New reimbursement in Belgium: Ebvallo®(Tabelecleucel)

Post-transplant lymphoproliferative disease (PTLD) is a rare disease characterised by the development of lymphoid neoplasms after solid organ or haematopoietic stem cell transplantation.^1,2 To date, approximately 90% of adults worldwide are carriers of the Epstein Barr virus (EBV).³ Patients who receive a transplant are subjected to a strong immunosuppressive regimen to prevent rejection, which can reactivate the EBV virus in the B-lymphocytes of the immune system.⁴ The risk of EBV is largely dependent on the level of immunosuppression, the patient’s age and EBV serological status and the “match” between donor and host of the transplant.^1,5-7 Importantly, PTLD can be caused by a reactivation of EBV in the patient or in the donor.^5,8 Children younger than 10 years old and adults above 50 (in case of stem cell transplantation) or 60 (in case of solid organ transplant) face a higher risk of developing PTLD.^6,7 The most common symptoms of PTLD are fever, weight loss, fatigue, night sweats, feeling unwell and swollen lymph nodes.^5,7,8

The main strategy in the treatment of early stages of PTLD is to reduce the suppression of the immune system, in order to allow the immune system to clear out the infected cells.^7-10 If lowering immune suppression is not sufficient or not appropriate, another treatment needs to be selected. In this light, some patients benefit from adding chemotherapy, immunotherapy, radiotherapy or specific T-cell therapies, such as tabelecleucel.^11-13

Ebvallo® (tabelecleucel)

Since July 1^st 2024, Ebvallo® (tabelecleucel) is reimbursed as monotherapy for the treatment of adults and children ≥2 years with relapsed/refractory, EBV-positive PTLD which developed after a hematopoietic stem cell transplantation (HSCT), or after a solid organ transplantation (SOT). The treatment is eligible after failure of at least one rituximab-based treatment after a HSCT, or at least one rituximab-chemotherapy based therapy after a SOT (unless if chemotherapy was contra-indicated). In addition, the PTLD must be confirmed on a biopsy and EBV positivity has to be demonstrated in the PTLD biopsy. Furthermore, results need to be available for a high-resolution HLA determination of the patient (HLA-A, HLA-B, HLA-C, HLA DRB1 and HLA-DQB1) and at least a low-resolution HLA determination for the donor (HLA-A, HLA-B, HLA-C, HLA DRB1 and HLA-DQB1). If clinically relevant, a chimerism test result needs to be available to determine the PTLD origin. More detailed information on the reimbursement criteria and specific information on the stopping rules is available on the RIZIV/INAMI website.¹⁴

Click here to learn more on EBV+ PTLD in Dutch or in French.

References

1. Engels EA, et al. JAMA. 2011;306(17):1891-901.
2. Kinch A, et al. Acta Oncol. 2014;53(5):669-79.
3. Styczynski J, et al. Haematologica. 2016;101(7):803-11.
4. Samant H, et al. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK513249/
5. Loren AW, et al. Bone Marrow Transplant. 2003;31(3):145-55.
6. Al-Mansour Z, et al. Curr Hematol Malig Rep. 2013;8(3):173-83.
7. Gulley ML, et al. Clin Microbiol rev. 2010;23(2):350-66.
8. DeStefano CB, et al. Br J Haematol. 2018;182(3):330-43.
9. Starzl TE, et al. Lancet. 1984;1(8377):583-7.
10. Roschewski M, et al. Best Pract Res Clin Haematol. 2012;25(1):75-89.
11. Oertel SHK, et al. Am J Transplant. 2005;5(12):2901-6.
12. Choquet S, et al. Blood. 2006;107(8):3053-7.
13. Choquet S, et al. Ann Hematol. 2007;86(8):599-607.
14. https://webappsa.riziv-inami.fgov.be/ssp/ProductSearch

BE-EBV-07-24-2400002