Non-steroidal Anti-Inflammatory Agents - PA, ST
Indications for Prior Authorization
Cambia (diclofenac) powder
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For diagnosis of Migraine
Indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older).Limitations of Use: Cambia is not indicated for the prophylactic therapy of migraine. Safety and effectiveness of CAMBIA not established for cluster headache, which is present in an older, predominantly male population.
Celebrex (celecoxib) capsule
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For diagnosis of Multiple Indications
Indicated for osteoarthritis (OA), rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA) in patients 2 years of age or older, ankylosing spondylitis (AS), acute pain, and primary dysmenorrhea.
Fenopron (fenoprofen calcium) capsule
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For diagnosis of Multiple Indications
Indicated for relief of mild to moderate pain in adults, relief of the signs and symptoms of rheumatoid arthritis (RA), and relief of the signs and symptoms of osteoarthritis (OA).
Indocin (indomethacin), Indomethacin suspension 25mg/5ml
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For diagnosis of Multiple Indications
Indicated for the treatment for the following: moderate to severe rheumatoid arthritis including acute flare of chronic disease, moderate to severe ankylosing spondylitis, moderate to severe osteoarthritis, acute painful shoulder (bursitis and/or tendinitis) or acute gouty arthritis.
Lofena (diclofenac potassium) tablet
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For diagnosis of Multiple Indications
Indicated for treatment of primary dysmenorrhea, for relief of mild to moderate pain, for relief of the signs and symptoms of osteoarthritis, for the relief of the signs and symptoms of rheumatoid arthritis.
Pennsaid (diclofenac sodium) topical solution
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For diagnosis of Osteoarthritis (OA)
Indicated for the treatment of the pain of osteoarthritis of the knee(s).
Sprix (ketorolac tromethamine) nasal spray
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For diagnosis of Pain
Indicated in adult patients for the short term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level.
Tolectin (tolmetin sodium) tablet
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For diagnosis of Multiple Indications
Indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis. TOLECTIN tablets are indicated in the treatment of acute flares and the long-term management of the chronic disease. Indicated for treatment of juvenile rheumatoid arthritis. The safety and effectiveness of TOLECTIN tablets have not been established in pediatric patients under 2 years of age.
Zipsor (diclofenac potassium) capsule
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For diagnosis of Pain
Indicated for relief of mild to moderate acute pain in adult and pediatric patients 12 years of age and older.
Criteria
Sprix nasal spray, Brand Ketorolac nasal spray
Prior Authorization
Length of Approval: 5 Days [A]
- Diagnosis of moderate to moderately severe pain AND
- One of the following:
- Trial (of a minimum 30-day supply) or intolerance to oral ketorolac* tablets OR
- Patient is unable to take medications orally
Brand Pennsaid topical solution, Generic diclofenac topical solution*
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
- Diagnosis of osteoarthritis of the knee(s) AND
- One of the following:
- Trial and failure (minimum 30-day supply), contraindication, or intolerance to at least two prescription strength oral NSAIDs (e.g., diclofenac, diclofenac ER, ibuprofen, indomethacin, etc.) OR
- Documented swallowing disorder OR
- History of peptic ulcer disease/gastrointestinal bleed OR
- Patient is older than 65 years of age with one additional risk factor for gastrointestinal adverse events (e.g., use of anticoagulants, chronic corticosteroids)
- For Brand Pennsaid only, trial (of a minimum 30-day supply) or intolerance to both of the following:
- generic topical diclofenac 1.5% solution
- generic topical diclofenac 2% solution
Brand Pennsaid topical solution, Generic diclofenac topical solution*
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
- Patient demonstrates positive clinical response to therapy (e.g., improvement in pain symptoms of osteoarthritis) AND
- For Brand Pennsaid only, trial (of a minimum 30-day supply) or intolerance to both of the following:
- generic topical diclofenac 1.5% solution
- generic topical diclofenac 2% solution
Brand Cambia**^, generic diclofenac powder packet**, Celebrex, Fenopron, Indocin* suspension or suppository, generic indomethacin* suspension or suppository, Lofena**, Tolectin, Brand Zipsor**, generic diclofenac 25mg capsule**
Step Therapy
Length of Approval: 12 Month(s)
- Requested drug is being used for a Food and Drug Administration (FDA)-approved indication AND
- Trial and failure (of a minimum 30 day supply), contraindication, or intolerance to two of the following:
- celecoxib
- diclofenac potassium tab or diclofenac sodium
- diflunisal
- etodolac
- fenoprofen
- flurbiprofen
- ibuprofen
- indomethacin
- ketoprofen
- ketorolac
- meclofenamate
- meloxicam
- nabumetone
- naproxen
- oxaprozin
- piroxicam
- sulindac
- tolmetin
P & T Revisions
2026-04-21, 2026-02-25, 2025-12-18, 2025-12-18, 2025-05-28, 2025-03-14, 2025-02-26, 2025-01-27, 2024-11-26, 2024-06-06, 2024-04-05, 2024-02-01, 2023-11-29, 2023-11-01, 2023-11-01, 2023-04-26, 2023-04-05, 2023-01-20, 2022-12-01, 2022-10-04, 2022-08-04, 2022-07-06, 2022-05-03, 2022-01-06, 2021-09-28, 2021-05-21, 2021-04-02, 2020-10-28, 2020-10-07, 2020-03-30, 2019-10-31
References
- Sprix Prescribing Information. Zyla Life Sciences US LLC. Wayne, PA. November 2024.
