CurrentMass General Brigham Health PlanPolicy N/A

Opdualag (nivolumab and relatlimab-rmbw) — Coverage Criteria for Unresectable or Metastatic Melanoma

Defines prior authorization, quantity/step therapy, and coverage criteria for Opdualag for Mass General Brigham Health Plan members (commercial/Exchange, MassHealth UPPL, Plan). Affects providers requesting pharmacy benefit coverage for eligible patients.

Policy Summary

PayerMass General Brigham Health Plan

PolicyOpdualag (nivolumab and relatlimab-rmbw) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateNov 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization and provide documentation of diagnosis, age (≥12 yrs), weight (≥40 kg), oncologist prescribing specialty, and prior therapy or clinical inappropriateness.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12min age

40 kgmin weight

6 monthsapproval length

PArequirement

Coverage Criteria for Opdualag

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Initial Authorization Criteria

Covered when ALL of the following are met

Primary criteria: Member is 12 years of age or older and weighs at least 40 kg; Member has a diagnosis of unresectable or metastatic melanoma; Prescribing physician is an oncologist; Documentation of prior therapy or clinical inappropriateness (references to prior PD-1 monotherapy such as Keytruda or Opdivo) is provided.

Authorization may be granted when all the following criteria are met and documentation is provided.

Reauthorization Criteria

Reauthorization (Continuation of Therapy)

Reauthorization criteria: Physician attestation that there is no evidence of unacceptable toxicity or disease progression while on the current regimen.6 months

Reauthorization will be granted for a covered indication with physician attestation; reauthorizations are granted for 6 months.

Authorization review may exclude members who are new to the plan but are already receiving the requested product when that therapy was obtained as samples or through a manufacturer's patient assistance program. In these situations, the member’s receipt of the product via those channels may remove them from further coverage consideration under the standard authorization review process. Reviewers should document the source of product provision when assessing coverage eligibility.

Initial Therapy

Initial authorization requirements

Initial therapy: Member is ≥12 years of age and weighs ≥40 kg; diagnosis of unresectable or metastatic melanoma; prescribing physician is an oncologist; documentation of prior therapy or clinical inappropriateness (e.g., Keytruda monotherapy or Opdivo monotherapy) provided.

Initial approvals will be granted for 6 months when all criteria and documentation requirements are met.

Continuation of Therapy / Reauthorization

Reauthorization rules

Continuation: Reauthorization requires physician attestation that there is no evidence of unacceptable toxicity or disease progression while on the current regimen.6 months

Reauthorizations are granted for 6 months.

Key Clinical Thresholds

inv-04: Minimum weight

Minimum weight>= 40 kg

Source contextMember is 12 years of age or older weighing at least 40 kg (policy initial criteria)

Use for eligibility determinationMember must meet the minimum weight threshold before authorization is considered

inv-05: Minimum age

Minimum age>= 12 years

PopulationAdult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma

Policy roleAge must be documented to support authorization request

What Providers Must Do

Prior Authorization

Prior Authorization Required

Prior authorization is required for coverage under affected Mass General Brigham Health Plan products. Submit prior authorization requests to the phone or fax numbers on the plan-specific contact information; authorization may be reviewed for members new to the plan who are currently receiving the medication.

All Plans: Phone: 877-519-1908; Fax: 855-540-3693
Non-Specialty Medications: Phone: 800-711-4555; Fax: 844-403-1029

Step Therapy

Step Therapy / Prior Treatment

Document prior therapies or why they are clinically inappropriate. For members starting Opdualag, provide treatment history demonstrating failure, intolerance, or clinical inappropriateness of prior indicated therapies where applicable.

Document prior use of anti–PD-1 monotherapy (e.g., pembrolizumab/Keytruda, nivolumab/Opdivo) and reasons for discontinuation if applicable
If step therapy is being bypassed, provide clear clinical rationale why prior therapy is inappropriate or contraindicated

Documentation Required

Required Documentation

Provide complete clinical documentation with the authorization request. Include diagnosis, patient age and weight, treating physician specialty, prior therapy history, and rationale for use.

Diagnosis: unresectable or metastatic melanoma
Age: member is ≥ 12 years
Weight: member weighs ≥ 40 kg
Prescriber: treating oncologist (document specialty)
Prior therapies: list agents tried (e.g., pembrolizumab, nivolumab) and dates/outcomes
Clinical rationale: if prior therapy not used or being bypassed, provide explanation of inappropriateness

Denial Risk

Triggers for Denial

Authorizations may be denied if required information is missing or insufficient. Common denial triggers include lack of diagnosis, missing age/weight, absent prescriber specialty, or failure to document prior therapy or rationale.

Missing or unclear diagnosis (unresectable or metastatic melanoma)
Age or weight not documented (must be ≥12 years and ≥40 kg)
Prescribing physician specialty not documented as oncology
No documentation of prior therapies or inadequate rationale for why prior therapy is clinically inappropriate

Step Therapy / Prior Treatment Requirements

Requirement	Documentation required
Member is 12 years of age or older and weighs at least 40 kg
Evidence of prior appropriate therapies failed or are clinically inappropriate (examples referenced: pembrolizumab [Keytruda] monotherapy or nivolumab [Opdivo] monotherapy)
Diagnosis of unresectable or metastatic melanoma
Prescribing physician is an oncologist

Background

Opdualag (nivolumab and relatlimab-rmbw) is indicated for treatment of unresectable or metastatic melanoma in adult and pediatric patients. The policy applies to members 12 years of age and older who meet the clinical criteria and to members seeking continuation of therapy after plan transfer; prior authorization is required under the pharmacy benefit for affected plans. For members new to the plan, authorization review will consider whether the product was obtained as samples or via a manufacturer's patient assistance program when determining coverage.

Indication

inv-11: Indication

Covered indicationTreatment of unresectable or metastatic melanoma

Eligible patientsAdult and pediatric patients 12 years of age or older who meet weight requirement (>= 40 kg)

Prescriber requirementPrescribing physician must be an oncologist

Prior therapy documentationDocumentation of prior therapies or clinical inappropriateness (references include Keytruda and Opdivo monotherapy) is required