Medical Drug Criteria (MDC)

Policy Num:       P1.001.012
Policy Name:    TECVAYLI^® (teclistamab-cqyv)
Policy ID:          [P1.001.012] [Ac/L /MDC/P+ ]

Last Review:       September 22, 2025
Next Review:      September 20, 2026
 

Related MDC:NONE

TECVAYLI^® (teclistamab-cqyv)

Summary

Teclistamab (Tecvayli) is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engaging antibody for the treatment of adult patients with relapsed or refractory multiple myeloma (MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. This indication was approved under accelerated approval based on response rate,and continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). 

Teclistamab binds to the CD3 receptor expressed on the surface of T-cells and BCMA expressed on the surface of multiple myeloma cells and some healthy B-lineage cells. In vitro, teclistamab activated T-cells, caused the release of various proinflammatory cytokines, and resulted in the lysis of multiple myeloma cells.

Teclistamab (Tecvayli) has boxed warnings due to cytokine release syndrome (CRS) and  neurologic toxicity.  Tecvayli is available only through a restricted program called the TECVAYLI and TALVEY Risk Evaluation and Mitigation Strategy (REMS).

Policy Statements

Initiation of Teclistamab (Tecvayli) meets the definition of medical necessity when all the criteria below are met.

Policy Guidelines

Authorization period: up to 6 months for initial requests.
 
Coverage is for subcutaneous administration in certified settings under the TECVAYLI & TALVEY REMS.
 
Hospitalization/monitoring: Patients must be hospitalized for 48 hours after each step-up dose.
 
Premedication (step-up doses and first treatment dose): dexamethasone, H1 antihistamine, and antipyretic. Consider antiviral prophylaxis for herpes zoster prior to initiation per guidelines.
 
Dose modifications: No dose reductions; manage toxicities with dose holds/restarts per PI (CRS/neurotoxicity/ICANS/infections/cytopenias).

Restart after delays: follow PI table for timing and restart level.

DOSAGE/ADMINISTRATION

The recommended dosage of Tecvayli is:

•    Day 1 (Step-up dose 1) - 0.06 mg/kg

•    Day 4 (Step-up dose 2) - 0.3 mg/kg

•    Day 7 (First treatment dose) – 1.5 mg/kg

•    One week after first treatment dose and weekly thereafter - 1.5 mg/kg once weekly

For subcutaneous injection only. Patients should be hospitalized for 48 hours after administration of all doses within the Tecvayli step-up dosing schedule.

REQUIRED MEDICAL INFORMATION

Initial Approval Criteria

Initiation of teclistamab (Tecvayli) meets the definition of medical necessity when EITHER of the following criteria are met (“1” or “2”):

1.    Member has a diagnosis of relapsed or refractory multiple myeloma (MM) and ALL of the following (“a” to “f”) - medical record documentation confirming the patient’s diagnosis and complete treatment history must be submitted:

a.    Member has received FOUR or more appropriate prior lines of therapy of adequate duration for the treatment of their MM. 

       NOTE: Primary therapy, with or without subsequent hematopoietic cell transplant, followed by maintenance therapy is considered a single line of therapy

b.    Member’s prior MM treatments have included ALL of the following (“i”, “ii”, and “iii”):

i)    An anti-CD38 monoclonal antibody [for example - daratumumab (Darzalex), daratumumab hyaluronidase (Darzalex Faspro), or isatuximab (Sarclisa)]

ii)    A proteasome inhibitor [for example - bortezomib, carfilzomib (Kyprolis), or ixazomib (Ninlaro)]

iii)    An immunomodulatory agent [for example - lenalidomide (Revlimid), pomalidomide (Pomalyst), or thalidomide (Thalomid)]

c.    Member’s MM was NOT previously refractory (i.e., disease progression on treatment or progression within 60 days after the last dose of a given therapy) to a teclistamab-containing treatment regimen

d.    Teclistamab will be used as single-agent therapy for the member’s MM (i.e., not used in combination with other MM treatments)

e.    The ordering provider and the infusing healthcare facility is certified in the TECVAYLI REMS program

f.    Dosage of teclistamab does not exceed the following: 

i)    Day 1 (Step-up dose 1) - 0.06 mg/kg

ii)    Day 4 (Step-up dose 2) - 0.3 mg/kg

iii)    Day 7 (First treatment dose) – 1.5 mg/kg

iv)    One week after first treatment dose and weekly thereafter - 1.5 mg/kg once weekly

