Use Alongside MAYZENT® to get your patients started on Mayzent

A SEAMLESS START WITH Alongside MAYZENT®

Alongside Mayzent

Alongside MAYZENT is committed to providing the right support, right when your patients need it. We’ll adapt to your process, so you and your patients have transparency and predictability.

Alongside Mayzent

Alongside MAYZENT is committed to providing the right support, right when your patients need it. We’ll adapt to your process, so you and your patients have transparency and predictability.

GET YOUR PATIENTS STARTED OR REINITIATED ON TREATMENT IN JUST 2 STEPS—ASSESSMENTS AND INITIATION

STEP 1: ASSESSMENTS

GET YOUR PATIENTS STARTED OR REINITIATED ON TREATMENT IN JUST 2 STEPS—ASSESSMENTS AND INITIATION

STEP 1: ASSESSMENTS

Take care of all baseline assessments in just one or two visits*

  • Assessments may be available in your patient's home, at your office, or at your preferred local lab partner

  • Using the Start Form, select exactly what assessments we can assist with

Did you know 
? that all onboarding assessments may be done in a single in-home visit, so that eligible patients do not have to leave their home?
Did you know 
? you have a broad set of options for genotype testing?
  • Blood draw in your office, with pick-up and results returned to you by LabCorp or Quest Diagnostics‡

  • Blood draw in ANY LabCorp or Quest Diagnostics community site, with analysis returned to you

  • Blood draw in your patient’s home through the program’s in-home service, and results are returned to you by LabCorp

No matter which option you choose, Novartis will cover the cost of genotype testing for your patients.

For information on all supported tests, download the Alongside MAYZENT Onboarding Brochure
DOWNLOAD Download button

STEP 2: TREATMENT INITIATION

STEP 2: TREATMENT INITIATION

Start and help keep patients on treatment

  • Several first-dose observation (FDO) support options are available for you and your patients (note that most MAYZENT patients do not require an FDO)

  • Once genotype results are available, your patient’s maintenance dose can be determined, so treatment can begin immediately for all commercially insured and approved government-insured patients

  • The MAYZENT Welcome Kit contains everything patients need to titrate and start their maintenance dose

  • Refills can be managed through 100+ specialty pharmacies, depending on preference or insurance

  • Receive ongoing one-on-one patient support from dedicated coordinators

Did you know 
? that, since launch, less than 15% of patients had a first-dose observation (FDO) requested?1

FDO is required for select patients with preexisting cardiac conditions.2 You can coordinate the FDO directly, or you can refer patients to Alongside MAYZENT to conduct the FDO at a program-sponsored medical facility or conveniently at the patient’s home for eligible patients.‡

Ask your Novartis team member about how you can be loaned ECG equipment for MAYZENT initiation.§

MAYZENT IS NOW ACCESSIBLE TO MORE RMS PATIENTS2

MAYZENT IS NOW ACCESSIBLE TO MORE RMS PATIENTS2

For all commercially insured and government-insured patients:

More
than
85 % of

patient reimbursement claims
are being approved3||

In case of approval challenges, Novartis is able to support commercially insured patients as they start on MAYZENT with a free bridge supply until commercial insurance coverage is approved and, if eligible, referral to the Novartis Patient Assistance Foundation.

ADDITIONAL PATIENT SUPPORT WITH Alongside MAYZENT

  • Dedicated reimbursement support

  • Financial support information

  • For commercially insured patients, the Bridge Program covers all drug costs while coverage is pursued for up to 1 year

  • Patient adherence support

  • $0 Rx co-pay and additional medical co-pay support for commercially insured patients

  • Innovative technology to keep patients on track during initiation and throughout treatment

HELPFUL RESOURCES AND TOOLS FOR YOUR PATIENTS

  • 24/7 helpline at 1-877-MAYZENT
    (1-877-629-9368)

  • Dedicated one-on-one support for up to 2 years

  • Additional program-provided educational and adherence support content

  • Phone, text, and e-mail reminders

Novartis Field Reimbursement Managers (FRMs) and Case Managers are available to provide dedicated, in-office access and reimbursement support.

Novartis Alongside MAYZENT Coordinators help optimize your patient’s experience by delivering efficient patient initiation, including coordination and scheduling support.

ECG=electrocardiogram; MOA=mechanism of action; MOD=mechanism of disease; MS=multiple sclerosis; RMS=relapsing MS.

*Common for eligible and commercially insured patients.

Free for commercially insured patients and those without insurance who are starting or restarting MAYZENT. Covered medical assessments include recommended blood tests, macular edema screening, electrocardiogram (ECG), and first-dose observation (FDO), as prescribed, provided via a Program sponsored medical facility or at home. Macular edema screening is available in select areas only. Health care providers overseeing FDO will evaluate preexisting conditions or concomitant medications that may preclude the patients from completing their FDO. This offer is not valid for medical assessments (i) performed in RI, (ii) for which payment may be made in whole or in part under federal or state health care programs, including, but not limited to, Medicare or Medicaid, or (iii) where prohibited by law. There is a cash-pay option for residents of RI choosing to use a Program-sponsored medical facility. No purchase required. This Program is subject to termination or modification at any time. Medicare may be accepted at some Program-sponsored facilities.

As of July 2020.

§The ECG equipment and over-read services provided in connection with the MAYZENT ECG Access Program may be used solely for MAYZENT patients undergoing a baseline assessment and/or first-dose observation. Limitations apply. See Health Care Provider Certification, which will be provided by CardioNet. Program is subject to termination or modification at any time.

As of June 16, 2020.3

Limitations apply. Up to an $18,000 annual limit. Offer not valid under Medicare, Medicaid, or any other federal or state program. Novartis reserves the right to rescind, revoke, or amend this Program without notice. See complete Terms & Conditions for details at www.mayzent.com.

