Even with an escalating focus on securing reimbursement and sizeable investments by biopharmaceutical companies in large market access teams, the commercial success of many novel pharmaceutical products continues to be disadvantaged by market access hurdles. Payors and regulators openly weigh different criteria when determining approval of new therapies. Regulators place more emphasis on efficacy, or the degree to which a new therapy does more good than harm under ideal conditions. Payors, on the other hand, stress a therapy’s relative effectiveness or the extent to which an intervention does more good than harm compared with other clinically similar alternatives under the usual situations encountered in health care practice.
These different points of view, ideal versus real-world environment, create a substantial gap between the way that regulators and payors rate the quality and usefulness of product data. As a...
