Abecma (idecabtagene vicleucel) IV prior authorization
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Prior authorization form and medical necessity criteria for Abecma (idecabtagene vicleucel) IV (HCPCS Q2055) for treatment of relapsed or refractory multiple myeloma, including provider, patient, dosing, quantity limits, and required clinical documentation.
No material changes to clinical coverage or policy criteria.
Coverage Summary
Prior authorization form and medical necessity criteria for Abecma (idecabtagene vicleucel) IV (HCPCS Q2055) for treatment of relapsed or refractory multiple myeloma, including provider, patient, dosing, quantity limits, and required clinical documentation. Authorization is limited to 1 dose of up to 510 million autologous CAR-positive viable T-cells. Documentation must be provided for each checked clinical criterion (lab results, diagnostics, chart notes) or the request may be denied. Coverage stance: Covered with criteria. Administration requires enrollment in the ABECMA REMS program due to risks of cytokine release syndrome (CRS) and neurological toxicities.
Medical Necessity / Approval Criteria (Initial Therapy)
Medical Necessity / Approval Criteria
All criteria must be met for approval. To support each line checked, documentation (lab results, diagnostics, chart notes) must be provided or request may be denied.
ALL of the following
- Member is 18 years of age or older
- Provider is an oncologist and the administrating healthcare facility has enrolled in the ABECMA REMS Program and training has been given to providers on the management of cytokine release syndrome (CRS) and neurological toxicities
- Member has NOT received prior CAR-T therapy
- Member does NOT have a clinically significant active systemic infection or inflammatory disorder
- Member has NOT received live vaccines within 6 weeks prior to the start of lymphodepleting chemotherapy, during treatment, and will not receive live vaccines until immune recovery following treatment
- Member has been screened for cytomegalovirus (CMV), hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) in accordance with clinical guidelines prior to collection of cells (leukapheresis)
- Prophylaxis for infection has been followed according to local guidelines or clinical practice
- Provider attests Abecma will be used as single agent therapy (not applicable to lymphodepleting or additional chemotherapy while awaiting manufacture)
- Member does NOT have known central nervous system involvement, including a history or presence of clinically relevant pathology, with myeloma
- Member does NOT have active or a history of plasma cell leukemia
- Member has an ECOG performance status of 0-1
- Member has a diagnosis of relapsed or refractory multiple myeloma
- Member must have received 2 or more prior lines of therapy including a proteasome inhibitor (e.g., bortezomib), immunomodulatory agent (e.g., lenalidomide, thalidomide) AND an anti-CD38 antibody (e.g., daratumumab, isatuximab)
Unapproved / Exclusion Criteria & Precautions
Standalone exclusions/precautions specified in the criteria: known active systemic infection or inflammatory disorder; prior CAR-T therapy (member must NOT have received prior CAR-T); receipt of live vaccines within 6 weeks prior to lymphodepleting chemotherapy, during treatment, and until immune recovery; known central nervous system (CNS) involvement with myeloma; and active or prior plasma cell leukemia. The REMS program is required because of risks of cytokine release syndrome (CRS) and neurologic toxicities. Members must be screened for CMV, HBV, HCV, and HIV in accordance with clinical guidelines prior to leukapheresis, and infection prophylaxis should be followed per local guidelines or clinical practice.
Applicable Codes
| Q2055 | idecabtagene vicleucel, abecma, autologous CAR-positive viable T-cells, up to 510 million cells, infusion |
Provider Actions & Authorization Requirements
Prior authorization submission
Prescribing physician must sign and clearly print name on request (preprinted stamps not valid). All other information may be filled in by office staff; fax request to 1-877-535-1391. Incomplete, incorrect, or illegible information may delay or deny authorization.
Documentation to support criteria
Provide supporting documentation for each checked clinical criterion including lab results, diagnostics, and chart notes. Prior therapies will be verified through pharmacy paid claims or submitted chart notes; failure to provide required documentation may result in denial.
REMS enrollment and training
Ensure the administrating healthcare facility is enrolled in the ABECMA REMS Program and that providers have completed training on the management of cytokine release syndrome (CRS) and neurological toxicities prior to administration.
Quantity limit per authorization
Authorization is limited to 1 dose of up to 510 million autologous CAR-positive viable T-cells per authorization (unit/HCPCS as specified).
Urgent review process
For urgent review requests (where lack of treatment could seriously jeopardize life, health, or ability to regain maximum function), the practitioner should call the AvMed Pre-Authorization Department to request urgent review.
Background & Definitions
Abecma (idecabtagene vicleucel) is an autologous CAR-T cell therapy for relapsed or refractory multiple myeloma. Administration requires enrollment in the ABECMA REMS program because of the risk of cytokine release syndrome (CRS) and neurological toxicities. Prior to collection of cells and treatment, patients must be screened for infections (including CMV, HBV, HCV, and HIV) per clinical guidelines, and live vaccines must be avoided within the specified period around treatment.
| Term | Definition |
|---|---|
| Abecma | |
| Brand name for idecabtagene vicleucel, autologous CAR-positive viable T-cell therapy. | |
| REMS | |
| Risk Evaluation and Mitigation Strategy program; enrollment required for administration of Abecma. | |
| ECOG | |
| Eastern Cooperative Oncology Group performance status scale. |
Medicare Coverage Notes
The brief lists a Medicare coverage note titled "Medicare Coverage for outpatient (Part B) drugs" (an NCD-type entry) but does not provide an effective date or NCD number; no additional Medicare specifics are provided in the document.
Revision History
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