References: 1. Data on file. Mayzent FDO Analysis. Novartis Pharmaceuticals Corp; 2020. 2. Mayzent [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; July 2020. 3. Data on file. Mayzent Approval Rate Analysis. Novartis Pharmaceuticals Corp; June 2020.

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Indication and Important Safety Information

INDICATION

MAYZENT® (siponimod) is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

IMPORTANT SAFETY INFORMATION

Contraindications

  • 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 atrioventricular block, or sick sinus syndrome, unless patient has a functioning pacemaker

INDICATION

MAYZENT® (siponimod) is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Infections: MAYZENT may increase risk of infections with some that are serious in nature. Life-threatening and rare fatal infections have occurred.

Before starting MAYZENT, review a recent complete blood count (CBC) (ie, within 6 months or after discontinuation of prior therapy). Delay initiation of treatment in patients with severe active infections until resolved. Employ effective treatments and monitor patients with symptoms of infection while on therapy. Consider discontinuing treatment if patient develops a serious infection.

Cases of fatal cryptococcal meningitis (CM) were reported in patients treated with another sphingosine 1-phosphate (S1P) receptor modulator. Rare cases of CM have occurred with MAYZENT. If CM is suspected, MAYZENT should be suspended until cryptococcal infection has been excluded. If CM is diagnosed, appropriate treatment should be initiated.

No cases of progressive multifocal leukoencephalopathy (PML) were reported in MAYZENT clinical trials; however, they have been observed in patients treated with another sphingosine 1-phosphate (S1P) receptor modulator and other multiple sclerosis (MS) therapies. If PML is suspected, MAYZENT should be discontinued.

Cases of herpes viral infection, including one case of reactivation of varicella zoster virus leading to varicella zoster meningitis, have been reported. Patients without a confirmed history of varicella zoster virus (VZV) or without vaccination should be tested for antibodies before starting MAYZENT. If VZV antibodies are not present or detected, then VZV immunization is recommended and MAYZENT should be initiated 4 weeks after vaccination.

Use of live vaccines should be avoided while taking MAYZENT and for 4 weeks after stopping treatment.

Caution should be used when combining treatment (ie, anti-neoplastic, immune-modulating, or immunosuppressive therapies) due to additive immune system effects.

Macular Edema: In most cases, macular edema occurred within 4 months of therapy. Patients with history of uveitis or diabetes are at an increased risk. Before starting treatment, an ophthalmic evaluation of the fundus, including the macula, is recommended and at any time if there is a change in vision. The use of MAYZENT in patients with macular edema has not been evaluated; the potential risks and benefits to the individual patient should be considered.

Bradyarrhythmia and Atrioventricular Conduction Delays: Prior to initiation of MAYZENT, an ECG should be obtained to determine if preexisting cardiac conduction abnormalities are present. In all patients, a dose titration is recommended for initiation of MAYZENT treatment to help reduce cardiac effects.

MAYZENT was not studied in patients who had:

Reinitiation of treatment (initial dose titration, monitoring effects on heart rate and AV conduction [ie, ECG]) should apply if ≥4 consecutive daily doses are missed.

Respiratory Effects: MAYZENT may cause a decline in pulmonary function. Spirometric evaluation of respiratory function should be performed during therapy if clinically warranted.

Liver Injury: Elevation of transaminases may occur in patients taking MAYZENT. Before starting treatment, obtain liver transaminase and bilirubin levels. Closely monitor patients with severe hepatic impairment. Patients who develop symptoms suggestive of hepatic dysfunction should have liver enzymes checked, and MAYZENT should be discontinued if significant liver injury is confirmed.

Increased Blood Pressure: Increase in systolic and diastolic pressure was observed about 1 month after initiation of treatment and persisted with continued treatment. During therapy, blood pressure should be monitored and managed appropriately.

Fetal Risk: Based on animal studies, MAYZENT may cause fetal harm. Women of childbearing potential should use effective contraception to avoid pregnancy during and for 10 days after stopping MAYZENT therapy.

Posterior Reversible Encephalopathy Syndrome (PRES): Rare cases of PRES have been reported in patients receiving a sphingosine 1-phosphate (S1P) receptor modulator. Such events have not been reported for patients treated with MAYZENT in clinical trials. If patients develop any unexpected neurological or psychiatric symptoms, a prompt evaluation should be considered. If PRES is suspected, MAYZENT should be discontinued.

Unintended Additive Immunosuppressive Effects From Prior Treatment or After Stopping MAYZENT: When switching from drugs with prolonged immune effects, the half-life and mode of action of these drugs must be considered to avoid unintended additive immunosuppressive effects.

Initiating treatment with MAYZENT after treatment with alemtuzumab is not recommended.

After stopping MAYZENT therapy, siponimod remains in the blood for up to 10 days. Starting other therapies during this interval will result in concomitant exposure to siponimod.

Lymphocyte counts returned to the normal range in 90% of patients within 10 days of stopping therapy. However, residual pharmacodynamic effects, such as lowering effects on peripheral lymphocyte count, may persist for up to 3-4 weeks after the last dose. Use of immunosuppressants within this period may lead to an additive effect on the immune system, and therefore, caution should be applied 3-4 weeks after the last dose of MAYZENT.

Severe Increase in Disability After Stopping MAYZENT: Severe exacerbation of disease, including disease rebound, has been rarely reported after discontinuation of an S1P receptor modulator. The possibility of severe exacerbation of disease should be considered after stopping MAYZENT treatment, thus patients should be monitored upon discontinuation.

Most Common Adverse Reactions: Most common adverse reactions (>10%) are headache, hypertension, and transaminase increases.

Please click here for full Prescribing Information, including Medication Guide.