A new study has suggested that procedure and administrative codes from a clinical database can be used to provide information about quality and cost outcomes in children and young adults with relapsed or refractory leukemia who have been treated with chimeric antigen receptor T cell (CAR-T) therapy.

The data were collected from centers with the Vizient Clinical Database/Resource Manager,1 an analytical platform used by health systems and medical centers across the United States to analyze performance. As part of this resource, codes are assigned to specific procedures, allowing tracking of patients throughout their treatments and their associated costs and hospital admissions. The work was presented at a Transplantation and Cellular Therapy (TCT) meeting in February 2020 in Orlando, Florida.

The study used data from this platform and the procedure codes assigned to peripheral or central venous administration of tisagenlecleucel (Kymriah®) (XW033C3 and XW043C3, respectively)2 to analyze quality and cost outcomes in 139 patients with acute lymphoblastic leukemia (ALL) aged 25 years and under, with a mean age of 15.8 years.

Of the 139 patients, 93.5% had their infusion of CAR-T in an inpatient setting, with a median length of stay of 21 days. Within 30 days of the procedure, 20.1% of patients had an unplanned readmission to the hospital; just under half of these patients were readmitted within 7 days of the CAR-T procedure. Eight patients, comprising 5.8% of the cohort, died in hospital.


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The study found that the median total cost of hospitalization resulting from CAR-T treatment was $380,052, with a median direct cost of $262,981. Of costs not pertaining to drugs, such as accommodations, laboratory tests and blood transfusions, the median cost was $44,427, with a median direct cost of $23,491.

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The study also looked at the number of encounters patients had with the health care system, finding that in addition to an average of 16.2 clinic and diagnostic testing encounters, patients had an average of 1.8 encounters in the 30 days preceding the infusion of CAR-T cells and 4.3 encounters in the 100 days after infusion.

Two-thirds of patients experienced an adverse effect due to the immunotherapy, with the most common side effects being fever, headaches, tachycardia, and nausea. Other adverse effects included hypotension in 28 patients, acute kidney failure in 22 patients, and sepsis in 18 patients.

The study authors concluded that analyzing the cost-effectiveness and quality outcomes of treatments using administrative data and procedural codes is a viable way to analyze newly approved treatments before large, public datasets become widely available.

The authors also mentioned that because the number of patients currently treated with CAR-T is reasonably small, especially at individual centers, combining data in this way allows for analysis of bigger data sets than might otherwise be published from clinical trials.

References

  1. Harris A, Hohmann S, Epting G, Shippey E; MA Center for Advanced Analytics and Informatics, Vizient Inc. Quality and cost outcomes in chimeric antigen receptor T-cell immunotherapy in pediatric and young adult patients with acute lymphoblastic leukemia from the Vizient Clinical Database. Poster presented at: Transplantation and Cellular Therapy Meetings of ASTCT and CIBMTR; February 12-23, 2020; Orlando, FL. Abstract LBA15.
  2. Novartis Pharmaceuticals Corporation. Coding and billing guide for Kymriah® (tisagenlecleucel). Published August 7, 2019. Accessed March 30, 2020.