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Understanding Insurance

Trying to understand healthcare coverage can be confusing. So let us help. Here, we’ll help you understand the differences between commercial or private insurance and government coverage, figure out which one you have, and point you in the right direction to learn more about what this means for you.

Insurance 101

With all of the different health insurance options available, it can be hard to know which is right for you. These videos explain how health insurance works, important things to think about when considering a health plan, and ways to help you make the most of your plan.

What is commercial or private insurance?

Commercial or private insurance is a health insurance plan that is not offered by the government. You can get it through your or your spouse’s job. You can also purchase a commercial plan directly from an insurance carrier, at Healthcare.gov, or an insurance broker.

 
 

What is government coverage?

Government coverage is when your healthcare program is funded by the government. These programs include:
  • Medicare
  • Medicaid
  • Children’s Health Insurance Program (CHIP)
  • The Department of Defense TRICARE (DOD TRICARE)
  • The Veterans Health Administration (VHA) Program
  • The Indian Health Service (IHS) Program
 

Learn more about

Medicare

 

Learn more about

Medicaid

How do I find out what my coverage is?

If you’re not sure what type of healthcare coverage you have, we can help.

Give us a call to speak with a Janssen CarePath Care Coordinator.

What do I do if my healthcare plan does not approve my treatment?

Sometimes, you may not be able to get the medication that your doctor has prescribed for you. For example, your health plan might not cover the medication if it is not on the drug list (formulary). Or your medication cost could be higher than you think it should be. When this happens, you and your doctor can ask your health plan about it. You can also see if your plan can make the medication available to you as an exception.

IMPORTANT SAFETY INFORMATION

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What is OPSYNVI® (macitentan and tadalafil)?

OPSYNVI® is a prescription medicine that contains 2 medicines called macitentan and tadalafil. OPSYNVI® is used for long-term treatment of adults with pulmonary arterial hypertension (PAH), which is high blood pressure in the arteries of your lungs.

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

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about OPSYNVI® (macitentan and tadalafil)?

OPSYNVI® can cause serious birth defects if taken during pregnancy. Females must not be pregnant when they start taking OPSYNVI® or become pregnant during treatment with OPSYNVI® or for 1 month after stopping treatment with OPSYNVI®.

Females who are able to get pregnant must have a negative pregnancy test before beginning treatment, each month during treatment and for 1 month after stopping treatment with OPSYNVI®. Your doctor will decide when to do the pregnancy test.

  • Females who are able to get pregnant are females who:
    • have entered puberty, even if they have not started their menstrual period, and
    • have a uterus, and
    • have not gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed
  • Females who are not able to get pregnant are females who:
    • have not yet entered puberty, or
    • do not have a uterus, or
    • have gone through menopause. Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed, or
    • are infertile for other medical reasons and this infertility is permanent and cannot be reversed

Females who are able to get pregnant must use 2 acceptable forms of birth control during treatment with OPSYNVI®, and for 1 month after stopping OPSYNVI® because the medicine may still be in the body. If you have had a tubal sterilization, have a progesterone implant, or have an IUD (intrauterine device), these methods can be used without another form of birth control. Talk with your doctor or gynecologist (a doctor who specializes in female reproduction) to find out about options for acceptable birth control that you may use to prevent pregnancy during treatment with OPSYNVI®. If you decide that you want to change the form of birth control that you use, talk with your doctor or gynecologist to be sure that you choose another acceptable form of birth control. Also review the Medication Guide for acceptable birth control options.

Do not have unprotected sex. Talk to your doctor or pharmacist right away if you have unprotected sex or if you think your birth control has failed. Your doctor may talk with you about using emergency birth control.

Tell your doctor right away if you miss a menstrual period or think you may be pregnant.

Females can only receive OPSYNVI® through a restricted program called the Macitentan-Containing Products Risk Evaluation and Mitigation Strategy (REMS). If you are a female who can get pregnant, you must talk to your doctor, understand the benefits and risks of OPSYNVI®, and agree to all of the instructions in the Macitentan-Containing Products REMS. Males can receive OPSYNVI® without taking part in the Macitentan-Containing Products REMS.

Who should not take OPSYNVI® (macitentan and tadalafil)?

