PHARMACY COVERAGE GUIDELINES ORIGINAL EFFECTIVE DATE: 5/18/17 SECTION: DRUGS LAST REVIEW DATE: 5/17/18 LAST CRITERIA REVISION DATE: ARCHIVE DATE:

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1 ALLZITAL (butalbital and acetaminophen) 25 mg/325 mg oral tablet Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Pharmacy Coverage Guideline must be read in its entirety to determine coverage eligibility, if any. This Pharmacy Coverage Guideline provides information related to coverage determinations only and does not imply that a service or treatment is clinically appropriate or inappropriate. The provider and the member are responsible for all decisions regarding the appropriateness of care. Providers should provide BCBSAZ complete medical rationale when requesting any exceptions to these guidelines. The section identified as Description defines or describes a service, procedure, medical device or drug and is in no way intended as a statement of medical necessity and/or coverage. The section identified as Criteria defines criteria to determine whether a service, procedure, medical device or drug is considered medically necessary or experimental or investigational. State or federal mandates, e.g., FEP program, may dictate that any drug, device or biological product approved by the U.S. Food and Drug Administration (FDA) may not be considered experimental or investigational and thus the drug, device or biological product may be assessed only on the basis of medical necessity. Pharmacy Coverage Guidelines are subject to change as new information becomes available. For purposes of this Pharmacy Coverage Guideline, the terms "experimental" and "investigational" are considered to be interchangeable. BLUE CROSS, BLUE SHIELD and the Cross and Shield Symbols are registered service marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. All other trademarks and service marks contained in this guideline are the property of their respective owners, which are not affiliated with BCBSAZ. This Pharmacy Coverage Guideline does not apply to FEP or other states Blues Plans. Information about medications that require precertification is available at Some large (100+) benefit plan groups may customize certain benefits, including adding or deleting precertification requirements. All applicable benefit plan provisions apply, e.g., waiting periods, limitations, exclusions, waivers and benefit maximums. Precertification for medication(s) or product(s) indicated in this guideline requires completion of the request form in its entirety with the chart notes as documentation. All requested data must be provided. Once completed the form must be signed by the prescribing provider and faxed back to BCBSAZ Pharmacy Management at (602) Page 1 of 5

2 or ed to Incomplete forms or forms without the chart notes will be returned. Criteria: See Resources section for FDA-approved dosage. Precertification for BUPAP (butalbital-acetaminophen) 50/300 mg, Butalbital and Acetaminophen 50/300 mg and Allzital (butalbital-acetaminophen) 25/325 mg requires completion of the specific request form in its entirety. All requested data must be provided. Once completed the form must be signed by the prescribing provider and faxed back to BCBSAZ Pharmacy Management at (602) or ed to Incomplete forms will be returned. Initial therapy: FDA-approved product labeling (indication, age, dosage, testing, contraindications, exclusions, etc.) of BUPAP (butalbital-acetaminophen) 50/300 mg, Butalbital and Acetaminophen 50/300 mg and Allzital (butalbital-acetaminophen) 25/325 mg is considered medically necessary when ALL of the following criteria are met: 1. Individual is 12 years of age or older 2. Medical record documentation of a confirmed diagnosis of tension (or muscle contraction) headache 3. Medical record documentation that the individual is unable to use ALL of the following due to failure, adverse drug event, or contraindication: Acetaminophen Ibuprofen Naproxen Aspirin Butalbital-acetaminophen mg tablet Butalbital-acetaminophen-caffeine mg Butalbital-acetaminophen-caffeine mg Butalbital-acetaminophen-caffeine mg tablet Butalbital-aspirin-caffeine mg 4. Absence of ALL of the following contraindications: Hypersensitivity or intolerance to any component of the product Porphyria 5. Absence of ALL of the following exclusions: Acetaminophen allergy Woman who is breast feeding an infant or child Page 2 of 5

