CurrentPremera BluecrossPolicy 8.01.66

MEDICAL POLICY 8.01.66 Chimeric Antigen Receptor Therapy for Multiple Myeloma

Defines medical necessity criteria, documentation, coding, and coverage application for idecabtagene vicleucel (Abecma) and ciltacabtagene autoleucel (Carvykti) for treatment of relapsed/refractory multiple myeloma under the medical benefit.

Policy Summary

PayerPremera Bluecross

PolicyMEDICAL POLICY 8.01.66 Chimeric Antigen Receptor Therapy for Multiple Myeloma

Policy CodePolicy 8.01.66

Change TypeRevised coverage criteria; coding removals; authorization clarifications

Effective DateMar 1, 2025

Next Review Date

Key ActionDocument age ≥18, diagnosis, prior lines of therapy and organ/bone marrow function, absence of active infection/inflammatory disorders, and no prior CAR‑T or gene therapy in medical records.

SourceLink

POLICY UPDATE CHANGES

Updated Abecma and Carvykti coverage criteria and authorization details (multiple updates 2024–2025).

Removed CPT status B codes 0537T-0539T from policy (March 01, 2025).

2Drugs covered (by name)

≥18Minimum age for coverage

1-2Prior lines of therapy required

18Policy reference number (BCBSA Ref. Policy)

1Material changes in recent updates

Coverage Summary

Defines coverage as covered with criteria for idecabtagene vicleucel (Abecma) and ciltacabtagene autoleucel (Carvykti) under the medical benefit (policy 8.01.66). Effective date: Mar 1, 2025; Last review: Mar 1, 2025. Scope covers medical necessity criteria, documentation, coding, and benefit application for these BCMA-directed CAR‑T therapies.

Headline policy statistics: 2 drugs named (Abecma, Carvykti); policy reference number 18; minimum age for coverage ≥18; prior lines of therapy required vary by drug (1–2 prior lines per policy updates).

Quick Reference

Minimum age for coverage≥18

Prior lines of therapy required1-2

Policy reference number8.01.66

Abecma FDA dose300 to 460 x 10^6 CAR-positive viable T cells

Carvykti FDA dose0.5 to 1.0 x 10^6 CAR-positive viable T cells per kg (max 1 x 10^8)

Medical Necessity Criteria

Abecma (idecabtagene vicleucel) - Medical Necessity

Abecma may be considered medically necessary when ALL of the following are met:

ALL of the following

Individual is aged 18 years or older at the time of infusion
Documented diagnosis of multiple myeloma
Relapsed or refractory disease after 2 or more lines of therapy, including an immunomodulatory agent; a proteasome inhibitor; and an anti-CD38 monoclonal antibody
Has adequate organ and bone marrow function as determined by the treating oncologist or hematologist

Coding

Relevant CPTCPT

0540T

Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous

Covered HCPCS (Abecma)HCPCSCovered

Q2055

Idecabtagene vicleucel, up to 460 million autologous BCMA-directed CAR-positive T cells, including leukapheresis and dose preparation procedures, per therapeutic dose (use to report: Abecma)

Covered HCPCS (Carvykti)HCPCSCovered

Q2056

Ciltacabtagene autoleucel, up to 100 million autologous BCMA-directed CAR-positive T cells, including leukapheresis and dose preparation procedures, per therapeutic dose (use to report: Carvykti)

Other CPT status B codes (removed)CPT

0537T-0539T

Status B codes previously listed; removed from policy (status B, not billable separately)

Note: Per the policy history, CPT status B codes 0537T–0539T were removed from this policy (March 1, 2025). There is a separate payment policy that addresses all status B codes; refer to that payment policy for coding and billing guidance for status B codes.

Provider Actions

Documentation Required

Medical record documentation required

Medical records must document that the individual is aged 18 years or older at the time of infusion; has a documented diagnosis of multiple myeloma; prior lines of therapy as specified (including an immunomodulatory agent, a proteasome inhibitor, and an anti‑CD38 monoclonal antibody, as applicable); adequate organ and bone marrow function as determined by the treating oncologist or hematologist; absence of active infection(s) or inflammatory disorders; and no prior chimeric antigen receptor T therapy or any other gene therapy.

Age ≥18 years at time of infusion
Documented diagnosis of multiple myeloma
Prior lines of therapy as specified (including immunomodulatory agent, proteasome inhibitor, anti‑CD38 antibody as applicable)
Adequate organ and bone marrow function per treating oncologist/hematologist
No active infections or inflammatory disorders
No prior CAR‑T or other gene therapy

Background & Evidence

CAR‑T therapies in this policy target BCMA for treatment of relapsed/refractory multiple myeloma. The evidence base includes single‑arm pivotal trials: KarMMa for idecabtagene vicleucel (Abecma) demonstrating a 72% overall response rate (n=100; median follow‑up 10.7 months) with frequent cytokine release syndrome and neurotoxicity, and CARTITUDE‑1 for ciltacabtagene autoleucel (Carvykti) demonstrating a 98% overall response rate (95 of 97) with high rates of hematologic toxicity.

