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Your Janssen CarePath Care Coordinator can:

  • Review your health plan benefits to help answer questions you may have about insurance coverage for PONVORY®
  • Identify options that may help make PONVORY® more affordable, if needed
  • Provide more information about a trial program that helps patients start on PONVORY®. At the conclusion of the trial program, you and your healthcare provider decide whether to continue treatment
  • Connect you with the Wellness Companion Program* by Janssen CarePath (see below)

The Wellness Companion Program* by Janssen CarePath

Here for your MS journey.

The Wellness Companion Program* by Janssen CarePath provides one-on-one education to help you get started and continue treatment with PONVORY®. Your Wellness Companion can connect you to resources to help you partner with your healthcare professional during your treatment journey with relapsing multiple sclerosis (MS).

Look to the Wellness Companion Program for:

  • Engagement: A dedicated companion for your relapsing MS journey with PONVORY®, available to you via phone and email.
  • Education: Resources to help you learn more about PONVORY® and living with relapsing MS.
  • Empowerment: An educational support program built around your needs, your daily life, and your schedule.

Find out more!

Talk with your doctor about PONVORY®. If you and your doctor have decided that PONVORY® is right for you, ask your healthcare professional about enrolling into the Wellness Companion program.

*The Wellness Companion Program is limited to education about PONVORY®, its administration, and/or relapsing MS. It is intended to supplement your understanding of your prescribed therapy. It does not provide medical advice, health coaching or improved wellness as a result of engaging with the program, replace a treatment plan from your healthcare professional, or serve as a reason for you to start or stay on treatment. Only your healthcare professional can provide medical advice and design your treatment plan.

In-Home Pretest Program

The In-Home Pretest Program, for eligible commercially insured patients, provides in-home pretest support at no cost for pretests that may be required when starting treatment with PONVORY®. You may be eligible for the In-Home Pretest Program if you are age 18 or older with commercial or private health insurance. There is no income requirement. Terms expire at the end of each calendar year and may change. The program is not valid for residents of MA, MI, MN, or RI. Please see full program requirements here.

How the In-Home Pretest Program Works

If you are eligible, and your healthcare professional has selected in-home testing for you, Janssen CarePath will call you to schedule in-home testing for the pretests your healthcare provider has selected on the Prescription Enrollment Form. Available pretests will be completed at the patient's home by a qualified healthcare provider. All test results will be sent back to your healthcare provider for review. Your healthcare provider will need to complete an attestation to confirm you are ready to start treatment with PONVORY®.

How to Get Started with the In-Home Pretest Program

  • To get started, your healthcare provider must complete the Prescription Enrollment Form, select In-Home Pretest Program, and fax to Janssen CarePath to enroll patients.
  • You will need to sign the Janssen Patient Support Program Patient Authorization Form. The Patient Authorization can be found on the Prescription Enrollment Form or can be completed online at MyJanssenCarePath.com/PatientAuth.

Pretest Scheduling Support

If you chose not to have in-home testing, your Care Coordinator can still help you schedule certain tests your doctor may order before you start treatment.

If you have questions, please call a Janssen CarePath Care Coordinator at 877-CarePath (877-227-3728), Monday–Friday, 8:00 AM to 8:00 PM ET. Multilingual phone support is available.

If your health plan does not approve PONVORY® treatment

Sometimes you may not be able to obtain the medication that your doctor has ordered for you. For example, your health plan might not cover the medication because it is not on the plan’s drug list (formulary) or the cost is higher than you think you should have to pay. In these situations, you and your doctor have the right to ask the health plan to explain its decision and to consider making the medication available to you as an exception to its policies.

Janssen Link for PONVORY®

Supports eligible, commercially insured patients until they receive coverage for their prescribed treatment.

Janssen Link for PONVORY® lets eligible patients get PONVORY® (ponesimod) at no cost until you receive coverage or for up to 24 months from program enrollment, whichever comes first, if these requirements are met.

