Healthcare Industry News: sinusitis
News Release - November 5, 2007
Sepracor Inc. Announces the Establishment of a Unique Product-Specific Billing Code (or J-Code) for BROVANA(R)MARLBOROUGH, Mass.--(HSMN NewsFeed)--Sepracor Inc. (Nasdaq: SEPR ) today announced that the Centers for Medicare and Medicaid Services (CMS) has established a product-specific billing code, or J-code, for BROVANA® (arformoterol tartrate) Inhalation Solution under the Medicare Part B benefit. The J-code becomes effective on January 1, 2008. BROVANA is a 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.
The new J-code, J7605, replaces the miscellaneous J-code J7699 under which BROVANA is currently reimbursed. The J7605 code should be accepted by the Part B Durable Medical Equipment-Medicare Administrative Contractors (DME-MACs) for all BROVANA claims for reimbursement submitted for Medicare beneficiaries on or after January 1, 2008. CMS is expected to publish the first quarter 2008 payment rate for J7605 in December 2007. This reimbursement rate, based on 106% of the average selling price for BROVANA, will be updated quarterly thereafter. Private insurers may pay for BROVANA at rates different than those paid by Medicare.
“This is an important milestone as the use of long-acting bronchodilators is central to the long-term, maintenance treatment of bronchoconstriction in patients with COPD, a disease area with significant unmet need,” stated Adrian Adams, President and Chief Executive Officer of Sepracor. “The establishment of this product-specific J-code should help patients get timely access to BROVANA and it should also help providers bill accurately and uniformly for this product across the U.S.”
According to the National Center for Health Statistics, COPD is the fourth leading cause of death in the U.S. and it is estimated to be the third leading cause by the year 2020. Approximately 12 million adults in the U.S. are reported to have COPD, although approximately 24 million adults have evidence of impaired lung function, which may indicate that COPD is under-diagnosed, according to the National Heart, Lung, and Blood Institute. COPD is a slowly progressive disease of the airways that is characterized by a gradual loss of lung function and includes chronic bronchitis, chronic obstructive bronchitis and emphysema, or combinations of these conditions.
BROVANA has not been demonstrated to have an impact on the progression of disease or the survival of patients with COPD.
Important Safety Information
Long-acting beta2-adrenergic agonists may increase the risk of asthma-related death. Data from a large placebo-controlled U.S. 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 may apply to arformoterol (a long-acting beta2-adrenergic agonist), the active ingredient in BROVANA.
Data are not available to determine whether the rate of death in patients with COPD is increased by long-acting beta2-adrenergic agonists. BROVANA is indicated for the long-term, twice-daily (morning and evening) maintenance treatment of bronchoconstriction in COPD, including chronic bronchitis and emphysema. BROVANA is for use by nebulization only. BROVANA is not indicated for the treatment of acute episodes of bronchospasm, i.e. rescue therapy. 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. 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. Although such effects are uncommon after administration of BROVANA at the recommended dose, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTC interval and ST segment depression. The clinical significance of these findings is unknown. BROVANA, as with other sympathomimetic amines, 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.
In clinical studies, the numbers and percent of patients who reported adverse events were comparable in the BROVANA 15 mcg twice daily and placebo groups. The most frequent adverse events reported in patients taking BROVANA were pain (8%), chest pain (7%), back pain (6%), diarrhea (6%) and sinusitis (5%). BROVANA, as with other long-acting beta2-adrenergic 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 these agents may potentiate the action of adrenergic agonists on the cardiovascular system.
Please visit the BROVANA web site at www.brovana.com for complete prescribing information.
Sepracor Inc. is a research-based pharmaceutical company dedicated to treating and preventing human disease by discovering, developing and commercializing innovative pharmaceutical products that are directed toward serving unmet medical needs. Sepracor’s drug development program has yielded a portfolio of pharmaceutical products and candidates with a focus on respiratory and central nervous system disorders. Sepracor’s corporate headquarters are located in Marlborough, Massachusetts.
This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to safety, efficacy and potential benefits of BROVANA; the timing of actions by CMS with respect to publishing the new J7605 code and payment rates for BROVANA; the potential acceptance by the DME-MACs for all BROVANA claims for reimbursement submitted for Medicare beneficiaries on or after January 1, 2008; private insurers paying for BROVANA at rates different than those paid by Medicare; the importance of BROVANA to the long-term, maintenance treatment of bronchoconstriction in patients with COPD; the potential size of the COPD market; the establishment of the product-specific J-code helping patients get timely access to BROVANA and helping providers bill accurately and uniformly for BROVANA across the U.S. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: Sepracor’s ability to successfully commercialize BROVANA; market acceptance of BROVANA by medical professionals, patients and other parties; continued growth of the COPD market; the acceptance by DME-MACs of the J7605 code; the use of long-acting bronchodilators remaining central to the long-term maintenance treatment of bronchoconstriction in patients with COPD; the scope of Sepracor’s trademarks and patents and the success of challenges by others of Sepracor's patents and trademarks; Sepracor’s ability to attract and retain qualified sales personnel and other employees; and certain other factors that may affect future operating results and are detailed in Sepracor's Quarterly Report on Form 10-Q for the quarter ended June 30, 2007 and other periodic filings that Sepracor has made with the Securities and Exchange Commission.
In addition, the statements in this press release represent Sepracor's expectations and beliefs as of the date of this press release. Sepracor anticipates that subsequent events and developments may cause these expectations and beliefs to change. However, while Sepracor may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Sepracor's expectations or beliefs as of any date subsequent to the date of this press release.
Brovana is a registered trademark of Sepracor Inc.
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