CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Abecma (idecabtagene vicleucel) — Coverage Criteria for Multiple Myeloma

Defines accepted indications, coverage criteria, exclusions, and management for Abecma (idecabtagene vicleucel) use in treating multiple myeloma for members of Neighborhood Health Plan of Rhode Island; applies to provider authorization/UM processes.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAbecma (idecabtagene vicleucel) — Coverage Criteria for Multiple Myeloma

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMay 31, 2024

Next Review DateN/A

Key ActionObtain prior authorization and document prior exposure to required therapy classes and measurable disease per policy thresholds.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

May 31, 2024Effective date

MultipleCommittee approvals

460 x 10^6Dose limit

≥2Required prior lines

Coverage Criteria for Abecma (idecabtagene vicleucel)

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Initial therapy coverage criteria

Covered when ALL of the following are met:

Eligibility for Abecma in multiple myeloma: Adult member with relapsed or refractory multiple myeloma.

Reference: FDA indication and policy purpose.

Prior lines of therapy: Disease has relapsed/refractory status after two or more prior lines of therapy including an immunomodulatory agent (e.g., lenalidomide, thalidomide, pomalidomide), a proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib), and an anti-CD38 monoclonal antibody (e.g., daratumumab, isatuximab).

Class-based prior therapy requirement.

Measurable disease: Member has measurable disease defined as any of: serum M-protein ≥ 1.0 g/dL; urine M-protein ≥ 200 mg/24 h; or involved serum free light chain (FLC) ≥ 10 mg/dL (100 mg/L) with an abnormal FLC ratio.

Per policy definitions for measurable disease.

Dosing and administration limits: Intended use does not exceed a single administration and dosing does not exceed 460 × 10^6 CAR‑positive T cells for the single dose.<= 460 × 10^6 CAR-positive T cells

Single-administration and cell-dose limits per policy.

Concomitant therapy and investigational use: Not concurrently receiving other anti-myeloma therapy AND not being requested for an off‑label or investigational indication lacking sufficient supporting evidence (per CMS compendia, NCCN/ASCO guidelines, FDA label, or acceptable peer‑reviewed literature).

Requests must be supported by FDA labeling, CMS-recognized compendia, NCCN or ASCO guidelines, or acceptable peer-reviewed literature.

Exclusions that will result in noncoverage or denial include the following: disease progression while receiving Abecma (idecabtagene vicleucel); concurrent use with other anti-myeloma therapy; and lack of measurable disease as defined by the policy (see thresholds below). The policy specifically defines measurable disease as any of: serum M-protein ≥ 1.0 g/dL, urine M-protein ≥ 200 mg/24 h, or involved serum free light chain (FLC) ≥ 10 mg/dL (100 mg/L) with an abnormal FLC ratio. Additional exclusions include solitary plasmacytomas or non-secretory myeloma without other evidence of measurable disease, exceeding the one-time administration limit, and dosing that exceeds the single-dose limit of 460 × 10^6 CAR-positive T cells.

Use of Abecma for investigational or off-label indications that lack sufficient supporting evidence is considered not medically necessary. The policy requires that supportive evidence be available in CMS-recognized compendia or acceptable peer-reviewed literature; case reports, meeting abstracts without a full published article, and other anecdotal sources are generally inadequate. When evidence does not adequately represent the patient population, regimen, or clinically meaningful outcomes, or when study design is insufficient to address the question, the indication will not meet medical necessity criteria.

Regimen	Indication	Coverage status	Supporting evidence / notes
Idecabtagene vicleucel (Abecma)	Relapsed/refractory multiple myeloma after two or more prior lines of therapy (including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody)	Covered	Per FDA labeling and pivotal trials (e.g., KarMMa); use must be supported by FDA product labeling, CMS-recognized compendia, NCCN or ASCO guidelines, or acceptable peer-reviewed literature.

