Subject: Specialty Quantity Limit vigabatrin-Sabril-Vigadrone-Vigpoder 1769-H P2023a
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SABRIL
(vigabatrin)
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VIGADRONE
(vigabatrin)
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VIGPODER
(vigabatrin)
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vigabatrin
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Policy:
I. PROGRAM DESCRIPTION
The standard limit is designed to allow a quantity sufficient for the most common uses of the medication. The recommended dosing parameters for all FDA-approved indications fall within the standard limits. Coverage of an additional quantity may be reviewed on a case-by-case basis upon request.
II. COVERED QUANTITIES
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Medication
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Standard Limit*
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FDA-recommended dosing
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Sabril (vigabatrin) powder
500 mg packet
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180 packets per 30 days
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Refractory Complex Partial Seizures:
• Adults (17 years of age and older) – Initiate at
1000 mg/day (500 mg twice daily). Increase
total daily dose in 500 mg/day increments at
weekly intervals, to the recommended dose of
3000 mg/day (1500 mg twice daily).
• Pediatric (2 to 16 years of age) –
– 10 kg to 15 kg: 350 mg/day to 1050
mg/day
– Greater than 15 kg to 20 kg: 450 mg/day
to 1300 mg/day
– Greater than 20 kg to 25 kg: 500 mg/day
to 1500 mg/day
– Greater than 25 kg to 60 kg: 500 mg/day
to 2000 mg/day
Administer as two divided doses. Increase total daily
dose weekly. Dose patients weighing more than 60
kg according to adult recommendations.
Infantile Spasms:
• Initiate at a daily dose of 50 mg/kg given in 2
divided doses (25 mg/kg twice daily). Increase
total daily dose every 3 days, in increments of
25 mg/kg/day to 50 mg/kg/day, up to a
maximum daily dose of 150 mg/kg given in 2
divided doses (75 mg/kg twice daily).
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|
Sabril (vigabatrin)
500 mg tablet
|
180 tablets per 30 days
|
|
Vigabatrin powder
500 mg packet
|
180 packets per 30 days
|
|
Vigabatrin 500 mg tablet
|
180 tablets per 30 days
|
|
Vigadrone (vigabatrin)
powder 500 mg packet
|
180 packets per 30 days
|
|
Vigadrone (vigabatrin)
500 mg tablet
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180 tablets per 30 days
|
|
Vigpoder (vigabatrin)
powder 500 mg packet
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180 packets per 30 days
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Place of Service:
Outpatient
The above policy is based on the following references:
- Sabril [package insert]. Deerfield, IL: Lundbeck; October 2021.
- Vigabatrin for oral solution [package insert]. Chestnut Ridge, NY: Par Pharmaceutical; March 2020.
- Vigadrone [package insert]. Maple Grove, MN: Upsher-Smith Laboratories, LLC; February 2020.
- Vigpoder [package insert]. Parsippany, NJ: Pyros Pharmaceuticals, Inc; July 2023.
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.
February 29, 2024
