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It’s the things you do today that make a big difference to their tomorrow

See what TRELEGY could do for your appropriate patients

See Efficacy Data

TRELEGY has BROAD Coverage

Get Coverage Info

Individual access may vary by geography and plan benefit design.

*“Covered" is defined as any potential for reimbursement from a health plan and may include step edits, prior authorizations, and other restrictions. Formulary status may vary and is subject to change. Formulary coverage does not imply clinical efficacy or safety.

†“Patients" means covered lives for all commercial and employer payer types (excluding Managed Medicaid), and covered lives enrolled in Medicare payer types as calculated by MMIT as of .

Veterans Affairs (VA) and Indian Health Service (IHS) lives have been omitted when calculating the percentage of lives for this geography.

Source: Managed Markets Insight & Technology, LLC (MMIT), database as of .

Click here for important details

What you need to know about this formulary information:

Individual access may vary by geography and plan benefit design.

Formulary status may vary and is subject to change. Formulary coverage does not imply clinical efficacy or safety. This is not a guarantee of partial or full coverage or payment. Consumers may be responsible for varying out-of-pocket costs based on an individual’s plan and its benefit design. Each plan administrator determines actual benefits and out-of-pocket costs per its plan’s policies.

Verify coverage with plan sponsor or Centers for Medicare & Medicaid Services. Medicare Part D patients may obtain coverage for products not otherwise covered via the medical necessity process.

One Inhaler. One Daily Inhalation. One Co-pay.*

Could simplified delivery of triple therapy make a big difference for your patients?

For patients with COPD, once-daily dosing with TRELEGY may help simplify delivery of triple therapy.

TRELEGY does not replace a rescue inhaler.

*One co-pay is not a guarantee of coverage or lower out-of-pocket costs for patients than alternative treatments. Formulary status and patient out‑of‑pocket costs may vary, may be up to the prescription’s retail cost, and are subject to change.

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Designed to help patients with COPD breathe better today

TRELEGY delivers rapid and lasting improvements in lung function

As early as 15 minutes

TRELEGY provided improvement in FEV1 vs BREO, as measured by LS mean change from baseline in FEV1, beginning at 15 minutes on Day 11

TRELEGY is not a rescue inhaler and should not be used for the relief of acute symptoms.

Maintained for 24 hours

Improvement persisted for 24 hours on Day 1 and Day 841

In 2 replicate studies, the primary efficacy endpoint was trough FEV1 at Day 85. The LS mean change from baseline in trough FEV1 at Day 85 for TRELEGY (n=206 in each trial) vs placebo + BREO (n=206 in each trial) was 124 mL for trial 1 and 122 mL for trial 2.1

Trials 1 & 2: Study Description

Trials 1 & 2: Study Description1,2

Design: Two 12-week, randomized, double-blind, parallel-group, multicenter studies were conducted to evaluate the efficacy and safety of INCRUSE or placebo added to BREO 100/25. Treatment with TRELEGY refers to patients who received INCRUSE added to BREO 100/25. Eligible patients entered a 4-week open-label run-in period following screening where they received BREO 100/25. Patients were then randomized to receive INCRUSE (n=206 in each trial) or placebo (n=206 in each trial) added to open-label BREO 100/25.

Patients: At screening, patients with COPD (mean age: 64 years) had a mean postbronchodilator percent predicted FEV1 of 46%, a mean postbronchodilator FEV1/FVC ratio: 0.48, and a mean mMRC score of 2.4.

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INDICATION

TRELEGY is for maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). TRELEGY is NOT indicated for relief of acute bronchospasm or asthma.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • TRELEGY is contraindicated in patients with severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate (FF), umeclidinium (UMEC), vilanterol (VI), or any of the excipients.

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

TRELEGY is for maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). TRELEGY is NOT indicated for relief of acute bronchospasm or asthma.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • TRELEGY is contraindicated in patients with severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate (FF), umeclidinium (UMEC), vilanterol (VI), or any of the excipients.

