OBJECTIVES:

Cell and gene therapies (CGT) have prompted innovation in the life sciences landscape and captured national attention. However, the real-world use across this therapeutic class is not well quantified. This study aims to evaluate CGT uptake and quantify utilization patterns in the US, from 2015-2021.

METHODS:

This study analyzed patient-level US claims data in the Komodo Healthcare Map™, a dataset including longitudinal medical and prescription claims encompassing adjudicated claims of >150 million unique enrollees from the US commercial, Medicare, and Medicaid insured population. Patients were eligible for inclusion if they had ≥1 claim including the identified National Drug Codes and HCPCS Level II codes. Of the 22 FDA-approved CGTs, seven therapies were analyzed based on data availability. Therapies that rose to the top in terms of usage from January 1, 2015-December 14, 2021 (data may be incomplete for the last 6 months of 2021), included PROVENGE^®, MACI^®, IMLYGIC^®, KYMRIAH^®, YESCARTA^®, ZOLGENSMA^®, and LUXTURNA^®. Descriptive statistics for patient and sample-level analyses were reported as means, standard deviations (SD), frequencies, and percentages, as appropriate.

RESULTS:

A total of 21,198 patients were included in the analysis (76% males) with a mean age (±SD) of 66.8 years (±16.4). The year-over-year utilization showed an increasing uptake of CGTs, with 3,097 patients prescribed CGTs in 2021 compared to 1,825 in 2015, with the utilization peaking at 4,189 patients in 2019. Highest utilization over the entire analysis period (2015-2021) was seen for PROVENGE^® (52%), MACI^® (33%), and IMLYGIC^® (10%). Notably, the top three physician specialties prescribing CGTs were urologists (28%), orthopedics (26%), and hematologists or oncologists (14%).

CONCLUSIONS:

CGT utilization has steadily grown in the US, providing innovative treatments across many conditions (some of which are life-threatening). It is important to study trends in these emerging therapies to prepare the market, both clinically and economically.