| Coverage Policy Manual | |
| Policy #: | 2024041 |
| Category: | Pharmacy |
| Initiated: | August 2024 |
| Last Review: | August 2025 |
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| Idecabtagene Vicleucel (e.g., Abecma) | |
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| Description: |
Idecabtagene vicleucel is a chimeric antigen receptor (CAR)-positive T cell therapy targeting B-cell maturation antigen (BCMA), which is expressed on the surface of normal and malignant plasma cells. The CAR construct includes an anti-BCMA scFv-targeting domain for antigen specificity, transmembrane domain, a CD3-zeta T cell activation domain, and a 4-1BB costimulatory domain. Antigen-specific activation of ABECMA results in CAR-positive T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells. This product is prepared from the individual's peripheral blood mononuclear cells (PBMCs), which are obtained via a standard leukapheresis procedure. The mononuclear cells are enriched for T cells, through activation with anti-CD3 and anti-CD28 antibodies in the presence of IL-2, which are then transduced with the replication incompetent lentiviral vector containing the anti-BCMA CAR transgene. The transduced T cells are expanded in cell culture, washed, formulated into a suspension, and cryopreserved.
REGULATORY STATUS
On March 26, 2021, the Food and Drug Administration approved idecabtagene vicleucel (e.g., Abecma) as the first anti-BCMA CAR-T cell therapy for relapsed or refractory multiple myeloma.
On April 5, 2024, the Food and Drug Administration approved idecabtagene vicleucel (e.g., Abecma) to include an indication for the treatment of adult individuals with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
On June 26, 2025, the Food and Drug Administration approved streamlined patient monitoring requirements and removed REMS program requirement for idecabtagene vicleucel (e.g., Abecma).
Coding
See CPT/HCPCS Code section below.
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Policy/ Coverage: |
Please refer to AR policy # 2020001 for separate policy on Adoptive Immunotherapy.
Prior Approval is required for Idecabtagene Vicleucel (e.g., Abecma).
The use of this drug/therapy requires documentation of direct involvement and ordering by a physician with expertise in specified condition and in a center approved for administration of CAR-T or gene product.
Effective November 1, 2025
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Idecabtagene vicleucel (e.g., Abecma) meets member benefit primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for the treatment of adults with relapsed or refractory multiple myeloma when ALL the following criteria are met:
MULTIPLE MYELOMA
The use of this drug is covered if an FDA-approved oncologic indication exists (not listed as an indication above) with the member meeting all of the additional requirements of the prescribing information (package insert listed in the “Indications and Usage”) AND/OR a NCCN category 1 or 2A recommendation is recognized in the NCCN Drugs and Biologics Compendium with the member meeting specified criteria (See policy #2000030).
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Idecabtagene vicleucel (e.g., Abecma), for any indication or circumstance not described above, does not meet primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For individuals without primary coverage criteria, idecabtagene vicleucel (e.g., Abecma), for any indication or circumstance not described above, is considered
investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
POLICY GUIDELINES
Provider is responsible for assessing suitability for CAR-T therapy, including verification of adequate renal function (creatinine clearance is not less than or equal to 45 mL/min), adequate cardiovascular function (left cardiac ejection fraction (EF) is not less than 45%, or other clinically significant cardiac disease has not been present within in the past 6 months), adequate immunological status (no active hepatitis B, active hepatitis C, human immunodeficiency virus (HIV) positive, or other active, uncontrolled infection).
DOSAGE AND ADMINISTRATION
For FDA labeled indications, idecabtagene vicleucel (e.g., Abecma), must be dosed in accordance with the indication specific recommended dose per FDA label unless otherwise specified below.
The recommended dose range for adult individuals with relapsed or refractory multiple myeloma is 300 to 510 x 1 million CAR-positive T cells as a single dose infusion.
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Effective August 21, 2024 to October 31, 2025
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
The use of idecabtagene vicleucel meets member benefit primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for the treatment of adults with relapsed or refractory multiple myeloma when ALL the following criteria are met:
The use of this drug is covered if an FDA-approved oncologic indication exists (not listed as an indication above) with the member meeting all of the additional requirements of the prescribing information (package insert listed in the “Indications and Usage”) AND/OR a NCCN category 1 or 2A recommendation is recognized in the NCCN Drugs and Biologics Compendium with the member meeting specified criteria (See policy #2000030).
