CurrentMass General Brigham Health PlanPolicy N/A

Lung cancer agents (Emrelis, Portrazza, Rybrevant, Zepzelca)

Medical benefit prior authorization requirements and coverage criteria for specific lung cancer infusion agents for Mass General Brigham Health Plan members (MassHealth UPPL). Applies to providers requesting medical benefit coverage for Emrelis, Portrazza, Rybrevant, and Zepzelca.

Policy Summary

PayerMass General Brigham Health Plan

PolicyLung cancer agents (Emrelis, Portrazza, Rybrevant, Zepzelca)

Policy CodePolicy N/A

Change TypeMaterial updates — added agent and revised Rybrevant and approval durations

Effective DateFeb 17, 2026

Next Review DateN/A

Key ActionSubmit medical benefit prior authorization with documentation of diagnosis, oncologist prescriber, required biomarker test results, prior therapies and response, and planned regimen.

SourceLink

POLICY UPDATE CHANGES

Emrelis (telisotuzumab vedotin-tllv) was added and requires prior authorization under the medical benefit.

Initial approval duration changed to 6 months and reauthorization changed to 12 months.

Rybrevant expanded label and criteria updated to include combination first-line use with carboplatin and pemetrexed for EGFR exon 20 insertion mutations and for selected EGFR exon 19/21 mutations in combination regimens.

4named lung cancer agents in policy

6 moinitial approval duration

12 mo

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reauthorization duration

MassHealth UPPLapplicable plan listed

Coverage Criteria for Listed Agents

Emrelis (telisotuzumab vedotin-tllv) Initial Therapy

Emrelis (telisotuzumab vedotin-tllv) is covered when ALL of the following are met:

Emrelis coverage criteria: Diagnosis of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC)

Emrelis coverage criteria: Prescriber is an oncologist

Emrelis coverage criteria: Appropriate dosing

Emrelis coverage criteria: Cancer has high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining]

Emrelis coverage criteria: Inadequate response or adverse reaction to ONE or contraindication to the use of ALL first-line systemic therapies (prior therapy based on histologic subtype and prior biomarker testing)

Rybrevant (amivantamab-vmjw) Initial Therapy

Rybrevant (amivantamab-vmjw) is covered when ALL of the following are met (choose path a OR b depending on mutation and line):

Mutation requirement: Diagnosis of locally advanced or metastatic non small cell lung cancer and ONE of: a) EGFR exon 20 insertion mutation OR b) EGFR exon 19 deletion or exon 21 L858R mutation

Common criteria: Prescriber is an oncologist

Common criteria: Appropriate dosing

EGFR exon 20 insertion paths: For EGFR exon 20 insertion mutation, ONE of: a) BOTH: i) Disease progression during or following ONE platinum-containing regimen AND ii) Requested agent will be used as monotherapy; OR b) Requested agent will be used in combination with carboplatin and pemetrexed (first-line)

Portrazza (necitumumab) Initial Therapy

Portrazza (necitumumab) is covered when ALL of the following are met:

Portrazza coverage criteria: Diagnosis of metastatic non-small cell lung cancer

Portrazza coverage criteria: Prescriber is an oncologist

Portrazza coverage criteria: Appropriate dosing

Portrazza coverage criteria: Documentation in medical records that cancer is of squamous cell histology

Portrazza coverage criteria: Member will use the requested agent in combination with gemcitabine and cisplatin

Zepzelca (lurbinectedin) Initial Therapy

Zepzelca (lurbinectedin) is covered when ALL of the following are met:

Zepzelca coverage criteria: Diagnosis of metastatic small cell lung cancer

Zepzelca coverage criteria: Prescriber is an oncologist

Zepzelca coverage criteria: Appropriate dosing with documentation of weight/height or BSA

Zepzelca coverage criteria: Inadequate response, adverse reaction, or contraindication to ONE platinum-based chemotherapy

Continuation / Reauthorization

Reauthorizations require physician attestation of continuation of therapy and positive response to therapy.

Reauthorization requirement: Reauthorizations require physician attestation of continuation of therapy and positive response to therapy.

