Example referral form
Below is an example of selected completed sections of a patient referral form. It is being provided by United Therapeutics Corporation for educational purposes only and is not a guarantee of coverage or reimbursement. It is the responsibility of the healthcare provider to determine coverage and reimbursement parameters and appropriate coding for specific patients and/or procedures.
Please provide complete patient information. It is helpful to include the contact information for a caregiver or family member.
To avoid delays in the approval process, please provide complete insurance information.
Ensure the patient signs and dates the release in section C. This authorizes ASSIST to provide access and support and to arrange other services with a Specialty Pharmacy.
A TID dosing schedule is recommended, as Orenitram is best tolerated when taken every 8 hours.
Be sure to check all dosing strengths, as patients may require different strengths as they titrate to maximum tolerated doses.
Physician signature is required at the bottom of page 3 before submitting the form.
You can provide information about your preferred methods for managing side effects for your patients in this section. Instructions listed will be communicated to the Specialty Pharmacy.
Be sure to specify all recommended treatments for side effect management. This allows the Specialty Pharmacy to discuss these treatments with the patient.
Important Safety Information
- 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.
- The Orenitram tablet shell does not dissolve. In patients with diverticulosis, Orenitram tablets can lodge in a diverticulum.
- 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.
- Co-administration of Orenitram and the CYP2C8 enzyme inhibitor gemfibrozil increases exposure to treprostinil; therefore, Orenitram dosage reduction may be necessary in these patients.
- 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.
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%).
BID=2 times daily; TID=3 times daily.