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Janssen CarePath can:

  • Review your health plan benefits to help answer questions you may have about insurance coverage for OPSUMIT®
  • Identify options that may help make OPSUMIT® more affordable, if needed
  • Connect you with a dedicated PAH Companion* for one-on-one educational conversations and support
  • Identify and coordinate with a specialty pharmacy to arrange shipment of your Janssen medication

*The PAH Companion Program is limited to education about your Janssen therapy, its administration, and/or PAH. It is intended to supplement your understanding of your therapy, and does not provide medical advice or replace a treatment plan from your doctor, nurse, or healthcare team.

OPSUMIT® Voucher Program

A free 30-day trial offer is available for eligible patients to help you become familiar with OPSUMIT®.

At the conclusion of the program, you and your healthcare provider decide if it is appropriate to continue treatment. Subject to 1 (one) use per lifetime for the first 30-day supply of OPSUMIT®. Terms expire at the end of each calendar year and may change. This Voucher Program is open to patients who have commercial insurance, government coverage, or no insurance coverage; however, there is no guarantee of continuous accessibility after the program ends. Ask your doctor about the OPSUMIT® Voucher Program.

See full program requirements

Getting Started with OPSUMIT®

OPSUMIT® is delivered by a specialty pharmacy—it's not something that's kept in stock at your local retail pharmacy. The following is a typical process when starting out with OPSUMIT®, though your experience may vary.

  1. Prescription Prescription

    Your doctor selects OPSUMIT® as your new treatment.

    • Your healthcare team completes all the forms necessary to start you on the Janssen medicine. For OPSUMIT®, these forms include your prescription and, for females, enrollment in a program to make sure you use effective birth control during OPSUMIT® treatment and for 1 month after treatment discontinuation

    OPSUMIT® REMS Program enrollment

    OPSUMIT® can cause serious birth defects if taken during pregnancy. If you are female, you must enroll in the OPSUMIT® Risk Evaluation and Mitigation Strategy (REMS) Program.

    The OPSUMIT® REMS Program requires that, if you are able to get pregnant, you use 2 acceptable forms of birth control during treatment with OPSUMIT® and for 1 month after stopping OPSUMIT®, because the medicine may still be in your body. It also includes a monthly pregnancy test.

    If you are female, your healthcare team will enroll you in the OPSUMIT® REMS Program at the start of your treatment.

  2. Insurance Verification Insurance verification

    The insurance company may ask your healthcare provider for additional information before they pay for your medicine.

    • A Janssen CarePath Care Coordinator can help with this process by gathering additional information from your healthcare team
  3. Delivery of Medicine Delivery of medicine

    OPSUMIT® is shipped to you by a specialty pharmacy.

    • A Janssen CarePath Coordinator will help you connect with a specialty pharmacy that delivers OPSUMIT® in your area
    • Each month, the specialty pharmacy will call you to confirm details of the delivery, make sure you've completed a pregnancy test if required, and arrange your refill
    • The shipment is usually quick, but the process leading up to your first delivery could take more than 2 weeks
    • Before shipping, the specialty pharmacy will call you to confirm some details, including the shipment date and verification that you've completed a pregnancy test (if required). Be sure to answer, or call the specialty pharmacy back if they leave a message

    Remember, the call from your specialty pharmacy may come from a phone number that you don't know. If you miss the call, it's important that you call back.

  4. Refills Refills

    Females who are able to get pregnant will need to complete required monthly testing and your doctor must verify your prescription. Once this is completed, the specialty pharmacy will ship your refill.

Your Janssen CarePath Care Coordinator may need additional information from you at the start of treatment

When you speak with a Care Coordinator, they may ask for additional information, including:

  • Details of your healthcare plan, including the name and contact information for the insurance company and your policy number
  • The name and contact information of your prescribing doctor (including the fax number)
  • Further details from your healthcare team, if your initial claim is denied

If you change insurance plans or healthcare providers, speak with your healthcare team and a Care Coordinator in a timely manner to make sure you can continue your treatment.

Contact a Care Coordinator with questions at 866-228-3546, Monday–Friday, 8:00 AM to 8:00 PM ET.

If your health plan does not approve OPSUMIT® 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 PAH Link for OPSUMIT®

The Janssen PAH Link program enables eligible commercially insured patients to receive OPSUMIT® (macitentan) at no cost until you receive coverage or through the rest of the calendar year if an approval decision has not been made in 90 days.

See full eligibility requirements

This program is not available to individuals who use any state or federal government-funded healthcare program to cover a portion of medication costs, such as Medicare, Medicaid, TRICARE, Department of Defense, or Veterans Administration. Program is for medication only. Terms expire at the end of each program year and may change.

 

IMPORTANT SAFETY INFORMATION

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What is OPSUMIT® (macitentan)?

OPSUMIT® is a prescription medicine used to treat pulmonary arterial hypertension (PAH, WHO Group 1). PAH is high blood pressure in the arteries of your lungs. OPSUMIT® can:

  • Improve your ability to exercise as measured by the 6-minute walk distance (6MWD). In a clinical study of mainly WHO FC II-III patients, those taking OPSUMIT® walked, on average, 22 meters farther at Month 6 than patients not taking it
  • Improve some of your symptoms
  • Help slow down the progression of your disease
  • Lower your chance of being hospitalized for PAH

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

The most important information about OPSUMIT® (macitentan)

Do not take OPSUMIT® if you are pregnant or trying to get pregnant. OPSUMIT® can cause serious birth defects if taken while pregnant.