2.    Member has another FDA-approved or NCCN-supported diagnosis, and ALL of the following are met (“a” to “d”):

a.    EITHER of the following (“i” or “ii”):

i)    Member is diagnosed with a condition that is consistent with an indication listed in the product’s FDA-approved prescribing information (or package insert) AND member meets any additional requirements listed in the “Indications and Usage” section of the FDA-approved prescribing information (or package insert)

ii)    Indication AND usage are recognized in NCCN Drugs and Biologics Compendium as a Category 1 or 2A recommendation

b.    Teclistamab is used in a treatment regimen in accordance with the FDA-approved prescribing information or applicable NCCN guideline recommendation for the diagnosis

c.    The ordering provider and the infusing healthcare facility is certified in the TECVAYLI REMS program

d.    Dosage of teclistamab does not exceed the maximum recommended in the FDA-approved prescribing information or the maximum recommended by the applicable NCCN guidelines for the diagnosis

Renewal Approval Criteria 

Continuation* of teclistamab (Tecvayli) meets the definition of medical necessity when ALL of the following criteria are met (“1” to “3”):

1.    An authorization or reauthorization for teclistamab has been previously approved by Florida Blue or another health plan in the past 2 years for the treatment of multiple myeloma, or other FDA-approved or NCCN-supported diagnosis; OR the member previously met ALL indication-specific initiation criteria

2.    The ordering provider and the infusing healthcare facility is certified in the TECVAYLI REMS program

3.    EITHER of the following based on the member’s diagnosis (“a” or “b”):

a.    Multiple myeloma, and ALL of the following (“i”, “ii”, and “iii”):

i)    Teclistamab is being used as single-agent therapy for the member’s MM (i.e., not used in combination with other MM treatments)

ii)    Dosage of teclistamab does not exceed 1.5 mg/kg once weekly

iii)    Provider attestation that the member has not had disease progression during teclistamab treatment

b.    Other FDA-approved or NCCN-supported diagnosis, and ALL of the following (“i”, “ii”, and “iii”):

i)    Dosage of teclistamab does not exceed the maximum recommended in the FDA-approved prescribing information or the maximum recommended by the applicable NCCN guideline for the specific diagnosis

ii)    Teclistamab is used in a treatment regimen in accordance with the FDA-approved prescribing information or applicable NCCN guideline recommendation for the diagnosis

iii)    Member has had a beneficial response to treatment with teclistamab

* For members that may have only completed the initial step-up dosing schedule during an inpatient admission, please refer to the initiation criteria
 

EXCLUSION CRITERIA

No absolute exclusions beyond PI; apply Boxed Warnings/Precautions and REMS requirements (e.g., hold for active serious infection during step-up; manage CRS/ICANS per PI).

BENEFIT APPLICATION

BlueCard/National Account Issues:

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered. Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

OTHER CRITERIA

Validate that the treatment regimen is following the most up to date NCCN guidelines recommendations.

Follow dose-delay/restart rules per PI.

Supplemental Information

Premedication prior to each step-up and first treatment dose (dexamethasone, H1 blocker, antipyretic).

Antiviral prophylaxis for herpes zoster: consider prior to initiation per PI.  

Restart rules after delays and hold/resume algorithms for CRS/ICANS per PI tables.

Practice Guidelines and Position Statements

NCCN Multiple Myeloma (v2.2025 era; Compendium 2025): teclistamab recommended Category 2A in RRMM after ≥4 prior therapies that include PI, IMiD, and anti-CD38. Refer to NCCN Drugs & Biologics Compendium for the most current, detailed regimen notes.

MEDICARE NATIONAL COVERAGE

No NCD specific to teclistamab; Part B coverage generally applies for physician-administered drugs when reasonable and necessary per MAC policy. 

References

1. TECVAYLI Prescribing Information. Revised 08/2025. Janssen Biotech.
 
2. TECVAYLI & TALVEY REMS (FDA letter noting latest modification 07/02/2024).
 
3. NCCN Drugs & Biologics Compendium / NCCN Multiple Myeloma Guidelines (2025).
 
4. HOPA: NCCN Category 2A recommendation for teclistamab after ≥4 prior lines.

Codes

Applicable Modifiers

N/A

Policy History