“Unfortunately, limited access to these therapies worldwide appears to be a major challenge,” the researchers wrote.
A recent study featured at the 65th American Society of Hematology Annual Meeting and Exposition exposed disparities in the accessibility of B cell maturation antigen (BCMA)-directed therapies. With chimeric antigen receptor (CAR) T-cell therapies like idecabtagene vicleucel (ide-cel) and ciltacabtagene autoleucel (cilta-cel), alongside the innovative BCMA-directed T-cell-engager (TCE) teclistamab, approved for relapsed/refractory MM, the results revealed limited global access and financial hurdles impeding patient reach.
“Unfortunately, limited access to these therapies worldwide appears to be a major challenge,” the researchers wrote.
Surveying Global Perspectives
The study, conducted in collaboration with the US Myeloma Innovations Research Collaborative (USMIRC), involved 176 hematologists/oncologists from diverse centers worldwide, excluding the United States. Distributed from June 18 to July 15, 2023, the electronic survey aimed to evaluate the variation in access to these therapies and identify the barriers hindering their availability.
Among the 33 countries represented in the study, 54% of respondents provided completed responses, with a predominant presence of university-based academic centers (51%). Only 17% reported adequate access to ide-cel and 16% to cilta-cel, suggesting limited availability. Teclistamab, the TCE therapy, fared slightly better, with 23% reporting adequate access.
Global Disparities in Access
Globally, only 9% of countries had access to either ide-cel, cilta-cel, or both, with notable exceptions being France, Morocco, and Saudi Arabia. No continent boasted adequate access to CAR-T therapies. Both high health care investing nations (HHIN) and low health care investing nations (LHIN) faced limited access to CAR-T.
For TCE, 21% of countries, including Switzerland, Netherlands, France, Portugal, Czech Republic, Morocco, and Saudi Arabia, reported adequate access. However, similar to CAR-T, no continent could claim comprehensive access to TCE. Therefore, TCE demonstrated comparatively better accessibility than CAR-T therapies, according to the data.
Financial Hurdles and Regional Barriers
Apart from Europe, the common denominator obstructing access was the financial burden on patients, with Asia (83%), South America (64%), Africa (71%), Australia (100%), and North America (100%) all citing this as a major barrier. In Europe, financial constraints persisted, particularly for CAR-T therapies, along with challenges related to local agency approval. The study noted reimbursement in Europe requires phase 3 randomized controlled trial data, contributing to the hurdles.
The researchers explained this survey as the first attempt to highlight the global limitations when it comes to accessibility of novel therapies for the treatment of MM. They also acknowledged even HHIN had limited access to CAR-T and TCE, and despite being approved earlier CAR-T is less accessible than TCE.
“The main barrier to both CART and TCE is reported as financial burden for patients,” the researchers wrote. “USMIRC in collaboration with oncologists worldwide, global agencies, governments, regulatory agencies, policymakers, and industry partners, is planning to further explore restrictions to access to CART and TCE and strategies to overcome these barriers.”
Reference
Atallah R, Shatnawi Y, Mammadzadeh A, et al. The GLAMM1 Study - Global access to myeloma medications: Potential barriers to chimeric antigen receptors (CART) and T-cell engaging bispecific antibodies (TCE) globally. Paper presented at the American Society of Hematology Annual Meeting and Exposition; December 10, 2023; San Diego, CA. Session 3327. https://ash.confex.com/ash/2023/webprogram/Paper179050.html
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