CurrentMass General Brigham Health PlanPolicy N/A

Rybrevant (amivantamab-vmjw) coverage

Defines prior authorization, coverage criteria, and quantity/authorization limits for Rybrevant for treatment of advanced/metastatic NSCLC with EGFR exon 20 insertion mutations under the payer's pharmacy/specialty benefits.

Policy Summary

PayerMass General Brigham Health Plan

PolicyRybrevant (amivantamab-vmjw) coverage

Policy CodePolicy N/A

Change TypeNo material change

Effective DateApr 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization and provide documentation of diagnosis, oncologist involvement, confirmed EGFR exon 20 insertion mutation, and prior platinum chemotherapy status.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsApproval duration

EGFR exon 20Required mutation

OncologistPrescriber

Prior authProgram type

Coverage Criteria for Rybrevant (amivantamab-vmjw)

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Initial Authorization

Diagnosis: The member has a diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC)
Prescriber: The prescriber specialty is an oncologist or the medication is written in consultation with an oncologist
Molecular Test: Member has EGFR exon 20 insertion mutation
Prior platinum-based chemotherapy requirement
- Contraindication to ALL platinum-based chemotherapy (e.g., carboplatin, oxaliplatin, cisplatin)
- Inadequate response or adverse reaction to at least one platinum-based chemotherapy regimen (e.g., carboplatin, oxaliplatin, cisplatin)
Single agent use: The medication will be used as a single agent.

Documentation supporting the above criteria must be provided at authorization review.

Authorization review excludes products obtained as samples or via manufacturer's patient assistance programs. This means requests for Rybrevant will not be considered under prior authorization when the medication was provided to the member as a manufacturer sample or through the manufacturer’s patient assistance program.

Initial Therapy

inv-10: Initial therapy

Initial authorization criteria

Initial: Diagnosis of advanced/metastatic NSCLC; oncologist prescriber or consult; documented EGFR exon 20 insertion mutation; contraindication to ALL platinum-based chemotherapy OR inadequate response/adverse reaction to at least one platinum-based regimen; used as single agent

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required for Rybrevant (amivantamab-vmjw). Approval is granted only when all coverage criteria are met and required documentation is provided.

Prior authorization contact for all plans: Phone: 877-519-1908, Fax: 855-540-3693
Pharmacy benefit/Quantity limit/Step therapy may apply per benefit design

Step Therapy

Step Therapy Overview

Step therapy is indicated as part of the benefit (where applicable). For Rybrevant, step edits require documentation of prior platinum‑based chemotherapy unless there is a documented contraindication or intolerance. If the member has an inadequate response or adverse reaction to at least one platinum‑based chemotherapy regimen, this satisfies the step requirement.

Step requirement: prior platinum‑based chemotherapy (e.g., carboplatin, oxaliplatin, cisplatin) OR documented contraindication to all platinum agents OR documented inadequate response/adverse reaction to ≥1 platinum regimen

Documentation Required

Required Documentation

Authorization requires submission of documentation to support the clinical criteria. Missing or incomplete documentation may result in denial.

Diagnosis of advanced or metastatic non‑small cell lung cancer (NSCLC)
Documentation confirming EGFR exon 20 insertion mutation
Prescriber specialty: oncologist or documentation of oncologist consultation
Evidence of prior platinum‑based chemotherapy OR documentation of contraindication to all platinum agents OR documentation of inadequate response/adverse reaction to at least one platinum regimen
If new to plan, documentation of current treatment with Rybrevant (excluding samples or manufacturer patient assistance program supply)
For continuation: physician attestation of positive response to therapy

Denial Risk

Denial Triggers for Missing Required Criteria

Authorizations may be denied if required criteria or documentation are missing.

Missing or absent documentation of EGFR exon 20 insertion mutation
Lack of documentation of diagnosis of advanced/metastatic NSCLC
Prescriber not an oncologist and no documented oncologist consultation
No documentation of prior platinum‑based chemotherapy and no documented contraindication or inadequate response/adverse reaction
Failure to provide documentation of current treatment when member is new to the plan
No physician attestation of positive response for reauthorization

Step	Requirement
1	Prior platinum-based chemotherapy is expected unless there is a contraindication to all platinum agents (examples: carboplatin, oxaliplatin, cisplatin) or the member had an inadequate response or adverse reaction to at least one platinum-based chemotherapy regimen.

Key Definitions

EGFR exon 20 insertion mutation — definition and coverage role

DefinitionA specific mutation in the EGFR gene detectable by an approved test; presence is required for Rybrevant coverage.

Detection methodDetected by an approved test as specified in the indication.

Clinical contextAssociated with locally advanced or metastatic non-small cell lung cancer (NSCLC) eligible for Rybrevant after progression on or after platinum-based chemotherapy.

Role in coverage decisionMember must have documented EGFR exon 20 insertion mutation for authorization to be granted.

Quantity / Dosing Limits

Rybrevant (amivantamab-vmjw) — key program facts

Drug nameRybrevant (amivantamab-vmjw)

Program typePrior Authorization; Pharmacy Benefit with Step Therapy noted.

Quantity limitsNot specified in the document.

Site of careInfusion center — site of care not otherwise specified in the document.

Indication summaryFor adults with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations after progression on or after platinum-based chemotherapy.

Background

Rybrevant (amivantamab) is indicated for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring an EGFR exon 20 insertion mutation after progression on or after platinum-based chemotherapy. Treatment is intended as a single agent and prior authorization is required; initial and reauthorization approvals are granted for 12 months when the coverage criteria are met.