Prescribing BROVANA®

Prescribing Nebulized BROVANA® (arformoterol tartrate) Inhalation Solution for patients with different types of coverage

Medicare Part B
Outpatient and Assisted Living Settings

BROVANA is covered under Medicare Part B; prior use of short-acting beta-agonists (SABAs) is no longer required.*
See the Guide >

Medicare Part A
Hospital, Skilled-Nursing, LTAC (Long-Term Acute Care) Facilities

BROVANA may be covered under Medicare Part A for Hospital, LTAC and Skilled-Nursing facilities.*

Medicare Part D
Long-Term Care Settings

BROVANA may be covered under Medicare Part D for Long-Term Care.*

*No guarantee of coverage.

Prescription Requirements for Medicare Patients

New patients need 2 separate prescriptions and a detailed written order*

When prescribing BROVANA for Medicare patients new to nebulized therapy, include the following:

1) A prescription for BROVANA

Be sure to specify:

• Dosing instructions

• "By nebulizer"

• Number of refills

• ICD code(s)

 

 

2) A prescription for a nebulizer

Be sure to specify:

• Compressor-E0570

• Administration set-A7005

• Mask-A7015

 

 

3) Detailed written order1

Medicare requires a physician to document that a face-to-face encounter/examination with the patient, detailing the treatment and/or evaluation of a condition that supports the need for the nebulizer, occurred within the 6 months prior to the written order for a nebulizer.

• A copy of this face-to-face encounter must be signed and dated by the physician; only physicians with a National Provider Identifier (NPI) can sign the prescription

• The date of the written order must not be prior to the date of the face-to-face encounter

Always include the beneficiary’s name, item of durable medication equipment (DME) ordered, and prescribing practitioner’s NPI. 

*No guarantee of coverage.
DME suppliers may require additional documentation.

Need support? Ask Sunovion Answers.

If your patients have questions about reimbursement, give them Sunovion Answers—a dedicated support service for BROVANA patients.

1-844-BROVANA (1-844-276-8262)

8 am-8 pm ET, Monday-Friday


Reference:
1. Centers for Medicare & Medicaid Services. MLN Matters® Number: MM8304. https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Medical-Review/Downloads/DetailedWrittenOrdersandFacetoFaceEncounters.pdf. Accessed February 9, 2016.

Important Safety Information & Indication

WARNING: ASTHMA-RELATED DEATH

Long-acting beta2-adrenergic agonists (LABA) increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including arformoterol, the active ingredient in BROVANA (see WARNINGS). The safety and efficacy of BROVANA in patients with asthma have not been established. All LABA, including BROVANA, are contraindicated in patients with asthma without use of a long-term asthma control medication (see CONTRAINDICATIONS).

BROVANA is not indicated for the treatment of acute episodes of bronchospasm, ie, rescue therapy, and does not replace fast-acting rescue inhalers. BROVANA should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition. 

BROVANA should not be used in conjunction with other inhaled, long-acting beta2-agonists. BROVANA should not be used with other medications containing long-acting beta2-agonists. Patients who have been taking inhaled short-acting beta2-agonists on a regular basis should be instructed to discontinue their regular use and to use them only for symptomatic relief for acute respiratory symptoms.

All LABA, including BROVANA, are contraindicated in patients with asthma without use of a long-term asthma control medication.

As with other inhaled beta2-agonists, BROVANA can produce paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs, BROVANA should be discontinued immediately and alternative therapy instituted.

BROVANA, like other beta2-agonists, can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, blood pressure, and/or symptoms.

BROVANA should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; in patients with convulsive disorders or thyrotoxicosis; and in patients who are unusually responsive to sympathomimetic amines.

BROVANA, as with other beta2-agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval because the action of adrenergic agonists on the cardiovascular system may be potentiated by these agents.

Overall efficacy of BROVANA was maintained throughout the 12-week trial duration. Some tolerance to the bronchodilator effect of BROVANA was observed after 6 weeks of dosing (at the end of the dosing interval), although the FEV1 improvement remained statistically significant. This was not accompanied by other clinical manifestations of tolerance.

The five most common adverse events reported with frequency ≥2% in patients taking BROVANA, and occurring more frequently than in patients taking placebo, were pain (8% vs 5%), chest pain (7% vs 6%), back pain (6% vs 2%), diarrhea (6% vs 4%), and sinusitis (5% vs 4%).

For additional information, please see the full Prescribing Information including Boxed Warning, and Medication Guide for BROVANA (arformoterol tartrate) Inhalation Solution, at www.sunovionprofile.com/brovana.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Indication
BROVANA® (arformoterol tartrate) Inhalation Solution is indicated for the long-term, twice-daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. BROVANA is for use by nebulization only.