EXTON, Pa., Nov. 7, 2011 /PRNewswire/ -- Pharmaxis, Inc. today announced that the Centers for Medicare and Medicaid Services (CMS) has assigned a unique, Level II Health Care Common Procedural Coding System (Level II HCPCS), commonly referred to as a J-code, to ARIDOL® (mannitol inhalation powder) Bronchial Challenge Test Kit,which is used to assess bronchial hyperresponsiveness in patients six years of age and older who do not have clinically apparent asthma. ARIDOL should not be used as a stand alone test to assess asthma or as a screening test for asthma, but as part of a physician's overall assessment of asthma. The new J-code becomes effective on January 1, 2012.
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J-codes are used by providers to bill Medicare Part B, Medicaid and most private plans for drugs administered in physicians' offices and hospital outpatient settings.
"This is an important milestone for Pharmaxis, and we are very pleased to have made substantial progress on the reimbursement front since launching ARIDOL in February 2011," said Stephen Beckman, President, Pharmaxis,Inc. "The J-code should facilitate reimbursement for providers who currently use bronchial challenge tests as part of their asthma assessment protocol, as well as for office-based physicians that would like to offer ARIDOL due to its ease of administration."
ARIDOL® (mannitol inhalation powder)Bronchial Challenge Test Kit is a single-use, indirect test that is easy-to-administer, requires minimal preparation time and a 15% reduction in lung function from baseline for a positive test. ARIDOL was approved by the U.S. Food and Drug Administration (FDA) on October 5, 2010, and demonstrated safety and efficacy in two Phase III clinical trials.
ARIDOL can be ordered directly from Pharmaxis and is available to pulmonary function labs and physicians' offices by calling Pharmaxis Customer Service at 1-888-416-1828.
Mannitol, the active ingredient in ARIDOL, is a sugar alcohol indicated for the assessment of bronchial hyperresponsiveness in patients 6 years of age or older who do not have clinically apparent asthma.
ARIDOL is not a stand alone test or a screening test for asthma. Bronchial challenge testing with ARIDOL should be used only as part of a physician's overall assessment of asthma.
Important Safety Information
WARNING: RISK OF SEVERE BRONCHOSPASM
Mannitol, the active ingredient in ARIDOL, acts as a bronchoconstrictor and may cause severe bronchospasm. Bronchial challenge testing with ARIDOL is for diagnostic purposes only. Bronchial challenge testing with ARIDOL should only be conducted by trained professionals under the supervision of a physician familiar with all aspects of the bronchial challenge test and the management of acute bronchospasm. Medications (such as short acting inhaled beta-agonist) and equipment to treat severe bronchospasm must be present in the testing area. If severe bronchospasm occurs it should be treated immediately by administration of a short acting inhaled beta-agonist. Because of the potential for severe bronchoconstriction, bronchial challenge testing with ARIDOL should not be performed in any patient with clinically apparent asthma or very low baseline pulmonary function tests (e.g., FEV1 <1-1.5 liters or <70% of the predicted values).
ARIDOL is contraindicated in patients with known hypersensitivity to mannitol, the active ingredient in ARIDOL, or to the gelatin used to make the capsules. The product is also contraindicated for patients with medical conditions that may be compromised by induced bronchospasm or repeated spirometry maneuvers.
Bronchial challenge testing with ARIDOL should not be performed in children less than 6 years of age due to their inability to provide reliable spirometric measurements.
Use with caution in patients with conditions that may increase sensitivity to the bronchoconstricting or other potential effects of ARIDOL such as: severe cough, ventilatory impairment, unstable angina, or active upper or lower respiratory tract infection that may worsen with use of a bronchial irritant.
The most common adverse reactions (rate greater than or equal to 1%) were headache, pharyngolaryngeal pain, throat irritation, nausea, cough, rhinorrhea, dyspnea, chest discomfort, wheezing, retching and dizziness. No formal drug-drug interaction studies have been conducted with ARIDOL.
Pharmaxis is a global specialty pharmaceutical company involved in the research, development and commercialization of therapeutic products for chronic respiratory and immune disorders. The company's development pipeline includes Bronchitol for cystic fibrosis, bronchiectasis and chronic obstructive pulmonary disease (COPD), PXS25 for the treatment of lung fibrosis and PXS4159 for asthma. Founded in 1998, Pharmaxis is listed on the Australian Securities Exchange (symbol PXS). The company is headquartered in Sydney, Australia with regional offices in the U.S. (Exton, PA), Europe and Asia Pacific. For more information about Pharmaxis, visit http://www.pharmaxis.com.
SOURCE Pharmaxis, Inc.