Coverage & Reimbursement
If you decide that Remodulin 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 Remodulin 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.
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 Remodulin Prescribers.
Remodulin is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%).
In patients with PAH requiring transition from epoprostenol, Remodulin is indicated to diminish the rate of clinical deterioration. Consider the risks and benefits of each drug prior to transition.
Important Safety Information for Remodulin
- Chronic intravenous (IV) infusions of Remodulin delivered using an external infusion pump with an indwelling central venous catheter are associated with the risk of blood stream infections (BSI) and sepsis, which may be fatal. Therefore, continuous subcutaneous (SC) infusion is the preferred mode of administration.
- Avoid abrupt withdrawal or sudden large reductions in dosage of Remodulin, which may result in worsening of PAH symptoms.
- Titrate slowly in patients with hepatic or renal insufficiency, because such patients will likely be exposed to greater systemic concentrations relative to patients with normal hepatic or renal function.
- Remodulin is a pulmonary and systemic vasodilator. In patients with low systemic arterial pressure, treatment with Remodulin may produce symptomatic hypotension.
- Remodulin inhibits platelet aggregation and increases the risk of bleeding.
- In clinical studies of SC Remodulin infusion, the most common adverse events reported were infusion site pain and infusion site reaction (redness, swelling, and rash). These symptoms were sometimes severe and sometimes required treatment with narcotics or discontinuation of Remodulin. The IV infusion of Remodulin with an external infusion pump has been associated with a risk of blood stream infections, arm swelling, paresthesias, hematoma, and pain. Other common adverse events (≥3% more than placebo) seen with either SC or IV Remodulin were headache (27% vs. 23%), diarrhea (25% vs. 16%), nausea (22% vs. 18%), rash (14% vs. 11%) jaw pain (13% vs. 5%), vasodilatation (11% vs. 5%), edema (9% vs. 3%), and hypotension (4% vs. 2%).
- Remodulin dosage adjustment may be necessary if inhibitors or inducers of CYP2C8 are added or withdrawn.
- In patients with mild or moderate hepatic insufficiency, decrease the initial dose of Remodulin to 0.625 ng/kg/min of ideal body weight, and monitor closely. Remodulin has not been studied in patients with severe hepatic insufficiency.
- Safety and effectiveness of Remodulin in pediatric patients have not been established.
- It is unknown if geriatric patients respond differently than younger patients. Caution should be used when selecting a dose for geriatric patients.
- There are no adequate and well-controlled studies with Remodulin in pregnant women. It is not known whether treprostinil is excreted in human milk or if it affects the breastfed infant or milk production.
For additional information please see Full Prescribing Information or call Customer Service at 1-877-UNITHER (1-877-864-8437)