TYVASO DPI® (treprostinil)
Behind you all the way.
Our team will work with your patients to identify any potential obstacles to access and affordability and how we may be able to assist with overcoming them.
Start a referral.
Referral form
To start your patients on TYVASO DPI® (treprostinil) and help them enroll in United Therapeutics Cares™, work with them to complete the referral form and fax it to 1-800-380-5294.
Download referral form
Electronic prescription
If you prefer, you can also prescribe electronically with iAssist. To get started, follow these simple steps:
- Follow the 3-step registration process
- Set up users for the account
- Go to the Start Now section on your dashboard
- Search for TYVASO DPI®
Step 1
Education & Expectations
Upon enrollment, the Patient Navigator will introduce your patient to our program offerings, and establish an appropriate check-in schedule. They will be there to help answer questions your patient may have regarding the safe and effective use of their United Therapeutics treatment and review what to expect in their treatment journey.
Step 2
Coverage & Reimbursement
United Therapeutics Cares will educate your office on the benefits investigation process, including the requirements for prior authorizations and appeals. For patients, we’ll walk through the ins and outs of the insurance landscape and where their specific plan fits in.
Benefits investigations
Our Patient Navigators will initiate the benefits investigation process and educate your patients on navigating access and affordability challenges that may arise.
Benefits investigations
Our Patient Navigators will initiate the benefits investigation process and educate your patients on navigating access and affordability challenges that may arise.
Prior authorizations
Certain medications may require prior authorization. These requirements vary by health plan or pharmacy benefit manager (PBM), but we’ll offer materials that can help educate you through the submission process and keep you informed of your patient’s status.
Prior authorizations
Certain medications may require prior authorization. These requirements vary by health plan or pharmacy benefit manager (PBM), but we’ll offer materials that can help educate you through the submission process and keep you informed of your patient’s status.
Denials and appeals
If your patient’s coverage is denied, we can provide education on next steps regarding the appeal process and the information needed by the insurer.
Denials and appeals
If your patient’s coverage is denied, we can provide education on next steps regarding the appeal process and the information needed by the insurer.
Step 3
Cost & Savings
If a patient is in need of financial assistance to cover the remaining out-of-pocket costs of their prescription, their Patient Navigator can connect them with one of our Access & Affordability Specialists who can provide information on options that may be available to them.
Co-pay assistance
If your patient has a commercial insurance plan, our co-pay assistance program can help cover out-of-pocket expenses. Eligible patients pay as little as a $0 co-pay per prescription of TYVASO® or TYVASO DPI®. The United Therapeutics Cares Co-Pay Assistance Program will pay the difference up to the annual maximum benefit.*
Terms & Conditions *Patients must meet certain eligibility criteria to qualify for assistance. Patients receiving reimbursement under Medicare, Medicaid, VA, DoD (TRICARE), Indian Health Services, or similar federal or state programs, may not be eligible for some assistance. Some portion of this patient assistance may be administered by third-party patient assistance organizations. The Program is subject to additional state law restrictions. Patients residing in select states may not be eligible for the Program.Co-pay assistance
If your patient has a commercial insurance plan, our co-pay assistance program can help cover out-of-pocket expenses. Eligible patients pay as little as a $0 co-pay per prescription of TYVASO® or TYVASO DPI®. The United Therapeutics Cares Co-Pay Assistance Program will pay the difference up to the annual maximum benefit.*
Terms & Conditions *Patients must meet certain eligibility criteria to qualify for assistance. Patients receiving reimbursement under Medicare, Medicaid, VA, DoD (TRICARE), Indian Health Services, or similar federal or state programs, may not be eligible for some assistance. Some portion of this patient assistance may be administered by third-party patient assistance organizations. The Program is subject to additional state law restrictions. Patients residing in select states may not be eligible for the Program.
Patient Assistance Program (PAP)
If patients are uninsured or underinsured, they may meet the eligibility requirements for our Patient Assistance Program (PAP). For more eligibility information, you can contact their Patient Navigator.
Patient Assistance Program (PAP)
If patients are uninsured or underinsured, they may meet the eligibility requirements for our Patient Assistance Program (PAP). For more eligibility information, you can contact their Patient Navigator.
Additional financial resources
Our commitment to your patients’ care goes beyond our program’s support and education. If their situation requires more assistance, there may be additional options for your patient to explore.
Additional financial resources
Our commitment to your patients’ care goes beyond our program’s support and education. If their situation requires more assistance, there may be additional options for your patient to explore.
Step 4
Prescription Coordination
Once all benefits have been verified and financial assistance options are reviewed, the Patient Navigator will walk your patient through getting set up with their Specialty Pharmacy. The Specialty Pharmacy will work directly with your patient to coordinate any final prescription details and confirm shipping preferences.
