Currentharvard pilgrim health carePolicy N/A

Idecabtagene vicleucel (Abecma) — Coverage Criteria for Multiple Myeloma

Medical necessity and prior authorization criteria for coverage of Abecma (idecabtagene vicleucel) for adults with relapsed or refractory multiple myeloma under Harvard Pilgrim / affiliated Tufts products.

Policy Summary

Payerharvard pilgrim health care

PolicyIdecabtagene vicleucel (Abecma) — Coverage Criteria for Multiple Myeloma

Policy CodePolicy N/A

Change TypeMaterial clinical and operational revisions

Effective DateSeptember 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and submit documentation of diagnosis, prior lines of systemic therapy with dates, and ECOG performance status prior to approval.

SourceLink

POLICY UPDATE CHANGES

REMS language removed from both Overview and Criteria sections; two notes added to the Overview section; limitation regarding immunosuppressive therapy refined to specify high risk to interfere with T cell function.

Updated ECOG eligibility expanded from 0-1 to 0-2 in criteria.

Changed prior-line requirement from fourth-line to third-line (moved from fourth line treatment to third line treatment).

Specified that authorization is limited to one single dose treatment and prior CAR-T therapy is an exclusion.

1authorized therapeutic dose (single dose limit)

>=2required prior systemic therapy lines for coverage

ECOG 0-2acceptable performance status range

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Coverage Criteria for Idecabtagene vicleucel (Abecma)

Initial Therapy

Covered when ALL of the following are met for Members aged 18 years or over:

Eligibility for Abecma

Required prior regimens: Previous treatments must have included ALL of the following unless contraindicated: (a) an immunomodulatory agent (e.g., lenalidomide, pomalidomide); (b) a proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib); (c) an anti-CD38 monoclonal antibody (e.g., daratumumab, isatuximab)
Member must have undergone at least 2 consecutive cycles of treatment for each regimen unless progressive disease was the best response
No prior CAR-T: No prior treatment with any form of CAR-T therapy (including clinical trials)
Organ function and infection screening: Adequate organ function including bone marrow, cardiac, pulmonary, and neurological with no anticipated decline near apheresis timeframe; no untreated active systemic infection (e.g., HIV, active hepatitis B or C); screening completed at time of leukapheresis
GVHD: If prior allogeneic stem cell transplantation, no evidence of active graft-versus-host disease
Performance status: ECOG performance status 0 to 2
ECOG definitions provided in policy

Required documentation: Documentation submitted must list previous lines of treatment/systemic therapies and date of each therapy

Prior authorization is required regardless of inpatient or outpatient setting

third-line_or_later

Line requirement: Relapsed or refractory after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody

Moved from fourth-line to third-line requirement in policy history; prior regimens must include at least 2 consecutive cycles unless progression was the best response

Coverage is not permitted for certain exclusionary or limiting conditions. Specifically, pregnancy is a contraindication to Abecma (idecabtagene vicleucel) therapy. Members receiving immunosuppressive therapy that is likely (high risk) to interfere with T‑cell function will not be approved. Untreated underlying primary immunodeficiency syndromes are excluded. Members with active and/or metastatic malignancy that is unlikely to respond to treatment will not be approved. Authorization is limited to a single therapeutic dose, and members who have had prior treatment with any form of CAR‑T cell therapy (including clinical trials) will not be approved for additional CAR‑T therapy. Coverage may also be denied if the member demonstrates clinical decompensation between authorization and infusion such that they no longer meet coverage criteria.

Any indication for CAR‑T cell therapy that is not encompassed by the criteria above is considered investigational and will not be covered. This includes non‑FDA‑approved uses of CAR‑T therapies.

Covered Regimens and Product Details

Regimen	Indication / Eligibility Summary	HCPCS
Idecabtagene vicleucel (Abecma), autologous BCMA-directed CAR‑T	For adults (≥18 years) with active, measurable 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; adequate organ function, ECOG performance status 0–2, no prior CAR‑T therapy, no active untreated systemic infection, and not pregnant	Q2055

Coding and Dose Information

CPT CodesCPT

No codes listed

HCPCS CodesHCPCSCovered

Q2055

Idecabtagene vicleucel, up to 460 million autologous B-cell maturation antigen (BCMA) directed CAR-positive T cells, including leukapheresis and dose preparation procedures, per therapeutic dose

Dose (inv-06)

Authorized therapeutic doseUp to 460 million CAR-positive T cells per therapeutic dose

Dose components includedIncludes leukapheresis and dose preparation procedures as part of the therapeutic dose description

Single-dose policy noteAuthorization is limited to one single therapeutic dose (repeat CAR‑T therapy is excluded)

BCMA (inv-15)

Target antigenTherapy directed at B-cell maturation antigen (BCMA)

Code linkageHCPCS Q2055 describes idecabtagene vicleucel as up to 460 million autologous BCMA‑directed CAR‑positive T cells

Provider Actions, Authorization & Documentation

Prior Authorization

Prior authorization required for Q2055

Prior authorization is required for idecabtagene vicleucel (HCPCS Q2055) for any inpatient or outpatient use; supporting clinical documentation must be submitted.

Prior authorization required regardless of inpatient or outpatient setting

Step Therapy

Required prior therapies (>=2 lines)

Patient must have relapsed or refractory multiple myeloma after two or more prior lines of systemic therapy, including specified agent classes; the member must have undergone at least 2 consecutive cycles of each regimen unless progression was the best response.

Required prior regimens include: an immunomodulatory agent (e.g., lenalidomide, pomalidomide)
a proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib)
an anti-CD38 monoclonal antibody (e.g., daratumumab, isatuximab)

Definitions

Apheresis (inv-12)

DefinitionApheresis is a process that removes blood from the body, isolates one or more blood components (such as white blood cells), and returns the remainder to the body.

Role in CAR‑T therapyFirst procedural step to collect the patient’s T‑cells for genetic engineering into CAR‑T cells.

OutcomeCollected T‑cells are sent to a manufacturing facility where they are engineered, expanded, frozen, and later returned for infusion.

Idecabtagene vicleucel (Abecma) (inv-13)

Product descriptionIdecabtagene vicleucel (Abecma) is an autologous BCMA‑directed CAR‑T cell therapy for adults with relapsed or refractory multiple myeloma.

Approved indicationIndicated for patients after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti‑CD38 monoclonal antibody.

Background

Chimeric antigen receptor T‑cell (CAR‑T) therapy is an autologous cellular immunotherapy in which a patient’s T cells are collected (apheresis), genetically modified to express a chimeric antigen receptor that targets a tumor antigen, expanded, and reinfused. For multiple myeloma, approved CAR‑T targets the B‑cell maturation antigen (BCMA) on malignant plasma cells. Idecabtagene vicleucel (Abecma) is an autologous BCMA‑directed CAR‑T product indicated for adults with relapsed or refractory multiple myeloma after prior systemic therapy; the manufactured dose for a therapeutic administration is up to 460 million CAR‑positive T cells. CAR‑T can produce durable remissions but carries risks of serious toxicities (for example cytokine release syndrome) that necessitate specialized monitoring and access to therapies such as tocilizumab.