CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Opdualag (nivolumab and relatlimab-rmbw)

Defines accepted indications, exclusion criteria, continuation rules, and administrative approval authority for Opdualag (nivolumab and relatlimab-rmbw) across Commercial, Exchange, and Medicaid lines of business. Includes requirements for evidence sources and references FDA labeling and oncology guidelines.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOpdualag (nivolumab and relatlimab-rmbw)

Policy CodePolicy N/A

Change TypeRevised (committee approval)

Effective DateSep 27, 2024

Next Review Date

Key ActionSubmit medication requests to Evolent with supporting evidence per FDA labeling, ASCO guidelines, or CMS-acceptable peer-reviewed literature for authorization.

POLICY UPDATE CHANGES

Policy updated and approved by Utilization Management Committee with approval date September 18, 2024 and effective date September 27, 2024.

1Covered Indications (melanoma)

7Exclusion criteria items

3Continuation exemption conditions

Coverage Summary

Opdualag (nivolumab and relatlimab-rmbw) is covered with criteria for the treatment of unresectable or metastatic (Stage III-IV) cutaneous melanoma per FDA labeling and the RELATIVITY-047 trial and consistent with ASCO/NCCN guidance. Coverage requires that all indication criteria are met: the member is age 12 years or older, has a weight of at least 40 kg (88 pounds), and dosing does not exceed the single-dose maximum of 480 mg nivolumab and 160 mg relatlimab. This coverage stance applies as an overview threshold; specific authorization requires meeting the full policy criteria.

Initial Therapy Criteria (Indications)

Initial Therapy

Opdualag may be used when ALL of the following are met:

ALL of the following

Diagnosis of unresectable or metastatic (Stage III-IV) cutaneous melanoma
Member is age 12 years or older>= 12 years
Member weight is at least 40 kg (88 pounds)>= 40 kg (88 pounds)
Can be used as first-line therapy regardless of BRAF mutation status
Can be used as second-line or subsequent therapy regardless of BRAF mutation status

Continuation Therapy Criteria (Exemptions)

Continuation Therapy - Exemption

Continuation requests are exempt from the policy provided ALL of the following are met:

ALL of the following

The member has not experienced disease progression on the requested medication
The requested medication was used within the last year without a lapse of more than 30 days of having an active authorizationNo lapse > 30 days within the last year
No additional medication(s) are being added to the continuation request

Documentation Required

Continuation request documentation

For continuation requests, document that the member has not experienced disease progression on the requested medication; the requested medication was used within the last year with no lapse of more than 30 days in an active authorization; and no additional medication(s) are being added to the continuation request.

No disease progression on the requested medication
Requested medication used within the last year without a lapse > 30 days of having an active authorization
No additional medication(s) are being added to the continuation request

Unproven / Exclusions (Not Covered / Denied)

Exclusion Criteria (Not covered/denied)

Any of the following

Disease progression on or after receiving Opdualag (nivolumab and relatlimab-rmbw)
Concurrent use with other anticancer therapy
Use for treatment of uveal melanoma
Use in members 12 years and older weighing less than 88 pounds (40 kg); safety and efficacy unknown< 40 kg (for >=12 years)
Dosing exceeds single dose limit of 480 mg nivolumab and 160 mg relatlimab (for members greater than 40 Kg)> single dose maximum: 480 mg nivolumab and 160 mg relatlimab
Investigational use for an off-label indication that is not sufficient in evidence or not generally accepted by the medical community
Criteria for insufficient evidence (any of the following indicate insufficiency)
- Clinical characteristics of the patient and cancer are not adequately represented in the published evidence
- The administered regimen is not adequately represented in the published evidence
- Reported study outcomes do not represent clinically meaningful outcomes (ASCO: e.g., HR >= 0.80 or survival benefit < 3 months)HR >= 0.80 or survival benefit < 3 months
- Experimental design is inappropriate to address the investigative question
- Non-randomized trials without significant subject numbers may be insufficient as primary supportive evidence

Denial Risk

Denial conditions - exclusions

Common grounds for denial include disease progression on or after receiving Opdualag, concurrent use with other anticancer therapy, use for uveal melanoma, treatment of eligible-age patients who weigh less than 40 kg (88 pounds), dosing that exceeds the single-dose limits (480 mg nivolumab and 160 mg relatlimab), and investigational or off-label uses lacking sufficient evidence per the policy's evidence criteria.

