NEW YORK, April 16, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq: MESO; ASX: MSB), a pioneering global leader in the field of allogeneic cellular medicines specifically designed to treat inflammatory diseases, has made significant strides in expanding the coverage for its revolutionary therapy, Ryoncil (remestemcel-L). This milestone now extends the therapy's reach to an impressive 104 million insured lives across the United States, encompassing both government and commercial payers.

As of now, 37 out of the 51 states in the U.S. have successfully implemented fee-for-service Medicaid coverage for Ryoncil. This coverage is facilitated through either Orphan Drug Lists or through a medical exception and prior authorization (PA) processes. Collectively, this represents coverage for approximately 20 million lives, amounting to around 80% of total Medicaid fee-for-service lives included. Notably, additional coverage will become effective starting July 1, 2025, which will introduce mandatory coverage for an additional 24 million lives.

In the realm of commercial insurance, private payers and managed Medicaid have already established comprehensive policies, prior authorization requirements, and formulary lists that include Ryoncil, covering an additional 84 million lives. It is important to note that this figure does not account for the medical exceptions policies that many commercial payers have instituted for Ryoncil. Essentially, this means that the actual commercial coverage achieved to date is very likely to be underestimated, particularly as many plans do not explicitly publish policies for ultra-rare diseases like steroid-refractory acute graft versus host disease (SR-aGvHD), opting instead to manage these cases through PA and medical exception processes.

About Ryoncil and Mesoblast

Ryoncil represents a groundbreaking therapeutic option as it is the first mesenchymal stromal cell (MSC) therapy to receive approval from the U.S. Food and Drug Administration (FDA) for any indication. This innovative treatment is specifically indicated for the management of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients aged two months and older. For a detailed overview, interested individuals can refer to the full Prescribing Information available at Forward-Looking Statements

This press release contains forward-looking statements that pertain to future events or our anticipated financial performance. These predictions involve various known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those expressed or implied herein. The forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other relevant federal securities laws. Readers are cautioned not to interpret these statements as guarantees of future performance or results, as actual outcomes may significantly vary.

Factors influencing these forward-looking statements include, but are not limited to, the initiation and outcomes of Mesoblasts clinical studies, the progress of its research and development programs, and the company's ability to achieve regulatory approvals for its products. Additionally, uncertainties regarding market acceptance, competitive pressures, and financial performance can further impact the outcomes. Therefore, it is advised not to place undue reliance on these forward-looking statements, and the company does not intend to publicly update or revise them based on new information or future developments.

This announcement has been authorized for release by the Chief Executive.

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