CurrentmhnPolicy CP.PMN.287

Clinical Policy: Nabumetone Double-Strength (Relafen DS)

Defines medical necessity criteria, prior authorization requirements, dosing limits, covered diagnoses, contraindications/boxed warnings, and approval durations for Relafen DS (nabumetone 1000 mg tablet) for Commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyClinical Policy: Nabumetone Double-Strength (Relafen DS)

Policy CodePolicy CP.PMN.287

Change TypeStep therapy bypass added; annual review

Effective DateJun 1, 2023

Next Review Date

Key ActionProvider must submit documentation supporting that the member meets all approval criteria.

POLICY UPDATE CHANGES

Added step therapy bypass for IL HIM per IL HB 5395.

2Q 2025 annual review: no significant changes; references reviewed and updated.

Policy created per February SDC.

2Covered Indications (OA, RA)

18+Minimum Age

2000 mg/dayMaximum Daily Dose

2Maximum Tablets per Day

Coverage Summary

Coverage stance: covered_with_criteria for Relafen DS (nabumetone 1000 mg tablet). Covered indications: osteoarthritis (OA) and rheumatoid arthritis (RA). Minimum age: ≥ 18 years. Dose/tablet limits: maximum daily dose ≤ 2000 mg per day and ≤ 2 tablets per day. Approval duration when authorized: 12 months. Scope summary: defines medical necessity criteria, prior authorization requirements (including step therapy with generic nabumetone 500 mg or 750 mg unless contraindicated or intolerant), documentation/continuation requirements, dosing limits specific to the 1000 mg tablet, contraindications/boxed warnings, and approval durations for Commercial, HIM, and Medicaid lines of business.

Initial Therapy Criteria

I. Initial Approval Criteria - Osteoarthritis or Rheumatoid Arthritis

Covered when ALL of the following are met:

ALL of the following

Diagnosis of osteoarthritis (OA) or rheumatoid arthritis (RA)
Age ≥ 18 years
Step therapy/Generic nabumetone requirement: Member must use generic nabumetone 500 mg or 750 mg tablet, unless contraindicated or clinically significant adverse effects are experienced
Step therapy requirement does not apply for Illinois HIM requests as of 1/1/2026 per IL HB 5395
Generic tablet substitution documentation: Documentation supports inability to use multiple generic nabumetone 500 mg tablets to achieve the requested Relafen DS dose
Step therapy requirement does not apply for Illinois HIM requests as of 1/1/2026 per IL HB 5395
Dose limits
- Maximum daily dose: Daily dose does not exceed 2,000 mg per day≤ 2000 mg/day
- Maximum tablets per day: Dose does not exceed 2 tablets per day≤ 2 tablets/day

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I. Initial Approval Criteria - Other diagnoses/indications

Covered when ONE of the following applies:

ANY of the following

Label change - drug on formulary/PDL: Drug has recently (within last 6 months) undergone a label change not yet reflected in this policy and drug is on formulary/PDL; refer to no coverage criteria policy for relevant line of business (CP.CPA.190 for commercial, HIM.PA.33 for marketplace, CP.PMN.255 for Medicaid)
Label change - drug NOT on formulary/PDL: Drug has recently (within last 6 months) undergone a label change not yet reflected in this policy and drug is NOT on formulary/PDL; refer to non-formulary policy for relevant line of business (CP.CPA.190 for commercial, HIM.PA.103 for marketplace, CP.PMN.16 for Medicaid)
Other uses not listed in section III: Requested use not listed under section III and above does not apply; refer to off-label use policy for relevant line of business (CP.CPA.09 for commercial, HIM.PA.154 for marketplace, CP.PMN.53 for Medicaid)

Continuation / Renewal Criteria

II. Renewal/Continuation Criteria - Osteoarthritis or Rheumatoid Arthritis

Covered when ALL of the following are met:

ALL of the following

Continuity of care: Member is currently receiving medication via Centene benefit or previously met initial approval criteria, OR member is currently receiving medication and is enrolled in a state/product with continuity of care regulations
Positive response: Member is responding positively to therapy
Dose limits for renewal
- Maximum daily dose - renewal: If request is for a dose increase, new dose does not exceed 2,000 mg per day≤ 2000 mg/day
- Maximum tablets per day - renewal: If request is for a dose increase, new dose does not exceed 2 tablets per day≤ 2 tablets/day

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Diagnoses / Indications Not Authorized

III. Diagnoses/Indications NOT authorized

Not covered unless meeting off-label policies or evidence of coverage:

ALL of the following

Off-label not authorized: Non-FDA approved indications not addressed in this policy, unless sufficient documentation of efficacy and safety per off-label use policies (CP.CPA.09 for commercial, HIM.PA.154 for marketplace, CP.PMN.53 for Medicaid)

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Provider Actions / Prior Authorization Requirements

Documentation Required

Support approval criteria

Provider must submit documentation supporting that the member meets all approval criteria. Acceptable documentation includes office chart notes, laboratory results, or other clinical information demonstrating diagnosis, age, prior therapy and dosing history.

