CAR-T Therapy Not Cost-Effective for DLBCL in the Second-Line Setting

Neither axicabtagene ciloleucel (axi-cel) nor lisocabtagene maraleucel (liso-cel) were found to be cost-effective as a second-line treatment for diffuse large B-cell lymphoma (DLBCL). These findings were published in the Annals of Internal Medicine.

First-line chemoimmunotherapy is successful for approximately 60% of patients with DLBCL. But only approximately 20% of patients with relapsed or refractory disease achieve durable remission with salvage chemoimmunotherapy and consolidative autologous stem cell transplantation (ASCT). 

For those with disease progression, chimeric antigen receptor T-cell (CAR-T) therapy is an available treatment option. However, the cost of CAR-T therapy, more than $400,000 per infusion, is concerning.

Therefore, researchers sought to determine the cost-effectiveness of CAR-T therapy vs salvage chemoimmunotherapy and consolidative ASCT as second-line therapy in this patient population.

ZUMA-7 (axi-cel) and TRANSFORM (liso-cel) clinical trials demonstrated the effectiveness of CAR-T therapy in patients with DLBCL. In this study, these data were evaluated to assess the cost-effectiveness of CAR-T therapy as a second-line treatment for DLBCL. A willingness-to-pay (WTP) threshold was defined as $200,000 per quality-adjusted life-year (QALY) gained. Cost estimates were based on January 2022 US dollars.

In the comparison of axi-cel and ASCT, the median overall survival was 38 months (95% uncertainty interval (UI, 31-45) and 42 months (95% UI, 33-51), respectively. The incremental cost-effectiveness ratio (ICER) was $684,225 per QALY for axi-cel relative to ASCT.

In the comparison of liso-cel and ASCT, the median overall survival was 33 months (95% UI, 29-38) and 34 months (95% UI, 25-42), respectively. The ICER was $1,171,909 per QALY for liso-cel compared with ASCT.

In 10,000 simulations, axi-cel was cost-effective at the WTP threshold in 1996 simulations, and liso-cel was cost-effective in 1898 simulations. CAR-T therapy did not become cost effective in most simulations until the WTP is increased to $720,000 and $6,640,000 per QALY for axi-cel and liso-cel, respectively.

If axi-cel was substituted for ASCT among high-risk patients with DLBCL in the first relapse, healthcare spending in the United States would increase by $6.84 billion in 5 years. Similarly, substituting liso-cel for ASCT among high-risk patients would increase spending by $6.71 billion in 5 years.

If the prices for axi-cel and liso-cel were lowered to $321,123 and $313,730, respectively, the budgetary impact would be reduced to $4.58 billion for axi-cel and $4.40 billion for liso-cel.

This study was designed to assess healthcare costs in the US and findings may not be generalizable to other locales.

“When compared with ASCT, neither axi-cel nor liso-cel was cost-effective as the ICERs exceeded $200,000 per QALY, which is a WTP threshold higher than the threshold in most countries with established thresholds,” the study authors reported.