Subject: Specialty Quantity Limit Jakafi 2284-H P2023
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
|
Medication
|
Standard Limit
|
FDA-recommended dosing
|
|
Jakafi
(ruxolitinib)
5 mg tablets
|
60 per 30 days
|
Intermediate or high-risk myelofibrosis,
including primary myelofibrosis, post-
polycythemia vera myelofibrosis and post-
essential thrombocythemia myelofibrosis:
• The recommended starting dose of Jakafi is
based on platelet count. Doses may be titrated
based on safety and efficacy.
• The starting dose for platelet count of > 200 x
109/L is 20 mg orally twice daily.
• The starting dose for platelet count of 100 x
109/L to 200 x 109/L is 15 mg orally twice
daily.
• The starting dose for platelet count of 50 x
109/L to < 100 x 109/L is 5 mg orally twice
daily.
• If the response is insufficient and platelet and
neutrophil counts are adequate, doses may be
increased in 5 mg twice daily increments to a
maximum of 25 mg twice daily.
Polycythemia vera:
• The recommended starting dose of Jakafi is 10
mg orally twice daily. Doses may be titrated
based on safety and efficacy.
• If response is insufficient and platelet,
hemoglobin, and neutrophil counts are
adequate, doses may be increased in 5 mg
twice daily increments to a maximum of 25 mg
twice daily.
Acute graft-versus-host disease:
• The recommended starting dose of Jakafi is 5
mg orally twice daily.
• Consider increasing the dose to 10 mg twice
daily after at least 3 days of treatment if the
ANC and platelet counts are not decreased by
50% or more relative to the first day of dosing
with Jakafi.
• Doses may be titrated based on safety and
efficacy.
Chronic graft-versus-host disease:
• The recommended starting dose of Jakafi is
10 mg orally twice daily.
• Consider tapering Jakafi after 6 months of
treatment in patients with response who have
discontinued therapeutic doses of
corticosteroids.
|
|
Jakafi
(ruxolitinib)
10 mg tablets
|
60 per 30 days
|
|
Jakafi
(ruxolitinib)
15 mg tablets
|
60 per 30 days
|
|
Jakafi
(ruxolitinib)
20 mg tablets
|
60 per 30 days
|
|
Jakafi
(ruxolitinib)
25 mg tablets
|
60 per 30 days
|
Place of Service:
Outpatient
The above policy is based on the following references:
- Jakafi [package insert]. Wilmington, DE: Incyte Corporation; December 2022.
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.
June 18, 2023
