-Author name in bold denotes the presenting author
-Asterisk * with author name denotes a Non-ASH member
Clinically Relevant Abstract denotes an abstract that is clinically relevant.

PhD Trainee denotes that this is a recommended PHD Trainee Session.

Ticketed Session denotes that this is a ticketed session.

3327 The GLAMM1 Study - Global Access to Myeloma Medications: Potential Barriers to Chimeric Antigen Receptors (CART) and T-Cell-Engaging Bispecific Antibodies (TCE) Globally

Program: Oral and Poster Abstracts
Session: 652. Multiple Myeloma: Clinical and Epidemiological: Poster II
Hematology Disease Topics & Pathways:
Research, Clinical Practice (Health Services and Quality), Clinical Research, health disparities research, Diseases, Therapies
Sunday, December 10, 2023, 6:00 PM-8:00 PM

Rawan Atallah1,2*, Yara Shatnawi, MD2,3*, Aytaj Mammadzadeh2,4*, Shahrukh K Hashmi, MD, MPH5,6*, Shabeeha K Rana, MBBS, MRCP, FRCPath7*, Muhammad Umair Mushtaq, MD2,8, Benlazar Mohamed, MD9*, Nihar Desai, MBBS10*, Thiago Xavier Carneiro, MD11*, Rakesh Popat12*, Joseph P McGuirk, DO13, Shebli Atrash, MD2,14*, Zahra Mahmoudjafari, PharmD2,13*, Al-Ola Abdallah, MD2,15 and Nausheen Ahmed, MD2,8

1Division of Hematologic Malignancies & Cellular Therapeutics, University of Kansas Cancer Center, Kansas City, KS
2US Myeloma Innovations Research Collaborative (USMIRC), Kansas City, KS
3Jordan University of Science & Technology, Irbid, Jordan
4Division of Hematology/Oncology, Mayo Clinic, Rochester, MN
5Department of Medicine, Sheikh Shakhbout Medical City, Mayo Clinic, Abu Dhabi, United Arab Emirates
6Department of Medicine, Mayo Clinic, Rochester, MN
7American Hospital, Dubai, United Arab Emirates
8Division of Hematologic Malignancies & Cellular Therapeutics, University of Kansas Medical Center, Westwood, KS
9Hematology Department, University of Sidi Bel Abbès, Sidi Bel Abbès, Algeria
10Princess Margaret Cancer Centre, Toronto, ON, Canada
11Hospital Ophir Loyola/State University of Para, Belém, PA, Brazil
12Department of Haematology, University College London Hospitals NHS Foundation Trust, London, United Kingdom
13University of Kansas Medical Center, Westwood, KS
14Department of Hematologic Oncology & Blood Disorders, Atrium Health Levine Cancer Institute, Charlotte, NC
15Division of Hematologic Malignancies & Cellular Therapeutics, University of Kansas Cancer Center, Westwood, KS

Introduction: Novel B cell maturation antigen (BCMA) directed therapies including chimeric antigen receptor- T (CART) such as idecabtagene vicleucel (ide-cel) and ciltacabtagene autoleucel (cilta-cel) have been approved since 2021. More recently in 2022, the first BCMA-directed T-cell-engager (TCE), teclistamab (tec), was also approved for the treatment of relapsed/ refractory multiple myeloma (RRMM). Unfortunately, limited access to these therapies worldwide appears to be a major challenge. This study aims to gain insight into the variation in access to these therapies, and barriers to access.

Methods: This study was an electronic survey of 176 hematologists/oncologists in centers across the globe outside the USA who treat MM and was conducted in collaboration with US Myeloma Innovations Research Collaborative (USMIRC). The survey was distributed from June 18th, 2023, to July 15th, 2023. Sections included demographics of respondents, availability of drugs in the country, and barriers to access. The respondents categorized each medication as “easily accessible”, “moderately accessible,” “not readily accessible” or “no access”. To categorize a country/region as having “adequate access”, the cut-off was 60% of responders affirming easy/moderately easy access. We investigated whether higher healthcare spending in a country is associated with better drug accessibility. Health expenditure (HE) of a country's Gross domestic product (GDP) from the World Bank was utilized to categorize countries into two groups: “High healthcare investing nations” (HHIN), which included countries spending >10% of their GDP on healthcare, while “Low healthcare investing nations” (LHIN) included countries spending <10% on healthcare. An interim analysis is reported.

Results: There were 95 (54%) completed responses from 33 countries. Most (51%) were university-based academic centers and only 17% were centers with a dedicated focus in plasma cell disorders. Only 17% reported adequate access to ide-cel and 16% to cilta-cel, while a limited, yet higher number of respondents had adequate access to tec (23%). Refer to Table 1

Access to CART (ide-cel and cilta-cel): Globally, only 3 of the 33 (9%) countries had access to ide-cel, cilta-cel or both (France, Morocco, Saudi-Arabia). All other countries had limited access. When grouped by continent, none of the continents had adequate access to CART. Both HHIN and LHIN countries had limited access to CART.

Access to TCE (tec): Seven of the 33 (21%) countries had adequate access to tec (Switzerland, Netherlands, France, Portugal, Czech Republic, Morrocco, Saudi Arabia). All other countries had limited access. When grouped by continent, although Europe had the most access, none of the continents had adequate access to TEC. Both HHIN and LHIN countries had limited access to TCE, although relatively, TEC was more accessible compared to CART. Figure 1 summarizes access to CART and TCE

Barriers to access: Other than Europe, the most common barrier for ide-cel, cilta-cel and tec was cited as financial burden for patients. Financial burden for patients as a top barrier for each of the products by continent was as follows: Asia (83%), South America (64%), Africa (71%) Australia (100%), and North America (100%). In Europe, for CART, financial burden remained a top barrier (50%) along with local agency approval (50% for ide-cel, 44% for cilta-cel). In Europe, the most cited barrier for TCE was the financial burden for patients (44%), while (33%) of oncologists reported no barrier to TCE. Reimbursement for CART and TCE in Europe requires phase 3 randomized controlled trial data, which is just emerging since 2022 for CART and relatively increased access may be due to the presence of compassionate use programs.

Conclusion: The survey is the first attempt to highlight the significantly limited global access to novel therapies (ide-cel, cilta-cel, and tec) for the treatment of RRMM. All continents including HHIN had limited access to CART and TCE. Noticeably, CART is less accessible than TCE, even though approved earlier. The main barrier to both CART and TCE is reported as financial burden for patients. 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.

Disclosures: Popat: Abbvie: Honoraria; GSK: Consultancy, Honoraria, Research Funding; BMS: Honoraria; Janssen: Honoraria; Roche: Honoraria. McGuirk: Juno Therapeutics: Consultancy; Kite: Consultancy, Research Funding; Fresenius Biotech: Research Funding; Bellicum Pharmaceuticals: Research Funding; Novartis: Research Funding; EcoR1 Capital: Consultancy; Allovir: Consultancy, Research Funding; Magenta Therapeutics: Consultancy; Astellas Pharma: Research Funding; Gamida Cell: Research Funding; Pluristem Therapeutics: Research Funding. Mahmoudjafari: Omeros: Speakers Bureau; Pfizer, Genentech, Inc., BMS, KITE, Sanofi, Janssen: Honoraria; Genentech, Inc.: Consultancy. Ahmed: Kite, a Gilead company: Research Funding; Bristol Myers Squibb: Consultancy.

*signifies non-member of ASH