ASSIST® for ORENITRAM® (treprostinil)

Coverage and Reimbursement Options for Patients on Orenitram

If you decide that Orenitram is right for your patient, support is available at initiation of treatment and as needed throughout the patient journey. ASSIST is a centralized referral hub for Orenitram that facilitates the referral process for patients.

For any questions about the forms, the status of referrals, or available financial support programs for patients, please contact your ASSIST Associate.

Benefit investigations

ASSIST can conduct a benefit investigation to help research and verify whether your patient’s prescribed medication is covered, their estimated co-payments, if prior authorization is required, and which Specialty Pharmacy the health plan prefers.

Prior Authorization (PA)

  • PAH medications typically require prior authorization
  • Prior Authorization requirements will vary by health plan or PBM

The downloadable PA Checklist is a resource that provides a list of general information typically requested by a health plan or a pharmacy benefit manager (PBM) to render a decision on medications used to treat pulmonary arterial hypertension (PAH).

Please verify the specific health plan or PBM coverage criteria and policies for your patient’s prescribed medication. Coverage criteria and patient’s out-of-pocket cost varies.

 These codes are not all-inclusive; appropriate codes can vary by patient, setting of care, and payer. Correct coding is the responsibility of the provider submitting the claim for the item or service. Please check with the payer to verify codes and special billing requirements. United Therapeutics does not make any representation or guarantee concerning reimbursement or coverage for any service or item.

Many payers will not accept unspecified codes. If you use an unspecified code, please check with your payer.

Denial and appeal resources

If your patient’s prior authorization is denied, you may be able to appeal the determination with the insurance company. An ASSIST Associate can help you coordinate an appeal with the insurer by providing insurer-specific forms, contact information, and sample letters for reference.

You may call ASSIST at 1-877-864-8437, and select the prompt for Orenitram Prescribers.

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