Oral Non-steroidal Anti-inflammatory Drugs (NSAIDs) – NC Standard

Restricted Product(s): 

• ARTHROTEC® (diclofenac w/ misoprostol tab delayed release)
• DAYPRO® (oxaprozin)
• DICLOFENAC CAP (authorized generic Zorvolex)
• EC-NAPROSYN® (naproxen ec)
• FELDENE® (piroxicam)
• FENORTHO® (fenoprofen calcium)
• FENOPROFEN (authorized generic Fenortho®)
• INDOCIN® (indomethacin)
• INDOMETHACIN (authorized generic Tivorbex)
• KETOPROFEN 25mg, 75mg capsules
• KETOPROFEN ER
• LODINE® (etodolac)
• MECLOFENAMATE SODIUM
• MOBIC® (meloxicam)
• MELOXICAM SUSPENSION
• NALFON® (fenoprofen calcium)
• NAPRELAN® (naproxen sodium er)
• NAPROSYN® (naproxen)
• NAPROXEN ER 750 MG (authorized generic Naprelan®)
• QMIIZ ODT™ (meloxicam)
• RELAFEN® DS (nabumetone)
• TIVORBEX® (indomethacin)
• TOLMETIN SODIUM
• VIVLODEX® (meloxicam)
• ZIPSOR® (diclofenac potassium)
• ZORVOLEX® (diclofenac)

FDA Approved Use:

• For pain and multiple inflammatory conditions

Criteria for Approval of Restricted Product(s):

1. The requested product is a Brand medication with an unrestricted generic equivalent:
   1. The patient had a sub-therapeutic or intolerant response (therapeutic failure) to an inactive ingredient of the generic product, but not present in the Brand; OR
      1. The patient has a documented intolerance to an inactive ingredient of the generic product that are not found in the brand product; AND
   2. The patient has tried and failed ONE other unrestricted, prescription, oral NSAID product; OR
      1. The patient has a clinical contraindication/intolerance to all unrestricted NSAID products that have not been trialed; OR
2. For all other requests:
   1. The patient has tried and failed TWO, unrestricted, prescription, oral NSAID products; OR
   2. The patient has a clinical contraindication/intolerance to those unrestricted NSAID products that have not been trialed; AND
3. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 365 days (1 year)

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information:

December 2021: Criteria update: Added fenoprofen (AG Fenortho) to policy.

November 2021: Criteria update: Removed Diclofenac 25mg tablet from policy due to MSC change.

October 2021: Criteria update: Added new to market Diclofenac 25mg tablet to policy.

October 2021: Criteria update: Added Relafen DS to policy. Duration of approval changed to 365 days.

March 2021: Criteria change: Annual criteria review. Require t/f of generic equivalent of branded medications. Removed discontinued products Anaprox DS and Ponstel.

Jan 2021: Criteria update: Added new authorized generic to Naprelan CR 750mg (naproxen ER 750mg) to the policy.

Oct 2020: Criteria update: Added new authorized generic to Zorvolex (diclofenac capsule) to the policy.

July 2020: Criteria update: Removed EC Naproxen from policy (product moved from MSC O to Y).

April 2020: Criteria update: Added Brand Ketoprofen 25mg, 75mg capsules to policy.

Feb 2020: Criteria update: Added new authorized generic to Tivorbex (indomethacin capsule) to the policy and deleted generic from criteria point #1 & #2.

Mar 2019: Added new to market Qmiiz ODT to the criteria and updated duration of approval to 1095 days (3 years)

Feb 2019: Added new to market EC-Naproxen to the criteria.

Jan 2018: Criteria reformatted; Brand Lodine added to criteria; authorized generic Fenoprofen 600 added to policy; Tivorbex, Vivlodex, and

Zorvolex excluded from Net Results and added to standard criteria.

Jan 2017: Reviewed for Net Results formulary; non-formulary verbiage added

Oct 2016: Original Utilization management criteria issued.