“Stick or Twist?” Negotiating Price and Data in an Era of Conditional Approval

Changes in the regulatory context enable faster approval of transformative medicines. They also lead to health technology assessment (HTA) agencies having to make decisions with less evidence. In response, HTA agencies have also initiated forms of conditional approval. When the evidence base for a new oncology treatment leaves substantial uncertainty, the new Cancer Drugs Fund allows the National Institute for Heath and Care Excellence to give the manufacturer two options: (1) offer a low price based on conservative assumptions and obtain immediate approval ( “stick”) or (2) wait until the evidence base has further matured before finalizing a potentially higher agreed price (“twist”).

Source: Value in Health - December 2, 2019 Category: International Medicine & Public Health Authors: Daniel Gladwell, Ash Bullement, Warren Cowell, Karl Patterson, Mark Strong Source Type: research