Belatacept Initiation is NOT Medically Necessary for This Patient Due to Unknown Tuberculosis Status
Belatacept (NULOJIX) is contraindicated in this patient until tuberculosis status is definitively established, as untreated latent or active tuberculosis is an absolute exclusion criterion for belatacept therapy. 1
Critical Missing Information That Precludes Approval
- Tuberculosis screening is mandatory before belatacept initiation, and this patient's TB status is documented as "unknown" 1
- The FDA label explicitly requires exclusion of untreated latent or active tuberculosis before starting belatacept 1
- Tuberculosis has been reported as a severe infection occurring more frequently with belatacept compared to calcineurin inhibitors 2
Additional Concerns Regarding Mycophenolate Requirement
- Belatacept must be administered in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids according to FDA labeling 1
- This patient has a documented allergy to Cellcept (mycophenolate), and the case notes indicate it is "UNSURE" whether belatacept will be administered with mycophenolate 1
- The FDA-approved regimen specifically requires mycophenolate mofetil as part of the combination therapy 1
EBV Status Meets Requirements
- The patient is EBV seropositive (positive test 7/3/2025), which satisfies the mandatory requirement that belatacept recipients must be EBV seropositive 1
- EBV seronegative or unknown status patients are absolutely contraindicated from receiving belatacept due to increased risk of post-transplant lymphoproliferative disorder (PTLD), particularly CNS-PTLD 1
Valid Clinical Indication for Switch from Tacrolimus
- The patient has a legitimate indication for switching from tacrolimus to belatacept based on the 6/27/2025 biopsy showing 20-30% fibrosis, moderate tubular atrophy, and severe arteriosclerosis 3
- These findings are consistent with calcineurin inhibitor nephrotoxicity, which is an FDA-approved indication for switching to belatacept 1
- Belatacept has been shown to preserve renal function better than calcineurin inhibitors, with higher glomerular filtration rates and less chronic kidney scarring 4
Required Actions Before Approval Can Be Granted
- Tuberculosis screening must be completed immediately, including tuberculin skin test (TST) or interferon-gamma release assay (IGRA), and chest radiograph 3
- If latent TB is identified, treatment with isoniazid or rifampin must be initiated and documented before belatacept can be started 3
- Clarification is required regarding mycophenolate administration - either the allergy must be re-evaluated or an alternative immunosuppressive regimen must be considered, as belatacept without mycophenolate is not FDA-approved 1
PTLD Risk Considerations (Once TB Status Resolved)
- The patient's EBV seropositive status significantly reduces PTLD risk compared to seronegative patients 1
- CMV serostatus should be documented, as EBV seropositive/CMV seronegative patients may have increased PTLD risk 1
- CMV prophylaxis for at least 3 months post-transplant is recommended when using belatacept 1
- The overall PTLD risk with belatacept is approximately 1.4% versus 0.9% with cyclosporine, with most cases involving the CNS 2, 5
Monitoring Requirements If Approved After TB Clearance
- Neurological assessment should be performed regularly to detect early signs of PTLD or progressive multifocal leukoencephalopathy (PML) 1
- Renal function monitoring should continue, as belatacept recipients maintain better GFR than CNI-treated patients (approximately 10 mL/min/1.73 m² higher) 4
- Blood pressure and lipid profiles typically improve with belatacept compared to tacrolimus 4
Recommendation: DENY pending completion of tuberculosis screening and clarification of mycophenolate administration plan. Once TB status is confirmed negative (or treated if positive) and mycophenolate compatibility is established, belatacept would be medically appropriate for this patient given the biopsy evidence of calcineurin inhibitor nephrotoxicity.