Oncology drug and biologics makers face increasing demands for data that demonstrates the benefit and cost-effectiveness of their products. Not only are treatment cost increases considered unsustainable, questions about new product effectiveness are being openly raised by physicians and payers alike. Pharmaceutical companies are increasingly being expected to demonstrate the overall economic and clinical value (ECV) of new products to justify premium payment.

Historically, cancer drugs have enjoyed “special status” because they are used to treat patients with generally incurable diseases whose life expectancies are often measured in months. This “special status” has permeated clinical medicine where new drugs and biologics have been rapidly adopted, even when the scientific rationale is weak. It has also permeated regulatory approval processes, marketing authorization, and reimbursement policies. In fact, the cost and value of new cancer treatments has (historically) rarely been questioned. Payers have typically deferred to oncologists in their network when establishing coverage and reimbursement policy. Policy and common practice have traditionally provided mostly unlimited access to drugs and biologics as most of these products would only be used for very short periods of time – often only providing marginal benefits.