ACAAI’s Advocacy Council has been deeply engaged in advocacy efforts to oppose Local Coverage Determinations (LCDs) by several Medicare Administrative Contractors (MAC) that would require Tezspire to be placed on the Self-Administration Drug (SAD) list, effective July 1. Due to the efforts of the Advocacy Council and other medical organizations, Tezspire administration remains in the physician office setting.
MACs have authority to issue LCDs that apply within their administrative jurisdiction. Several MACs announced LCDs that would move Tezspire to the Self-Administration Drug (SAD) list, but this is a major departure from how Tezspire is intended to be administered to patients.
When initially approving Tezspire, the FDA acknowledged that it is intended for administration by a health care provider. Requiring patients to self-administer Tezspire presents many challenges that could jeopardize correct utilization and stability of the drug.
Tezspire, a new biologic that is used to treat severe asthma in patients, is administered every four weeks. Failure to administer the treatment correctly could reduce its therapeutic effectiveness. Receiving the biologic in their physician’s office helps to ensure that patients receive the treatment as indicated and administered using the correct protocol.
Additionally, many patients lack the information and skill necessary to safely and effectively administer the treatment. While Tezspire is available in pre-filled syringes, it was intended to be administered by health care professionals in the physician office setting under the direct supervision of a physician. Furthermore, there are no FDA-approved Instructions for Use or labeling instructions that would indicate how a patient should self-administer this medication.
On June 23, the ACAAI sent a letter to the Centers for Medicare and Medicaid Services’ (CMS) Administrator Chiquita Brooks-LaSure explaining our opposition to moving Tezspire to the SAD list. ACAAI sent copies of this letter to every regional MAC and also signed on to a coalition letter representing multiple patient and provider stakeholders that oppose the Tezspire LCD.
Fortunately, ACAAI received a response indicating that CMS directed the MACs to indefinitely delay the movement of Tezspire to the SAD list until a thorough review could be completed. We will continue to advocate for the MACs to formally rescind these LCDs. However, this indefinite delay is a major win for allergists and our patients.
The Advocacy Council – ADVOCATING FOR ALLERGISTS AND THEIR PATIENTS.
