Subject: Specialty Quantity Limit Promacta-Alvaiz 1757-H P2023a
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PROMACTA
(eltrombopag olamine)
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ALVAIZ
(eltrombopag choline)
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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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Promacta (eltrombopag olamine) 12.5 mg tablets
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60 per 30 days
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Persistent or chronic immune thrombocytopenia (ITP): Initiate at 50 mg once daily for most adult and pediatric patients 6 years and older and at 25 mg once daily for pediatric patients aged 1 to 5 years. Dose reductions are needed for patients of East-/Southeast-Asian ancestry or those with hepatic impairment. Adjust to maintain platelet count greater than or equal to 50 x 109/L. Do not exceed 75 mg per day.
Chronic Hep C-associated thrombocytopenia: Initiate at 25 mg once daily. Adjust to achieve target platelet count required to initiate antiviral therapy. Do not exceed a daily dose of 100 mg.
First-line severe aplastic anemia: Initiate once daily at 2.5 mg/kg (in pediatric patients aged 2 to 5 years old), 75 mg (pediatric patients aged 6 to 11 years old), or 150 mg for patients aged 12 years and older concurrently with standard immunosuppressive therapy. Reduce initial dose in patients of East-/Southeast-Asian ancestry or those with hepatic impairment. Modify dosage for toxicity or elevated platelet counts.
Refractory severe aplastic anemia: Initiate at 50 mg once daily for most patients. Reduce initial dose in patients with hepatic impairment or patients of East-/Southeast-Asian ancestry. Adjust to maintain platelet count greater than or equal to 50 x 109/L. Do not exceed 150 mg per day.
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Promacta (eltrombopag olamine) 25 mg tablets
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90 per 30 days
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Promacta (eltrombopag olamine) 12.5 mg oral suspension packets
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120 packets per 30 days
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Promacta (eltrombopag olamine) 25 mg oral suspension packets
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180 packets per 30 days
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Promacta (eltrombopag olamine) 50 mg tablets
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90 per 30 days
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Promacta (eltrombopag olamine) 75 mg tablets
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60 per 30 days
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Alvaiz (eltrombopag choline) 9 mg tablets
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60 per 30 days
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Persistent or chronic ITP: Initiate at 36 mg once daily for most adult and pediatric patients 6 years and older. Dose reductions are needed for patients of East-/Southeast-Asian ancestry or those with hepatic impairment. Adjust to maintain platelet count greater than or equal to 50 x 109/L. Do not exceed 54 mg per day.
Chronic hepatitis C-associated thrombocytopenia: Initiate at 18 mg once daily. Adjust to achieve target platelet count required to initiate antiviral therapy. Do not exceed a daily dose of 72 mg.
Refractory severe aplastic anemia: Initiate at 36 mg once daily for most patients. Reduce initial dose in patients with hepatic impairment or patients of East-/Southeast-Asian ancestry. Adjust to maintain platelet count greater than or equal to 50 x 109/L. Do not exceed 108 mg per day.
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Alvaiz (eltrombopag choline) 18 mg tablets
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90 per 30 days
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Alvaiz (eltrombopag choline) 36 mg tablets
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90 per 30 days
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Alvaiz (eltrombopag choline) 54 mg tablets
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60 per 30 days
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Place of Service:
Outpatient
The above policy is based on the following references:
- Promacta [package insert]. Research Triangle Park, NC: GlaxoSmithKline; March 2023.
- Alvaiz [package insert]. Parsippany, NJ: Teva Pharmaceuticals; November 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.
April 22, 2024