Adaptive
Licensing (AL) is a flexible approach to drug development and regulation, with
two live pilot schemes accepted by the European Medicines Agency (EMA). The
system acknowledges that levels of uncertainty will always surround innovative
treatments. An initial license is granted at an earlier stage than possible
under the traditional system, with less clinical information from Randomized
Controlled Trials (RCTs).
After the initial license is granted, the
entry to market is heavily restricted, and the patient population is carefully
monitored through observational studies, electronic devices and registries.
Data from ongoing RCTs, and the more robust data from post-license surveillance
studies are used to determine full license permission. By improving the
alignment of stakeholder needs in a fluid system, overall costs and patient
access times can be reduced. However, uncertainty still exists around the
approach, and it is clear that cultural and political changes will be necessary
to realize the full potential of AL.
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Scope
- Adaptive
Licensing: Overview
-
Introduction
- A
Declining Industry - How AL can tackle issues with the current system
-
Strengths
-
Challenges for AL
-
Proponents
- Current
Adaptive Licensing
-
Precursors - Current systems within the traditional drug licensing framework
that will act as facilitators to AL
- Legality
- Feasibility of AL across different jurisdictions
-
Employing Adaptive Licensing - EMA pilot scheme information, practical
strategies
- Future
Adaptive Licensing
-
Transformative Strategies - Future utility of AL requiring legislative change
-
Commercial Considerations
- Pricing
and Reimbursement with AL
- Market
Exclusivity
-
Achieving Value through AL
-
Value-at-risk
Key
Reasons to Purchase
- Adaptive
Licensing is a highly current topic. In March 2014, the EMA (European Medicines
Agency) began to invite drug developers to apply for involvement in the pilot
projects.
-
Currently, two drug development programs have been accepted by the EMA as
pilots. Three were rejected, four are in reserve and 11 are still under
consideration.
- AL is
part of a suite of global initiatives with shared features. These include:
Staggered Approval, Progressive Authorisation, Conditional Licensing and, more
recently, Medicines Adaptive Pathways (MAPs) or Medicines Adaptive Pathways to
Patients (MAPPs).
- The high
level of variance in AL approaches and scarcity of practical information
justifies the need for an unbiased report of the strengths, weaknesses and
opportunities for this system.
- If
pilots are successful, AL may become more widely used across all regions, and
also play an important role in shaping future regulatory policy, with the
potential to affect all healthcare stakeholders.
- This new
CBR report examines all existing information, and builds on that with
conference attendance and new primary research with KOLs and figures central to
the movement. It creates a balanced view, and provides an understanding of the
current status and potential implications.
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