days after infusion. The most common cause of hospitalization was fever and the average length of stay was four days, with a range of 1 day to 49 days.
Home-based administration of CAR-T therapies and bispecific antibodies, however, is likely a future managed care strategy, Michelle Pannone-Booth, Pharm.D., senior director, specialty clinical solutions at Magellan Rx Management, said during the session.
She pointed out the many cell therapies cannot be given on an outpatient because of the risk of serious adverse events — such as cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome ICANS — or because an FDA Risk Evaluation and Mitigation Strategy (REMS) program is in place.
Both Ndujiuba and Pannone-Booth indicated that remote patient monitoring (RPM) tools were used as part of outpatient monitoring in the Mayo study and would likely be needed if more cell and gene therapies were administered on an outpatient basis. The remote monitoring can help with compliance but also but also identify early signs of cytokine release syndrome.