ASSIST® for ORENITRAM® (treprostinil)

The Referral Process

When you prescribe a United Therapeutics treatment, please explain the following referral process to your patient.

  • Your patient must sign the appropriate referral form to give ASSIST permission to contact them
  • An ASSIST Associate will contact your patient to collect any incomplete information, review their insurance information, and review applicable coverage options
  • The Associate will also explain the next steps, including which Specialty Pharmacy will receive the patient’s referral, and answer any questions your patient may have about the referral process

Complete and submit the Orenitram referral form

Send the completed referral form and copy of patient’s insurance cards to ASSIST via:

Secure email:

assist@unither.com

Fax: 1-800-380-5294

Use the Fax Cover Sheet. Include any comments in the section provided on the cover sheet.

Referral Process

Refer to the following steps to better understand the process after you prescribe Orenitram.

Referral is faxed to Hub

Hub collects any missing info, performs benefit investigation

Hub calls qualifying patient with benefit summary, preferred SP, financial assistance options

Hub sends referral to preferred SP

SP confirms medication coverage with patient and insurance

SP schedules shipment and in-home nursing support

Let your patient know that after your office submits the referral form, an ASSIST Associate will call them to verify insurance coverage or to obtain additional information.

It is very important that the patient answers or returns this call, or the approval process could be delayed. You may want to let your patient know that the call will come from Melbourne, Florida, showing an area code of 321.

Questions?

If you have any questions about completing the referral form, contact ASSIST at 1-877-UNITHER (1-877-864-8437), Monday - Friday, 8:30 am to 7:00 pm ET.

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