Use Alongside™ MAYZENT® to get your patients started on Mayzent

DEDICATED SUPPORT FOR PATIENTS PRESCRIBED MAYZENT®

Alongside Mayzent

Alongside™ MAYZENT is committed to providing the right support, right when your patients need it. We’ll adapt to your process and your schedule—so you and your patients have clarity and know what to expect.

Alongside Mayzent

Alongside™ MAYZENT is committed to providing the right support, right when your patients need it. We’ll adapt to your process and your schedule—so you and your patients have clarity and know what to expect.

GET YOUR PATIENTS STARTED IN JUST 2 STEPS—ASSESSMENTS AND INITIATION

STEP 1: ASSESSMENTS

GET YOUR PATIENTS STARTED 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 or at your office†

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

Did you know 
? that all onboarding assessments may typically 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‡

  • Blood draw in ANY LabCorp collection 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.

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

  • Assessments may be available in your patient's home or at your office†

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

Did you know 
? that all onboarding assessments may typically 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‡

  • Blood draw in ANY LabCorp collection 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 patients stay on track with treatment§

Once genotype results are available, you will determine your patient’s maintenance dose. Then, treatment with MAYZENT can begin immediately for all commercially insured and approved government-insured patients. Alongside MAYZENT offers:

  • Several first-dose observation (FDO) support options are available for your patients (most patients may not require an FDO)

  • Ongoing one-on-one patient assistance from dedicated Coordinators

  • Technology to help patients stay on track during initiation and throughout treatment

  • The MAYZENT Welcome Kit, information patients may need to start and stay on treatment

Did you know 
? that, since launch, approximately 15% of MAYZENT patients required an FDO?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 sponsor the FDO conveniently at the patient’s home for eligible patients.

STEP 2: TREATMENT INITIATION

Start and help patients stay on track with treatment§

Once genotype results are available, you will determine your patient’s maintenance dose. Then, treatment with MAYZENT can begin immediately for all commercially insured and approved government-insured patients. Alongside MAYZENT offers:

  • Several first-dose observation (FDO) support options are available for your patients (most patients may not require an FDO)

  • Ongoing one-on-one patient assistance from dedicated Coordinators

  • Technology to help patients stay on track during initiation and throughout treatment

  • The MAYZENT Welcome Kit, information patients may need to start and stay on treatment

Did you know 
? that, since launch, approximately 15% of MAYZENT patients required an FDO?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 sponsor the FDO conveniently at the patient’s home for eligible patients.

BROAD COVERAGE WITH MAYZENT3

For all commercially insured and government-insured patients:

Approximately

87 % 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. Alongside MAYZENT can also refer eligible patients to the Novartis Patient Assistance Foundation.

BROAD COVERAGE WITH MAYZENT3

BROAD COVERAGE WITH MAYZENT3

For all commercially insured and government-insured patients:

Approximately
87 % 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. Alongside MAYZENT can also refer eligible patients to the Novartis Patient Assistance Foundation.

ADDITIONAL PATIENT SUPPORT WITH ALONGSIDE MAYZENT

Alongside MAYZENT provides patients with access & financial support options, as well as additional tools, resources, and services to help them stay on track.


Strong access for commercially insured patients

  • 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**

  • Technology to help patients stay on track during initiation and throughout treatment


Strong access for commercially insured patients

  • 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**

  • Technology to help patients stay on track during initiation and throughout treatment

GOING DIRECTLY THROUGH A SPECIALTY PHARMACY?

Your patients can enroll at start.mayzent.com for help with treatment initiation, ongoing one-on-one assistance from dedicated Coordinators, and access and reimbursement support

GOING DIRECTLY THROUGH A SPECIALTY PHARMACY?

Your patients can enroll at start.mayzent.com for help with treatment initiation, ongoing one-on-one assistance from dedicated Coordinators, and access and reimbursement support

RESOURCES AND TOOLS FOR YOUR ENROLLED PATIENTS

  • 1-877-MAYZENT (1-877-629-9368) Helpline
    available 8AM to 8PM Monday through Friday

  • 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.

RESOURCES

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

*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. Skin examinations are also recommended prior to or shortly after initiation but are not currently covered by the Alongside MAYZENT program. 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.

‡A CYP2C9 genotype blood test is available at no cost to any patient who is being considered for treatment with MAYZENT. Limitations may apply. The cost of the test may not be billed to any third-party payer. Providers are responsible for obtaining patient consent for genetic testing in accordance with all applicable laws. This Program is not contingent on any orders or purchase of products or services from LabCorp or Novartis. This Program is subject to termination or modification at any time.

§Once appropriate maintenance dose has been determined based on genotype results.

||As of March 2022.

Listed services are for eligible commercial patients. For questions regarding services for your commercially and government-insured patients, see contact information above.

#As of August 2021.3

**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; March 2022. 2. Mayzent [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp. 3. Data on file. Mayzent Approval Rate Analysis. Novartis Pharmaceuticals Corp; August 2021.

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Indication and Important Safety Information

COLLAPSE

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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 S1P receptor modulator and other multiple sclerosis (MS) therapies. If PML is suspected, MAYZENT should be discontinued.

Cases of herpes viral infection, including cases of meningitis or meningoencephalitis caused by VZV reactivation, 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.

Cutaneous Malignancies: The risk of cutaneous malignancies (including basal cell carcinoma (BCC), squamous cell carcinoma (SCC), and melanoma) is increased in patients treated with S1P modulators. Use of MAYZENT has been associated with an increased risk of BCC and SCC. Cases of other cutaneous malignancies, including melanoma, have also been reported in patients treated with MAYZENT and in patients treated with another S1P modulator.

Skin examinations are recommended at the start of treatment and periodically thereafter for all patients. Monitor for suspicious skin lesions and promptly evaluate any that are observed. Exposure to sunlight and ultraviolet light should be limited by wearing protective clothing and using a sunscreen with high protection factor. Concomitant phototherapy with UV-B radiation or PUVA-photochemotherapy is not recommended.

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. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to MAYZENT during pregnancy. Healthcare providers are encouraged to enroll pregnant patients, or pregnant women may register themselves in the MotherToBaby Pregnancy Study in Multiple Sclerosis by calling 1-877-311-8972, sending an email to MotherToBaby@health.ucsd.edu, or visiting www.mothertobaby.org/join-study.

Posterior Reversible Encephalopathy Syndrome (PRES): Rare cases of PRES have been reported in patients receiving an 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.

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.

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