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 20-200 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 therapyJ 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