Dosage and Administration
Dosing per FDA Guidelines
The recommended dose range for adult individuals with relapsed or refractory multiple myeloma is 300 to 510 x 1 million CAR-positive T cells as a single dose infusion.
Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Idecabtagene vicleucel, for any indication or circumstance not described above, does not meet primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For individuals without primary coverage criteria, idecabtagene vicleucel, for any indication or circumstance not described above, is considered
investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
For coverage criteria prior to August 21, 2024, for
Idecabtagene Vicleucel (e.g., Abecma), please email codespecificinquiry@arkbluecross.com
for a hardcopy print of the coverage policy.
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| Rationale: |
Evidence reviews assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is balance of benefits and harms.
To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice. Adoptive immunotherapy has been investigated for the treatment of relatively common cancers in which novel treatments have been adopted when randomized clinical trials show efficacy. The selected studies included only new randomized clinical trials.
August 2021 Update
From UpToDate: “Chimeric antigen receptor (CAR)-T cell therapy is an option for patients with MM relapsed after four or more lines of systemic therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. The use of CAR-T therapy is individualized weighing disease tempo, availability of other treatments, and expected toxicity. While initial studies suggest that CAR-T therapy has activity against relapsed or refractory MM, the quality of the evidence is low, treatment is associated with substantial toxicity, and the manufacturing process is complex and expensive.”
In a phase 2 study of the anti-BCMA CAR-T cell product idecabtagene vicleucel (ide-cel) in 128 patients with RRMM, objective responses were seen in 73 percent with an estimated median progression-free survival of 8.8 months. All but one patient experienced at least one grade 3 or 4 toxicity, with hematologic toxicity being most common. Cytokine release syndrome occurred in 84 percent and was usually grade 1 or 2. Grade
≥ 3 CRS occurred in 5% (7/128) of patients (Munshi et al., 2021).
Neurologic toxicities, including severe or life-threatening. In clinical trial, neurological toxicities (NT) occurred in 18% (23/128) of patients. Grade 3 neurologic toxicities occurred in 3% (4/128) of patients and no NT greater than grade 3 occurred (Munshi et al. 2021). Hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), including fatal and life-threatening reactions. In clinical trial, HLH/MAS occurred in 4% (5/127) of patients (Celgene, 2021a).
Persistent cytopenia with bleeding and infection, including fatal outcomes following stem cell transplantation for hematopoietic recovery. In clinical trial, neutropenia occurred in 91% (117/128) of patients, anemia occurred in 70% (89/128), and thrombocytopenia occurred in 63% (81/128) (Munshi et al., 2021).
Response durations were longer in patients who achieved a stringent complete response (CR) as compared to patients with a partial response (PR) or very good partial response (VGPR). Of the 28 patients who achieved a stringent CR, it is estimated that 65% (95% CI: 42%, 81%) had a remission lasting at least 12 months. The median duration of response for VGPR patients (n=25) was 11.1 months (95% CI: 8.7, 11.3) and the median duration of response for PR patients (n=19) was 4.0 months (95% CI: 2.7, 7.2). Results of the KarMMa study support Abecma (idecabtagene vicleucel) induced responses in a majority of heavily pretreated patients with refractory and relapsed myeloma.
The NCCN guideline for Multiple Myeloma version 6.2021 idecabtagene vicleucel was added to therapy for previously treated multiple myeloma other recommended regimens and is indicated for patients who have received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.