Authorizations for these agents may be reviewed case-by-case for members who are new to the plan and are currently receiving the requested medication; this review does not apply when the product is obtained as samples or through the manufacturer's patient assistance programs. For new requests, coverage is granted only when the member meets all applicable policy criteria and required documentation is provided, including prescriber specialty, diagnosis, dosing, biomarker results (when specified), prior therapy history and response/toxicity, and any planned combination regimens.

Covered Regimens and Regimen Context

Regimen	Indication	Coverage
Amivantamab (Rybrevant) in combination with carboplatin and pemetrexed	First-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations (detected by an FDA-approved test)	Covered with criteria

Regimen	Indication	Coverage
Necitumumab (Portrazza) in combination with gemcitabine and cisplatin	First-line treatment of metastatic non-small cell lung cancer of squamous histology	Covered with criteria

Regimen	Indication	Coverage
Amivantamab (Rybrevant) monotherapy	Treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease progressed on or after platinum-based chemotherapy	Covered with criteria

Prior Authorization and Provider Requirements

Prior Authorization

Medical benefit prior authorization required

Prior authorization under the medical benefit is required for Emrelis (telisotuzumab vedotin-tllv), Portrazza (necitumumab), Rybrevant (amivantamab-vmjw), and Zepzelca (lurbinectedin) for members on MassHealth UPPL. Authorizations for members new to the plan who are currently receiving treatment may be reviewed on a case‑by‑case basis.

Step Therapy

Prior therapy requirements

Approval requires documentation of inadequate response, adverse reaction, or contraindication to specified prior therapies as applicable to the requested agent and indication (for example: ONE platinum-containing regimen for Rybrevant monotherapy path; inadequate response/adverse reaction/contraindication to osimertinib for certain Rybrevant combinations; ONE platinum‑based chemotherapy for Zepzelca; or failure/contraindication to ALL first‑line systemic therapies for Emrelis).

Emrelis: inadequate response/adverse reaction to ONE or contraindication to ALL first‑line systemic therapies (chunk 4).
Rybrevant: progression after ONE platinum regimen for monotherapy path, or inadequate response/adverse reaction/contraindication to osimertinib for combination paths (chunk 5).

Biomarker and Testing Requirements

inv-17: c-Met (protein overexpression) — ≥50% of tumor cells with strong (3+) staining (FDA-approved test)

Biomarkerc-Met (protein overexpression)

Threshold≥50% of tumor cells with strong (3+) staining

Test requirementAs determined by an FDA-approved test

Required forEmrelis (telisotuzumab vedotin-tllv) coverage

inv-18: EGFR mutations (exon 20 insertion; exon 19 deletion; exon 21 L858R) — detected by an FDA-approved test

BiomarkerEGFR mutations

Included variants

Line of Therapy Definitions and Uses

first-line

Rybrevant line: First-line in combination with carboplatin and pemetrexed for EGFR exon 20 insertion mutations OR monotherapy after progression on platinum-based chemotherapy for EGFR exon 20 insertion

salvage

Salvage line: Used for metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy (salvage/later-line use)

Coding and Test Result Criteria

inv-13: ≥50% of tumor cells with strong (3+) staining as determined by an FDA-approved test — definition of high c-Met protein overexpression

DefinitionHigh c-Met protein overexpression equals ≥50% of tumor cells with strong (3+) staining

VerificationDetermination must be by an FDA-approved test

Clinical useRequired biomarker for Emrelis coverage in non-squamous NSCLC

Definitions

inv-14: Mutation detected by an FDA-approved test — EGFR exon 20 insertion mutation definition

DefinitionEGFR exon 20 insertion mutation defined as mutation detected by an FDA-approved test

Related variantsAlso includes consideration of exon 19 deletion and exon 21 L858R in policy pathways

Clinical implicationPresence guides Rybrevant use (combination first-line or monotherapy after platinum progression)

