Emrelis (telisotuzumab vedotin‑tllv) — Coverage Criteria
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Defines prior authorization requirements and medical benefit coverage criteria for Emrelis (telisotuzumab vedotin-tllv) for adults with locally advanced or metastatic non‑squamous non‑small cell lung cancer with high c‑Met overexpression; applies to Mass General Brigham Health Plan medical benefit members including MassHealth UPPL.
Emrelis now requires prior authorization under the medical benefit.
Coverage criteria for Emrelis specifying c‑Met high protein overexpression (≥50% tumor cells with strong 3+ staining) and prior systemic therapy requirement.
Initial approvals will be granted for 6 months with reauthorizations for 12 months.
Coverage Criteria for Emrelis (telisotuzumab vedotin-tllv)
Initial Therapy (Emrelis)
Authorization may be granted when ALL of the following are met:
Documentation of dosing per label required
Prior therapy must reflect histology and prior testing (e.g., EGFR, ALK, KRAS, ROS1, PD‑L1)
Continuation of Therapy
Reauthorization requires:
Initial approvals will be granted for 6 months; reauthorizations granted for 12 months.
| Regimen | Indication | Dose / Schedule | Line of Therapy | Coverage Status |
|---|---|---|---|---|
| Telisotuzumab vedotin‑tllv (Emrelis) monotherapy | Adults with locally advanced or metastatic non‑squamous non‑small cell lung cancer (NSCLC) with high c‑Met protein overexpression (≥50% of tumor cells with strong (3+) staining) | Per appropriate dosing (per label) — documentation of dosing per label required | Use after prior systemic therapy (patients who have received a prior systemic therapy); requires inadequate response or adverse reaction to ONE or contraindication to ALL first‑line systemic therapies appropriate for histology and prior biomarker testing | Covered with criteria |
For members who are new to the plan and are currently receiving the requested medication, authorization may be reviewed on a case‑by‑case basis. Coverage consideration does not include drug product provided as samples or obtained through a manufacturer’s patient assistance program; requests for therapy supplied by those means are excluded from coverage consideration.
Providers should submit medical records documenting ongoing treatment, source of drug supply, and clinical rationale for continuation when requesting coverage for a member new to the plan. Absence of such documentation may result in denial.
Biomarker and Coding Details
Provider Actions, Documentation, and Prior Authorization
Prior authorization required for Emrelis
Prior authorization is required under the medical benefit for Emrelis; requests must demonstrate the coverage criteria are met, including diagnosis, prescriber specialty, dosing, biomarker status, and prior therapy history.
Prior therapy requirement
Authorization requires documentation of an inadequate response or adverse reaction to ONE, or a contraindication to the use of ALL, first-line systemic therapies appropriate for the histologic subtype and prior biomarker testing.
- Prior therapy must reflect histologic subtype (e.g., adenocarcinoma, large cell, NSCLC NOS).
- Prior therapy assessment should consider prior molecular or PD‑L1 testing results (EGFR, ALK, KRAS, ROS1, etc.).
Required documentation to support PA
Include medical records that document the diagnosis, c‑Met biomarker testing results, prior systemic therapy history (including inadequate response/adverse reaction/contraindication), prescriber specialty (oncologist), and for reauthorization a physician attestation of continued positive response.
- c‑Met testing showing percent and intensity (see threshold ≥50% with strong (3+) staining).
- Dates and outcomes of prior systemic therapies and reason for discontinuation.
Potential denial triggers
Requests may be denied if there is no documentation of high c‑Met protein overexpression per policy threshold, or if required prior systemic therapy information is missing.
- High c‑Met overexpression not documented as ≥50% of tumor cells with strong (3+) staining.
- Absence of documentation showing inadequate response/adverse reaction to or contraindication for required prior first‑line systemic therapies.
Line of Therapy Criteria
Second‑line
Policy requires documentation of inadequate response or contraindication to first‑line therapies appropriate for histology and prior biomarker testing.
Background
Emrelis (telisotuzumab vedotin‑tllv) is indicated for adult patients with locally advanced or metastatic non‑squamous non‑small cell lung cancer (NSCLC) who have tumors with high c‑Met protein overexpression as determined by an FDA‑approved test and who have received prior systemic therapy. The policy applies to Emrelis provided under the medical benefit and specifies biomarker and prior‑therapy requirements for coverage.
High c‑Met overexpression for coverage is defined as ≥50% of tumor cells with strong (3+) staining on an FDA‑approved test. Initial approval is intended for patients who have had an inadequate response or adverse reaction to one or who have contraindications to all appropriate first‑line systemic therapies for their histology and prior biomarker testing.
Definitions
Covered Regimens and Dosing
| Agent | Indication (as stated) | Dosing requirement | Prior therapy / Line | Authorization duration |
|---|---|---|---|---|
| Telisotuzumab vedotin‑tllv (Emrelis) | Emrelis monotherapy for adults with locally advanced or metastatic non‑squamous NSCLC with high c‑Met protein overexpression [≥50% of tumor cells with strong (3+) staining] | Appropriate dosing per product label; documentation of dosing per label required | After prior systemic therapy — requires inadequate response or adverse reaction to ONE or contraindication to the use of ALL first‑line systemic therapies appropriate for histologic subtype and prior biomarker testing | Initial approvals granted for 6 months; reauthorizations granted for 12 months |
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