OBJECTIVES: Several new therapies with novel mechanisms of action have recently been approved for the treatment of r/r DLBCL, particularly for patients ineligible for stem cell transplant. We evaluated the access and reimbursement situation of treatments recommended in r/r DLBCL in major markets such as the US, EU4 (France, Germany, Italy, and Spain), the UK and Japan.

METHODS: Therapies recommended for second line (2L) and third line (3L) DLBCL treatment were identified from the NCCN guidelines version 2.2024. Access and pricing information such as health technology assessment (HTA) summary which includes the reimbursement decision, rationale, limitations, and annual price of therapy (POT) was extracted from the NAVLIN® database and via secondary desk research.

RESULTS: A total of four therapies were approved for 2L DLBCL and seven for 3L DLBCL, with the exceptions of Polivy® in the US and Monjuvi® in Japan for 2L and 3L, respectively. Robust clinical evidence demonstrated through endpoints including overall response rate, progression-free survival and overall survival were the major factors driving positive reimbursement decisions. The lack of a head-to-head clinical comparator and incomplete, unreliable quality-of-life data were common limitations stated by HTA bodies. The annual POT of therapies in 2L ranged from US$ 105,258 to $487,477 in 2L and in 3L it ranged from US$357,664 to 487,477 in the US, primarily attributed to the price of CAR-Ts. The corresponding prices in ex-US markets were substantially lower. Overall, there was a general lack of evidence showcasing clinical superiority among the currently approved agents for r/r DLBCL.

CONCLUSIONS: The absence of clear consensus on the optimal selection and timing of therapies for r/r DLBCL poses a challenge, particularly in the context of constrained financial resources. Future therapies could gain value by including comparative and cost-effectiveness evidence, alongside patient perspectives, in pivotal trials.