Background

This policy covers targeted infusion agents used in advanced lung cancers that require specific molecular or histologic selection. Emrelis (telisotuzumab vedotin-tllv) is indicated for locally advanced or metastatic non-squamous NSCLC with high c-Met protein overexpression (≥50% of tumor cells with strong (3+) staining by an FDA‑approved test). Rybrevant (amivantamab‑vmjw) is indicated for NSCLC with EGFR mutations including exon 20 insertion (with options for first‑line combination with carboplatin and pemetrexed or monotherapy after platinum progression) and select exon 19 or 21 mutations in defined combination scenarios. Portrazza (necitumumab) is intended for metastatic squamous NSCLC when used in combination with gemcitabine and cisplatin. Zepzelca (lurbinectedin) is used for metastatic small cell lung cancer after progression on platinum‑based chemotherapy. FDA‑approved tests are required where biomarker criteria are specified.

Policy Summary

PayerMass General Brigham Health Plan

PolicyLung cancer agents (Emrelis, Portrazza, Rybrevant, Zepzelca)

Policy CodePolicy N/A

Change TypeMaterial updates — added agent and revised Rybrevant and approval durations

Effective DateFeb 17, 2026

Next Review DateN/A

Key ActionSubmit medical benefit prior authorization with documentation of diagnosis, oncologist prescriber, required biomarker test results, prior therapies and response, and planned regimen.

SourceLink

On This Page

EGFR exon 19/21 paths: For EGFR exon 19 deletion or exon 21 L858R mutation, ONE of: a) BOTH: i) Inadequate response, adverse reaction, or contraindication to Tagrisso (osimertinib) with or without chemotherapy AND ii) Requested agent will be used in combination with Lazcluze (lazertinib); OR b) BOTH: i) Disease progression during or following therapy with an EGFR tyrosine kinase inhibitor AND ii) Requested agent will be used in combination with carboplatin and pemetrexed

Portrazza coverage criteria: Medical necessity for using the requested agent instead of all other clinically appropriate alternatives

Zepzelca: inadequate response/adverse reaction/contraindication to ONE platinum‑based chemotherapy (chunk 7).

Documentation Required

Required clinical documentation

Medical records must document the diagnosis, that the prescriber is an oncologist, appropriate dosing (including weight/height or BSA when specified), and relevant biomarker and prior therapy information as required by the specific agent and indication.

Diagnosis consistent with the agent's indication (e.g., non‑squamous NSCLC for Emrelis; metastatic squamous NSCLC for Portrazza; metastatic SCLC for Zepzelca) (chunks 4, 6, 7).
Prescriber specialty: oncologist (chunks 4, 5, 6, 7).
Appropriate dosing; include weight/height or BSA when required (Zepzelca) (chunks 4, 5, 7).
Biomarker testing results when specified (e.g., high c‑Met overexpression ≥50% 3+ staining for Emrelis; EGFR mutation status for Rybrevant) (chunk 4, 5).
Documentation of prior therapies and the member's response, adverse reactions, or contraindications (chunks 4, 5, 7).
Planned combination regimens when applicable (e.g., Portrazza with gemcitabine and cisplatin; Rybrevant with carboplatin and pemetrexed or with lazertinib) (chunks 5, 6).

Denial Risk

Denial risks for missing documentation

Requests may be denied if documentation does not demonstrate the member meets the listed clinical criteria or if the prescriber is not documented as an oncologist.

Absence of biomarker results required by the criteria (e.g., c‑Met overexpression, EGFR mutation) may lead to denial.
Missing documentation of prior therapy response, adverse reaction, or contraindication as required by the agent-specific criteria may lead to denial.
Lack of prescriber specialty documentation (oncologist) may result in denial.

Exon 20 insertion; Exon 19 deletion; Exon 21 L858R

Test requirementDetected by an FDA-approved test

Associated agentRybrevant (amivantamab-vmjw)

inv-07: c-Met overexpression — concise criterion

Criterion (concise)≥50% tumor cells with strong (3+) staining

ContextDefines high c-Met protein overexpression for NSCLC

Measurement methodImmunohistochemistry with scoring of staining intensity and percent tumor cells