ABECMA (idecabtagene vicleucel) Coverage and Prior Authorization
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This policy governs prior authorization and administration of ABECMA (idecabtagene vicleucel) for adults with relapsed or refractory multiple myeloma in hospital inpatient or outpatient settings.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial ABECMA Therapy
Coverage is provided when ALL of the following criteria are met:
ALL of the following
- The patient is 18 years of age or older.
- The patient has a diagnosis of relapsed or refractory multiple myeloma.
- The patient has tried and failed at least 4 lines of prior therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
Initial Therapy Eligibility
Initial Therapy Eligibility
Initial therapy is covered when all of the following are met:
ABECMA initial therapy eligibility
- Age: The patient is at least 18 years of age.≥18 years
- Diagnosis: The patient has relapsed or refractory multiple myeloma.
- Prior therapy: The patient has tried and failed at least four lines of prior therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.At least 4 prior lines
Authorization and Safety Requirements
Clinical Eligibility Documentation
Document that the patient meets all clinical eligibility requirements for ABECMA prior authorization.
- Patient is ≥ 18 years of age.
- Patient has a diagnosis of relapsed or refractory multiple myeloma.
- Patient has tried and failed at least 4 lines of prior therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
ABECMA REMS Enrollment Required
ABECMA must be provided only through the restricted ABECMA Risk Evaluation and Mitigation Strategy (REMS) program because of the risks of cytokine release syndrome, neurological toxicities, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, and prolonged cytopenia.
- Enroll and comply with the ABECMA REMS before providing treatment.
- Additional information is available at www.AbecmaREMS.com or 1-888-423-5436.
Failure to Meet Clinical Eligibility Criteria
Authorization may be denied when the patient does not meet the required clinical eligibility criteria for ABECMA.
- Patient is younger than 18 years of age.
- Patient does not have relapsed or refractory multiple myeloma.
- Patient has not tried and failed at least 4 lines of prior therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
Permitted Administration Settings
Hospital outpatient administration permitted
ABECMA administration is permitted in a hospital outpatient setting.
Hospital inpatient administration permitted
ABECMA administration is permitted in a hospital inpatient setting.
Key Definitions
Therapy Background
ABECMA (idecabtagene vicleucel) is a CAR-positive T-cell therapy used for adults with relapsed or refractory multiple myeloma after extensive prior treatment. Coverage requires that the patient be at least 18 years of age and have tried and failed at least four prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
Treatment with ABECMA carries risks of cytokine release syndrome, neurological toxicities, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, and prolonged cytopenia. Because of these serious risks, ABECMA is available only through the restricted ABECMA REMS program.
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