Disease progression on or after receiving Opdualag
Concurrent use with other anticancer therapy
Use for treatment of uveal melanoma
Members ≥12 years old weighing less than 40 kg (88 pounds)
Dosing exceeds single-dose limit of 480 mg nivolumab and 160 mg relatlimab
Investigational/off-label use without sufficient supporting evidence (per listed evidence criteria)

Provider Actions

Prior Authorization

Authorization requirement and evidence

Medication requests are processed by Evolent. Use of Opdualag must be supported by FDA-approved product labeling, ASCO clinical guidelines, or peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements.

Medications not authorized by Evolent may be deemed not approvable and not reimbursable

Documentation Required

Continuation request documentation

The member has not experienced disease progression on the requested medication
The requested medication was used within the last year without a lapse of more than 30 days of having an active authorization
No additional medication(s) are being added to the continuation request

Clinical Evidence

Key evidence sources supporting this policy include the RELATIVITY-047 clinical trial (Tawbi HA, et al.), the Opdualag prescribing information (Bristol-Myers Squibb, 2024), and the NCCN Cancer Guidelines and Drugs & Biologics Compendium (2024).

Per Evolent policy, authorization decisions must be supported by FDA-approved product labeling, ASCO clinical guidelines, or peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements.

Background

Opdualag (nivolumab and relatlimab-rmbw) is indicated for unresectable or metastatic cutaneous melanoma based on the RELATIVITY-047 trial and FDA labeling. The policy notes use as first-line or second-line therapy in adult or pediatric members ≥12 years who weigh ≥40 kg (88 pounds), regardless of BRAF mutation status.

Evolent manages authorization decisions for this medication and requires that use be supported by FDA labeling, ASCO clinical guidelines, or peer-reviewed literature that meets CMS requirements. The RELATIVITY-047 trial, the Opdualag prescribing information (2024), and guideline compendia (e.g., NCCN) are cited as primary references informing the policy.

TermClinically meaningful outcomes

ASCO definitionHazard ratio < 0.80 and recommended survival benefit for OS and PFS at least 3 months

Revision History

05/11/22committee_review

Committee review per Utilization Management Committee (policy updated and reviewed).

02/08/23committee_review

Committee review per Utilization Management Committee (policy updated and reviewed).

02/14/24committee_review

Committee review per Utilization Management Committee (policy updated and reviewed).

06/12/24committee_review

Committee review per Utilization Management Committee (policy updated and reviewed).

09/18/24committee_approvalLatest

Policy updated and approved by Utilization Management Committee with approval date September 18, 2024 and effective date September 27, 2024.

2024-09-27effective_dateLatest

Effective date of the approved policy: September 27, 2024.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOpdualag (nivolumab and relatlimab-rmbw)

Policy CodePolicy N/A

Change TypeRevised (committee approval)

Effective DateSep 27, 2024

Next Review Date

Key ActionSubmit medication requests to Evolent with supporting evidence per FDA labeling, ASCO guidelines, or CMS-acceptable peer-reviewed literature for authorization.

On This Page

OpenPayer

Opdualag (nivolumab and relatlimab-rmbw)

Coverage Summary

Initial Therapy Criteria (Indications)

Continuation Therapy Criteria (Exemptions)

Unproven / Exclusions (Not Covered / Denied)

Provider Actions

Applicable Codes

Clinical Evidence

Background

Revision History