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Chronic wounds may take years to heal and are impactful to a patient’s quality of life, but they can also be a financial burden. As new products come to market, it is essential that efficacy has been established to justify the treatment that the patient is undergoing as well as the cost.
The federal government has created a program called the Cell and Gene Therapy Access Model, the goal of which is to provide people with Medicaid who have rare and severe diseases access to potentially transformative treatments.
The first gene therapy for hearing loss, a dual adeno-associated viral (AAV) vector-based gene therapy, is currently being evaluated in the phase 1/2 AK-OTOF-101 clinical trial (NCT05821959). It seeks to replace the nonfunctioning OTOF gene in the cochlea with a working copy of the OTOF gene.
With the approval of Casgevy, there are now two gene therapies, Casgevy and Lyfgenia, for the treatment of transfusion dependent thalassemia (TDT).
Most plans have a precertification process in place for high-dollar drugs that addresses the appropriateness for diagnosis as well as provider network status; however, this is where it stops.