Beyond the value of ATMPs for healthcare and considering the total cost for a single patient, it is important to consider healthcare-related costs as well as non-healthcare and indirect costs to perform an appropriate evaluation. It is necessary to have a holistic view on expenses for the government, especially in the case of therapies with high up-front costs.
The excessive inflammatory response seen in the most serious cases of Covid-19, along with shortages of ventilators, has caused a healthcare crisis in many countries around the world. Could cell therapy provide an answer to this dilemma?
Gene therapy is defined as the transfer of genetic information to a patient for treatment of a disease. Clinical investigation of such therapies began in 1990 with a treatment for a rare immunodeficiency disorder and since has expanded to almost 1,000 clinical studies in 2019. In its most straightforward incarnation, the goal of gene therapy for genetic diseases is long-term expression of a transferred gene at levels that are high enough to be therapeutic.
The Alliance for Regenerative Medicine (ARM) says CMS’ plan to create new reimbursement category for CAR-T helps validate entire field, but it may not make it any easier for other products to navigate the payment landscape. ARM is prioritizing value-based payment legislation in its Congressional lobbying.
