Medicaid coverage practices for approved gene and cell therapies: Existing barriers and proposed policy solutions.

Autor:	Allen J; Spark Therapeutics, Inc., Philadelphia, PA 19104, USA., Berry D; Sarepta Therapeutics, Inc., Cambridge, MA 02142, USA., Cook F; REGENXBIO Inc., Rockville, MD 20850, USA., Hume A; Emerging Therapy Solutions, Bloomington, MN 55425, USA., Rouce R; Center for Cell and Gene Therapy, Texas Children's Cancer Center, Baylor College of Medicine, Houston, TX 77030, USA., Srirangam A; Bristol Myer Squibb Company, Washington, DC 20004, USA., Wellman J; Akouos, Inc., a Wholly Owned Subsidiary of Eli Lilly and Company, Boston, MA 02210, USA., McCombs C; American Society of Gene and Cell Therapy, Waukesha, WI 53186, USA.
Jazyk:	angličtina
Zdroj:	Molecular therapy. Methods & clinical development [Mol Ther Methods Clin Dev] 2023 May 16; Vol. 29, pp. 513-521. Date of Electronic Publication: 2023 May 16 (Print Publication: 2023).
DOI:	10.1016/j.omtm.2023.05.015
Abstrakt:	The current Medicaid system is ill equipped to handle the anticipated approvals of new gene and cell therapy products. These advanced therapies tend to be single-dose, potentially durable options for a variety of indications spanning oncology, rare disease, and more. The up-front cost of these therapies contrasts with chronic care treatment, which may incur cost over the life of a patient. The cost of these innovative treatments, along with the anticipated larger patient pools, can limit patient access as Medicaid programs operate on limited or fixed budgets. Given the value of these therapies for diseases that may have large Medicaid populations, the system will need to grapple with the existing barriers to access to ensure equitable patient care. This review focuses on one such barrier, discrepancies between product indications and state Medicaid and Medicaid Managed Care Organization coverage policies, and it proposes federal policy solutions to this barrier to better accommodate the exponential growth of the gene and cell therapy pipeline. Competing Interests: J.W. is an Independent Director on the Board of Atsena Therapeutics, Inc., and sits on the Board of Directors at ASGCT. R.R. has consulting agreements with and receives honoraria from Pfizer Inc., sits on ASGCT’s Board of Directors, receives research funding from Tessa Therapeutics, and receives honoraria from Kite-Gilead Sciences. The content of this article represents the authors’ opinions and may not necessarily represent the views of their employers. (© 2023 The Authors.)
Databáze:	MEDLINE
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