Emerging Therapy Solutions

September is National #SickleCellAwarenessMonth. According to the Centers for Disease Control and Prevention (CDC), sickle cell disease (SCD) affects around 100,000 people in the US. Two groundbreaking #genetherapies have been approved by the US Food and Drug Administration (FDA) to treat SCD: Casgevy® (exagamglogene autotemcel), from Vertex Pharmaceuticals and CRISPR Therapeutics, and Lyfgenia™ (lovotibeglogene autotemcel) from bluebird bio. These treatments offer new hope for those living with SCD. To learn more about these costly treatments and to understand your risk, reach out to ETS at 877.445.482 or visit us at https://bit.ly/4dQuTk3. #SickleCellMatters2024. Sickle Cell Disease Association of America: https://bit.ly/47cUDou

Emerging Therapy Solutions® (ETS) wishes you a happy #LaborDay weekend! We appreciate the hard work, dedication, and commitment of all the incredible professionals who drive innovation and excellence in healthcare, and who help provide access to life-changing therapies.

So far in 2024, we’ve already seen 11 cell and gene therapy approvals, with more target action dates on the horizon! To help payers understand risk and anticipate potential exposure, Emerging Therapy Solutions (ETS) offers a comprehensive suite of products and services, including a Quarterly Pipeline Forecast Report for cell and gene therapies that is built to estimate cost and utilization of emerging treatments. Learn how to manage your risk and plan ahead for these high-cost therapies by visiting us at https://bit.ly/3XwWlhn or give us a call at 877.445.4822.

Cell Therapy News! Adaptimmune Therapeutics has announced the US Food and Drug Administration (FDA) accelerated approval of Tecelra® (afamitresgene autoleucel; afami-cel), its T-cell receptor (TCR) therapy for the treatment of advanced MAGE-A4+synovial sarcoma in adults with certain HLA types who have received prior chemotherapy. Tecelra is the first approved engineered T-cell therapy for solid tumors. The accelerated approval is based on overall response rate and durability of response. Emerging Therapy Solutions (ETS) helps payers and other risk-bearing entities prepare for and manage risk related to the pipeline of upcoming cell and gene therapies. Reach out to ETS to learn more at 877.445.4822. #celltherapy #synovialsarcoma https://bit.ly/4d6Ea7h

This week, Mesoblast Limited announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (#BLA) resubmission for Ryoncil® (remestemcel-L), its investigational #celltherapy for children with steroid-refractory acute graft versus host disease (SR-aGvHD). The company indicated that the resubmission addressed remaining Chemistry, Manufacturing, and Control (CMC) concerns the FDA had with the previous submission. The FDA considers the resubmission to be a complete response and has set a Prescription Drug User Fee Act (#PDUFA) target date of January 7, 2025. Emerging Therapy Solutions (ETS) helps payers and other risk-bearing entities prepare for and manage risk related to the pipeline of upcoming cell and gene therapies. Reach out to ETS to learn more at 877.445.4822 or visit us at https://bit.ly/3SriVF7. https://bit.ly/3SssALE

July is #SarcomaAwarenessMonth! Synovial sarcoma is a rare type of #cancer. It is a type of soft tissue sarcoma, which are tumors that can appear in the arm, leg, foot, lung, abdomen, or near joints such as the ankle or wrist. Approximately one-third of patients are diagnosed under the age of 30. The five-year survival rate for individuals with metastatic diseases is 20%, and patients often experience reoccurrence and exhaust available treatment options. Adaptimmune Therapeutics has investigational T-cell receptor (#TCR) T-cell therapies in development targeting solid tumors, including synovial sarcoma. One therapy is letetresgene autoleucel (lete-cel), which targets a subset of individuals that who have cancer with the antigen NY-ESO-1. The other is afamitresgene autoleucel (afami-cel) which targets the MAGE-A4 antigen. Afami-cel has a US Food and Drug Administration (FDA) Prescription Drug User Fee Act (#PDUFA) decision date of August 4, 2024. Cell and gene therapies can offer additional treatment options for more patients. Know what's coming. To learn about ETS' pipeline monitoring and other services, contact us at 877.445.4822, or visit us at https://bit.ly/3Yih1dB.

We couldn't be more excited for the Self-Insurance Institute of America (SIIA) International Conference in Dublin from July 22-24! President of ETS, Ashley Hume, will be at the conference and would love to connect with other attendees. If you are attending and would like to schedule a meeting with Ashley to learn more about how ETS can help you, please contact [email protected]. #SIIA #SIIAInternational https://bit.ly/4d9OnzF

Date to watch! The US Food and Drug Administration (FDA) has added another therapy target action date to the calendar. Atara Biotherapeutics has announced that the FDA has accepted its Biologics License Application (#BLA) for tabelecleucel (tab-cel®), its investigational cell therapy for adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (#EBV+ #PTLD) who have received at least one prior therapy. The press release notes that for solid organ transplant, prior therapy includes chemotherapy, unless chemotherapy is inappropriate. The FDA granted Priority Review and set a Prescription Drug User Fee Act (#PDUFA) date of January 15, 2025. Stay tuned for more updates! Emerging Therapy Solutions (ETS) can help payers and other risk-bearing entities prepare for and manage risk related to the pipeline of upcoming cell and gene therapies. Reach out to ETS to learn more at 877.445.4822 or visit us at https://bit.ly/4d3hTa6 https://bit.ly/4bN9Ugb

ETS is excited to be attending the Health Care Administrators Association (HCAA) TPA Summit from July 15-17! We're looking forward to this opportunity to engage with industry experts. Hope to see you there! #HCAA #HCAATPASUMMIT https://bit.ly/3WkL7vM

We are thrilled to announce that Julie Ceno-England, M.D., has joined Emerging Therapy Solutions (ETS) as our new Chief Medical Officer! Julie brings a wealth of experience that will be invaluable as we continue to innovate and offer payers a comprehensive suite of services to help manage risk for highly specialized care such as cell and gene therapies, and transplants. Welcome to ETS, Dr. England! #PrecisionMedicine #EmergingTherapies #CellAndGeneTherapy #ETS