Medical Drug Criteria (MDC)

Policy Num:       P1.001.012
Policy Name:    TECVAYLI^® (teclistamab-cqyv)
Policy ID:          [P1.001.012] [Ac/L /MDC/P+ ][0.00.00]

Last Review:       September 17, 2024
Next Review:      September 20, 2025
 

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

Coverage eligibility for Teclistamab (Tecvayli) will be considered when the following criteria is met:

• Authorization of 6 months may be granted for the treatment of relapsed or refractory multiple myeloma in adults who have received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

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

NONE

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.

Population Reference No. 1 Policy Statement

References

1. Drug Facts and Comparisons online, Facts and Comparisons eAnswers online. Waltham, MA: UpToDate Inc. https://fco.factsandcomparisons.com. Accessed August 29, 2023.
2.  Florida Blue Medical Coverage Guidelines. http://mcgs.bcbsfl.com/MCG

3.  NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma 3.2023 National Comprehensive Cancer Network. Retrieved September 14, 2023, from https://www.nccn.org/
4. Tecvayli (teclistamab) [prescribing information]. Horsham, PA: Janssen Biotech Inc; 2/2024 .

Codes

Applicable Modifiers

N/A

Policy History