AAH: Preserve coverage for levalbuterol

Sunday, January 21, 2007

WASHINGTON - Inhalation drugs play a critical role in the management of COPD, and Medicare must ensure coverage of these drugs with a national coverage determination, says AAHomecare.

CMS initiated a review Dec. 20 on the use of levalbuterol in the treatment of COPD. The public comment period closed Friday and CMS is expected to announce a decision this summer.

In comments submitted to CMS Friday, AAHomecare stated: While it may be argued there is only modest evidence demonstrating the benefits of levalbuterol over racemic albuterol in COPD, it is important to note that the absence of voluminous published clinical studies does not by itself establish a lack of clinical efficacy or medical need. This kind of extrapolation on limited data is purely speculative and conflicts with current standards of clinical practice, which defer to the patient's physician the selection and prescription of the most clinically appropriate drug therapies.

AAHomecare also stated:

* With regard to levalbuterol, there is limited published data demonstrating its effectiveness over albuterol. However, studies have shown that patients treated with levalbuterol required less medication, had shorter hospital stays, decreased costs for nebulizer therapy and hospitalization and a more prolonged therapeutic benefit.

* COPD is the fourth leading cause of death worldwide and costs the United States over $18 billion annually in direct costs and another $11 billion in indirect costs.

* Effective management of COPD includes relieving symptoms, preventing disease progression, and preventing and treating complications and exacerbations. Bronchodilator therapy is the preferred therapy.