Medical Policy

Effective Date:04/01/2012 Title:Jakafi (Ruxolitinib)
Revision Date:11/01/2019 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)    Diagnosis of intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia Vera myelofibrosis, and post-essential thrombocythemia myelofibrosis.  AND

Patient has two or more of the following:

a.    Age older than 65 years

b.    White blood cell count > 25 x 109/L

c.    Hemoblobin < 10g/dl

d.    Peripheral blasts > 1%

e.    Constitutional symptoms (e.g., night sweats, fevers, unintentional weight loss, debilitating fatigue)

2)    Diagnosis of Polycythemia Vera (PV) who has had an inadequate response to or is intolerant to hydroxyurea.

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 following criteria are met:

Patient has experienced an objective response to therapy defined as one of the following:

·         At least 35% reduction in spleen volume from baseline as measured by CT or MRI or a 50% reduction in spleen size from baseline based on palpation OR

·         A > 2g/dl increase in hemoglobin level (in transfusion-independent) or becoming transfusion independent (for transfusion dependent) OR

·         Improvement in symptoms (i.e. abdominal discomfort, pain under left ribs, early satiety, night sweats, itching, bone or muscle pain) without progressive splenomegaly or worsening of anemia (i.e. newly transfusion dependent or hemoglobin reduction by 2g/dl that persists for at least 12 weeks), thrombocytopenia (more than 2-grade decline but above 25,000 x 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.  Additional 6-month authorization for treatment of myelofibrosis or PV allowed if reduction in spleen size and improvement in symptoms is documented.  Prescribing information directs physicians to discontinue product after 6 months if no spleen reduction or symptom improvement seen.

2)    Additional authorization for treatment of GVHD allowed with dose tapering only unless documentation provided of persistent GVHD that will not allow dose tapering.

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

Reference

1)    Jakafi Product Information.  Incyte Corporation. November 2011.

2)    Clinical Pharmacology Online. “Ruxolitinib”, retrieved March 2012.

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.