ASSIST for ADCIRCA (tadalafil)

Coverage & Reimbursement

If you decide that Adcirca 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 Adcirca 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.

Benefit investigations

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 Adcirca Prescribers.

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)