Subject: Colchicine Limit 678-H P12-2024

Drug

COLCRYS  (colchicine)

GLOPERBA  (colchicine solution)

MITIGARE  (colchicine)

Policy:

Indications

FDA-Approved Indications

Colcrys

Gout Flares

Colcrys (colchicine, USP) tablets are indicated for prophylaxis and the treatment of acute gout flares.

• Prophylaxis of Gout Flares: Colcrys is indicated for prophylaxis of gout flares.
• Treatment of Gout Flares: Colcrys tablets are indicated for treatment of acute gout flares when taken at the first sign of a flare.

Familial Mediterranean Fever (FMF)

Colcrys (colchicine, USP) tablets are indicated in adults and children four years or older for treatment of familial Mediterranean fever (FMF).

Compendial Uses

Behcet’s Syndrome ^6,8

Pericarditis, Recurrent; Prophylaxis ^6,7

Gloperba

Gloperba (colchicine USP) Oral Solution is indicated for prophylaxis of gout flares in adults.

Limitations of use

The safety and effectiveness of Gloperba for acute treatment of gout flares during prophylaxis has not been studied. Gloperba is not an analgesic medication and should not be used to treat pain from other causes.

Mitigare

Mitigare (colchicine) capsules are indicated for prophylaxis of gout flares in adults.

Limitations of use

The safety and effectiveness of Mitigare for acute treatment of gout flares during prophylaxis has not been studied. Mitigare is not an analgesic medication and should not be used to treat pain from other causes.

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 and 75 days is used for a 90-day fill period to allow time for refill processing.

Drug	1 Month Limit	3 Month Limit
Colcrys	120 tablets / 25 days	360 tablets / 75 days
Mitigare	60 capsules / 25 days	180 capsules / 75 days
Gloperba	300 mL / 25 days	900 mL / 75 days

Place of Service:

Outpatient

The above policy is based on the following references:

1. Colcrys [package insert]. Deerfield, IL: Takeda Pharmaceuticals America, Inc.; May 2020.
2. Gloperba [package insert]. Palto Alto, CA: Scilex Pharmaceuticals, LLC; August 2022.
3. Mitigare [package insert]. Memphis, TN: Hikma Specialty USA Inc.; May 2024.
4. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2024. https://online.lexi.com. Accessed October 23, 2024.
5. Lexicomp Online, Lexi-Drugs Online. Waltham, MA: UpToDate, Inc.; 2024.https://online.lexi.com. Accessed October 23, 2024.
6. Micromedex (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 10/23/2024).
7. Imazio M, Brucato A, Cemin R, et al. Colchicine for Recurrent Pericarditis (CORP): a randomized trial. Ann Intern Med. 2011;155(7):409-414.
8. Behçet’s Syndrome. Last updated 05/17/2023. Available at: https://rarediseases.org/rare-diseases/behcets-syndrome/#therapies Accessed October 23, 2024.
9. FitzGerald JD, Dalbeth N, Mikuls T, et al. 2020 American College of Rheumatology guideline for the management of gout. Arthritis Rheumatol. 2020;72(6):879-895.

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.

April 23, 2025