ANORO HAS BROAD COVERAGE

Formulary status may vary and is subject to change. Formulary coverage does not imply clinical efficacy or safety.

Individual access may vary by geography and plan benefit design.

ANORO is covered without restrictions* for % of Medicare Part D patients † and % commercial patients in . This may mean fewer callbacks for prior authorizations and/or step edits. ‡

Formulary status may vary and is subject to change. Formulary coverage does not imply clinical efficacy or safety.

WHAT YOU NEED TO KNOW ABOUT THIS FORMULARY INFORMATION:

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.

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This chart does not represent all plans in this area. GSK does not endorse individual plans. Preferred is defined as covered in the lowest branded tier. Formulary comparisons do not imply comparable indications, safety, or efficacy.

*”Covered without restrictions” means reimbursement from a health plan without accompanying step edits or prior authorizations.

† ”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 January 2021 .

Commercial calculations do not include Indian Health Service or Department of Veterans Affairs lives.

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

‡ Source: American Medical Association. 2016 AMA Prior Authorization Physician Survey. 2016, 1-2.

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

ANORO is for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

ANORO is NOT for the relief of acute bronchospasm or for asthma.

ANORO is for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

ANORO is NOT for the relief of acute bronchospasm or for asthma.

ANORO is contraindicated in:

• patients with severe hypersensitivity to milk proteins or who have demonstrated hypersensitivity to umeclidinium, vilanterol, or any of the excipients.

CONTRAINDICATIONS

ANORO is contraindicated in:

• patients with severe hypersensitivity to milk proteins or who have demonstrated hypersensitivity to umeclidinium, vilanterol, or any of the excipients.
• use of a long-acting beta₂-adrenergic agonist (LABA), including vilanterol, one of the active ingredients in ANORO, without an inhaled corticosteroid (ICS), in patients with asthma. ANORO is not indicated for the treatment of asthma.

CONTRAINDICATIONS

ANORO is contraindicated in:

• patients with severe hypersensitivity to milk proteins or who have demonstrated hypersensitivity to umeclidinium, vilanterol, or any of the excipients.
• use of a long-acting beta₂-adrenergic agonist (LABA), including vilanterol, one of the active ingredients in ANORO, without an inhaled corticosteroid (ICS), in patients with asthma. ANORO is not indicated for the treatment of asthma.

WARNINGS AND PRECAUTIONS

• The safety and effectiveness of ANORO in patients with asthma have not been established. ANORO is not indicated for the treatment of asthma. Use of LABA as monotherapy (without ICS) for asthma is associated with an increased 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. Available data do not suggest an increased risk of death with use of LABA in patients with COPD.
• ANORO should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD.
• ANORO 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.
• ANORO should not be used more often or at higher doses than recommended or with another LABA (eg, salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) 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.
• Caution should be exercised when considering the coadministration of ANORO with ketoconazole and other known strong CYP3A4 inhibitors (including, but not limited to ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole) because increased cardiovascular adverse effects may occur.
• If paradoxical bronchospasm occurs, discontinue ANORO and institute alternative therapy.
• Hypersensitivity reactions such as anaphylaxis, angioedema, rash, and urticaria may occur after administration of ANORO. Discontinue ANORO 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, ANORO may need to be discontinued. ANORO should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
• Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines.
• 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.
• Be alert to hypokalemia and hyperglycemia.

ADVERSE REACTIONS

• The most common adverse reactions (≥1% and more common than placebo) reported in four 6‑month clinical trials with ANORO (and placebo) were: pharyngitis, 2% ( <1%); sinusitis, 1% (<1%); lower respiratory tract infection, 1% (<1%); constipation, 1% (<1%); diarrhea, 2% (1%); pain in extremity, 2% (1%); muscle spasms, 1% (<1%); neck pain, 1% (<1%); and chest pain, 1% (<1%).
• In addition to the 6-month efficacy trials with ANORO, a 12-month trial evaluated the safety of umeclidinium/vilanterol 125 mcg/25 mcg in subjects with COPD. Adverse reactions (incidence ≥1% and more common than placebo) in subjects receiving umeclidinium/vilanterol 125 mcg/25 mcg were: headache, back pain, sinusitis, cough, urinary tract infection, arthralgia, nausea, vertigo, abdominal pain, pleuritic pain, viral respiratory tract infection, toothache, and diabetes mellitus.