This is how Specialty Pharmacies work:
- Your Specialty Pharmacy will conduct a review of your patient’s insurance benefits.
- Your Specialty Pharmacy will confirm your patient’s medication coverage.
- Your Specialty Pharmacy will call your patient to review co-payment and insurance coverage.
- Shipments will be scheduled for delivery where it’s most convenient for your patient.
Our TYVASO DPI® (treprostinil) Specialty Pharmacy network and Specialty Distributor
Step 5
Treatment Support
After working with your patients to determine how often it’s helpful for us to be in touch, the Patient Navigator will set up regular check-ins. This is an opportunity for United Therapeutics Cares to share important information about your patient’s therapy journey and connect them with additional education or resources as needed.
Education specialists
Our Patient Education Specialists are available to work with your patients one-on-one to provide education on their condition and answer questions about the safe and effective use of their United Therapeutics therapy.
Get to know them
Support organizations
There are organizations that understand your patient’s condition and have firsthand experience to help them through their treatment journey.
Explore the communityLooking for additional resources?
Patients deserve ready access to education and support. That’s why we offer a suite of resources, including treatment-specific brochures, to offer education anytime your patient may need it.
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Explore resourcesIMPORTANT SAFETY INFORMATION FOR TYVASO AND TYVASO DPI
WARNINGS AND PRECAUTIONS
- TYVASO and TYVASO DPI are pulmonary and systemic vasodilators. In patients with low systemic arterial pressure, either product may produce symptomatic hypotension.
- Both products inhibit platelet aggregation and increase 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.
- Like other inhaled prostaglandins, TYVASO and TYVASO DPI may cause acute bronchospasm. Patients with asthma or chronic obstructive pulmonary disease (COPD), or other bronchial hyperreactivity, are at increased risk for bronchospasm. Ensure that such patients are treated optimally for reactive airway disease prior to and during treatment with TYVASO and TYVASO DPI.
IMPORTANT SAFETY INFORMATION FOR TYVASO AND TYVASO DPI
WARNINGS AND PRECAUTIONS
- TYVASO and TYVASO DPI are pulmonary and systemic vasodilators. In patients with low systemic arterial pressure, either product may produce symptomatic hypotension.
- Both products inhibit platelet aggregation and increase 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.
- Like other inhaled prostaglandins, TYVASO and TYVASO DPI may cause acute bronchospasm. Patients with asthma or chronic obstructive pulmonary disease (COPD), or other bronchial hyperreactivity, are at increased risk for bronchospasm. Ensure that such patients are treated optimally for reactive airway disease prior to and during treatment with TYVASO and TYVASO DPI.
DRUG INTERACTIONS/SPECIFIC POPULATIONS
- The concomitant use of either product 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 drug-associated 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 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 Arterial Hypertension (WHO Group 1)
In a 12-week, placebo-controlled study (TRIUMPH I) of 235 patients with PAH (WHO Group 1 and nearly all NYHA Functional Class III), the most common adverse reactions seen with TYVASO in ≥4% of PAH patients and more than 3% greater than placebo 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.
In a 3-week, open-label, single-sequence, safety and tolerability study (BREEZE) conducted in 51 patients on stable doses of TYVASO who switched to a corresponding dose of TYVASO DPI, the most commonly reported adverse events seen with TYVASO DPI in ≥4% of PAH patients during the 3-week treatment phase included cough (35.3%), headache (15.7%), dyspnea (7.8%), and nausea (5.9%). -
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 reactions with TYVASO were similar to the experience in studies of PAH.
INDICATION
TYVASO (treprostinil) Inhalation Solution and TYVASO DPI (treprostinil) Inhalation Powder are prostacyclin mimetics indicated for the treatment of:
-
Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise
ability. Studies with TYVASO establishing effectiveness predominately
included patients with NYHA Functional Class III symptoms and etiologies
of idiopathic or heritable PAH (56%) or PAH associated with connective
tissue diseases (33%).
The effects diminish over the minimum recommended dosing interval of 4 hours; treatment timing can be adjusted for planned activities.
While there are long-term data on use of treprostinil by other routes of administration, nearly all clinical experience with inhaled treprostinil has been on a background of an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor. The controlled clinical experience with TYVASO was limited to 12 weeks in duration. - Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. The study with TYVASO 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%).
Please see Full Prescribing Information for TYVASO or TYVASO DPI, Instructions for Use manuals for TD-100 and TD-300 TYVASO® Inhalation System and TYVASO DPI™ Inhalation Powder, and additional information at www.TYVASOhcp.com or call 1-877-UNITHER (1-877-864-8437).
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