Coding and Measurable Disease Thresholds

inv-04: Single dose CAR-positive T cell limit — 460 × 10^6

Single-administration cell-dose limit460 × 10^6 CAR-positive T cells per single administration

Exceeding dose leads to exclusionDosing that exceeds the single dose limit (460 × 10^6 CAR-positive T cells) is an exclusion criterion

Applies to Abecma (idecabtagene vicleucel)Limit specifically stated for Abecma (idecabtagene vicleucel)

inv-05: Serum M-protein measurable disease threshold — >= 1.0 g/dL

Serum M-protein threshold>= 1.0 g/dL

Usage in measurable disease definitionSerum M-protein ≥ 1.0 g/dL qualifies as measurable disease per policy

Absence is exclusionLack of serum M-protein at or above this threshold contributes to exclusion for Abecma coverage

inv-06: Urine M-protein measurable disease threshold — >= 200 mg/24 h

24-hour urine M-protein threshold>= 200 mg/24 h

Part of measurable disease criteriaUrine M-protein ≥ 200 mg/24 h qualifies as measurable disease per policy

Non-secretory disease exclusionSolitary plasmacytomas or non-secretory myeloma without measurable disease (including urine) are excluded

inv-07: Involved serum FLC measurable disease threshold — >= 10 mg/dL (100 mg/L) with abnormal ratio

Involved serum free light chain (FLC) threshold>= 10 mg/dL (100 mg/L) with abnormal serum FLC ratio

Requirement of abnormal ratioInvolved FLC must be ≥ 10 mg/dL and the serum FLC ratio must be abnormal to meet measurable disease

Included in measurable disease definitionThis FLC criterion is listed alongside serum and urine M-protein thresholds for measurable disease

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. For multiple myeloma, member must have relapsed/refractory disease after ≥2 prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti‑CD38 monoclonal antibody. Requests must be supported by FDA labeling, CMS‑recognized compendia, NCCN or ASCO guidelines, or acceptable peer‑reviewed literature.

Affected indication: Relapsed/refractory multiple myeloma after ≥2 prior lines including immunomodulatory agent, proteasome inhibitor, and anti‑CD38 antibody
Acceptable supporting sources: FDA label, CMS‑recognized compendia, NCCN or ASCO guidelines, or acceptable peer‑reviewed literature

Denial Risk

Common Exclusion / Denial Triggers

Providers must confirm and document absence of any exclusion criteria before approval; submissions lacking documentation of exclusions may be denied.

Disease progression while receiving Abecma is an exclusion
Concurrent use of Abecma with other anti‑myeloma therapy is not allowed
Member must have measurable disease; lack of measurable disease is an exclusion
Solitary plasmacytomas or non‑secretory myeloma without other evidence of measurable disease are excluded
Abecma is limited to one time administration per member (duration limit)
Dosing limit: single dose must not exceed 460 × 10^6 CAR‑positive T cells
Investigational or off‑label use lacking sufficient evidence (not supported by CMS compendia or acceptable peer‑reviewed literature) is excluded — assess whether patient characteristics, regimen representation, clinically meaningful outcomes, and study design are adequate

Documentation Required

Required Supporting Documentation

Documentation required to support medical necessity must include clinical evidence of measurable disease and prior therapy history, and cite one of the accepted references (FDA label, CMS compendia, NCCN/ASCO, or peer‑reviewed literature).

Document prior lines of therapy detailing agents/classes (immunomodulatory agents, proteasome inhibitors, anti‑CD38 antibodies)
Provide objective measurements for measurable disease (one or more of): serum M‑protein ≥ 1.0 g/dL; urine M‑protein ≥ 200 mg/24 h; involved serum free light chain ≥ 10 mg/dL with abnormal ratio
If non‑secretory disease or solitary plasmacytoma, include supporting evidence demonstrating other measurable disease (if present); otherwise excluded
Confirm single administration and dosing does not exceed 460 × 10^6 CAR‑positive T cells
If requesting off‑label use, include strong supporting literature or compendia evidence addressing patient representation, regimen relevance, clinically meaningful outcomes, and study design

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAbecma (idecabtagene vicleucel) — Coverage Criteria for Multiple Myeloma

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMay 31, 2024

Next Review DateN/A

Key ActionObtain prior authorization and document prior exposure to required therapy classes and measurable disease per policy thresholds.

SourceLink

On This Page

OpenPayer

Abecma (idecabtagene vicleucel) — Coverage Criteria for Multiple Myeloma

Coverage Criteria for Abecma (idecabtagene vicleucel)

Covered Regimens and Indications

Coding and Measurable Disease Thresholds

Provider Requirements, Prior Authorization, and Documentation

Salvage and Line-of-Therapy Criteria

Definitions and Measurable Disease

Background on Abecma (idecabtagene vicleucel)