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INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Effective Date: 04/01/2012 Title: Jakafi (Ruxolitinib)
Revision Date: 07/01/2021 Document: BI356:00
CPT Code(s): None
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Jakafi (Ruxoliltinib) requires prior authorization.

2)    Jakafi is considered a specialty medication and must be obtained through the contracted specialty pharmacy.

3)    Jakafi is used to treat patients with intermediate or high-risk myelofibrosis and treatment resistant Polycythemia Vera or Graft Versus Host Disease.


Medical Statement

Jakafi is considered medically necessary for members who meet the following criteria:

 

1)    Myelofibrosis (must meet all):

a.    Diagnosis of intermediate or high-risk myelofibrosis (includes primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis);

b.    Prescribed by or in consultation with a hematologist or oncologist;

c.    Age ≥ 18 years;

d.    Dose does not exceed 25 mg twice daily.

Approval duration: 6 months

2)    Polycythemia Vera (must meet all):

a.    Diagnosis of polycythemia vera;

b.    Prescribed by or in consultation with a hematologist or oncologist;

c.    Age ≥ 18 years;

d.    Failure (i.e., inadequate response) of hydroxyurea unless contraindicated or clinically significant adverse effects are experienced;

e.    Dose does not exceed 25 mg twice daily.

Approval duration: 6 months

3)    Diagnosis of acute Graft Versus Host Disease (GVHD) with failure of high dose steroids

 

Authorization for continued use (for myelofibrosis or PV) after initial 6 months shall be approved annually if the patient is responding positively to therapy.

·         109/L) or neutropenia (more than 2-grade decline but above 0.5 x 109/L)

Authorization for continued use for GVHD will be approved with dose tapering unless documentation provided of persistent GVHD that will not allow dose tapering.


Limits

1)    Initial authorization is approved for 6 months.

2)    Jakafi is limited to 60 tablets per 30-day supply.


Reference

1)    Jakafi Product Information.  Incyte Corporation. October 2017.

2)    Clinical Pharmacology Online. “Ruxolitinib”, retrieved May 2021.

3)    NCCN Drugs & Biologics Compendium. Accessed online 05-16-21.

 

 

Addendum:

Effective 11/1/2019: Added indication/criteria for GVHD.

Effective 0701/2021: Updated criteria for myelofibrosis and polycythemia vera with age range changed to 18 years and older.


Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
This policy has recently been updated. Please use the index above or enter policy title in search bar for the latest version.