2024 Update
In the randomised, open-label, phase 3 KarMMa-3 trial, 386 patients in hospitals (≥18 years of age, with measurable disease and an Eastern Cooperative Oncology Group performance status score of 0 or 1, who had received two to four previous regimens-including an immunomodulatory agent, a proteasome inhibitor, and daratumumab-and had documented disease progression after receiving their last dose of the last therapy) were randomly assigned to ide-cel (n=254) or standard regimens (daratumumab, pomalidomide, and dexamethasone; daratumumab, bortezomib, and dexamethasone; ixazomib, lenalidomide, and dexamethasone; carfilzomib and dexamethasone; or elotuzumab, pomalidomide, and dexamethasone; n=132). Patients were expected to complete the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life C30 Questionnaire (QLQ-C30), Multiple Myeloma Module (QLQ-MY20), EQ 5 dimensions (EQ-5D), and EQ-5D visual analogue scale (VAS) at baseline and follow-up timepoints (data cutoff April 18, 2022). PROs included nine prespecified primary domains: EORTC QLQ-C30 GHS-quality of life (QoL), physical functioning, cognitive functioning, fatigue, and pain; QLQ-MY20 disease symptoms and side effects of treatment; and five-level EQ-5D (EQ-5D-5L) index score and EQ-5D visual VAS. Differences in overall least-squares mean changes from baseline to month 20 were analysed using post-hoc constrained longitudinal data analysis. Time to confirmed improvement or deterioration from baseline was analysed using Cox proportional hazard models.
Patients were randomly assigned between May 6, 2019, and April 8, 2022. Overall, the median age was 63 years (IQR 55-68); 151 (39%) patients were female; and 250 (65%) patients were White, 36 (9%) Black or African American, 19 (5%) Hispanic or Latino, 12 (3%) Asian, and seven (2%) of another race. The median follow-up was 18·6 months (IQR 14·0-26·4). PRO compliance was higher than 75% throughout. Overall, least-squares mean changes from baseline favoured ide-cel with Hedges' g effect sizes from 0·3 to 0·7 for most domains. Patients in the ide-cel group showed statistically significant and clinically meaningful improvements across the primary PRO domains of interest, with the exception of QLQ-MY20 disease symptoms, side effects of treatment, and EQ-5D-5L index score, which showed improvement across assessment visits but did not exceed the within-group minimally important difference thresholds. The ide-cel group had shorter times to clinically meaningful improvement than the standard regimens group in QLQ-C30 domains except in role functioning, diarrhoea, and financial difficulties; in QLQ-MY20 domains except body image; and in EQ-5D-VAS.
Ide-cel offers improved health-related quality of life compared with standard regimens for patients with relapsed and refractory multiple myeloma after previous lines of therapy. The PRO data highlight the extended QoL benefits of a one-time infusion with ide-cel compared with continuous treatment with standard regimens in the treatment of triple-class exposed patients with relapsed and refractory multiple myeloma. (Delforge M, Patel K, Eliason L, et.al., 2024)
2025 Update
The FDA approved label updates for ide-cel reduce certain patient monitoring requirements and remove the Risk Evaluation and Mitigation Strategy (REMS) program that had been in place since product was initially approved. The changes include reduced driving restrictions (from 8 weeks to 2 weeks post-treatment) and reduced requirement to stay within proximity of a healthcare facility following infusion of CAR-T reduced from 4 weeks to 3 weeks. The FDA has also approved removal of the REMS requirement from ide-cel product label. A REMS program is often required to help mitigate known or potential risks associated with new drugs or therapies. The FDA has since determined that the established management guidelines and extensive experience of the medical hematology/oncology community are sufficient to diagnose and manage the risks of side effects, including cytokine release syndrome (CRS) and neurologic toxicities (NTs), without a REMS. This change is likely to help accelerate cell therapy into the community center setting.
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| CPT/HCPCS: | |
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| References: |
Abecma(2024) package insert Bristol-Meyers Squibb Company, Summit, NJ, 2024 Delforge M, Patel K, Eliason L, Dhanda D, Shi L, Guo S, Marshall TS, Arnulf B, Cavo M, Nooka A, Manier S, Callander N, Giralt S, Einsele H, Ailawadhi S, Popa McKiver M, Cook M, Rodríguez-Otero P.(2024) Health-related qual of life in patients with triple-class exposed relapsed and refractory multi myeloma treated with idecabtagene vicleucel or standard regimens: patient-rep outcomes from the phase 3, randomised, open-label KarMMa-3 clin trial. Lancet Haematol. 2024 Mar;11(3): e216-e227. doi: 10.1016/S2352-3026(24)00005-X. Erratum in: Lancet Haematol. 2024 May;11(5): e319. doi: 10.1016/S2352-3026(24)00080-2. PMID: 38423700. Munshi NC, Anderson LD Jr, Shah N, et al.(2021) Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma N Engl J Med 2021; 384:705 |
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| Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants. | |
| CPT Codes Copyright © 2025 American Medical Association. | |