Do not take OPSYNVI® if you:

  • are pregnant, plan to become pregnant, or become pregnant during treatment with OPSYNVI®. OPSYNVI® can cause serious birth defects (see “What is the most important information I should know about OPSYNVI®?”)
  • are allergic to macitentan, tadalafil, or any of the ingredients in OPSYNVI®. Review the Medication Guide for a complete list of ingredients in OPSYNVI®
  • take any medicines called nitrates
  • take any medicines called guanylate cyclase (GC) stimulators

Before taking OPSYNVI®, tell your doctor about all of your medical conditions, including if you:

  • have liver problems
  • have low blood pressure
  • have low red blood cell levels (anemia)
  • have heart problems including heart attack or heart failure
  • have narrowing of the pulmonary veins (veins in your lungs). This is called pulmonary veno-occlusive disease (PVOD)
  • have any eye problems, including non-arteritic anterior ischemic optic neuropathy (NAION) or an inherited eye disorder called retinitis pigmentosa
  • have hearing problems such as ringing in the ears, dizziness, or loss of hearing
  • have a deformed penis shape or Peyronie’s disease or have blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia. These conditions increase your risk of getting a prolonged erection
  • have kidney problems or get dialysis
  • are pregnant or plan to become pregnant during OPSYNVI® treatment. OPSYNVI® can cause serious birth defects
  • are breastfeeding or plan to breast feed. It is not known if OPSYNVI® passes into your breastmilk. Do not breastfeed during treatment with OPSYNVI®

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking OPSYNVI® with other medicines may affect the way OPSYNVI® and the other medicines work, and may increase your risk of side effects. Do not start any new medicine until you check with your doctor. Especially tell your doctor if you take:

  • nitrate medicines
  • HIV medicines
  • antifungal medicines
  • antiseizure medicines
  • medicines used to treat infection
  • erectile dysfunction medicines
  • blood pressure medicines
  • medicines used to treat PAH or heart problems

Ask your doctor or pharmacist if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list and show it to your doctor or pharmacist when you get a new medicine.

What should I avoid while taking OPSYNVI®?

Do not have more than 4 alcohol-containing drinks in a short period of time during treatment with OPSYNVI®. Drinking too much alcohol can increase your chances of getting low blood pressure, increased heart rate, dizziness and headache.

What are the possible side effects of OPSYNVI®?

OPSYNVI® can cause serious side effects, including:

  • Serious birth defects. See “What is the most important information I should know about OPSYNVI®?”
  • Liver problems. OPSYNVI® can cause liver problems. Your doctor should do blood tests to check your liver before you start taking OPSYNVI®. Tell your doctor if you have any of the following symptoms of liver problems during treatment with OPSYNVI®:
  • nausea or vomiting
  • pain in the upper right stomach
  • tiredness
  • loss of appetite
  • yellowing of your skin or whites of your eyes
  • dark urine
  • fever
  • itching
  • Decreased blood pressure (hypotension). OPSYNVI® can cause low blood pressure that lasts for a short time
  • Low red blood cell levels (anemia) can occur with OPSYNVI® treatment, usually during the first weeks after starting therapy. Your doctor will do blood tests to check your red blood cells before starting and as needed during treatment with OPSYNVI®
  • Vision loss. OPSYNVI® can cause decreased eyesight or permanent loss of vision in 1 or both eyes, which could be a sign of NAION. There is an increased risk of NAION in people who have already had NAION in 1 eye. If you notice a sudden decrease or loss of vision in 1 or both eyes, contact your doctor right away
  • Hearing problems. Sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness, can happen during treatment with OPSYNVI®. If you notice a sudden decrease or loss of hearing, contact your doctor right away
  • Fluid retention. Fluid retention can happen within weeks after starting OPSYNVI® and could lead to hospitalization. Tell your doctor right away if you have any unusual weight gain, trouble breathing, or swelling of your ankles or legs. Your doctor will look for the cause of any fluid retention and may stop treatment with OPSYNVI®
  • Decreased sperm count. OPSYNVI® can cause decreased sperm counts in males and may affect the ability to father a child. Tell your doctor if being able to have children is important to you
  • Prolonged erection. Erections that last more than 4 hours, with or without pain, can happen during treatment with OPSYNVI®. Painful erections (priapism) can cause permanent damage to the penis if not treated right away. Tell your doctor right away if you have an erection that lasts longer than 4 hours, with or without pain

The most common side effects of OPSYNVI® include:

  • too much fluid in your body (fluid retention) and swelling caused by too much fluid (edema)
  • low red blood cell levels (anemia)
  • headache, including migraine headache

These are not all the possible side effects of OPSYNVI®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please read full Prescribing Information, including Boxed Warning, and Medication Guide for OPSYNVI® and discuss any questions you have with your doctor.

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