Under the 21st Century Currs Act, the entire way that off-label drugs and expansion of options is being contemplated is to expand access to new drugs and “cures”, especially new immunotherapies, cell based cures and targeted treatments that target genes or proteins.
Expansion of labels and off-label use will be facilitated outside of the traditional clinical trials model using economic data and real world data. The fact is, the monthly cost for DCVax-L over 2-5 years is very low and the lack of side-effects or need for hospitalization or treatment of toxic effects is going to be a potential game changer in terms of cost. Patients going to their doctor’s office for their injection every few months and then 6 months is an incredible change in oncology care that I believe insurers will be very excited to see.
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