3 Continuation of coverage (renewal request): BUPAP (butalbital-acetaminophen) 50/300 mg, Butalbital and Acetaminophen 50/300 mg and Allzital (butalbital-acetaminophen) 25/325 mg is considered medically necessary with documentation of ALL of the following: 1. The individual has benefited from therapy but remains at high risk 2. The condition has not progressed or worsened while on therapy 3. Individual has not developed any contraindications or other exclusions to its continued use BUPAP (butalbital-acetaminophen) 50/300 mg, Butalbital and Acetaminophen 50/300 mg and Allzital (butalbital-acetaminophen) 25/325 mg for all other indications not previously listed is considered experimental or investigational based upon: 1. Lack of final approval from the Food and Drug Administration, and 2. Insufficient scientific evidence to permit conclusions concerning the effect on health outcomes, and 3. Insufficient evidence to support improvement of the net health outcome, and 4. Insufficient evidence to support improvement of the net health outcome as much as, or more than, established alternatives, and 5. Insufficient evidence to support improvement outside the investigational setting. This includes but is not limited to the following: Migraine headache Cluster headache Other non-tension type headaches Description: BUPAP (butalbital-acetaminophen), Butalbital and Acetaminophen, and Allzital (butalbital-acetaminophen) are combination products indicated for the treatment of tension (or muscle contraction) headache. The role each component plays in the relief of the complex of symptoms known as tension headache is unknown. Each BUPAP and Butalbital and Acetaminophen tablet contains 50 mg of the intermediate-acting barbiturate butalbital and 300 mg of the analgesic acetaminophen. Allzital tablets contain 25 mg of the intermediate-acting barbiturate butalbital and 325 mg of the analgesic acetaminophen. Other butalbital and acetaminophen combination products are available. Butalbital with acetaminophen may be combined with caffeine as a triple combination or codeine is added as a four drug combination. In addition, there are combination products that have 325 mg aspirin instead of acetaminophen. Evidence supporting the efficacy and safety of butalbital-acetaminophen combination product in the treatment of multiple recurrent headaches is unavailable. These product should be used with caution because the butalbital component is habit-forming and potentially may be abused. As a result, the extended use of butalbital is not recommended. Page 3 of 5

4 Tension type headache may be classified into three subtypes according to headache frequency. The first subtype is an infrequent episodic headache occurring at a frequency of less than 1 day of headache per month. Frequent episodic headaches that result in 1-4 days of headache per month is the second subtype. The last subtype is chronic headache, defined as 15 or more headache days per month. These headaches are not associated with the typical migraine features of vomiting, severe photophobia and phonophobia. The headache is characterized by a bilateral, pressing tightening pain of mild to moderate intensity, occurring either in short episodes of variable duration (episodic forms) or continuously (chronic form). Published guidelines indicate treatment of acute episodic tension headache recommend use of an over-thecounter (OTC) analgesic such as aspirin, ibuprofen, naproxen, and acetaminophen as first line therapy. The efficacy of these simple analgesics is increased when combined with caffeine but at a cost of increased medication overuse headache. However the caffeine combinations are considered drugs of second choice. Use of 5-hydroxytryptamine agonists (or triptans), muscle relaxants, and opioids are not recommended for tension or muscle contraction headache. A 2010 guideline on the treatment of tension headache by the European Federation of Neurological Societies (EFNS) recommends against the use of simple analgesics with codeine or a barbiturate. Prophylactic treatment of chronic tension headache consist of use of amitriptyline as drug of first choice, with mirtazapine or venlafaxine as drugs of second choice for prophylaxis. Definitions: Butalbital containing products for tension or muscle contraction headache: Butalbital APAP ASA Caffeine Codeine Allzital tablet tablets q 4h prn Max: 12 tabs (300 mg/3,900 mg) Usual: 1-2 tabs q 4h prn Max: 6 tabs (300 mg/1,800 mg) BUPAP tablet Butalbital and Acetaminophen tablet Butalbital-APAP tablet Usual: 1-2 tabs q 4h prn Butalbital-APAP-Caffeine-Codeine Butalbital-APAP-Caffeine-Codeine Usual: 1-2 caps q 4h prn Max: 6 tabs (300 mg/1,800 mg) Usual: 1-2 tabs q 4h prn Butalbital-APAP-Caffeine Usual: 1-2 caps q 4h prn Max: 6 caps (300 mg/1,800 mg) Butalbital-APAP-Caffeine Usual: 1-2 caps q 4h prn Butalbital-APAP-Caffeine tablet Usual: 1-2 tabs q 4h prn Butalbital-ASA-Caffeine-Codeine Usual: 1-2 caps q 4h prn Page 4 of 5

5 Butalbital-ASA-Caffeine Usual: 1-2 caps q 4h prn Resources: BUPAP (butalbital-acetaminophen) 50/300 mg. Package Insert. Revised by manufacturer 11/2015. Accessed Allzital (butalbital-acetaminophen) 25/325 mg. Package Insert. Revised by manufacturer 03/2016. Accessed Bendtsen L, Evers S, Linde M, et al.: European Federation of Neurological Societies (EFNS) guideline on the treatment of tension-type headache Report of an EFNS task force. Eur J Neurology 2010, 17: FDA-approved indication and dosage: Indication BUPAP Tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Recommended Dose BUPAP Tablets: One or two tablets every four hours. Total daily dosage should not exceed 6 tablets. Extended and repeated use of these products is not recommended because of the potential for physical dependence. Caution in this regard is required because butalbital is habit-forming and potentially abusable. ALLZITAL Tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. ALLZITAL Tablets: Two tablets every four hours. Total daily dosage should not exceed 12 tablets. Extended and repeated use of these products is not recommended because of the potential for physical dependence. Caution in this regard is required because butalbital is habit-forming and potentially abusable. Page 5 of 5