MAYZENT (siponimod)

MAYZENT (siponimod)

SELF ADMINISTRATION

Indication for Prior Authorization:

• Treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults

Coverage Criteria:

• Patient is 18 years of age or older, AND
• Prescribed by or in consultation with a neurologist, AND
• Patient has a documented diagnosis of a relapsing form of MS to include clinically isolated syndrome, relapsing-remitting disease, or active secondary progressive disease, AND
• Patient has been tested for CYP2C9 variants to determine CYP2C9 genotype (please note: per package insert, an FDA-cleared or -approved test for the detection of CYP2C9 variants to direct the use of siponimod is not currently available), AND
• Patient has experienced an inadequate response, contraindication, or intolerable side effect to two different preferred agents (e.g., Avonex®, Betaseron®, dimethyl fumarate [Tecfidera®], Gilenya®, glatiramer/Glatopa® [Copaxone®], Plegridy®, Rebif®/Rebif® Rebidose®, Vumerity™), AND
• Mayzent® will not be used in combination with any other disease-modifying therapy for MS, either oral or injectable, AND
• Patient does not have a contraindication to treatment:
  • Patients with a CYP2C9*3/*3 genotype
  • In the last 6 months, experienced myocardial infarction, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization, or Class III/IV heart failure
  • Presence of Mobitz type II second-degree, third-degree AV block, or sick sinus syndrome, unless patient has a functioning pacemaker

Reauthorization: 

• Patient has a documented positive response to treatment, AND
• Mayzent will not be used in combination with any other disease-modifying therapy for MS, either oral or injectable

Dosing:

• Titration is required for treatment initiation
• Initial dose: 0.25 mg daily
• Maintenance dose for patients with CYP2C9 genotypes *1/*1, *1/*2, or *2/*2: 2 mg daily starting on Day 6
• Maintenance dose for patients with CYP2C9 genotypes *1/*3 or *2/*3: 1 mg daily starting on Day 5
• Concomitant use of Mayzent with moderate CYP2C9 and moderate or strong CYP3A4 inhibitors is not recommended
• Concomitant use of Mayzent with moderate CYP2C9 and strong CYP3A4 inducers is not recommended

Coverage Duration:

• Initial: 1 year
• Reauthorization: 1 year

Authorization is Not Covered for the Following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics Committee.

Additional Information:

• Contraindications:
  • A CYP2C9*3/*3 genotype
  • In the last 6 months experienced myocardial infarction, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization, or Class III or IV heart failure
  • Presence of Mobitz type II second-degree, third-degree AV block, or sick sinus syndrome, unless patient has a functioning pacemaker
• Before initiation of treatment, assess the following: CYP2C9 genotype determination, complete blood count, ophthalmic evaluation, cardiac evaluation, current or prior medications, vaccinations, and liver function tests
• Because initiation of Mayzent treatment results in a decrease in heart rate (HR), first-dose 6-hour monitoring is recommended for patients with sinus bradycardia [HR less than 55 beats per minute (bpm)], first- or second-degree [Mobitz type I] AV block, or a history of myocardial infarction or heart failure
• Additional warnings: infections, macular edema, bradyarrhythmia and atrioventricular conduction delays, respiratory effects, liver injury, cutaneous malignancies, increased blood pressure, fetal risk, posterior reversible encephalopathy syndrome, unintended additive immunosuppressive effects from prior treatment with immunosuppressive or immune-modulating therapies, severe increase in disability after stopping Mayzent, immune system effects after stopping Mayzent
• Avoid live attenuated vaccines during and for up to 4 weeks after treatment with Mayzent
• Pregnancy: There are no adequate data on the developmental risk associated with the use of Mayzent in pregnant women. Based on animal data and its mechanism of action, Mayzent can cause fetal harm when administered to a pregnant woman
• Lactation: There are no data on the presence of siponimod in human milk, the effects of Mayzent on the breastfed infant, or the effects of the drug on milk production
• Safety and effectiveness in pediatric patients have not been established

Review History:

• 4/20/21- Criteria updated
• 11/17/20- Class review, format updated
• 5/22/19- Original review

References: 

• Mayzent [package insert]. East Hanover (NJ): Novartis Pharmaceuticals Corporation; 2021. 
• OptumRX Therapeutic Class Overview – Multiple Sclerosis Agents.  Publication Date:  June 22, 2020.