Drug - Zeposia® (ozanimod) [Bristol Myers Squibb.]
Therapeutic area - Multiple Sclerosis Agents
Initial approval criteria
- Patient ≥ 18 years old AND
- Patient has a diagnosis of a relapsing form of multiple sclerosis (MS) (e.g., relapsing-remitting disease (RRMS)*, active secondary progressive MS (SPMS)†, or clinically isolated syndrome (CIS)‡ AND
- Diagnosis is documented by a laboratory report (e.g., magnetic resonance imaging [MRI]) AND
- Patient has obtained a baseline electrocardiogram (ECG) AND
- Patient will NOT be initiating therapy after previous treatment with alemtuzumab AND
- Patient has been tested for antibodies to the varicella zoster virus (VZV) or has received immunization for VZV 4 weeks prior to beginning therapy AND
- Patient does NOT have any of the following contraindications to ozanimod:
- Severe, untreated sleep apnea OR
- Concurrent use with a monoamine oxidase inhibitor (MAOI; e.g., selegiline, phenelzine, linezolid) OR
- Recent myocardial infarction (MI), unstable angina (UA), stroke, transient ischemic attack (TIA), decompensated heart failure with hospitalization, or Class III/IV heart failure within the previous 6 months OR
- History of Mobitz Type II second- or third-degree atrioventricular (AV) block, sick sinus syndrome, or sinoatrial block (unless treated with a functioning pacemaker) AND
- Ozanimod will be prescribed in consultation with a specialist in cardiology in patients with a pre-existing cardiac condition and/or cardiovascular disease (e.g., conduction abnormalities, arrhythmias requiring treatment, heart disease, heart failure, history of cardiac arrest or myocardial infarction, cerebrovascular disease, uncontrolled hypertension, or sinoatrial heart block) AND
- Patient does NOT have prolonged QTc interval at baseline (e.g., QTcF > 450 msec in males, > 470 msec in females) AND
- Ozanimod will NOT be used in combination with the following, or, if therapy is unavoidable, the patient will be monitored closely for adverse reactions and/or dose modifications:
- Drugs known to prolong the QT-interval (e.g., fluoroquinolone or macrolide antibiotics, venlafaxine, fluoxetine, quetiapine, ziprasidone, sumatriptan, zolmitriptan) OR
- Strong cytochrome p450 2C8 (CYP2C8) inhibitors (e.g., gemfibrozil) or inducers (e.g., rifampin) OR
- BCRP inhibitors (e.g., cyclosporine, eltrombopag) OR
- Adrenergic or serotonergic drugs which can increase norepinephrine or serotonin (e.g., opioids, selective serotonin reuptake inhibitors [SSRIs], selective norepinephrine reuptake inhibitors [SNRIs], tricyclics, tyramine) OR
- Foods with large amounts of tyramine (e.g., > 150 mg), such as aged cheeses, cured meats, craft/unfiltered beers, beans) OR
- Other antineoplastic, immunosuppressive or immunomodulating drugs (Note: if there is a history of prior use of these drugs, consider possible unintended additive immunosuppressive effects) AND
- Patient will NOT receive live vaccines during and at least 4 weeks prior to and 12 weeks after treatment AND
- Patient does NOT have an active infection, including clinically important localized infections AND
- Patient has had a baseline ophthalmic evaluation of the fundus, including the macula, before starting treatment and subsequently re-evaluated during treatment if changes in vision have been experienced AND
- Patient has had inadequate response§ after a 6-month adherent trial of glatiramer, unless contraindicated AND
- Ozanimod will be used as a single agent therapy
- Initial approval is for 12 months
- Patient continues to meet above criteria AND
- Absence of unacceptable toxicity from the drug (e.g., macular edema, severe hepatic injury, bradyarrhythmia, atrioventricular [AV] blocks, active serious infection, decreased respiratory function, progressive multifocal leukoencephalopathy [PML], posterior reversible encephalopathy syndrome [PRES], uncontrolled hypertension) AND
- There is documented continuous monitoring of response§ to therapy (e.g., manifestations of MS disease activity include, but are not limited to, an increase in annualized relapse rate [ARR], development of new/worsening T2 hyperintensities or enhancing lesions on brain/spinal MRI, and progression of sustained impairment as evidenced by expanded disability status scale [EDSS], timed 25-foot walk [T25-FW)], 9-hole peg test [9-HPT]).
- Renewal approval is for 12 months
* Definitive diagnosis of RRMS is based on BOTH dissemination in time and space:
- Dissemination in time (development/appearance of new central nervous system [CNS] lesions over time) is defined as ≥ 2 clinical attacks or 1 clinical attack plus either select MRI indicators (e.g., simultaneous presence of gadolinium-enhancing and non-enhancing lesions at any time or by a new T2-hyperintense or gadolinium-enhancing lesion on follow-up MRI compared to baseline scan) or CSF-specific oligoclonal bands.
- Dissemination in space (development lesions in distinct anatomical locations within the CNS/multifocal) is defined by 2 lesions or 1 lesion plus either clear-cut historical evidence of a previous attack involving a lesion in a distinct anatomical location or MRI indicating ≥ 1 T2-hyperintense lesions characteristic of MS in ≥ 2 of 4 areas of the CNS (periventricular, cortical or juxtacortical, infratentorial, or spinal cord).
† Definitive diagnosis of SPMS is based on all of the following: EDSS score ≥ 3; disease is progressive ≥ 3 months following an initial relapsing-remitting course (e.g., EDSS score increase by 1 in patients with EDSS ≤ 5.5 or increase by 0.5 in patients with EDSS ≥ 6); and either ≥ 1 relapse within the previous 2 years or gadolinium-enhancing activity or new and unequivocally enlarging T2 contrast-enhancing lesions as evidenced by MRI.
‡Definitive diagnosis of CIS is based on all of the following: a monophasic clinical episode with patient-reported symptoms and objective findings reflecting a focal or multifocal inflammatory demyelinating event in the CNS; neurologic symptom duration of at least 24 hours, with or without recovery; absence of fever or infection; and resembles a typical MS relapse (attack and exacerbation) but occurs in a patient not known to have MS.
§ Inadequate response, in those who have been adherent and receiving therapy for sufficient time to realize the full treatment effect, is defined as ≥ 1 relapse, ≥ 2 unequivocally new MRI-detected lesions, or increased disability on examination over a 6 to 12-month period.
- 7-day Starter Pack: 1 pack/7 days
- Starter Kit: 1 kit/37 days
- Maintenance: 1 tablet (0.92 mg)/day
- Prior authorization request must indicate specific NDC associated with specific requested product (e.g., 7-day starter pack, starter kit, 0.92mg tablets)
MHCP Provider Call Center (651) 431-2700 or 1-800-366-5411