WOMEN IN BIO  |  "Discussion with the Expert" series

Arnold & Porter LLP hosted the second luncheon in the "Discussion with the Expert" series in downtown Washington, DC on Thursday, March 17, with live webcast streaming to Women In Bio Chapters in Research Triangle Park and Chicago. The topic of the discussion, coverage and reimbursement for drugs and devices, is one of growing importance in the pharmaceutical, medical device and diagnostics arenas. An esteemed panel representing government, biotech, and investment perspectives provided valuable insight into the process for ensuring your product is reimbursed once you have received regulatory approval to market.

(from left to right) Kristan Lansbery, Tamara Syrek Jensen, Rachel King, Caroline York, Sara Nayeem, Maura Kahn, Deb Bowes.

Tamara Syrek Jensen, J.D., Deputy Director, Coverage and Analysis Group, Centers for Medicare & Medicaid Services (CMS), U.S. Dept of Health & Human Services, presented "Coverage 101" as the featured speaker. Ms. Jensen described the role of the FDA as determining whether a new treatment is "safe and effective," in contrast to the role of her department, which is to determine whether the treatment is "reasonable and necessary" and therefore can be reimbursed by the government. She emphasized the importance of soliciting CMS input to your development program even before FDA approval. Within this context, she described a new pilot project where the FDA and CMS can work together to review core sets of data to provide efficiencies in processes related to approval and reimbursement guidelines.

	Rachel King, M.B.A., CEO and founder of GlycoMimetics, Inc.

Noxilizer’s Maura O. Kahn moderated the ensuing panel discussion. Rachel King, M.B.A., CEO and founder of GlycoMimetics, Inc., shared her .experience, emphasizing the importance of considering "how your drug will be paid for" early in the development process and developing a reimbursement strategy starting in Phase 2 clinical studies. Caroline York, Reimbursement Account Manager, Auxilium Pharmaceuticals, Inc., discussed the practical aspects of understanding how your product will be reimbursed, obtaining a HCPIC code, understanding both public and private reimbursement rates and assembling a tactical reimbursement team within your company. Finally, Sara Nayeem, M.D., M.B.A., Principal at New Enterprise Associates (NEA), discussed the importance of reimbursement considerations to the potential investor. The new reimbursement paradigm, which is less favorable to incremental improvements, is shifting technology and investment towards highly innovative medical products and a higher standard of efficacy.

Besides a wonderful opportunity to network with WIB colleagues and enjoy a delicious lunch, this panel discussion provided invaluable advice for developing your corporate reimbursement strategy. Special thanks to Arnold & Porter for hosting this informative event.