Viva Health Tecvayli Prior Auth Policy Update

Coverage Criteria

Initial Therapy

Covered when ALL of the following are met

Initial Eligibility: Member is at least 18 years of age; AND used as continuation therapy following inpatient administration of all step-up doses; AND (Member had an absence of unacceptable toxicity while on inpatient administration of step-up doses OR provider confirms the first three doses are planned for inpatient administration and will only continue treatment if the member had an absence of unacceptable toxicity to the inpatient administration of step-up doses).

Prior authorization validity provided after inpatient step-up dosing

Universal Safety Criteria: Member does not have an active infection (including clinically important localized infections); AND will receive infection prophylaxis per local guidelines; AND immunoglobulin levels will be monitored throughout treatment; AND no history of stroke or seizure; AND no active CNS involvement or clinical signs of meningeal involvement of multiple myeloma; AND no allogeneic stem cell transplant within the previous 6 months or autologous stem cell transplant within the previous 12 weeks.

Safety exclusions and monitoring requirements

Multiple Myeloma Indication-specific: Member has relapsed or refractory multiple myeloma AND (a) used as a single agent and has received at least four (4) prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody; OR (b) used in combination with talquetamab and has received at least three (3) prior lines of therapy; OR (c) used in combination with daratumumab and hyaluronidase-fihj and has received at least one (1) prior line of therapy including a proteasome inhibitor and an immunomodulatory agent).

Line-of-therapy requirements vary by regimen

Continuation Therapy / Renewal

Renewal may be granted when ALL of the following are met

Renewal Requirements: Member continues to meet the universal and indication-specific criteria (including concomitant therapy requirements where applicable); AND disease response demonstrated by stabilization of disease or decrease in tumor size or tumor spread; AND absence of unacceptable toxicity from the drug (examples include ICANS, severe administration-related/local injection-site reactions, CRS, hepatotoxicity, neutropenia/febrile neutropenia, severe infections).

Prior authorization may be renewed based on these findings

Coverage is excluded for members with an active infection, including clinically important localized infections, until the infection is resolved. Members must receive infection prophylaxis per local guidelines and have immunoglobulin levels monitored during treatment. Coverage is also not available for members with certain neurologic comorbidities (history of stroke or seizure) or with active CNS or meningeal involvement of multiple myeloma. Additionally, members who have had an allogeneic stem cell transplant within the previous 6 months or an autologous stem cell transplant within the previous 12 weeks are excluded from coverage until those time-based criteria are met.

Medicare Part B coverage determinations for outpatient drugs are governed by the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50, and by any applicable National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), or Local Coverage Articles (LCAs). These CMS requirements are separate from the non‑Medicare coverage criteria in this document; providers should search the CMS Medicare Coverage Database for relevant NCDs/LCDs/LCAs prior to submitting Part B drug claims.

Use of teclistamab (Tecvayli) outside the specified relapsed or refractory multiple myeloma regimens is not covered. Specifically, single‑agent teclistamab is covered only after at least 4 prior lines of therapy (including a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 antibody); combinations with talquetamab require at least 3 prior lines; and combination with daratumumab plus hyaluronidase‑fihj requires at least 1 prior line including a proteasome inhibitor and an immunomodulatory agent. Requests that do not meet these regimen‑specific prior‑therapy thresholds will be considered not meeting criteria.

Regimen	Prior-line requirements	Dosing / step-up & maintenance	Coverage status
Tecvayli (teclistamab-cqyv) — single-agent for relapsed or refractory multiple myeloma	Member has received at least four (4) prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody	Step-up dosing: step-up dose 1 = 0.06 mg/kg (Day 1); step-up dose 2 = 0.3 mg/kg (Day 3, may be given 2–4 days after dose 1 and up to 7 days for resolution). Maintenance: 1.5 mg/kg weekly (Weeks 2–8), then 3 mg/kg every 2 weeks (Weeks 9–24), then 3 mg/kg every 4 weeks (Week 25 onwards). Members should be hospitalized for 48 hours after administration of all step-up doses to monitor for CRS/neurologic toxicity.
Tecvayli in combination with talquetamab for relapsed or refractory multiple myeloma	Member has received at least three (3) prior lines of therapy	Dosing follows Tecvayli step-up and maintenance schedule: step-up dose 1 = 0.06 mg/kg; step-up dose 2 = 0.3 mg/kg; maintenance 1.5 mg/kg weekly then 3 mg/kg Q2W then 3 mg/kg Q4W as indicated. (See package insert for specifics on timing relative to talquetamab.)	Covered
Tecvayli in combination with daratumumab and hyaluronidase-fihj for relapsed or refractory multiple myeloma	Member has received at least one (1) prior line of therapy including a proteasome inhibitor and an immunomodulatory agent	Note: Step-up dosing is not applicable to the daratumumab + hyaluronidase-fihj dosing component; when used with daratumumab + hyaluronidase-fihj follow timing instructions in product labeling: step-up dose 1 = 0.06 mg/kg (administer ≥20 hours after daratumumab/hyaluronidase-fihj), step-up dose 2 = 0.3 mg/kg (2–4 days after dose 1, may be up to 7 days), then maintenance 1.5 mg/kg weekly then 3 mg/kg Q2W then 3 mg/kg Q4W; administer Tecvayli at least 3 hours after daratumumab/hyaluronidase-fihj for the first treatment dose (subsequent doses ≥15 minutes).	Covered

