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Janssen CarePath Oral PAH Savings Program for OPSUMIT®

Eligible patients using commercial or private insurance can save on out-of-pocket medication costs for OPSUMIT®. Depending on your health insurance plan, savings may apply toward co-pay, co-insurance, or deductible. Eligible patients pay $5 per prescription fill with a $20,000 maximum program benefit per calendar year across all oral PAH therapies in the program. Not valid for patients using Medicare, Medicaid, or other government-funded programs to pay for their medications. Terms expire at the end of each calendar year and may change. There is no income requirement.

We provide cost support directly to patients through the Janssen CarePath Savings Program. This benefit is intended to help eligible patients afford their out-of-pocket obligations as set by their health plans. The cost support is meant solely for patients—not health plans and/or their partners. If you are having any difficulty accessing cost support through the Janssen CarePath Savings Program, please contact us at 866-228-3546.

See program requirements

Call a Janssen CarePath Care Coordinator at 866-228-3546 to enroll or for more information.

State-Sponsored Programs

Some states sponsor prescription financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help you.

Visit this program site

Independent co-pay assistance foundations

Independent co-pay assistance foundations have their own rules for eligibility, which are subject to change. We cannot guarantee a foundation will help you. We only can refer you to a foundation that supports your disease state. This information is provided as a resource for you. We do not endorse any particular foundation. The foundations on this list are not the only ones that might be able to help you.

For insured patients who are facing access and affordability challenges

Patient assistance is available if you have commercial, employer-sponsored, or government coverage that does not fully meet your needs. You may be eligible to receive your Janssen medication free of charge for up to one year. You must meet the eligibility and income requirements for the Janssen Patient Assistance Program. See terms and conditions at PatientAssistanceInfoPH.com or call 866-228-3546.

State-Sponsored Programs

Some states sponsor prescription financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help you.

Visit this program site

Medicare Savings Program

Many states have programs for people with limited income and resources that pay some or all of Medicare's premiums and may pay Medicare deductibles and co-insurance. Find out if your state has a program that can help you.

Visit this program site

Medicare Part D Extra Help — Low-Income Subsidy

Medicare patients who have limited income and resources may qualify for "extra help" to pay for prescription drugs. The Low-Income Subsidy (LIS) program from Medicare provides financial assistance for patients who may otherwise be unable to afford the costs associated with their Medicare Part D plan.

Those who are eligible for LIS may:

  • Receive assistance paying their monthly premium
  • Have a reduced or no deductible
  • Have reduced or no prescription co-insurance and co-payments
  • Have no gap in coverage

Visit this program site

Medicaid

Medicaid and the Children's Health Insurance Program (CHIP) provide free or low-cost health coverage to millions of Americans, including some low-income people, families and children, pregnant women, the elderly, and people with disabilities.

Some states have expanded their Medicaid programs to cover all people below certain income levels.

Visit this program site

Independent co-pay assistance foundations

Independent co-pay assistance foundations have their own rules for eligibility, which are subject to change. We cannot guarantee a foundation will help you. We only can refer you to a foundation that supports your disease state. This information is provided as a resource for you. We do not endorse any particular foundation. The foundations on this list are not the only ones that might be able to help you.

For insured patients who are facing access and affordability challenges

Patient assistance is available if you have commercial, employer-sponsored, or government coverage that does not fully meet your needs. You may be eligible to receive your Janssen medication free of charge for up to one year. You must meet the eligibility and income requirements for the Janssen Patient Assistance Program. See terms and conditions at PatientAssistanceInfoPH.com or call 866-228-3546.

State-Sponsored Programs

Some states sponsor prescription financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help you.

Visit this program site

Medicaid

Medicaid and the Children's Health Insurance Program (CHIP) provide free or low-cost health coverage to millions of Americans, including some low-income people, families and children, pregnant women, the elderly, and people with disabilities.

Some states have expanded their Medicaid programs to cover all people below certain income levels.

