Just a few years ago, most companies looked at market access, and specifically reimbursement, as the last step in the commercialization process. Only after a product was close to launch was it considered, and even then it was tactically addressed, as in “what price can we get?” The function was divorced from other aspects of the product plan — a “stepchild” in a silo frame.

This traditional approach may have been effective when physicians, pharmacists and care sites were the dominant decision-makers in selecting pharmaceuticals and medical devices. Today, however, payers are driving the agenda and demanding sophisticated clinical and economic data and analyses before agreeing to a price for reimbursement. The industry is now being challenged to demonstrate a strong, all-embracing “value proposition” for its products. In light of these shifts, companies will need to begin addressing market access questions early in the product development process.