Mesoblast Extends Payer Coverage For Ryoncil® to Over 100 Million US Lives
Mesoblast (MESO) has expanded insurance coverage for its FDA-approved therapy Ryoncil® (remestemcel-L) to reach over 104 million US lives. The coverage includes both government and commercial payers.
The therapy, which is the first mesenchymal stromal cell (MSC) treatment approved by the FDA, has achieved significant coverage milestones:
- 37 out of 51 states now provide fee-for-service Medicaid coverage through Orphan Drug Lists or medical exception/prior authorization process, covering 20 million lives (80% of total Medicaid fee-for-service lives)
- Remaining states will implement mandatory coverage for 24 million lives by July 1, 2025
- Commercial plans and managed Medicaid have established policies covering 84 million lives
Additional coverage through Medical Exceptions policies exists but is not included in these figures, suggesting the total coverage is higher than reported.
Mesoblast (MESO) ha ampliato la copertura assicurativa per la sua terapia approvata dalla FDA, Ryoncil® (remestemcel-L), raggiungendo oltre 104 milioni di persone negli Stati Uniti. La copertura include sia enti governativi che assicurazioni commerciali.
La terapia, che è il primo trattamento a base di cellule stromali mesenchimali (MSC) approvato dalla FDA, ha raggiunto importanti traguardi nella copertura:
- 37 stati su 51 offrono ora copertura Medicaid a pagamento diretto tramite elenchi di farmaci orfani o processi di eccezione medica/autorizzazione preventiva, coprendo 20 milioni di persone (l'80% del totale Medicaid a pagamento diretto)
- Gli stati rimanenti implementeranno una copertura obbligatoria per 24 milioni di persone entro il 1° luglio 2025
- I piani commerciali e Medicaid gestito hanno stabilito politiche che coprono 84 milioni di persone
Esistono ulteriori coperture tramite politiche di eccezioni mediche non incluse in queste cifre, suggerendo che la copertura totale sia superiore a quella riportata.
Mesoblast (MESO) ha ampliado la cobertura de seguro para su terapia aprobada por la FDA, Ryoncil® (remestemcel-L), alcanzando a más de 104 millones de personas en Estados Unidos. La cobertura incluye tanto pagadores gubernamentales como comerciales.
La terapia, que es el primer tratamiento con células madre mesenquimales (MSC) aprobado por la FDA, ha logrado hitos importantes en la cobertura:
- 37 de 51 estados ahora ofrecen cobertura Medicaid de pago por servicio a través de listas de medicamentos huérfanos o procesos de excepción médica/autorización previa, cubriendo a 20 millones de personas (80% del total de Medicaid de pago por servicio)
- Los estados restantes implementarán cobertura obligatoria para 24 millones de personas antes del 1 de julio de 2025
- Los planes comerciales y Medicaid administrado han establecido políticas que cubren a 84 millones de personas
Existe cobertura adicional a través de políticas de excepciones médicas que no se incluyen en estas cifras, lo que sugiere que la cobertura total es mayor a la reportada.
Mesoblast (MESO)는 FDA 승인 치료제 Ryoncil® (remestemcel-L)에 대한 보험 적용 범위를 확장하여 미국 내 1억 400만 명 이상의 인구를 대상으로 하게 되었습니다. 이 보험 적용은 정부 및 상업 보험 모두를 포함합니다.
이 치료제는 FDA가 승인한 최초의 중간엽 줄기세포(MSC) 치료제로서, 중요한 보험 적용 성과를 달성했습니다:
- 51개 주 중 37개 주가 현재 희귀의약품 목록 또는 의료 예외/사전 승인 절차를 통해 서비스별 Medicaid 보험을 제공하여 2천만 명(전체 Medicaid 서비스별 인구의 80%)을 커버합니다
- 나머지 주들은 2025년 7월 1일까지 2,400만 명에 대한 의무 보험 적용을 시행할 예정입니다
- 상업 보험 및 관리형 Medicaid는 8,400만 명을 커버하는 정책을 수립했습니다
의료 예외 정책을 통한 추가 보험 적용도 존재하지만 이 수치에는 포함되지 않아 실제 총 보험 적용 인구는 보고된 수치보다 더 많을 것으로 보입니다.
Mesoblast (MESO) a étendu la couverture d'assurance pour sa thérapie approuvée par la FDA, Ryoncil® (remestemcel-L), atteignant plus de 104 millions de personnes aux États-Unis. Cette couverture inclut à la fois les payeurs gouvernementaux et commerciaux.
