Molecularly-Targeted Cancer Therapy is Here Why is Change So Hard?

Advances in DNA Sequencing Technologies We can sequence DNA 1,000 times faster than just a few years ago, for about the same cost The technology is robust and highly reproducible between laboratories Instead of testing 1 to 3 genes in a cancer, we are now testing at a time Sequencing all 20,000 genes in the genome is being performed in some labs and will become commonplace in the near future

Clinical Utility of Broad-based DNA Sequencing in Cancer Our lab conducted a recent study of 301 cases of advanced cancer: A 37-gene panel was completed on all cases The results influenced patient care in ~20% of cases New options included: Entry into a clinical trial Use of a targeted therapy off-label In some cases, a decision not to use a particular therapy J Clin Oncol 32:5s, 2014 (suppl; abstr 11028)

Costs and Reimbursements The cost for sequencing a panel of 37 genes is only ~4 times the cost of sequencing 1 gene Most private insurers are reimbursing at ~40-50% of charges, but some pay nothing However, 45% of patients with the most common cancers are on Medicare In the eyes of Medicare, only half a dozen genes are relevant to cancer and only these are being paid New billing codes for gene panels have been created but are not assigned any $$ value

Summary There is an enormous and growing gap between what technology can deliver and what is accepted by payers as ‘standard of care’ Opportunities to benefit patients with common cancers (e.g. lung cancer) are being missed throughout the country Laboratories that strive to make state-of-the-art testing available are being financially penalized The FDA has announced it will begin to regulate all laboratory-developed tests in the U.S., which will add to costs and overall regulatory burden