Office chart notes showing diagnosis of OA or RA and clinical assessment
Relevant laboratory results
Medication history or prior therapy notes demonstrating steps tried

Step Therapy

Step therapy requirement

Member must use generic nabumetone 500 mg or 750 mg tablets unless contraindicated or clinically significant adverse effects occur. Documentation must support inability to use multiple 500 mg tablets to achieve the requested double-strength (1,000 mg) dose when applicable.

Statement of contraindication or adverse reaction to 500 mg/750 mg nabumetone
Clinical rationale why multiple 500 mg tablets cannot be used to reach 1,000 mg (e.g., swallowing difficulty)
Medication administration or adherence evidence if relevant

Step Therapy

Illinois HIM step therapy bypass

Step therapy requirements do not apply for Illinois Health Insurance Marketplace (HIM) requests as of 2026-01-01 per Illinois HB 5395; therefore the requirement to trial generic nabumetone prior to Relafen DS is bypassed for Illinois HIM starting 2026-01-01.

Change: Added step therapy bypass for IL HIM per IL HB 5395
Effective date of change: 2026-01-01

Documentation Required

Renewal requirements

For renewals, provider must document that the member is responding positively to therapy. If the request is for a dose increase, documentation must show the new dose remains within policy dose limits (≤ 2,000 mg per day and ≤ 2 tablets per day).

Clinical notes demonstrating symptomatic improvement on current therapy
Documentation of current dose and rationale for any proposed increase
Confirmation that increased dose will not exceed 2,000 mg/day or 2 tablets/day

Billing Rule

Approval duration

Authorizations are granted for a 12-month duration. Approval duration applies to both initial approvals and renewals per policy.

Approval duration: 12 months

Background

Background: Relafen DS is a double-strength formulation of nabumetone (NSAID) available as a 1,000 mg tablet and is indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis. This policy provides medical necessity criteria and dosing limits specific to the 1000 mg tablet, including a usual dosing regimen of 1,000 mg PO daily and a maximum dose of 2,000 mg/day.

Key Thresholds and Policy Limits

Minimum age≥ 18 years

Maximum daily dose≤ 2,000 mg per day

Maximum tablets per day≤ 2 tablets per day

IndicationsOsteoarthritis (OA) or Rheumatoid Arthritis (RA)

Approval duration12 months

Revision History

06.27.25policy_update

Added step therapy bypass for Illinois Health Insurance Marketplace (HIM) requests per IL HB 5395; step therapy requirements do not apply for Illinois HIM as of 01/01/2026.

01.16.25annual_review

2Q 2025 annual review: no significant changes; references reviewed and updated.

02.21.23policy_created

Policy created per February SDC (initial policy creation and P&T approval in 2023/2024 timeframe).

Policy Summary

Payermhn

PolicyClinical Policy: Nabumetone Double-Strength (Relafen DS)

Policy CodePolicy CP.PMN.287

Change TypeStep therapy bypass added; annual review

Effective DateJun 1, 2023

Next Review Date

Key ActionProvider must submit documentation supporting that the member meets all approval criteria.

On This Page

OpenPayer

Clinical Policy: Nabumetone Double-Strength (Relafen DS)

Coverage Summary

Initial Therapy Criteria

Continuation / Renewal Criteria

Diagnoses / Indications Not Authorized

Policy Reference Codes

Provider Actions / Prior Authorization Requirements

Clinical Evidence

Background

Revision History

CP.PMN.287	Reference number of this policy
CP.CPA.190	No coverage criteria policy (commercial) - referenced for label changes/non-formulary
HIM.PA.33	No coverage criteria policy (marketplace)
CP.PMN.255	No coverage criteria policy (Medicaid)
HIM.PA.103	Non-formulary policy (marketplace)
CP.PMN.16	Non-formulary policy (Medicaid)
CP.CPA.09	Off-label use policy (commercial)
HIM.PA.154	Off-label use policy (marketplace)
CP.PMN.53	Off-label use policy (Medicaid)