Financial support programs available for patients taking branded Letairis

For patients with commercial insurance

Patient out-of-pocket costs for Letairis may be less than generic ambrisentan

Eligible patients pay as little as $5 per month for Letairis

The Co-Pay Coupon Program is only available to patients taking Letairis

  • Patients with commercial insurance who are prescribed Letairis, and enrolled in LEAP, are automatically enrolled in the Letairis Co-Pay Coupon Program. See patient eligibility
  • Patients are not eligible if they are enrolled in a government healthcare prescription drug program such as Medicare Part D or Medicaid
  • The Letairis Co-Pay Coupon Program provides co-pay assistance of up to $20,000 per year

Help protect your prescription

Prescribe Letairis DAW to help ensure the brand you choose is what your patients receive

*Indicate “Dispense As Written (DAW),” or the language required by your state, on your prescription for Letairis.

For patients with Medicare Part D

Out-of-pocket costs for branded Letairis may vary

Under the standard Medicare Part D benefit design and coverage phases, it is possible that branded medications, like Letairis, may cost patients less out of pocket than a generic. This is due to differences in cost sharing for branded vs generic medications when patients are in the coverage gap phase, known as the "donut hole." Individual Medicare Part D Plan benefit designs may vary.

LEAP, the Letairis patient support program, can provide patients with information about their Medicare coverage and help them better understand how their out-of-pocket costs may vary each month

  • LEAP Case Specialists are available to help patients estimate the monthly out-of-pocket costs of Letairis for the entire year
  • LEAP can also help identify potential sources of financial assistance for patients who qualify

Encourage your patients to call LEAP to learn more about their coverage at 1-866-664-5327

Assumes Part D plan utilization of the standard Medicare Part D benefit design. Based on internal forecasts of generic pricing relative to Letairis.

For patients who are uninsured or underinsured

LEAP can offer guidance and may be able to help identify financial support for uninsured or underinsured patients

Uninsured—LEAP can determine if a patient’s financial situation qualifies them to receive the medication free of charge through the Letairis Patient Assistance Program.

Underinsured—Third-party resources may be able to help with a patient’s out-of-pocket costs, including co-pays, coinsurance, and deductibles. They are independent, nonprofit organizations that have their own eligibility criteria and application process.

If your patients are struggling to cover out-of-pocket costs or have no insurance at all, encourage them to call 1-866-664-5327 to explore possible support options


Learn more about how LEAP can help

Start a patient on Letairis

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Important Safety Information & Indication

BOXED WARNING: EMBRYO-FETAL TOXICITY

  • Do not administer Letairis to a pregnant female because it may cause fetal harm. Letairis is very likely to produce serious birth defects if used by pregnant females, as this effect has been seen consistently when it is administered to animals
  • Exclude pregnancy before the initiation of treatment with Letairis. Females of reproductive potential must use acceptable methods of contraception during treatment with Letairis and for one month after treatment. Obtain monthly pregnancy tests during treatment and 1 month after discontinuation of treatment
  • Because of the risk of embryo-fetal toxicity, females can only receive Letairis through a restricted program called the Letairis REMS program

Contraindications

  • Pregnancy: Letairis can cause fetal harm
  • Idiopathic Pulmonary Fibrosis (IPF), including IPF patients with pulmonary hypertension (WHO Group 3)

Warnings and Precautions

  • Embryo-fetal toxicity and Letairis REMS Program requirements:
    • Prescribers must be certified with the program by enrolling in and completing training
    • All female patients, regardless of reproductive potential, must enroll in the Letairis REMS Program
    • Male patients are not enrolled in the program
    • Pharmacies must be certified with the program and must dispense to female patients who are authorized to receive Letairis

    Further information is available at www.letairisrems.com or 1-866-664-5327.

  • Peripheral edema: Peripheral edema is a known class effect of endothelin receptor antagonists, and is also a clinical consequence of PAH and worsening PAH. Further evaluate patients who develop clinically significant fluid retention to determine the cause and possible need for edema treatment or to discontinue Letairis. In clinical studies, peripheral edema was more common with Letairis than with placebo (most edema was mild to moderate in severity); and with Letairis plus tadalafil than with either drug alone. There have also been postmarketing reports of fluid retention occurring within weeks after starting Letairis that required a diuretic, fluid management, or hospitalization for decompensating heart failure
  • Pulmonary edema with pulmonary veno-occlusive disease (PVOD): Consider PVOD in patients who develop acute pulmonary edema during Letairis initiation and discontinue Letairis if PVOD is confirmed
  • Decreased sperm counts have been observed in patients taking endothelin receptor antagonists and in animal fertility studies with ambrisentan. Counsel patients about potential effects on fertility
  • Hematologic changes: Measure hemoglobin prior to initiation of Letairis, at 1 month, and periodically thereafter. Letairis initiation is not recommended for patients with clinically significant anemia. Consider discontinuing Letairis if clinically significant decreases in hemoglobin occur and other causes have been excluded. Decreases in hemoglobin and hematocrit have been observed within the first few weeks of Letairis treatment, which may persist during treatment. There have also been postmarketing reports of anemia requiring transfusion

Adverse Reactions

  • Most common adverse reactions when used as monotherapy compared to placebo were peripheral edema (17% vs 11%), nasal congestion (6% vs 2%), sinusitis (3% vs 0%) and flushing (4% vs 1%)
  • Most common adverse reactions in combination with tadalafil compared to Letairis or tadalafil monotherapy were peripheral edema (45% vs 38% or 28%), headache (41% vs 34% or 35%), nasal congestion (19% vs 16% or 11%), cough (18% vs 13% or 16%), anemia (15% vs 7% or 11%), dyspepsia (11% vs 3% or 12%), and bronchitis (10% vs 4% or 9%)

Drug Interactions

  • Cyclosporine increases ambrisentan exposure by 2-fold, limit Letairis to 5 mg once daily

Use in Specific Populations

  • Breastfeeding: Choose Letairis or breastfeeding
  • Hepatic impairment: Letairis is not recommended in patients with moderate or severe hepatic impairment. Fully investigate cause of liver injury in patients who develop hepatic impairment; discontinue Letairis if liver aminotransferases are >5x ULN or if elevations are accompanied by bilirubin >2x ULN, or by signs or symptoms of liver dysfunction and other causes are excluded

Dosage and Administration

  • Adult dosage: Initiate Letairis 5 mg once daily, with or without tadalafil 20 mg once daily. At 4-week intervals, consider either increasing to Letairis 10 mg or tadalafil 40 mg. Do not split, crush, or chew tablets
  • Pregnancy testing: Initiate Letairis in females of reproductive potential only after a negative pregnancy test. Obtain monthly pregnancy tests during treatment

Indication

Letairis is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability and delay clinical worsening; and in combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability. Studies establishing effectiveness included predominantly patients with WHO Functional Class II–III symptoms and etiologies of idiopathic or heritable PAH (60%) or PAH associated with connective tissue diseases (34%).

Letairis is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability. The study establishing effectiveness included predominantly patients with WHO Functional Class II–III symptoms and etiologies of idiopathic or heritable PAH (58%) or PAH associated with connective tissue diseases (36%).1

Letairis is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability and delay clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II–III symptoms and etiologies of idiopathic or heritable PAH (64%) or PAH associated with connective tissue diseases (32%).

Please click to view full Prescribing Information, including BOXED WARNING.