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OPSUMIT Enrollment Forms

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Support and Financial Assistance for OPSUMIT® (macitentan)

An Actelion Pathways® Case Manager works with your office, the insurance company, the
specialty pharmacy, and your patients. When patients are prescribed an Actelion PAH medication, they will be contacted by an Actelion Pathways Case Manager or the specialty pharmacy, who can help by:

  • Answering questions about filling prescriptions with a specialty pharmacy
  • Coordinating with the doctor, insurance company, and specialty pharmacy to confirm patient coverage, or to let patients know if any additional information is needed
  • Informing patients of any financial assistance programs for which they may be eligible

Therapy Access Managers (TAMs)

TAMs serve as the primary field-based lead to support patient access, including starting and staying on Actelion therapies.

See a map of territories to contact the TAM in your area.

Connecting with financial assistance

There are several programs that can provide financial assistance to your patients taking OPSUMIT.

For all patients
The following program is open to all patients, regardless of their coverage
OPSUMIT Voucher Program A 30-day free trial of OPSUMIT through the OPSUMIT Voucher Program for your eligible patients. To submit your patient's application for the Voucher Program, fill out a fax request form and view Terms and Conditions.
Commercially insured
Patients who receive insurance through their employer or purchase it privately
Actelion Oral PAH Therapy Co-Pay Program* A savings program that lets your eligible patients pay $5 per prescription fill per product. Contact an Actelion Pathways Case Manager for more information. Call 1-866-ACTELION (1-866-228-3546) Mon-Fri, 8 am-8 pm ET.
Government insured
Patients who receive their medication through Medicare or other government funded plans
Independent foundations There may be support available from independent third-party patient support foundations. An Actelion Pathways Case Manager can provide general information about resources.
Uninsured or underinsured
Patients who are uninsured or the cost of their medicine is covered by insurance, but are unable to afford the out-of-pocket costs
Patient Assistance Program (PAP) A yearly program that helps patients receive medicine at no cost.
Bridge Program (temporary patient assistance program) Offers 90 days of free drug coverage for patients when coverage is not immediately available (e.g., waiting for coverage to start, waiting for approval of prior authorization appeal, etc).

*Applies to patients who have provided consent to services offered by Actelion Pathways. The Actelion Oral PAH Therapy Co-Pay Program is only available for residents of the US and Puerto Rico who are 18 or older and have commercial health insurance with co-pay/co-insurance exceeding $5 per prescription fill per product. Patients ineligible for the Actelion Oral PAH Therapy Co-Pay Program include those enrolled in Medicare, Medicaid, VA/DoD (Tricare), the Indian Health Service, or any other federal- or state-funded healthcare program, or where prohibited by law. The Actelion Oral PAH Therapy Co-Pay Program is not prescription drug coverage or insurance. Actelion reserves the right to terminate or modify this program at any time or without notice. Other terms and conditions apply.

Additional support resources

There are also independent organizations that may be able to offer support to your patients.

  • Pulmonary Hypertension Association is dedicated to increasing awareness and advocacy by providing information about PAH to both physicians and patients. Visit their website to learn more
  • The Scleroderma Foundation is a site for scleroderma patients, caregivers, and family members—dedicated to support, education, and research. Visit their website to learn more

Contact an Actelion Pathways Case Manager today. He or she can assist your patients with the support and services provided by Actelion. Call 1-866-ACTELION (1-866-228-3546) Mon-Fri, 8 am-8 pm ET.

Financial assistance for qualified low-income patients

Download the 2018 Medicare Low-Income Subsidy (LIS) brochure.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: EMBRYO-FETAL TOXICITY

  • Do not administer OPSUMIT to a pregnant female because it may cause fetal harm.
  • Females of reproductive potential: Exclude pregnancy before the start of treatment, monthly during treatment, and 1 month after stopping treatment. Prevent pregnancy during treatment and for one month after stopping treatment by using acceptable methods of contraception.
  • For all female patients, OPSUMIT is available only through a restricted program called the OPSUMIT Risk Evaluation and Mitigation Strategy (REMS).

CONTRAINDICATIONS

Pregnancy: OPSUMIT may cause fetal harm when administered to a pregnant woman. OPSUMIT is contraindicated in females who are pregnant. If OPSUMIT is used during pregnancy, apprise the patient of the

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Indication

OPSUMIT is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression. Disease progression included: death, initiation of intravenous (IV) or subcutaneous prostanoids, or clinical worsening of PAH (decreased 6-minute walk distance, worsened PAH symptoms and need for additional PAH treatment). OPSUMIT also reduced hospitalization for PAH.

Effectiveness was established in a long-term study in PAH patients with predominantly WHO Functional Class II-III symptoms treated for an average of 2 years. Patients were treated with OPSUMIT monotherapy or in combination with phosphodiesterase-5 inhibitors or inhaled prostanoids. Patients had idiopathic and heritable PAH (57%), PAH caused by connective tissue disorders (31%), and PAH caused by congenital heart disease with repaired shunts (8%).

IMPORTANT SAFETY INFORMATION

BOXED WARNING: EMBRYO-FETAL TOXICITY

  • Do not administer OPSUMIT to a pregnant female because it may cause fetal harm.
  • Females of reproductive potential: Exclude pregnancy before the start of treatment, monthly during treatment, and 1 month after stopping treatment. Prevent pregnancy during treatment and for one month after stopping treatment by using acceptable methods of contraception.
  • For all female patients, OPSUMIT is available only through a restricted program called the OPSUMIT Risk Evaluation and Mitigation Strategy (REMS).

CONTRAINDICATIONS

Pregnancy: OPSUMIT may cause fetal harm when administered to a pregnant woman. OPSUMIT is contraindicated in females who are pregnant. If OPSUMIT is used during pregnancy, apprise the patient of potential hazard to a fetus.

