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Cambia & Elyxyb - Enhanced/Essential
Restricted Product(s):
- Cambia® (diclofenac potassium)
- Diclofenac potassium (generic Cambia®)
- ElyxybTM (celecoxib) oral solution
FDA Approved Use:
- For acute treatment of migraine attacks with or without aura in adults 18 years of age or older
Criteria for Approval of Restricted Product(s):
1. The patient is 18 years or older; AND
2. The patient will be using the drug for the acute treatment of migraine attacks (prophylactic treatment is not a covered indication); AND
3. ONE of the following:
a. The patient has tried and failed at least TWO different oral non-steroidal anti-inflammatory drugs (NSAIDs); AND
i. If the requested product is Cambia or diclofenac potassium (generic Cambia), one of the tried and failed oral non-steroidal anti-inflammatory drugs (NSAIDs) is diclofenac; OR
ii. If the requested product is Elyxyb, one of the tried and failed medications is celecoxib capsules; OR
b. The patient has a clinical contraindication/intolerance to ALL oral NSAIDS that have not been tried; AND
4. The patient has tried and failed ANY generic triptan product; OR
a. The patient has a clinical contraindication/intolerance to ALL generic triptan products; AND
5. The patient is not taking another NSAID, including a Cox-2 inhibitor such as Celebrex, in any dosage form (e.g., oral, topical, etc.) at the same time as the requested medication; AND
6. The patient will NOT be using the requested agent in combination with another acute migraine therapy (i.e., 5HT-1F, acute use CGRP, Elyxyb, ergotamine, triptan); AND
7. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
Duration of Approval: 365 days (1 year)
Quantity Limitations:
quantity limitations apply to brand and associated generic products.
| Medication | Quantity |
|---|---|
| Cambia (diclofenac potassium) 50 mg packets | 9 packets every 30 days or 27 packets every 90 days |
| Elyxyb (celecoxib) oral solution 25 mg/mL | 9 bottles every 30 days or 27 bottles every 90 days |
Quantity Limit Exception Criteria:
1. The patient has met the above coverage criteria; AND
2. The patient has a diagnosis of moderate to severe migraine headache; AND
3. If the patient experiences > 4 migraine headaches per month, an adequate trial (least 2 – 3 months) of prophylactic therapy (Ex. amitriptyline, nortriptyline, topiramate, propranolol, divalproex) is required; AND
4. The possibility of medication-induced, rebound, or chronic daily headache has been ruled out.
Duration of Approval: 365 days (1 year)
References:
all information referenced is from FDA package insert unless otherwise noted below.
Policy Implementation / Update Information:
Jan 2023: Criteria update: Added new to market generic Cambia to policy and removed Cambia AG from policy.
Dec 2022: Criteria update: Added new to market Cambia AG to policy.
July 2022: Criteria change: Added requirement that the requested product cannot be used in combination with another acute migraine therapy.
November 2021: Criteria change: Added new to market Elyxyb solution to the policy.
February 2021: Criteria change: Required to try and fail any generic triptan product or unable to take all generic triptan products.
June 2020: Criteria update: Annual criteria review. Removed recommended alternatives.
Oct 2017: Added the requirement of oral diclofenac to prior NSAID use.
Aug 2017: Reformatted; No change to criteria
Jan 2017: Reviewed for Essential formulary; non-formulary verbiage added. Reformatted and added additional “triptan” requirement for annual review.
Jan 2014: Historical update
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