J9038 — Injection, axatilimab-csfr, 0.1 mg
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- Documentation of diagnosis of chronic graft-versus-host disease (cGVHD) using NIH consensus criteria components (clinical symptoms and signs).
- Documentation that patient underwent allogenic hematopoietic cell transplantation (HCT).
- Documentation of cGVHD severity classified as moderate or severe based on grading scale (e.g., NIH disease grade, CIBMTR score).
- Medical record documentation of failure of at least two prior lines of systemic therapy, including failure of a corticosteroid and failure of one of the specified agents (bortezomib; ibrutinib; immunosuppressant agent such as cyclosporine, mycophenolate, tacrolimus; ruxolitinib; belumosudil; or rituximab).
Key Coverage Criteria
- Treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg. (FDA indication; informational only in policy.)
- Niktimvo is medically necessary for the treatment of chronic graft-versus-host disease (cGVHD) in patients who meet all of the following criteria for initial therapy: Diagnosis of chronic graft-versus-host disease (cGVHD) as defined by all of the following: Patient has undergone allogenic hematopoietic cell transplantation (HCT); and Clinical symptoms and signs that are components of the National Institutes of Health (NIH) consensus criteria for diagnosis of cGVHD; and cGVHD is classified as mod [...]
- For continuation of therapy, Niktimvo is medically necessary when all of the following are met: Documentation of a positive clinical response to Niktimvo therapy; and Prescribed by or in consultation with a transplant specialist; and Niktimvo dosing is in accordance with the United States Food and Drug Administration approved labeling; and Reauthorization will be issued for no more than 12 months.
- Covered diagnosis codes referenced in policy (for reference): D89.811 Chronic graft-versus-host disease; D89.812 Acute on chronic graft-versus-host disease.
3 Active Policies
UHC-POL-niktimvo — Niktimvo (Axatilimab-Csfr)
UMR-POL-UMR-niktimvo — Niktimvo (Axatilimab-Csfr)
SUREST-POL-SUREST-niktimvo — Niktimvo (Axatilimab-Csfr)
Related Codes
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