DRUG INTERACTIONS

• Caution should be exercised when considering the coadministration of ANORO with ketoconazole and other known strong CYP3A4 inhibitors as increased systemic exposure to vilanterol and cardiovascular adverse effects may occur. See prior Warning and Precaution regarding CYP3A4 inhibitors.
• ANORO 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 ANORO with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects.

REFERENCES

1. Mapel DW, Dalal AA, Blanchette CM, Petersen H, Ferguson GT. Severity of COPD at initial spirometry-confirmed diagnosis: data from medical charts and administrative claims. Int J Chron Obstruct Pulmon Dis. 2011;6:573-581.
2. Cazzola M, Molimard M. The scientific rationale for combining long-acting β₂-agonists and muscarinic antagonists in COPD. Pulm Pharmacol Ther. 2010;23(4):257-267.
3. Decramer M, Anzueto A, Kerwin E, et al. Efficacy and safety of umeclidinium plus vilanterol versus tiotropium, vilanterol, or umeclidinium monotherapies over 24 weeks in patients with chronic obstructive pulmonary disease: results from two multicentre, blinded, randomised controlled trials. Lancet Respir Med. 2014;2(6):472-486.
4. Maleki-Yazdi MR, Kaelin T, Richard N, et al. Efficacy and safety of umeclidinium/vilanterol 62.5/25 mcg and tiotropium 18 mcg in chronic obstructive pulmonary disease: results of a 24-week, randomized, controlled trial. Respir Med. 2014;108(12):1752-1760.
5. Data on file, GSK.
6. Kerwin EM, Kalberg CJ, Galkin DV, et al. Umeclidinium/vilanterol as step-up therapy from tiotropium in patients with moderate COPD: a randomized, parallel-group, 12-week study. Int J Chron Obstruct Pulmon Dis. 2017;12:745-755.
7. Donohue JF, Worsley S, Zhu C-Q, et al. Improvements in lung function with umeclidinium/vilanterol versus fluticasone propionate/salmeterol in patients with moderate-to-severe COPD and infrequent exacerbations. Respir Med. 2015;109(7):870-881, Appendix B.
8. Donohue JF, Maleki-Yazdi MR, Kilbride S, et al. Efficacy and safety of once-daily umeclidinium/vilanterol 62.5/25 mcg in COPD. Respir Med. 2013;107(10):1538-1546.
9. Siler TM, Donald AC, O’Dell D, et al. A randomized, parallel-group study to evaluate the efficacy of umeclidinium/vilanterol 62.5/25 mcg on health-related quality of life in patients with COPD. Int J Chron ObstructPulmon Dis. 2016;11:971-979.
10. Jones PW, Quirk FH, Baveystock CM. The St George’s Respiratory Questionnaire. Respir Med. 1991;85(suppl B):25-31.
11. Nici L, Mammen MJ, Charbek E, et al. Pharmacologic Management of Chronic Obstructive Pulmonary Disease. An Official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020;201(9):e56-e69.

DEFINITIONS

CI=confidence interval; COPD=chronic obstructive pulmonary disease; FEV 1 =forced expiratory volume in 1 second; GOLD=Global Initiative for Chronic Obstructive Lung Disease; ICS=inhaled corticosteroid; LABA=long-acting beta 2 -adrenergic agonist; LAMA=long-acting muscarinic antagonist; LS=least squares; OR=odds ratio; QOL =quality of life; UMEC=umeclidinium; VI=vilanterol.