2022

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CLINICAL PRACTICE

HHS Delays Action on MAC Decision to List Tezspire as a Self-Administered Drug

Today, the Centers for Medicare and Medicaid Services posted a notice that the agency was delaying Medicare Administrative Contracts (MACs) proposed decision to list Tezspire as a self-administered drug. Tezspire is an FDA approved monoclonal antibody physician administered drug used to treat asthma. Earlier this summer, four MACs had proposed to move Tezspire from a Medicare Part B covered physician administered drug to a Medicare Part D patient self-administered drug – likely significantly increasing Medicare beneficiary copays for the drug.

 

In response to the MACs proposed decision, ATS joined letter led by the Allergy and Asthma Network opposing the decision and urging CMS to intervene. The letter noted that FDA approved the drug as a physician administered drug and that study have not yet been conducted to support its safety or efficacy as a self-administered drug.

 

The ATS is pleased CMS has intervened to prevent moving Tezspire to Medicare Part D at this time. The ATS will continue to urge MACs and CMS to await appropriate safety and efficacy studies before making further determinations on Tezspire.

Last Reviewed: July 2022