The Referral Process

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

  • Tyvaso is only available through select Specialty Pharmacy (SP) providers
  • The chosen Specialty Pharmacy will contact your patient to collect any incomplete information, review their insurance coverage with estimated co-pays, and schedule their prescription shipment along with any applicable nursing support

Referral Process

  1. Referral is sent to SP
  1. SP collects missing information, performs benefit investigation
  1. SP calls qualifying patient with benefit summary, reviews financial assistance, refers to Hub if needed
  1. Hub reviews financial assistance needs, notifies SP of outcome
  1. SP calls patient, confirms coverage and assistance with patient and insurance, and schedules shipment and nursing services

The TYVASO (treprostinil) referral form

Send the completed referral form and a copy of each of the patient’s insurance cards to one of the Specialty Pharmacies below or your local Veteran Affairs Pharmacy.

Tyvaso Specialty Pharmacy Network:

important reminder

Important reminder

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 1-877-864-8437, Monday - Friday, 8:30am to 7:00pm ET.

INDICATION

TYVASO (treprostinil) is a prostacyclin mimetic indicated for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. The study establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF), combined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO Group 3 connective tissue disease (22%).

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

  • TYVASO is a pulmonary and systemic vasodilator. In patients with low systemic arterial pressure, TYVASO may produce symptomatic hypotension.
  • TYVASO inhibits platelet aggregation and increases the risk of bleeding.
  • Co-administration of a cytochrome P450 (CYP) 2C8 enzyme inhibitor (e.g., gemfibrozil) may increase exposure (both Cmax and AUC) to treprostinil. Co-administration of a CYP2C8 enzyme inducer (e.g., rifampin) may decrease exposure to treprostinil. Increased exposure is likely to increase adverse events associated with treprostinil administration, whereas decreased exposure is likely to reduce clinical effectiveness.

DRUG INTERACTIONS/SPECIFIC POPULATIONS

  • The concomitant use of TYVASO with diuretics, antihypertensives, or other vasodilators may increase the risk of symptomatic hypotension.
  • Human pharmacokinetic studies with an oral formulation of treprostinil (treprostinil diolamine) indicated that co-administration of the cytochrome P450 (CYP) 2C8 enzyme inhibitor, gemfibrozil, increases exposure (both Cmax and AUC) to treprostinil. Co-administration of the CYP2C8 enzyme inducer, rifampin, decreases exposure to treprostinil. It is unclear if the safety and efficacy of treprostinil by the inhalation route are altered by inhibitors or inducers of CYP2C8.
  • Limited case reports of treprostinil use in pregnant women are insufficient to inform a drugassociated risk of adverse developmental outcomes. However, pulmonary arterial hypertension is associated with an increased risk of maternal and fetal mortality. There are no data on the presence of treprostinil in human milk, the effects on the breastfed infant, or the effects on milk production.
  • Safety and effectiveness in pediatric patients have not been established.
  • Across clinical studies used to establish the effectiveness of TYVASO in patients with pulmonary arterial hypertension (PAH) and PH-ILD, 268 (47.8%) patients aged 65 years and over were enrolled. The treatment effects and safety profile observed in geriatric patients were similar to younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of hepatic, renal, or cardiac dysfunction, and of concomitant diseases or other drug therapy.

ADVERSE REACTIONS

Pulmonary Hypertension Associated with ILD (WHO Group 3)
In a 16-week, placebo-controlled study (INCREASE) of 326 patients with PH-ILD (WHO Group 3), adverse events were similar to the experience in studies of PAH. The most common adverse reactions seen with TYVASO in ≥4% of PAH patients and more than 3% greater than placebo in the placebocontrolled study (TRIUMPH I) were cough (54% vs 29%), headache (41% vs 23%), throat irritation/pharyngolaryngeal pain (25% vs 14%), nausea (19% vs 11%), flushing (15% vs <1%), and syncope (6% vs <1%). In addition, adverse reactions occurring in ≥4% of patients were dizziness and diarrhea.

Please see Full Prescribing Information, the TD-100 and TD-300 TYVASO® Inhalation System Instructions for Use manuals, and other additional information at www.tyvaso.com or call 1-877-UNITHER (1-877-864-8437).