Pharmacy Prior Authorization Criteria

Non-steroidal Anti-Inflammatory Agents - PA, ST

Indications for Prior Authorization

Cambia (diclofenac) powder

• 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. The safety and effectiveness of Cambia have not been established for cluster headache, which is present in an older, predominantly male population.

Celebrex (celecoxib)

• For diagnosis of Multiple
  Indicated for: 1) Osteoarthritis (OA) 2) Rheumatoid Arthritis (RA) 3) Juvenile Rheumatoid Arthritis (JRA) in patients 2 years of age or older 4) Ankylosing Spondylitis (AS) 5) Acute Pain 6) Primary Dysmenorrhea

Sprix (ketorolac tromethamine) nasal spray

• For diagnosis of Moderate to moderately severe 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.

  Limitations of Use: Sprix is not for use in pediatric patients less than 2 years of age.

Tivorbex (indomethacin) capsules

• For diagnosis of Mild to moderate pain
  Indicated for treatment of mild to moderate acute pain in adults.

Pennsaid (diclofenac sodium) topical solution

• For diagnosis of Osteoarthritis (OA)
  Indicated for the treatment of the pain of osteoarthritis of the knee(s).

Indocin

• 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.

Vivlodex

• For diagnosis of Osteoarthritis (OA)
  Indicated for the treatment of osteoarthritis (OA) pain.

Zorvolex (diclofenac)

• For diagnosis of Pain
  Indicated for the treatment of mild to moderate acute pain and management of osteoarthritis (OA) pain.

Lofena

• For diagnosis of Primary dysmenorrhea, mild to moderate pain, osteoarthritis, and rheumatoid arthritis
  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.

Meloxicam oral suspension 7.5mg/5mL

• For diagnosis of Multiple
  Indicated for: 1) Osteoarthritis (OA) 2) Rheumatoid Arthritis (RA) 3) Juvenile Rheumatoid Arthritis (JRA) in patients 2 years of age or older

Zipsor (diclofenac potassium)

• For diagnosis of Mild to moderate acute pain
  Indicated for relief of mild to moderate acute pain in adult and pediatric patients 12 years of age and older.

Indomethacin Suspension 25mg/5ml

• 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.

Tolectin (tolmetin)

• 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.

Criteria

Sprix nasal spray, Brand Ketorolac nasal spray

*Ketorolac is recommended only for patients less than 65 years old. [B, C]

Prior Authorization

Length of Approval: 5 Days [A]

• Diagnosis of moderate to moderately severe pain
AND
• One of the following:
• Trial and failure, contraindication, 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, 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)
AND
• Trial and failure, contraindication, or intolerance to both of the following: (applies to Brand Pennsaid only)
• 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 (e.g., improvement in pain symptoms of osteoarthritis) to therapy

Tivorbex*, Brand Diclofenac 50mg, Brand Indomethacin 20mg*, Cambia**^, Brand Celebrex, Indocin*, Lofena, Vivlodex, Zorvolex, Brand diclofenac 35mg capsule, Meloxicam oral suspension 7.5mg/5mL, Brand Zipsor, generic diclofenac 25mg capsule, Generic Indomethacin Suspension 25mg/5ml*, Tolectin,Dolobid

*Per the American Geriatrics Society 2023 updated Beers criteria, indomethacin is not recommended for patients greater than or equal to 65 years old [B] **Per the American Geriatrics Society 2023 updated Beers criteria, chronic use of NSAIDs, including diclofenac, is not recommended for patients greater than or equal to 65 years old unless other alternatives are not effective and patient can take gastroprotective agent (proton pump inhibitor or misoprostol) [B] ^Product may be excluded depending on the plan.

Step Therapy

Length of Approval: 12 Month(s)

• Trial and failure (of a minimum 30 day supply), contraindication, or intolerance to two of the following:
• diclofenac potassium tab or diclofenac sodium
• diflunisal
• etodolac
• fenoprofen
• flurbiprofen
• ibuprofen
• indomethacin
• ketoprofen
• ketorolac
• meclofenamate
• meloxicam
• nabumetone
• naproxen
• oxaprozin
• piroxicam
• sulindac
• tolmetin
• celecoxib

P & T Revisions

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

1. Sprix prescribing information. Zyla Life Sciences US Inc. Wayne, PA. July 2023.
2. Pennsaid prescribing information. Horizon Therapeutics USA, Inc. Lake Forest, IL. February 2022.
3. 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.
4. The National Committee for Quality Assurance (NCQA). Use of high-risk medications in the elderly (DAE). Available at www.ncqa.org. Accessed March 9, 2022.
5. Tivorbex prescribing information. Iroko Pharmaceuticals LLC, Philadelphia, PA. January 2020.
6. Cambia prescribing information. Depomed, Inc, Newark, CA. October 2019.
7. Vivlodex prescribing information. Egalet US Inc. Wayne PA. April 2021.
8. Indocin prescribing information. Iroko Pharmaceuticals, LLC. Philadelphia, PA. October 2018.
9. Zorvolex prescribing information. Zyla Life Sciences US Inc. Wayne, PA. April 2021.
10. Lofena Prescribing Information. Carwin Pharmaceutical Associates, LLC. Hazlet, NJ. July 2021.
11. Diclofenac Sodium Solution Prescribing Information. Apotex Corporation. Weston, FL. April 2022.
12. Meloxicam Oral Suspension Prescribing Information. Avondale Pharmaceuticals, LLC. Birmingham, AL. January 2024.
13. Indomethacin Suspension Prescribing Information. ANI Pharmaceuticals Inc, Baudette, MN 56623. January 2024.
14. Tolectin prescribing information. Poly Pharmaceuticals, Inc, Owens Cross Roads, AL 35763. February 2024.

---

End Notes

1. 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]
2. This drug is included on the 2023 Beers Criteria for Potentially Inappropriate Medication Use in Older Adults greater than or equal to 65 years old. [3]
3. This drug is included on the 2013 Health Plan Employer Data and Information Set (HEDIS) list of high-risk medications in the elderly (greater than or equal to 65 years old) [4]

---

Revision History

• 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

---