INDICATION AND IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

  • TRELEGY is not for the treatment of asthma. Long-acting beta2-adrenergic agonist (LABA) monotherapy for asthma increases the risk of asthma-related death, and in pediatric and adolescent patients, available data also suggest an increased risk of asthma-related hospitalization. These findings are considered a class effect of LABA monotherapy. When LABA are used in fixed-dose combination with inhaled corticosteroids (ICS), data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone.
  • TRELEGY should NOT be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD.
  • TRELEGY is NOT a rescue medication and should NOT be used for the relief of acute bronchospasm or symptoms. Acute symptoms should be treated with an inhaled, short-acting beta2-agonist.
  • TRELEGY should not be used more often or at higher doses than recommended or with another LABA for any reason, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs, like LABA.
  • Oropharyngeal candidiasis has occurred in patients treated with orally inhaled drug products containing fluticasone furoate. Advise patients to rinse their mouths with water without swallowing after inhalation.
  • Physicians should remain vigilant for the possible development of pneumonia in patients with COPD, as clinical features of pneumonia and exacerbations frequently overlap. Lower respiratory tract infections, including pneumonia, have been reported following use of ICS, like fluticasone furoate.
  • Patients who use corticosteroids are at risk for potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. A more serious or even fatal course of chickenpox or measles may occur in susceptible patients.
  • Particular care is needed for patients transferred from systemic corticosteroids to ICS because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer. Taper patients slowly from systemic corticosteroids if transferring to TRELEGY.
  • Hypercorticism and adrenal suppression may occur with higher than the recommended dosage or at the regular dosage of ICS in susceptible individuals. If such changes occur, appropriate therapy should be considered.
  • Caution should be exercised when considering the coadministration of TRELEGY with ketoconazole and other known strong CYP3A4 inhibitors (eg, ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole) because increased systemic corticosteroid and cardiovascular adverse effects may occur.
  • If paradoxical bronchospasm occurs, discontinue TRELEGY and institute alternative therapy.
  • Hypersensitivity reactions such as anaphylaxis, angioedema, rash, and urticaria may occur after administration of TRELEGY. Discontinue TRELEGY if such reactions occur.
  • Vilanterol can produce clinically significant cardiovascular effects in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, and also cardiac arrhythmias, such as supraventricular tachycardia and extrasystoles. If such effects occur, TRELEGY may need to be discontinued. TRELEGY should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
  • Decreases in bone mineral density have been observed with long‐term administration of products containing ICS. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass (eg, anticonvulsants, oral corticosteroids) should be monitored and treated with established standards of care prior to initiating TRELEGY and periodically thereafter.
  • Glaucoma, increased intraocular pressure, and cataracts have been reported following the long‐term administration of ICS or inhaled anticholinergics. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use TRELEGY long term.
  • Use with caution in patients with narrow-angle glaucoma. Instruct patients to contact a healthcare provider immediately if signs or symptoms of acute narrow-angle glaucoma develop.
  • Use with caution in patients with urinary retention, especially in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to contact a healthcare provider immediately if signs or symptoms of urinary retention develop.
  • Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines.
  • Be alert to hypokalemia and hyperglycemia.

ADVERSE REACTIONS

  • The most common adverse reactions (≥1% and more common than placebo + FF/VI) reported in two 12-week clinical trials with UMEC + FF/VI, the components of TRELEGY, (and placebo + FF/VI) were: headache, 4% (3%); back pain, 4% (2%); dysgeusia, 2% (<1%); diarrhea, 2% (<1%); cough, 1% (<1%); oropharyngeal pain, 1% (0%); and gastroenteritis, 1% (0%).
  • Additional adverse reactions (≥1% incidence) reported in subjects taking TRELEGY in a 52-week trial included upper respiratory tract infection, pneumonia, bronchitis, oral candidiasis, arthralgia, influenza, sinusitis, pharyngitis, rhinitis, constipation, urinary tract infection, and dysphonia.

DRUG INTERACTIONS

  • TRELEGY should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval, or within 2 weeks of discontinuation of such agents, because they may potentiate the effect of vilanterol on the cardiovascular system.
  • Use beta‐blockers with caution, as they not only block the pulmonary effect of beta‐agonists, such as vilanterol, but may produce severe bronchospasm in patients with COPD.
  • Use with caution in patients taking non–potassium-sparing diuretics, as ECG changes and/or hypokalemia associated with these diuretics may worsen with concomitant beta-agonists.
  • Avoid coadministration of TRELEGY with other anticholinergic-containing drugs, as this may lead to an increase in anticholinergic adverse effects.

USE IN SPECIFIC POPULATIONS

  • Use TRELEGY with caution in patients with moderate or severe hepatic impairment, as fluticasone furoate systemic exposure may increase by up to 3-fold. Monitor for corticosteroid-related side effects.

Please see full Prescribing Information, including Patient Information, for TRELEGY.

References

  1. Siler TM, Kerwin E, Sousa A, et al. Efficacy and safety of umeclidinium added to fluticasone furoate/vilanterol in chronic obstructive pulmonary disease: results of two randomized studies. Respir Med. 2015;109(9):1155-1163.

  2. Data on file, GSK.

  3. Lipson DA, Barnhart F, Brealey N, et al; for the IMPACT Investigators. Once-daily single-inhaler triple versus dual therapy in patients with COPD. N Engl J Med. 2018;378(18):1671‑1680, Supplementary Appendix.

  4. Jones PW, Quirk FW, Baveystock CM. The St. George’s Respiratory Questionnaire. Respir Med. 1991;85(suppl B):25-31.

  5. Lipson DA, Barnacle H, Birk R, et al. FULFIL trial: once-daily triple therapy for patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2017;196(4):438-446.

  6. SYMBICORT [US package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals, LP; July 2019.

  7. SYMBICORT [UK package insert]. Luton, LU1, 3LU, UK; AstraZeneca UK Ltd; December 2018.

  8. SPIRIVA RESPIMAT [US package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; March 2019.

  9. SPIRIVA HANDIHALER [US package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; February 2018.

  10. Data on file, GSK. Study 201071.

  11. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. 2019 report. https://goldcopd.org. Accessed October 22, 2019.

Definitions

AESI=Adverse Events of Special Interest; CI=confidence interval; COPD=chronic obstructive pulmonary disease; FEV1=forced expiratory volume in 1 second; FF=fluticasone furoate; FULFIL=lung FUnction and quality of LiFe assessment in COPD with closed trIpLe therapy; FVC=forced vital capacity; [GOLD=Global Initiative for Chronic Obstructive Lung Disease;] ICS=inhaled corticosteroid; IMPACT=InforMing the PAthway of COPD Treatment; LABA=long-acting beta2-adrenergic agonist; LAMA=long-acting muscarinic antagonist; LS=least squares; MDI=metered-dose inhaler; OR=odds ratio; SGRQ=St. George's Respiratory Questionnaire; UMEC=umeclidinium; URTI=upper respiratory tract infection; UTI=urinary tract infection; VI=vilanterol.

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