FDA approvals occurred in 2021–2022 for adults after four or more prior lines of therapy (Abecma: March 26, 2021; Carvykti: February 28, 2022). These therapies carry significant risks including cytokine release syndrome, neurologic toxicity (neurotoxicity), and prolonged or recurrent cytopenias, and each agent is available only through a REMS with facility and tocilizumab access requirements.

Study / Endpoint	Result
KarMMa — overall response rate
72% (n=100; median follow-up 10.7 months)
KarMMa — cytokine release syndrome (any grade)
85% any grade; grade 2-3 9%
CARTITUDE-1 — overall response rate
98% (95 of 97); 78% stringent complete response
CARTITUDE-1 — cytokine release syndrome (any grade)
95% any grade; grade 3-4 5%

Definitions

Relapsed multiple myelomaPer 2016 IMWG criteria: development of new plasmacytomas or bone lesions; ≥50% increase in lesion size (≥1 cm); hypercalcemia (>11.5 mg/dL); hemoglobin decrease >2 g/dL or to <10 g/dL; rise in serum creatinine by ≥2 mg/dL; or hyperviscosity.

Refractory multiple myelomaProgressive disease during or within 60 days of completing the last anti-myeloma regimen; progression defined by IMWG increases in M-component, free light chains, bone marrow plasma cells, or new lesions.

Revision History

2024-04-01clarification

Clarified that Abecma or Carvykti may be approved as a one-time infusion and that repeat treatment is considered investigational.

2024-07-01interim_review

Updated Abecma coverage criteria to include treatment of certain adults who have tried two therapies and updated Carvykti coverage criteria to include treatment of certain adults who have tried one prior therapy and are lenalidomide-refractory.

2025-03-01removalLatest

Removed CPT status B codes 0537T-0539T from policy; noted there is a separate payment policy addressing all status B codes. Also clarified non-formulary exception review authorizations may be approved up to 12 months.

Policy Summary

PayerPremera Bluecross

PolicyMEDICAL POLICY 8.01.66 Chimeric Antigen Receptor Therapy for Multiple Myeloma

Policy CodePolicy 8.01.66

Change TypeRevised coverage criteria; coding removals; authorization clarifications

Effective DateMar 1, 2025

Next Review Date

SourceLink

On This Page

Does not have active infection(s) or inflammatory disorders

Has not received prior chimeric antigen receptor T therapy or any other gene therapy and is not being considered for treatment with any other gene therapy

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Carvykti (ciltacabtagene autoleucel) - Medical Necessity

Carvykti may be considered medically necessary when ALL of the following are met:

ALL of the following

Individual is aged 18 years or older at the time of infusion
Documented diagnosis of multiple myeloma
Relapsed or refractory disease after 1 or more prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent
Disease is refractory to lenalidomide
Has adequate organ and bone marrow function as determined by the treating oncologist or hematologist
Does not have active infection(s) or inflammatory disorders
Has not received prior chimeric antigen receptor T or any other gene therapy and is not being considered for treatment with any other gene therapy

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Investigational / Not Medically Necessary

The following are considered investigational:

ANY of the following

Use of Abecma or Carvykti when the above medical necessity criteria are not met
Repeat/repeat treatment of Abecma or Carvykti (repeat treatment is considered investigational)
All other uses of idecabtagene vicleucel and ciltacabtagene autoleucel for conditions not outlined in this policy

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Prior Authorization

Authorization length and exception

Non‑formulary exception reviews for the drugs listed in this policy may be approved for up to 12 months. Initial authorizations and other approval processes are handled per the policy's length of approval and authorization procedures.

Non‑formulary exception review authorizations may be approved up to 12 months
Initial authorizations follow the policy's standard approval processes

Billing Rule

Benefit application

Abecma and Carvykti are managed through the medical benefit.

Documentation Required

REMS program and facility requirements

Facilities and providers must comply with the product‑specific REMS and ensure readiness to manage known severe toxicities.

Enroll the health care facility in the product‑specific REMS
Have onsite, immediate access to tocilizumab with a minimum of 2 doses available per patient for administration within 2 hours after infusion if needed
Ensure health care providers who prescribe, dispense, or administer these therapies are trained to manage cytokine release syndrome and neurologic toxicities