  • You have been prescribed PONVORY® for an on-label, FDA-approved use
  • You have commercial insurance that has delayed (>5 business days) or denied your treatment
  • You do not use any state or federal government-funded healthcare program to cover medication costs. Examples of these programs are Medicare, Medicaid, TRICARE, Department of Defense, and Veterans Administration
  • You will need to sign a Patient Authorization Form
  • You cannot submit the value of the free product as a claim for payment to any health plan
  • You do not qualify if prior authorization is denied due to missing information, non-FDA-approved use, or invalid clinical rationale
  • You must contact the program if you switch from commercial health insurance to a government-funded healthcare program
  • Your prescriber must submit an enrollment form for Janssen Link for PONVORY®
  • Your prescriber completes and submits a form of coverage determination (i.e., prior authorization or prior authorization with an exception) to the commercial insurance
  • If coverage is denied, your prescriber must challenge the denial with an exception, Letter of Medical Necessity, or appeal within 90 days
  • Patients are eligible until they receive coverage or for up to 24 months of coverage from program enrollment, whichever comes first.
  • Program covers the cost of therapy only—not any associated assessments including pre-clinical tests, first dose observations, or administration costs
  • The value of the free product will not count towards your out-of-pocket cost-sharing obligations
  • Program good only in the United States and its territories. Void where prohibited, taxed, or limited by law.
  • Program terms may change.

Get started with a Janssen CarePath Account

Sign Up or Log In to your personal Janssen CarePath Account, so you can learn about your insurance coverage for PONVORY®; if eligible, enroll in the Janssen CarePath Savings Program or Pretest Rebate Program and manage program benefits; and find support to help you start and stay on track with your Janssen medication.

Connecting with others in your community

Resources are available online that can offer support and help you connect with others who are living with your condition. These include local support groups, fundraising walks, outreach programs, online communities, and volunteer opportunities. The websites below can help you learn more about your condition and connect with others.

PONVORY® Website
Ponvory.com
This website contains information about treatment with PONVORY®. Here, you can also get helpful information about multiple sclerosis.

Can Do MS
CanDo-MS.org
Can Do MS delivers health and wellness education programs to help families living with MS thrive.

The Multiple Sclerosis Association of America
MyMSAA.org
The Multiple Sclerosis Association of America (MSAA) is a national, nonprofit organization founded in 1970. This organization is dedicated to improving lives today through ongoing support and direct services to individuals with MS, their families, and their care partners.

The National Multiple Sclerosis Society
NationalMSSociety.org
The National Multiple Sclerosis Society (NMSS) is a nonprofit organization with chapters located throughout the United States. The organization funds research, advocates for social and political change, provides education, and sponsors services that help people with multiple sclerosis and their families.

Health Insurance Open Enrollment Guide

Even if you keep the same health plan year to year, your benefits can change. This guide can help you review your coverage and make changes if needed during the open enrollment period so you can stay on treatment in the new benefit period, usually beginning January 1.

Get Open Enrollment Guide [PDF]

If you’re enrolled in Medicare and using Medicare insurance to pay for your medications, our Medicare Resource Guide provides important information to consider as you are selecting your insurance coverage.

Get Medicare Resource Guide [PDF]

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IMPORTANT SAFETY INFORMATION
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WHAT IS PONVORY®?

PONVORY® is a prescription medicine that is used to treat relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

It is not known if PONVORY® is safe and effective in children.

IMPORTANT SAFETY INFORMATION

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT PONVORY®?

PONVORY® may cause serious side effects, including:

  • Infections - PONVORY® can increase your risk of serious infections that can be life‑threatening and cause death. PONVORY® lowers the number of white blood cells (lymphocytes) in your blood. This will usually go back to normal within 1 to 2 weeks of stopping treatment. Your healthcare provider should review a recent blood test of your white blood cells before you start taking PONVORY®. Call your healthcare provider right away if you have any of these symptoms of an infection during treatment and for 1 to 2 weeks after your last dose of PONVORY®:
  • fever
  • tiredness
  • body aches
  • chills
  • nausea
  • vomiting
  • headache with fever, neck stiffness, sensitivity to light, nausea, or confusion (these may be symptoms of meningitis, an infection of the lining around your brain and spine)

Your healthcare provider may delay starting or may stop your PONVORY® treatment if you have an infection.

