Subject: Ketorolac Limit 233-H P10-2024_R

Drug

ketorolac (all brands)  (ketorolac)

SPRIX  (ketorolac)

Policy:

Indications

FDA-approved Indications

Ketorolac Tablets

Carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

Ketorolac tromethamine tablets are indicated for the short-term (≤ 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with IV or IM dosing of ketorolac tromethamine and ketorolac tromethamine tablets are to be used only as continuation treatment, if necessary.

The total combined duration of use of ketorolac tromethamine tablets and ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses. Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine tablet therapy is not to exceed 5 days.

Sprix

Sprix is 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.

 

Initial Limit Quantity

Limits should accumulate across all drugs and strengths up to highest quantity listed depending on the order the claims are processed. Accumulation does not apply if limit is coded for daily dose.

The duration of 25 days is used for a 30-day fill period to allow time for refill processing

These drugs are for short-term acute use; therefore, the intent is for prescriptions of the requested drug to be filled one month at a time; there should be no 3 month supplies filled.

Drug	1 Month Limit	3 Month Limit
ketorolac tablets	20 tablets / 25 days	Does Not Apply
Sprix nasal spray (ketorolac nasal spray)	5 bottles / 25 days	Does Not Apply

Place of Service:

Outpatient

The above policy is based on the following references:

1. Ketorolac [package insert]. Parsippany, NJ: Teva Pharmaceuticals; July 2021.
2. Sprix [package insert]. Wayne, PA: Zyla Life Sciences US Inc.; April 2021.
3. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2024. https://online.lexi.com. Accessed September 5, 2024.
4. Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 09/05/2024).

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

March 16, 2025