ELYXYB (celecoxib solution)

ELYXYB (celecoxib solution)

Self-Administration - oral

Diagnosis considered for coverage: 

• Indicated for the acute treatment of migraine with or without aura in adults.
  • Limitations of Use-Elyxyb is not indicated for the preventive treatment of migraine.

Coverage Criteria:

For diagnosis of acute treatment of migraine:

• Dose does not exceed 120 mg (4.8 mL) per day and a limit of 6 doses (28.8 mL) per month, AND
• Patient is 18 years of age or older, AND
• Elyxyb is being use for the acute treatment of migraine, AND
• Chart note documentation is provided and confirms patient has tried and failed two preferred generic prescription strength oral NSAIDs (nonsteroidal anti-inflammatory drugs) OR there is a medically appropriate reason why generic alternatives cannot be tried

Reauthorization Criteria:

For diagnosis of acute treatment of migraine:

• Dose does not exceed 120 mg (4.8 mL) per day and a limit of 6 doses (28.8 mL) per month, AND
• Documentation of positive clinical response to therapy

Coverage Duration: 

• Initial: 1 year
• Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• NSAIDs with 5-50 fold COX-2 selectivity include Sulindac, Diclofenac, Celecoxib, Meloxicam and Etodolac
• COX-1 selective NSAIDs include Ketorolac, Flurbiprofen, Ketoprofen, Indomethacin, Aspirin, Naproxen, Tolmetin, Piroxicam, Meclofenamate
• Nonselective NSAIDs include Ibuprofen, Fenoprofen, Sodium salicylate, Diflunisal
• The reason for developing selective COX-2 inhibitors is the concept that the therapeutic effects of traditional NSAIDs are related to inhibition of COX-2 but the adverse effects (such as gastrointestinal ulcers or uncontrolled bleeding), are caused by the COX-1 inhibition. Selecting an NSAID that is a more COX-2 selective may be safer in patients at high risk for the gastrointestinal and bleeding adverse effects associated with traditional NSAIDs  (however, NSAIDs, regardless of selectivity, still pose some risk of these side effects.) NSAIDs that are more COX-2 selective have been associated with an increased risk in cardiovascular adverse effects. Weighing the patient’s benefits versus risks is important when recommending or prescribing an NSAID. All NSAIDs have been associated with some increased cardiovascular risks. If an NSAID is necessary in a patient at increased risk for cardiovascular events, the American Heart Association recommends using COX-1 selective NSAIDs first at the lowest dose and for the shortest duration.²
• The recommended maximum dose of Elyxyb in patients with moderate hepatic impairment or in patients who are known to be cytochrome P450 (CYP) 2C9 poor metabolizers is 60 mg (2.4 mL).
• Contraindications include:
  • Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to celecoxib, any components of the drug product.
  • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs, have been reported in such patients.
  • In the setting of coronary artery bypass graft (CABG) surgery.
  • In patients who have demonstrated allergic-type reactions to sulfonamides. 

Policy Updates:

• 8/16/2022 - Update to quantity limit, increase from 4 doses to 6 doses per month
• 5/17/2022 – New policy approved by P&T.

References:

• Elyxyb [package insert], East Princeton, NJ, Dr. Reddys Laboratories, Inc.; May, 2020. 
• Timpe Behnen E. Ask the Expert: Which NSAIDs are Most Selective for COX-1 and COX-2?. Pract Pain Manag. 2013;13(7).