Visit this program site

Independent co-pay assistance foundations

Independent co-pay assistance foundations have their own rules for eligibility, which are subject to change. We cannot guarantee a foundation will help you. We only can refer you to a foundation that supports your disease state. This information is provided as a resource for you. We do not endorse any particular foundation. The foundations on this list are not the only ones that might be able to help you.

Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF)

The Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is an independent, nonprofit organization. JJPAF gives eligible patients free prescription medicines donated by Johnson & Johnson companies. You may be eligible if you don't have insurance.

Want to see if you qualify? Get an application at JJPAF.org.

Questions? Call 833-919-3510 (toll free) / 308-920-4358 (direct dial), Monday through Friday, 8:00 AM to 8:00 PM ET.

Janssen CarePath Oral PAH Savings Program for OPSUMIT®

Eligible patients using commercial or private insurance can save on out-of-pocket medication costs for OPSUMIT®. Depending on your health insurance plan, savings may apply toward co-pay, co-insurance, or deductible. Eligible patients pay $5 per prescription fill with a $20,000 maximum program benefit per calendar year across all oral PAH therapies in the program. Not valid for patients using Medicare, Medicaid, or other government-funded programs to pay for their medications. Terms expire at the end of each calendar year and may change. There is no income requirement.

We provide cost support directly to patients through the Janssen CarePath Savings Program. This benefit is intended to help eligible patients afford their out-of-pocket obligations as set by their health plans. The cost support is meant solely for patients—not health plans and/or their partners. If you are having any difficulty accessing cost support through the Janssen CarePath Savings Program, please contact us at 866-228-3546.

See program requirements

Call a Janssen CarePath Care Coordinator at 866-228-3546 to enroll or for more information.

State-Sponsored Programs

Some states sponsor prescription financial assistance programs, each with its own eligibility requirements. Find out if your state has a program that can help you.

Visit this program site

Medicare Savings Program

Many states have programs for people with limited income and resources that pay some or all of Medicare's premiums and may pay Medicare deductibles and co-insurance. Find out if your state has a program that can help you.

Visit this program site

Medicare Part D Extra Help — Low-Income Subsidy

Medicare patients who have limited income and resources may qualify for "extra help" to pay for prescription drugs. The Low-Income Subsidy (LIS) program from Medicare provides financial assistance for patients who may otherwise be unable to afford the costs associated with their Medicare Part D plan.

Those who are eligible for LIS may:

  • Receive assistance paying their monthly premium
  • Have a reduced or no deductible
  • Have reduced or no prescription co-insurance and co-payments
  • Have no gap in coverage

Visit this program site

Medicaid

Medicaid and the Children's Health Insurance Program (CHIP) provide free or low-cost health coverage to millions of Americans, including some low-income people, families and children, pregnant women, the elderly, and people with disabilities.

Some states have expanded their Medicaid programs to cover all people below certain income levels.

Visit this program site

Independent co-pay assistance foundations

Independent co-pay assistance foundations have their own rules for eligibility, which are subject to change. We cannot guarantee a foundation will help you. We only can refer you to a foundation that supports your disease state. This information is provided as a resource for you. We do not endorse any particular foundation. The foundations on this list are not the only ones that might be able to help you.

For insured patients who are facing access and affordability challenges

Patient assistance is available if you have commercial, employer-sponsored, or government coverage that does not fully meet your needs. You may be eligible to receive your Janssen medication free of charge for up to one year. You must meet the eligibility and income requirements for the Janssen Patient Assistance Program. See terms and conditions at PatientAssistanceInfoPH.com or call 866-228-3546.

Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF)

The Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is an independent, nonprofit organization. JJPAF gives eligible patients free prescription medicines donated by Johnson & Johnson companies. You may be eligible if you don't have insurance.

Want to see if you qualify? Get an application at JJPAF.org.

Questions? Call 833-919-3510 (toll free) / 308-920-4358 (direct dial), Monday through Friday, 8:00 AM to 8:00 PM ET.

Questions? 866-228-3546

Monday–Friday, 8:00 AM–8:00 PM ET

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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 taking a placebo (sugar pill)
  • 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 Macitentan 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, for OPSUMIT®.

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