Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Double hit lymphoma (DHL)
Treatment: Abatacept Injection
The insurer denied coverage for: Abatacept Injection
The denial is: Overturned

The medical records indicate the patient has double hit lymphoma (DHL), for which the patient received a partially matched allogeneic transplant. The provider has prescribed treatment with Abatacept Injection to prevent the risk of graft vs. host disease (GvHD). The patient completed chemotherapy prior to stem cell transplant.  

In 2019, the patient presented to the Emergency Room (ER) due to pain and radiographs showed abdominal and cervical lymphadenopathy. In June 2019, a biopsy "revealed follicular lymphoma, grade 3B and high grade B cell lymphoma with MYC and BCL2 rearrangement."

The request for approval of Abatacept Injection is the topic of this review. Abatacept Injection is considered medically necessary for this patient. As noted, the patient had been transplanted with a partially matched donor, relying on Abatacept Injection to control the expected graft vs. host disease (GvHD). Without the use of Abatacept the patient is at a high risk for GvHD or graft rejection and death. As Abatacept is Food and Drug Administration (FDA) approved for the treatment of acute GvHD and significant support exists, the request for approval is medically necessary for this patient. 

According to the FDA Prescribing Label For Abatacept Injection, "ORENCIA is a selective T cell costimulation modulator indicated for:

.	the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). 
.	the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA). 
.	the treatment of adult patients with active psoriatic arthritis (PsA). 
.	the prophylaxis of acute graft versus host disease (aGvHD), in combination with a calcineurin inhibitor and Methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor."

"Administration of abatacept following transplantation has been reported to inhibit graft rejection and graft-versus-host-disease (GvHD) in mouse models associated with allogeneic hematopoietic stem cell transplant (HSCT). This strategy has recently been adopted in clinical practice for GvHD prevention in human allogeneic HSCT and offers a unique approach to optimizing GvHD prophylaxis following alternative donor HSCTs. When combined with calcineurin inhibitors and methotrexate, abatacept had shown to be safe and effective in preventing moderate to severe acute GvHD in myeloablative HSCT using human leukocyte antigen (HLA) unrelated donors." (Ngwube, A., et al., 2023).

"In the United States, Blacks and Hispanics are less likely than Whites to survive acute leukemias and other serious hematologic malignancies.1-3 Allogeneic hematopoietic cell transplantation (HCT) plays an important role in the treatment of high-risk hematologic malignancies, and 1 factor likely contributing to this disparity is the limited availability of 8/8 HLA-matched unrelated donors for persons of color (POC).4 Although most POC have access to 7/8 matched unrelated donors, mismatching is associated with increased risk for acute graft-versus-host disease (aGvHD), transplant-related mortality (TRM), and diminished overall survival (OS)...Taken together, these results suggest the addition of abatacept to standard CNI/MTX mitigates the disadvantages of mismatching by greatly reducing the risks of severe aGvHD and NRM without increasing the risk of relapse." (Qayed, M., et al., 2022). 

Based on the above, the insurer's denial must be reversed. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for Abatacept Injection (J0129) is substantiated.