  • Slow heart rate (bradycardia or bradyarrhythmia) when you start taking PONVORY®. PONVORY® can cause your heart rate to slow down, especially after you take your first dose. You should have a test to check the electrical activity of your heart called an electrocardiogram (ECG) before you take your first dose.

Only Start your treatment with PONVORY® using the Starter Pack. You must use the PONVORY® Starter Pack by slowly increasing the dose over a 14-day period to help reduce the effect of slowing of your heart rate. It is important to follow the recommended dosing instructions.

Call your healthcare provider if you experience the following symptoms of slow heart rate:

  • dizziness
  • lightheadedness
  • feeling like your heart is beating slowly or skipping beats
  • shortness of breath
  • confusion
  • chest pain
  • tiredness

Do not take PONVORY® if you:

  • have had a heart attack, chest pain called unstable angina, stroke or mini‑stroke (transient ischemic attack or TIA), or certain types of heart failure in the last 6 months.
  • have certain types of heart block or irregular or abnormal heartbeat (arrhythmia) unless you have a pacemaker.

Talk to your healthcare provider if you have any of these conditions, or do not know if you have any of these conditions.

Before you take PONVORY®, tell your healthcare provider about all your medical conditions, including if you:

  • have a fever or infection, or you are unable to fight infections due to a disease or taking medicines that lower your immune system.
  • have had chicken pox or have received the vaccine for chicken pox. Your healthcare provider may do a blood test for chicken pox virus. You may need to get the full course of vaccine for chicken pox and then wait 1 month before you start taking PONVORY®.
  • have slow heart rate.
  • have an irregular or abnormal heartbeat (arrhythmia).
  • have a history of stroke.
  • have heart problems, including a heart attack or chest pain.
  • have high blood pressure.
  • have breathing problems, including during your sleep (sleep apnea).
  • have liver problems.
  • had or now have a type of skin cancer called basal cell carcinoma (BCC), melanoma, or squamous cell carcinoma
  • have eye problems, especially an inflammation of the eye called uveitis.
  • have diabetes.
  • are pregnant or plan to become pregnant. PONVORY® may harm your unborn baby. Talk with your healthcare provider if you are pregnant or plan to become pregnant. If you are a woman who can become pregnant, you should use effective birth control during your treatment with PONVORY® and for 1 week after you stop taking PONVORY®. Talk to your healthcare provider about what method of birth control is right for you during this time. Tell your healthcare provider right away if you do become pregnant while taking PONVORY® or within 1 week after you stop taking PONVORY®.
  • are breastfeeding or plan to breastfeed. It is not known if PONVORY® passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take PONVORY®.

Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

Using PONVORY® and other medicines together may affect each other causing serious side effects. Especially tell your healthcare provider if you take or have taken: Medicines to control your heart rhythm (antiarrhythmics), or blood pressure (antihypertensives), or heart-beat (such as calcium channel blockers or beta-blockers); medicines that affect your immune system, such as alemtuzumab; and medicines such as rifampin, phenytoin, or carbamazepine.

You should not receive live vaccines during treatment with PONVORY®, for at least 1 month before taking PONVORY®, and for 1 to 2 weeks after you stop taking PONVORY®. If you receive a live vaccine, you may get the infection the vaccine was meant to prevent. Vaccines may not work as well when given during treatment with PONVORY®.

Talk with your healthcare provider if you are not sure if you take any of these medicines.

HOW SHOULD I TAKE PONVORY®?