Cette thérapie, qui est le premier traitement à base de cellules stromales mésenchymateuses (MSC) approuvé par la FDA, a atteint des étapes importantes en matière de couverture :
- 37 des 51 états offrent désormais une couverture Medicaid à paiement à l'acte via les listes de médicaments orphelins ou les processus d'exception médicale/autorisation préalable, couvrant 20 millions de personnes (80 % du total des bénéficiaires Medicaid à paiement à l'acte)
- Les états restants mettront en place une couverture obligatoire pour 24 millions de personnes d'ici le 1er juillet 2025
- Les régimes commerciaux et Medicaid gérés ont établi des politiques couvrant 84 millions de personnes
Une couverture supplémentaire via des politiques d'exceptions médicales existe mais n'est pas incluse dans ces chiffres, ce qui suggère que la couverture totale est supérieure à celle rapportée.
Mesoblast (MESO) hat die Versicherungsschutz für seine von der FDA zugelassene Therapie Ryoncil® (remestemcel-L) auf über 104 Millionen Menschen in den USA ausgeweitet. Der Schutz umfasst sowohl staatliche als auch kommerzielle Kostenträger.
Die Therapie, die die erste von der FDA zugelassene mesenchymale Stromazell-(MSC)-Behandlung ist, hat bedeutende Meilensteine beim Versicherungsschutz erreicht:
- 37 von 51 Bundesstaaten bieten nun Medicaid-Leistungen auf Gebührenbasis über Orphan-Drug-Listen oder medizinische Ausnahmen/Vorabgenehmigungen an und decken 20 Millionen Menschen ab (80 % der Medicaid-Leistungen auf Gebührenbasis)
- Die verbleibenden Bundesstaaten werden bis zum 1. Juli 2025 eine verpflichtende Deckung für 24 Millionen Menschen einführen
- Kommerzielle Pläne und verwaltetes Medicaid haben Richtlinien etabliert, die 84 Millionen Menschen abdecken
Zusätzlicher Schutz durch medizinische Ausnahmepolitiken besteht, wird aber in diesen Zahlen nicht berücksichtigt, was darauf hindeutet, dass die Gesamtdeckung höher ist als angegeben.
- Significant insurance coverage expansion reaching 104 million US lives
- Strong Medicaid coverage with 80% of fee-for-service lives already covered
- Guaranteed expansion of mandatory coverage to remaining states by July 2025
- Extensive commercial insurance coverage reaching 84 million lives
- Additional coverage through Medical Exceptions policies suggests higher total coverage
- 13 states still pending Medicaid coverage implementation
NEW YORK, April 16, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has continued to expand coverage for Ryoncil® (remestemcel-L), the first mesenchymal stromal cell (MSC) therapy approved by U.S. Food and Drug Administration (FDA) for any indication, to 104 million US lives insured by government and commercial payers.
To date, 37 of the 51 states provide fee-for-service Medicaid coverage for Ryoncil® through Orphan Drug Lists or medical exception / prior authorization (PA) process, representing 20 million covered lives, or
About Mesoblast
Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The therapies from the Company’s proprietary mesenchymal lineage cell therapy technology platform respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process.
Mesoblast’s RYONCIL® (remestemcel-L) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA approved mesenchymal stromal cell (MSC) therapy. Please see the full Prescribing Information at www.ryoncil.com.
Mesoblast is committed to developing additional cell therapies for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. RYONCIL is being developed for additional inflammatory diseases including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for heart failure and chronic low back pain. The Company has established commercial partnerships in Japan, Europe and China.
About Mesoblast intellectual property: Mesoblast has a strong and extensive global intellectual property portfolio, with over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions of matter, methods of manufacturing and indications. These granted patents and patent applications are expected to provide commercial protection extending through to at least 2041 in major markets.
About Mesoblast manufacturing: The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.
Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast
Forward-Looking Statements
This press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast’s preclinical and clinical studies, and Mesoblast’s research and development programs; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast’s ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast’s RYONCIL for pediatric SR-aGVHD and any other product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast’s product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast’s ability to enter into and maintain established strategic collaborations; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast’s expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast’s financial performance; developments relating to Mesoblast’s competitors and industry; and the pricing and reimbursement of Mesoblast’s product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.
Release authorized by the Chief Executive.
For more information, please contact:
| Corporate Communications / Investors | |
| Paul Hughes | |
| T: +61 3 9639 6036 | |
| Media – Global | |
| Allison Worldwide | |
| Emma Neal | |
| T: +1 603 545 4843 | |
| E: emma.neal@allisonworldwide.com | |
| Media – Australia | |
| BlueDot Media | |
| Steve Dabkowski | |
| T: +61 419 880 486 | |
| E: steve@bluedot.net.au |
FAQ
How many US lives are now covered by insurance for Mesoblast's Ryoncil® treatment?
What percentage of Medicaid fee-for-service lives are covered by MESO's Ryoncil®?
When will the remaining states implement mandatory Ryoncil® coverage for Medicaid?
How many commercial insurance lives are covered for Mesoblast's Ryoncil® treatment?
