CurrentMass General Brigham Health PlanPolicy N/A

Rybrevant (amivantamab-vmjw) Effective 04/01/2022

Covers prior authorization and quantity/continuation criteria for Rybrevant (amivantamab-vmjw) for treatment of adults with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations under Mass General Brigham Health Plan (MassHealth UPPL). Applies to pharmacy benefit with specialty/quantity limits and prior authorization requirements.

Policy Summary

PayerMass General Brigham Health Plan

PolicyRybrevant (amivantamab-vmjw) Effective 04/01/2022

Policy CodePolicy N/A

Change TypePolicy created

Effective Date04/01/2022

Next Review Date

Key ActionSubmit prior authorization with documentation of advanced/metastatic NSCLC, EGFR exon 20 insertion mutation, prescriber oncology specialty (or consult), and prior platinum-based chemotherapy history or contraindication; reauthorization requires physician attestation of positive response.

SourceLink

POLICY UPDATE CHANGES

Policy created and reviewed at Jan P&T meeting.

1Indication covered (NSCLC with EGFR exon 20 insertion)

12Approval duration (months)

Coverage Summary

Coverage stance: Covered with criteria for Rybrevant (amivantamab-vmjw). Scope: prior authorization, quantity/continuation criteria, and specialty limits apply under the pharmacy benefit. Rybrevant is indicated for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations who have disease progression on or after platinum-based chemotherapy. The benefit/program notes that Rybrevant is covered under the Pharmacy Benefit with specialty limitations and prior authorization requirements.

Policy metadata

Effective date04/01/2022

Last review date01/19/2022

Approval duration12 months

Coverage stanceCovered with criteria (prior authorization required)

Program / BenefitPharmacy Benefit; specialty limitations apply

Prior authorization notesRequests for members new to the plan currently receiving Rybrevant may be reviewed except when product obtained as samples or via manufacturer assistance; prescriber must be oncologist or consult with one and documentation of diagnosis and EGFR exon 20 insertion required.

Initial Authorization — Coverage Criteria

Authorization may be granted when ALL the following criteria are met; documentation must be provided:

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Platinum-based chemotherapy: Chemotherapy regimens that include agents such as carboplatin, oxaliplatin, or cisplatin.

EGFR exon 20 insertion mutation: A specific type of epidermal growth factor receptor (EGFR) mutation detectable by an approved test that qualifies the patient for therapy with Rybrevant.

Continuation Therapy Criteria (Reauthorization)

Allow Continuation (Reauthorization)

Reauthorization will be granted when the physician provides documentation:

ALL of the following

Physician provides attestation of positive response to therapy

Denial Risk

Continuation requires response attestation

Reauthorization requires the physician to provide attestation of positive response to therapy. Lack of this attestation may result in denial of continued therapy. Reauthorizations are granted for 12 months.

Exception / Members Already Receiving Therapy

Exception / Members already receiving therapy

Authorization may be reviewed for members new to the plan who are currently receiving treatment with Rybrevant except when product obtained as samples or via manufacturer's patient assistance programs.

ALL of the following

Member is new to the plan and currently receiving Rybrevant
Drug was not obtained as samples or via manufacturer's patient assistance program

Prior Authorization

Prior authorization required

Prior authorization is required for Rybrevant. Requests for members new to the plan who are currently receiving Rybrevant may be reviewed except when the product was obtained as samples or via the manufacturer's patient assistance program.

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for Rybrevant; authorization may be granted when all coverage criteria are met and required documentation is provided.

Documentation Required

Document diagnosis and mutation status

Document the diagnosis of advanced or metastatic non‑small cell lung cancer (NSCLC) and presence of an EGFR exon 20 insertion mutation detected by an approved test. The prescriber must be an oncologist or the medication must be written in consultation with an oncologist.

Documentation Required

Document prior chemotherapy history or contraindication

Document either a contraindication to all platinum‑based chemotherapy (e.g., carboplatin, oxaliplatin, cisplatin) OR an inadequate response or adverse reaction to at least one platinum‑based chemotherapy regimen.

Billing Rule

Approval duration

Initial approvals and reauthorizations are granted for 12 months.

Background

Rybrevant is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults with EGFR exon 20 insertion mutations following progression on or after platinum-based chemotherapy. It is used as a single agent and requires documentation of mutation status and prior chemotherapy history for authorization.