Women who are able to get pregnant must have negative pregnancy tests:

  • Before starting OPSUMIT®
  • Each month while taking OPSUMIT®
  • For 1 month after stopping OPSUMIT®

Your doctor will decide when you should take pregnancy tests.

You are medically able to get pregnant if you are a woman who fits all of the following guidelines:

  • has started puberty, even if you have not had a menstrual period yet
  • has a uterus
  • has not gone through menopause (menopause means you have not had a menstrual period for at least 12 months for natural reasons, or have had your ovaries removed)

You are not medically able to get pregnant if you are a woman who fits at least 1 of the following guidelines:

  • has not started puberty
  • does not have a uterus
  • has gone through menopause (you have not had a menstrual period for at least 12 months for natural reasons, or have had your ovaries removed)
  • is infertile for other medical reasons and this infertility is permanent and cannot be reversed

While taking OPSUMIT®, and for 1 month after stopping OPSUMIT®, women who are able to get pregnant must use 2 acceptable forms of birth control. Women who have had a tubal sterilization, a progesterone implant, or have an IUD (intrauterine device) do not need a second form of birth control. Talk to your doctor or gynecologist about which birth control to use while on OPSUMIT®. If you decide to change your form of birth control, talk with your doctor or gynecologist. This way you can be sure to choose another acceptable form of birth control. Also review the Medication Guide for acceptable birth control options.

It’s important not to have unprotected sex while taking OPSUMIT®. Tell your doctor right away if you have unprotected sex, think your birth control has failed, miss a menstrual period, or think you may be pregnant. He or she may recommend using a form of emergency birth control.

If you are the parent or caregiver of a female child who started taking OPSUMIT® before reaching puberty, check with your child regularly for any signs of puberty. Your child may reach puberty before having her first menstrual period. Talk to your doctor if you think your child is showing signs of puberty or if you have any questions about the signs of puberty.

Before starting OPSUMIT®, women must enroll in a program called the OPSUMIT® Risk Evaluation and Mitigation Strategy (REMS). If you are a woman who is able to get pregnant, you must talk to your doctor to learn the benefits and risks of OPSUMIT®. You must also agree to all of the instructions in the program. Men who are prescribed OPSUMIT® do not need to enroll in this program.

Who should not take OPSUMIT®?

Do not take OPSUMIT® if you are pregnant, plan to become pregnant, or become pregnant during treatment with OPSUMIT®. OPSUMIT® can cause serious birth defects. See "The most important information about OPSUMIT®."

Do not take OPSUMIT® if you are allergic to macitentan or any of the ingredients in OPSUMIT®. See the Medication Guide for a complete list of ingredients in OPSUMIT®.

Talk to your doctor about all your medical conditions, as well as all the medicines, vitamins, and supplements you take. OPSUMIT® and other medicines may affect each other causing side effects. Tell your doctor right away if you take an HIV medicine. Do not start any new medicine until you check with your doctor.

What should I avoid while taking OPSUMIT®?

  • Do not get pregnant. OPSUMIT® can cause serious birth defects. See "The most important information about OPSUMIT®." If you miss a menstrual period or think you may be pregnant, call your doctor right away
  • You should not breastfeed if you take OPSUMIT®. It is not known if OPSUMIT® passes into your breast milk. Talk to your doctor about the best way to feed your baby

What are the possible side effects of OPSUMIT®?

OPSUMIT® can cause serious side effects, including:

  • Serious birth defects. See "The most important information about OPSUMIT®"
  • Some medicines that are like OPSUMIT® can cause liver problems. Your doctor should do blood tests to check your liver before you start OPSUMIT®. Tell your doctor if you have any of these symptoms, which could be a sign of liver problems while on OPSUMIT®:
    • Nausea or vomiting
    • Pain in the upper right stomach
    • Feeling tired
    • Loss of appetite
    • Your skin or the whites of your eyes turn yellow
    • Dark urine
    • Fever
    • Itching
  • Fluid retention could happen during the first weeks after starting OPSUMIT®. Tell your doctor right away if you notice unusual weight gain or swelling in your ankles or legs. Your doctor will look for the cause
  • Low red blood cell levels (anemia) can happen while taking OPSUMIT®, usually during the first weeks after starting OPSUMIT®. In some cases a blood transfusion may be needed, but this is not common. Your doctor will do blood tests to check for anemia before you start OPSUMIT®. You may also need to do these blood tests while taking OPSUMIT®
  • Decreased sperm counts. OPSUMIT®, and other medicines like OPSUMIT®, may cause decreased sperm counts in men who take these medicines. If fathering a child is important to you, tell your doctor

The most common side effects are:

  • Stuffy nose or sore throat
  • Irritation of the airways (bronchitis)
  • Headache
  • Flu
  • Urinary tract infection

Talk to your doctor if you have a side effect that bothers you or does not go away. These are not all the possible side effects of OPSUMIT®. For more information, ask your doctor or pharmacist.

You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see accompanying full Prescribing Information and Medication Guide, including an Important Warning about Serious Birth Defects.

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