  • Take PONVORY® exactly as your healthcare provider tells you to take it.
  • Take PONVORY® 1 time each day.
  • Swallow PONVORY® tablets whole.
  • Take PONVORY® with or without food.
  • Do not stop taking PONVORY® without talking with your healthcare provider first.
  • Do not skip a dose.
  • Start taking PONVORY® with a 14-day starter pack.
  • If you miss taking 1, 2, or 3 tablets in a row of PONVORY® in the 14-day starter pack, continue treatment by taking the first dose you missed. Take 1 tablet as soon as you remember. Then, take 1 tablet a day to continue with the starter pack dose as planned.
  • If you miss taking 1, 2, or 3 tablets in a row of PONVORY® while taking the 20 mg maintenance dose, continue treatment with the 20 mg maintenance dose.
  • If you miss taking 4 or more tablets in a row of PONVORY®, while taking the 14-day starter pack or the 20 mg maintenance dose, you need to restart treatment with a new 14-day starter pack. Call your healthcare provider if you miss 4 or more doses of PONVORY®. Do not restart PONVORY® after stopping it for 4 or more days in a row without talking to your healthcare provider. If you have certain heart conditions, you may need to be monitored by your healthcare provider for at least 4 hours when you take your next dose.

What are the possible side effects of PONVORY®?

PONVORY® may cause serious side effects, including:

  • breathing problems. Some people who take PONVORY® have shortness of breath. Call your healthcare provider right away if you have new or worsening breathing problems.
  • liver problems. PONVORY® may cause liver problems. Your healthcare provider should do blood tests to check your liver before you start taking PONVORY®. Call your healthcare provider right away if you have any of the following symptoms of liver problems:
  • unexplained nausea
  • vomiting
  • stomach (abdominal) pain
  • tiredness
  • loss of appetite
  • yellowing of the whites of your eyes or skin
  • dark urine
  • increased blood pressure. Your healthcare provider should check your blood pressure during treatment.
  • types of skin cancer called basal cell carcinoma (BCC), melanoma, and squamous cell carcinoma. Certain types of skin cancer have happened with drugs in the same class. Tell your healthcare provider if you have any changes in the appearance of your skin, including changes in a mole, a new darkened area on your skin, a sore that does not heal, or growths on your skin, such as a bump that may be shiny, pearly white, skin-colored, or pink. Your doctor should check your skin for any changes during treatment with PONVORY®. Limit the amount of time you spend in sunlight and ultraviolet (UV) light. Wear protective clothing and use a sunscreen with a high sun protection factor.
  • a problem with your vision called macular edema. Tell your healthcare provider about any changes in your vision. Your healthcare provider should test your vision before you start taking PONVORY® and any time you notice vision changes during treatment with PONVORY®. Your risk of macular edema is higher if you have diabetes or have had an inflammation of your eye called uveitis.

Call your healthcare provider right away if you have any of the following symptoms:

  • blurriness or shadows in the center of your vision
  • a blind spot in the center of your vision
  • sensitivity to light
  • unusually colored (tinted) vision
  • swelling and narrowing of the blood vessels in your brain. A condition called Posterior Reversible Encephalopathy Syndrome (PRES) has happened with drugs in the same class. Symptoms of PRES usually get better when you stop taking PONVORY®. However, if left untreated, it may lead to a stroke. Call your healthcare provider right away if you have any of the following symptoms:
  • sudden severe headache
  • sudden confusion
  • sudden loss of vision or other changes in vision
  • seizure
  • severe worsening of multiple sclerosis (MS) after stopping PONVORY®. When PONVORY® is stopped, symptoms of MS may return and become worse compared to before or during treatment. Always talk to your healthcare provider before you stop taking PONVORY® for any reason. Tell your healthcare provider if you have worsening symptoms of MS after stopping PONVORY®.

The most common side effects of PONVORY® include:

  • upper respiratory tract infections
  • elevated liver enzymes (abnormal liver tests)
  • high blood pressure (hypertension)

These are not all the possible side effects of PONVORY®. For more information, ask your healthcare provider or pharmacist. See “What is the most important information I should know about PONVORY®?”

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You are also encouraged to report side effects to the FDA: visit http://www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736).

Please see full Prescribing Information and Medication Guide.

Trademarks are those of their respective owners.

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