Vermont Cell and Gene Therapy Grant Project - The purpose of this project is to acquire cooperative agreement funding for the State of Vermont to participate in the Cell and Gene Therapy (CGT) Access Model, leading to expanded and more comprehensive treatments for sickle cell disease (SCD) within Vermont Medicaid. If awarded, funding will support services related to implementation of the CGT model and necessary infrastructure updates, enhancing provider awareness and consideration of SCD gene therapy treatments, and providing patient assistance programs to remove any barriers to care for those considering treatment. The primary goal of this project is to review every document that has been provided related to the CGT Model and implement a framework for infrastructure changes within Vermont’s Medicaid program. The State Request for Application document provides a list of necessary state requirements for model involvement. The State of Vermont will need staffing and programmatic changes to accommodate the design of the CGT program and ensure equitable access is provided to SCD gene therapy products. These updates may include changes to Vermont Medicaid’s policy, coverage, rebate collection, data collection, reporting, legal review, and contracting. The additional goals of this project include connecting with the provider and patient community to expand access and knowledge related to SCD treatments, improve and inform about coverage allowances, and support case management. It is unlikely that there will be a treatment center that administers gene therapy products in Vermont, creating a need for provider education surrounding coverage for out-of-state treatment centers. To ensure access is provided for those seeking treatment for SCD, the Vermont Medicaid program will need to update agreements with out-of-state treatment centers and specialists. Additionally, members will need information provided detailing case management services and travel allowances. These additional goals will require staff involvement and funding to fundamentally connect those in need with external treatment centers. Funding for project implementation will assist with compensation and budgeting to accomplish the listed goals, the total budget for this project is $1,300,978.00. The funds will be used to compensate additional staff and legal involvement needed to review the entirety of the CGT Model, including Key Terms set by manufacturers through supplemental outcomes-based rebate offers. Funding will be allocated to support collection of additional rebate amounts, data collection and review, and subsequent follow-up reporting to the Centers for Medicaid and Medicaid Services. The cooperative agreement funding will also be used to support optional state activities including raising awareness for non-emergency medical transportation and related travel expenses, care coordination and case management services to assist with a patient’s treatment journey, drafting coverage guidance documents, and conducting direct informational outreach campaigns to providers and members. The State of Vermont will utilize cooperative agreement funding to establish a comprehensive coverage policy that meets all requirements of the CGT Model. As an outcome achieved through additional funding, there will be the development of a seamless protocol for incorporating coverage of CGT-Model gene therapy products and related care needs. An additional outcome will be the creation of a robust provider and patient awareness campaign, leading to the removal of any barriers to care.
