Coverage with Evidence Development & Adaptive Licensing Workshop

CMTP’s work in the area of coverage with evidence development (CED) continues with a joint workshop with MIT’s Center for Biomedical Innovation New Drug Development Paradigms (NEWDIGS) in November 2011.  This workshop is the first step towards exploring the barriers and potential solutions of aligning “adaptive licensing,” a regulatory policy tool with “coverage with evidence development,” a reimbursement policy tool.

Adaptive approaches to licensing health technologies seek to align licensing decisions on market access to new technologies with emerging information on benefits and risks of these interventions as used.  This regulatory policy tool is premised on the assumption that knowledge of a particular technology evolves over time.  In comparison to traditional one-time licensing approaches with a “magic moment” of approval, adaptive approaches go through an iterative process of evaluating the benefits and risks of emerging technologies with several smaller steps, as they are used in real-world clinical settings.

Managed entry schemes, such as CED, are the reimbursement analogue to adaptive licensing.  These schemes allow expedited payment for approved therapies along with a requirement for further data collection about real world effectiveness.  These schemes are designed such that the price, level or nature of reimbursement for a particular technology is tied to future measures of clinical endpoints; and also provide the flexibility to payers to cover these innovative, emerging technologies while generating valid evidence on the relative benefits and risks of these technologies.

These topics are often seen as distinct areas of pharmaceutical policy reform. Both approaches encourage faster and safer introduction of new products in the context of data collection of products as used. This common purpose suggests possible value in aligning the design and implementation of these two policy tools.

This workshop was designed as a structured brainstorming exercise with a small number of informed and interested individuals to explore the benefits and risks of linking regulatory policy tools such as adaptive licensing and reimbursement policy schemes such as CED on healthcare delivery.  A summary document that highlights the issues discussed during the workshop is available below.

CMTP has received funding from the California Healthcare Foundation to support this project.

Coverage with Evidence Development and Adaptive Licensing: Two Sides of the Same Coin? (pdf) (1.04 MB)