Coding

Covered HCPCS CodesHCPCSCovered

J9380

Injection, teclistamab-cqyv, 0.5 mg; 1 billable unit = 0.5 mg

NDCNDC

57894-0449-xx	Tecvayli 30 mg/3 mL solution for injection in a single-dose vial
57894-0450-xx	Tecvayli 153 mg/1.7 mL solution for injection in a single-dose vial

Covered Diagnosis CodesICD-10Covered

C90.00	Multiple myeloma not having achieved remission
C90.02	Multiple myeloma in relapse
C90.10	Plasma cell leukemia not having achieved remission
C90.12	Plasma cell leukemia in relapse
C90.20	Extramedullary plasmacytoma not having achieved remission
C90.22	Extramedullary plasmacytoma in relapse
C90.30	Solitary plasmacytoma not having achieved remission
C90.32	Solitary plasmacytoma in relapse
Z85.79	Personal history of other malignant neoplasms of lymphoid, hematopoietic and related tissues

Medicare Part B Covered Diagnosis CodesICD-10

No codes listed

inv-10: Maximum HCPCS units per 28 days

Maximum HCPCS units per 28 days2448 billable units every 28 days

Unit definitionHCPCS billing units as defined in coding section of policy (1 billable unit = 0.5 mg for J9380)

Billing intervalLimit applies to any rolling 28-day period

Provider Actions & Documentation Requirements

Prior Authorization

Prior Authorization Validity and Renewal

Prior authorization validity will be provided initially for 6 months (180 days) following initial inpatient administration of two step-up doses. Prior authorization may be renewed every 6 months (180 days) thereafter.

Initial PA: 6 months (180 days) following inpatient administration of step-up dose 1 and step-up dose 2.
Renewal PA: May be renewed every 6 months (180 days) based on renewal criteria and documentation.

Documentation Required

Required Documentation for Prior Authorization

Providers must document that the member meets age and inpatient step-up dosing requirements, absence of unacceptable toxicity to inpatient step-up dosing (or documented plan that first three doses will be given inpatient and continuation depends on absence of unacceptable toxicity), and that universal and indication-specific criteria are met. Required documentation should also address absence of active infection, transplant timing, monitoring and prophylaxis plans, and evidence of prior lines of therapy when applicable.

Line of Therapy

second-line | later

Line of therapy specifics: Single-agent use requires at least four (4) prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody; OR used in combination with talquetamab after at least three (3) prior lines; OR used with daratumumab and hyaluronidase-fihj after at least one (1) prior line including a proteasome inhibitor and an immunomodulatory agent.

Applies to multiple myeloma indications

Definitions

inv-20: Step-up dosing

Step-up dosing schedule (overview)Two step-up doses administered prior to first full treatment dose to mitigate CRS and neurologic toxicity

Timing between step-up dosesStep-up dose 2 may be given 2–4 days after step-up dose 1 (may be given up to 7 days after dose 1 to allow resolution of adverse reactions)

Timing to first treatment doseFirst treatment dose may be given 2–4 days after step-up dose 2 (may be given up to 7 days after dose 2 to allow resolution of adverse reactions)

Inpatient observation requirementMembers should be hospitalized for 48 hours after administration of all doses within the Tecvayli step-up dosing schedule

inv-21: CMS coverage documents referenced

National Coverage Determination (NCD)CMS national policies that may govern Medicare Part B coverage for outpatient drugs; search via CMS Medicare Coverage Database

Background

Teclistamab (Tecvayli) is a BCMA‑directed bispecific T‑cell engager indicated for relapsed or refractory multiple myeloma. Policy coverage is contingent on inpatient administration of the prescribed step‑up dosing and meeting regimen‑specific prior‑line requirements; safety monitoring includes infection prophylaxis and immunoglobulin surveillance to mitigate risks such as cytokine release syndrome and neurologic toxicity. This policy references the Tecvayli dosing and monitoring recommendations and notes that Medicare Part B coverage and any additional CMS NCD/LCD/LCA requirements must be followed where applicable.

OpenPayer

Tecvayli (teclistamab-cqyv) (Subcutaneous)