Subject: Butalbital Products Limit 38-H 07-2022

Drug

BUTALBITAL CONTAINING ANALGESICS (BRAND AND GENERIC)

butalbital and acetaminophen

butalbital, acetaminophen, and caffeine

butalbital, acetaminophen, caffeine, and codeine

butalbital, aspirin, and caffeine

butalbital, aspirin, caffeine, and codeine

Policy:

FDA-approved Indications          
Butalbital containing products are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.

Evidence supporting the efficacy and safety of these combination products in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.

Butalbital with codeine containing products are indicated for the relief of (or management of) the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate.

Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses, reserve butalbital with codeine products for use in patients for whom alternative treatment options (e.g. nonopioid, non-barbiturate analgesics) have not been tolerated or are not expected to be tolerated, or have not provided adequate analgesia or are not expected to provide adequate analgesia.

 

LIMIT CRITERIA
This quantity limit should accumulate across all drugs and strengths up to highest   quantity listed depending on the order the claims are processed.
Drug	1 Month Limit*	3 Month Limit*
butalbital, acetaminophen, and caffeine   syrup	720 mL / 25 days	2160 mL / 75 days
butalbital 25 mg and acetaminophen   325 mg	96 units / 25 days	288 units / 75 days
butalbital and acetaminophen	48 units / 25 days	144 units / 75 days
butalbital, acetaminophen, and caffeine	48 units / 25 days	144 units / 75 days
butalbital, acetaminophen, caffeine, and   codeine	48 units / 25 days	144 units / 75 days
butalbital, aspirin, and caffeine	48 units/ 25 days	144 units / 75 days
butalbital, aspirin, caffeine, and codeine	48 units / 25 days	144 units / 75 days
*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. *The limit criteria apply to both brand and generic, if available.

 

RATIONALE
Butalbital containing products are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of these combination products in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.^1-9

To decrease the risk of medication-overuse headache many experts limit acute therapy to two headache days per week on a regular basis. Drug treatment of acute headache should generally not exceed more than two days per week on a regular basis. More frequent treatment other than this may result in medication-overuse chronic daily headaches. ^10,11

The recommended dosage of butalbital 25 mg and acetaminophen 325 mg tablets is two tablets every four hours. The total daily dose should not exceed 12 tablets. The recommended dosage of all other butalbital combination products is one or two tablets/capsules/tablespoonfuls every four hours as needed. The total daily dose should not exceed 6 tablets/capsules/tablespoonfuls. Extended and repeated use of these products is not recommended because of the potential for physical dependence.^1-9

The limit is set to 6 doses per day at the maximum daily dose for acute treatment of 8 headaches per month. If the patient is requesting more than the initial quantity limit, then the claim will reject with a message indicating that quantity limits are exceeded.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Allzital [package insert]. Canton, MS: Larken Laboratories, Inc.; September 2020.
2. Butalbital, Aspirin, and Caffeine [package insert]. Kansas City, MO: Nostrum Laboratories, Inc.; October 2021.
3. Butalbital, Aspirin, Caffeine, and Codeine Phosphate [package insert]. Parsippany, NJ: Actavis Pharma, Inc.; April
4. Esgic [package insert]. Greenville, NC: Mayne Pharma; May 2019.
5. Fioricet [package insert]. Parsippany, NJ: Teva Pharmaceuticals USA, Inc.; January 2021.
6. Fioricet with Codeine [package insert]. Parsippany, NJ: Teva Pharmaceuticals USA, Inc.; March 2021.
7. VTOL LQ [package insert]. Atlanta, GA: Mikart, LLC; August 2019.
8. Lexicomp Online, AHFS DI (Adult and Pediatric) Online, Hudson, Ohio: UpToDate, Inc.; 2022; Accessed May 13, 2022.
9. Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com. Accessed May 13, 2022.
10. Marmura M, Silberstein S, Schwedt T. The Acute Treatment of Migraine in Adults: The American Headache Society Evidence Assessment of Migraine Pharmacotherapies. Headache 2015;55:3-20.
11. American Headache Society. The American Headache Society Consensus Statement: Update on integrating new migraine treatments into clinical practice. Headache 2021;61:1021-1039.

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.

December 10, 2022