See More

Indication

OPSUMIT is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression. Disease progression included: death, initiation of intravenous (IV) or subcutaneous prostanoids, or clinical worsening of PAH (decreased 6-minute walk distance, worsened PAH symptoms and need for additional PAH treatment). OPSUMIT also reduced hospitalization for PAH.

Effectiveness was established in a long-term study in PAH patients with predominantly WHO Functional Class II-III symptoms treated for an average of 2 years. Patients were treated with OPSUMIT monotherapy or in combination with phosphodiesterase-5 inhibitors or inhaled prostanoids. Patients had idiopathic and heritable PAH (57%), PAH caused by connective tissue disorders (31%), and PAH caused by congenital heart disease with repaired shunts (8%).

WARNINGS AND PRECAUTIONS

Embryo-fetal Toxicity and OPSUMIT REMS Program

Due to the risk of embryo-fetal toxicity, OPSUMIT is available for females only through a restricted program called the OPSUMIT REMS Program. For females of reproductive potential, exclude pregnancy prior to initiation of therapy, ensure use of acceptable contraceptive methods, and obtain monthly pregnancy tests.

Notable requirements of the OPSUMIT REMS Program include:

  • Prescribers must be certified with the program by enrolling and completing training.
  • All females, regardless of reproductive potential, must enroll in the OPSUMIT REMS Program prior to initiating OPSUMIT. Male patients are not enrolled in the REMS.
  • Females of reproductive potential must comply with the pregnancy testing and contraception requirements.
  • Pharmacies must be certified with the program and must only dispense to patients who are authorized to receive OPSUMIT.

Hepatotoxicity

  • ERAs have caused elevations of aminotransferases, hepatotoxicity, and liver failure. The incidence of elevated aminotransferases in the SERAPHIN study >3 x ULN was 3.4% for OPSUMIT vs 4.5% for placebo, and >8 x ULN was 2.1% vs 0.4%, respectively. Discontinuations for hepatic adverse events were 3.3% for OPSUMIT vs 1.6% for placebo.
  • Obtain liver enzyme tests prior to initiation of OPSUMIT and repeat during treatment as clinically indicated.
  • Advise patients to report symptoms suggesting hepatic injury (nausea, vomiting, right upper quadrant pain, fatigue, anorexia, jaundice, dark urine, fever, or itching).
  • If clinically relevant aminotransferase elevations occur, or if elevations are accompanied by an increase in bilirubin >2 x ULN, or by clinical symptoms of hepatotoxicity, discontinue OPSUMIT. Consider re-initiation of OPSUMIT when hepatic enzyme levels normalize in patients who have not experienced clinical symptoms of hepatotoxicity.

Fluid Retention

  • Peripheral edema and fluid retention are known consequences of PAH and ERAs. In the pivotal PAH study SERAPHIN, edema was reported in 21.9% of the OPSUMIT group vs 20.5% for placebo.
  • Patients with underlying left ventricular dysfunction may be at particular risk for developing significant fluid retention after initiation of ERA treatment. In a small study of pulmonary hypertension due to left ventricular dysfunction, more patients in the OPSUMIT group developed significant fluid retention and had more hospitalizations due to worsening heart failure compared to placebo. Postmarketing cases of edema and fluid retention occurring within weeks of starting OPSUMIT, some requiring intervention with a diuretic or hospitalization for decompensated heart failure, have been reported.
  • Monitor for signs of fluid retention after OPSUMIT initiation. If clinically significant fluid retention develops, evaluate the patient to determine the cause and the possible need to discontinue OPSUMIT.

Hemoglobin Decrease

  • Decreases in hemoglobin concentration and hematocrit have occurred following administration of other ERAs and in clinical studies with OPSUMIT. These decreases occurred early and stabilized thereafter.
  • In the SERAPHIN study, OPSUMIT caused a mean decrease in hemoglobin (from baseline to 18 months) of about 1.0 g/dL vs no change in the placebo group. A decrease in hemoglobin to below 10.0 g/dL was reported in 8.7% of the OPSUMIT group vs 3.4% for placebo. Decreases in hemoglobin seldom require transfusion.
  • Initiation of OPSUMIT is not recommended in patients with severe anemia. Measure hemoglobin prior to initiation of treatment and repeat during treatment as clinically indicated.

Pulmonary Edema with Pulmonary Veno-occlusive Disease (PVOD)

Should signs of pulmonary edema occur, consider the possibility of associated PVOD. If confirmed, discontinue OPSUMIT.

Decreased Sperm Counts

Other ERAs have caused adverse effects on spermatogenesis. Counsel men about potential effects on fertility.

ADVERSE REACTIONS

Most common adverse reactions (more frequent than placebo by ≥3%) were anemia (13% vs 3%), nasopharyngitis/pharyngitis (20% vs 13%), bronchitis (12% vs 6%), headache (14% vs 9%), influenza (6% vs 2%), and urinary tract infection (9% vs 6%).

DRUG INTERACTIONS

  • Strong inducers of CYP3A4 such as rifampin significantly reduce macitentan exposure. Concomitant use of OPSUMIT with strong CYP3A4 inducers should be avoided.
  • Strong inhibitors of CYP3A4 like ketoconazole approximately double macitentan exposure. Many HIV drugs like ritonavir are strong inhibitors of CYP3A4. Avoid concomitant use of OPSUMIT with strong CYP3A4 inhibitors. Use other PAH treatment options when strong CYP3A4 inhibitors are needed as part of HIV treatment.

Please click here for full Prescribing Information, including BOXED WARNING for embryo-fetal toxicity.