ASSIST® for ORENITRAM® (treprostinil)

Financial Support

Orenitram Co-Pay Assistance Card

For patients with commercial or private insurance plans, we offer a co-pay card to help patients cover some of their out-of-pocket expenses.

Eligible patients may pay as little as a $5 of their co-pay expense for their first Orenitram prescription. After the first prescription each month, each subsequent prescription within a 30-day period will have a $0 co-pay. The pharmacy will be reimbursed up to a maximum of $5,000 on the Orenitram prescription filled or maximum of $5,000 per 30-day period in the case of multiple prescriptions filled in the same 30-day period for a given patient. The patient will be responsible for any remaining balance that is not covered by their initial $5 co-pay and the maximum program benefit.*

Terms and Conditions

*Patients must meet certain eligibility criteria to qualify for assistance. Patients receiving reimbursement under Medicare, Medicaid, VA, DoD (TRICARE), Indian Health Services, or similar federal or state programs, may not be eligible for some assistance. Some portion of this patient assistance may be administered by third-party patient assistance organizations. The Program is subject to additional state law restrictions. Patients residing in select states may not be eligible for the Program.

Patient Assistance Program (PAP) for uninsured or underinsured patients

If your patient does not have insurance, their insurance does not cover the medication, or they are underinsured, United Therapeutics offers medication free of charge to eligible patients. Please contact ASSIST to check your patient’s eligibility.

Questions?

If you have any questions about available financial support programs, contact ASSIST at 1-877-UNITHER (1-877-864-8437), Monday - Friday, 8:30 am to 7:00 pm ET.

Important reminder

Please remind your patients to keep the Specialty Pharmacy informed about their current insurance status.

Indication

Orenitram is a prostacyclin vasodilator indicated for treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity.

The study that established effectiveness included predominately patients with WHO functional class II-III symptoms and etiologies of idiopathic or heritable PAH (75%) or PAH associated with connective tissue disease (19%). When used as the sole vasodilator, the effect of Orenitram on exercise is about 10% of the deficit, and the effect, if any, on a background of another vasodilator is probably less than this.

IMPORTANT SAFETY INFORMATION FOR ORENITRAM

CONTRAINDICATIONS

Orenitram is contraindicated in patients with severe hepatic impairment (Child Pugh Class C)

WARNINGS AND PRECAUTIONS

Abrupt discontinuation or sudden large reductions in dosage of Orenitram may result in worsening of PAH symptoms

Orenitram inhibits platelet aggregation and increases the risk of bleeding

The Orenitram tablet shell does not dissolve. In patients with diverticulosis, Orenitram tablets can lodge in a diverticulum

DRUG INTERACTIONS / SPECIFIC POPULATIONS

Concomitant administration of Orenitram with diuretics, antihypertensive agents, or other vasodilators increases the risk of symptomatic hypotension

Orenitram inhibits platelet aggregation; there is an increased risk of bleeding, particularly among patients receiving anticoagulants

Co-administration of Orenitram and the CYP2C8 enzyme inhibitor gemfibrozil increases exposure to treprostinil; therefore, Orenitram dosage reduction may be necessary in these patients

Pregnancy Category C. Animal reproductive studies with Orenitram have shown an adverse effect on the fetus. There are no adequate and well-controlled studies in humans

It is not known whether treprostinil is excreted in human milk or absorbed systemically after ingestion. Because many drugs are excreted in human milk, choose Orenitram or breastfeeding

Safety and effectiveness in patients under 18 years of age have not been established

There is a marked increase in the systemic exposure to treprostinil in hepatically impaired patients

ADVERSE REACTIONS

In the 12-week placebo-controlled monotherapy study, adverse reactions that occurred at rates at least 5% higher on Orenitram than on placebo included headache, diarrhea, nausea, flushing, pain in jaw, pain in extremity, hypokalemia, and abdominal discomfort