Subject: Specialty Quantity Limit Jakafi 2284-H P2025

Drug

JAKAFI  (ruxolitinib)

Policy:

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.

Covered Quantities

Medication	Standard Limit
Jakafi (ruxolitinib) 5 mg tablets	60 per 30 days
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

FDA-recommended Dosing

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.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Jakafi [package insert]. Wilmington, DE: Incyte Corporation; January 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.

June 07, 2025