ASSIST for ADCIRCA (tadalafil)

The Referral Process

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

  • Your patient must sign the appropriate referral form to give ASSIST permission to contact them
  • An ASSIST Associate will contact your patient to collect any incomplete information, review their insurance information, and review applicable coverage options
  • The Associate will also explain the next steps, including which Specialty Pharmacy will receive the patient’s referral, and answer any questions your patient may have about the referral process

Complete and submit the Adcirca referral form

Send the completed referral form and copy of patient’s insurance cards to ASSIST via:

Secure email:

assist@unither.com

Fax: 1-800-380-5294

Use the Fax Cover Sheet. Include any comments in the section provided on the cover sheet.

Referral Process

Refer to the following steps to better understand the process after you prescribe Adcirca.

Referral is faxed to Hub

Hub collects any missing info, performs benefit investigation

Hub calls qualifying patient with benefit summary, preferred SP, financial assistance options

Hub sends referral to preferred SP

SP confirms medication coverage with patient and insurance

SP schedules shipment

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

Indication

ADCIRCA (tadalafil) is a phosphodiesterase 5 inhibitor (PDE-5i) indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II–III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%).

Important Safety Information for ADCIRCA (tadalafil) tablets

CONTRAINDICATIONS

Nitrates and Guanylate Cyclase (GC) Stimulators: Do not use ADCIRCA in patients taking medicines that contain nitrates or guanylate cyclase stimulators (such as riociguat), as the combination could cause a sudden, unsafe drop in blood pressure Hypersensitivity Reactions: Patients with a known serious hypersensitivity to tadalafil should not take ADCIRCA

WARNINGS AND PRECAUTIONS

Cardiovascular: Patients who experience anginal chest pain after taking ADCIRCA should seek immediate medical attention

Cardiovascular: Phosphodiesterase 5 inhibitors (PDE-5is), including tadalafil, have mild systemic vasodilatory properties that may result in transient decreases in blood pressure. Before prescribing ADCIRCA, physicians should carefully consider whether their patients with underlying cardiovascular disease could be adversely affected by such actions. Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD) and administration of ADCIRCA to these patients is not recommended

Cardiovascular: The use of ADCIRCA with alpha blockers, blood pressure medications, or alcohol may lower blood pressure significantly and may lead to symptomatic hypotension (light-headedness or fainting)

Potential Drug Interactions: Tadalafil is metabolized predominately by CYP3A in the liver. Use of ADCIRCA with potent CYP3A inhibitors, such as ketoconazole and itraconazole, should be avoided. For patients on ADCIRCA therapy that require treatment with ritonavir, ADCIRCA should be discontinued at least 24 hours prior to starting ritonavir. For patients on ritonavir therapy that require treatment with ADCIRCA, start ADCIRCA at 20 mg once a day. Use of ADCIRCA with potent inducers of CYP3A, such as rifampin, should be avoided

Special Populations: The use of ADCIRCA is not recommended for patients with severe renal or hepatic impairment. Please see Full Prescribing Information for dosing recommendations for patients with mild to moderate renal or hepatic impairment

Potential Drug Interactions: ADCIRCA contains the same ingredient (tadalafil) as Cialis, which is used to treat erectile dysfunction (ED) and the signs and symptoms of benign prostatic hyperplasia (BPH). The safety and efficacy of combinations of ADCIRCA with Cialis or other PDE-5is have not been studied. Therefore, the use of such combinations is not recommended

Vision/Hearing: Patients who experience a sudden loss of vision in one or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), or sudden decrease or loss of hearing after taking ADCIRCA should seek immediate medical attention

Prolonged Erection: In rare instances, men taking PDE-5is (including tadalafil) for ED reported an erection lasting more than four hours. Male patients who experience a prolonged erection should seek immediate medical attention

ADVERSE REACTIONS

Adverse Reactions: The most common adverse event with ADCIRCA is headache (42% ADCIRCA vs 15% placebo). Other common adverse events (reported by ≥9% of patients on ADCIRCA and more frequent than placebo by 2%) include myalgia (14% vs 4%), nasopharyngitis (13% vs 7%), flushing (13% vs 2%), respiratory tract infection (13% vs 6%), extremity pain (11% vs 2%), nausea (11% vs 6%), back pain (10% vs 6%), dyspepsia (10% vs 2%), and nasal congestion (9% vs 1%)

For additional information please see Full Prescribing Information or call Customer Service at 1-877-UNITHER (1-877-864-8437)