- Pennsaid Prescribing Information. Horizon Medicines LLC. Deerfield, IL. November 2024.
- 2023 American Geriatrics Society Beers Criteria Update Expert Panel. American Geriatrics Society 2023 updated AGS Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2023; 71(7): 2052-2081.
- Cambia Prescribing Information. Assertio Therapeutics, Inc. Lake Forest, IL. November 2024.
- Vivlodex Prescribing Information. Ceutica Operations LLC. Princeton, NJ. November 2024.
- Indocin Prescribing Information. Zyla Life Sciences US, Inc. Wayne, PA. November 2024.
- Zorvolex Prescribing Information. Zyla Life Sciences US Inc. Wayne, PA. November 2024.
- Lofena Prescribing Information. Carwin Pharmaceutical Associates, LLC. Hazlet, NJ. July 2021.
- Diclofenac Sodium Solution Prescribing Information. Apotex Corporation. Weston, FL. August 2024.
- Indomethacin Suspension Prescribing Information. Zyla Life Sciences US, LLC. Wayne, PA. November 2024.
- Tolectin Prescribing Information. Poly Pharmaceuticals, Inc. East Brunswick, NJ. February 2024.
- Fenopron Prescribing Information. Galt Pharmaceuticals, LLC. Atlanta, GA. September 2024.
- Zipsor Prescribing Information. Assertio Therapeutics, Inc. Lake Forest, IL. November 2024.
- Celebrex Prescribing Information. Viatris Specialty LLC. Morgantown WV. November 2024.
End Notes
- The total duration of use of Sprix alone or sequentially with other formulations of ketorolac (IM/IV or oral) must not exceed 5 days because of the potential for increasing the frequency and severity of adverse reactions associated with the recommended doses. Treat patients for the shortest duration possible, and do not exceed 5 days of therapy with Sprix. [1]
- Ketorolac, indomethacin, and diclofenac are included on the 2023 Beers Criteria for Potentially Inappropriate Medication Use in Older Adults greater than or equal to 65 years old. [3]
Revision History
- 2026-04-21: Removed Zybic & meloxicam suspension as step target from guideline. Removed obsolete GPIs. Background updates.
- 2026-02-25: Added Zybic as step target. Annual Review 2026 - Removed mention of "failure/contraindication" in embedded steps through products with same active ingredient and defined minimum 30 days for trial throughout embedded steps. Added embedded step through generic in reauth for Brand Pennsaid. Added FDA diagnosis check in ST criteria. Removed obsolete products: Vivlodex, Zorvolex, diclofenac 35 mg. Added indomethacin suppositories as ST target. Background updates.
- 2025-12-18: No criteria change, bulk copy oRX-EHB
- 2025-12-18: no criteria changes, added IL statute operational note
- 2025-05-28: Removed Dolobid from the guideline
- 2025-03-14: 2025 Annual Review. No criteria changes. Background updates only.
- 2025-02-26: Added Dolobid Indication to guideline
- 2025-01-27: Added brand Fenopron to guideline
- 2024-11-26: Added Dolobid to guideline
- 2024-06-06: Added Tolectin as a target to guideline.
- 2024-04-05: 2024 Annual Review. No criteria changes. Background updates.
- 2024-02-01: Added generic Indomethacin suspension 25mg/5ml as target to guideline.
- 2023-11-29: Updated GL-135732 to add OptumRx-EHB formulary which was inadvertently removed during reauth verbiage update
- 2023-11-01: Program update to standard reauthorization language. No changes to clinical intent.
- 2023-11-01: Program update to standard reauthorization language. No changes to clinical intent.
- 2023-04-26: updated guideline
- 2023-04-05: Annual Review
- 2023-01-20: update guideline
- 2022-12-01: Addition of Brand/generic Zipsor and Brand Celebrex as targets
- 2022-10-04: Updated Pennsaid/generic diclofenac solution criteria
- 2022-08-04: Added meloxicam 7.5mg/5mL oral suspension as ST target. Updated background and references.
- 2022-07-06: Added generic diclofenac 2% solution to guideline. Added generic celecoxib as ST1 alt for Tivorbex ST. Removed obsolete products Klofensaid and Pennsaid 1.5%. Updated background and references.
- 2022-05-03: Background updates.
- 2022-01-06: Update guideline
- 2021-09-28: Addition of EHB formulary to guideline, no changes to criteria
- 2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
- 2021-04-02: Annual Review
- 2020-10-28: Added diclofenac 35mg capsule (ABA for Zorvolex) to guideline
- 2020-10-07: Added GPI for ketorolac nasal spray (ABA for Sprix) to guideline.
- 2020-03-30: Added ABA Indomethacin 20mg (ABA for Tivorbex) and ketorolac nasal spray (ABA for Sprix)
- 2019-10-31: Add examples of oral NSAIDs
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