Sepracor criticizes neb-med proposal

Friday, June 30, 2006

The comment period for Medicare's proposal to reimburse brand-name drugs Xopenex and DuoNeb at cheaper generic rates ended May 8, and providers are waiting to see what happens next. Meanwhile, the drugs' makers are fighting back. Sepracor, which manufactures Xopenex, generated 20,000 comments from patients, caregivers and physicians through HME News put some questions to Sepracor recently to get the company's thoughts on the issues at hand.
HME News: What is Sepracor's stand on the CMS proposal?
Sepracor: The proposed action represents an inappropriate restriction on access to one of only two products approved to treat the acute symptoms that can arise in Medicare beneficiaries suffering from asthma and chronic obstructive pulmonary disease (COPD). We recognize that Medicare has a significant and legitimate interest in controlling its expenditures. Sepracor has been and remains willing to work with the Medicare program to establish a new level of reimbursement for Xopenex that preserves Medicare beneficiary access to the product, maintains physician independence, and helps the Medicare program to control its costs.
HME: What are you hearing from Medicare beneficiaries?
Sepracor: Even Medicare beneficiaries who do not currently take Xopenex have expressed serious concerns with this decision. Those patients who are taking Xopenex understandably believe that they may suffer a significant setback in their condition if they are forced to switch to (generic) albuterol. Many have already failed to respond to albuterol.
HME: Has Sepracor developed a plan of action?
Sepracor: Sepracor does not believe that this action is allowable under the Medicare Modernization Act and is prepared to take all steps necessary to ensure that the statute is implemented in a manner consistent with the intent of Congress. Many members of Congress have expressed their concern with this decision and have expressed support for Sepracor's position. They are encouraging the Medicare program to work with Sepracor to find a reasonable solution, one that falls well short of the draconian action suggested by the regional carriers.
HME: Can Sepracor successfully carve Xopenex out of the proposal based on clinical arguments?
Sepracor: Sepracor believes that Xopenex is clinically differentiated from (generic) albuterol and that the Medicare program, in its final action, should withdraw the proposed reimbursement action for Xopenex. Sepracor has already made offers to the Medicare program that would significantly lower the reimbursement for Xopenex and remains willing to discuss these alternatives with the program. If these offers had simply been acted upon by the Medicare program in 2005, the program would have realized tens of millions of dollars in savings. Sepracor will continue to fight to preserve beneficiary access to Xopenex and to protect physicians from inappropriate interference with their ability to practice medicine in accordance with their professional judgment.