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 mimetic indicated for treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to delay disease progression and to improve exercise capacity.

The studies that established effectiveness included predominately patients with WHO functional class II-III symptoms and etiologies of idiopathic or heritable PAH (66%) or PAH associated with connective tissue disease (26%).

IMPORTANT SAFETY INFORMATION FOR ORENITRAM

CONTRAINDICATIONS

Avoid use of Orenitram in patients with severe hepatic impairment (Child Pugh Class C) due to increases in systemic exposure.

WARNINGS AND PRECAUTIONS

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

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

ADVERSE REACTIONS

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

DRUG INTERACTIONS

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

SPECIFIC POPULATIONS

Animal reproductive studies with Orenitram have shown an adverse effect on the fetus. There are no adequate and well-controlled studies with Orenitram in pregnant women.

It is not known whether treprostinil is excreted in human milk or if it affects the breastfed infant or milk production.

Safety and effectiveness of Orenitram in pediatric patients have not been established.

Use of Orenitram in patients aged 65 years and over demonstrated slightly higher absolute and relative adverse event rates compared to younger patients. Caution should be used when selecting a dose for geriatric patients.

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

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For additional information please see Full Prescribing Information or call Customer Service at 1-877-UNITHER (1-877-864-8437)