Comparison of Stakeholder Metrics for Traditional and Adaptive Development and Licensing Approaches to Drug Development

Earlier patient access to beneficial therapeutics that addresses unmet need is one of the main requirements of innovation in global healthcare systems already burdened by unsustainable budgets. "Adaptive pathways" encompass earlier cross-stakeholder engagement, regulatory tools, and iterative evidence generation through the life cycle of the medicinal product. A key enabler of earlier patient access is through more flexible and adaptive payer approaches to pricing and reimbursement that reflect the emerging evidence generated.

Section: Perceived and Real Issues With Adaptive Payer Pathways In Thmentioning

confidence: 99%

Pricing and reimbursement experiences and insights in the European Union and the United States: Lessons learned to approach adaptive payer pathways

Faulkner

Lee

Qin

et al. 2016

“…Although some argue that ABI is driven by an effort by industry to drive more profits faster, there are many factors that may come into play in ABI with potential implications for sponsor profitability . For example, in some cases, profitability may be significantly impacted by smaller markets for initial authorizations for more targeted subpopulations of patients, particularly given the current laws and policies related to intellectual property and market exclusivities.…”

Section: Common Abi Misconceptionsmentioning

confidence: 99%

Adaptive Biomedical Innovation: Evolving Our Global System to Sustainably and Safely Bring New Medicines to Patients in Need

Hirsch

Trusheim

Cobbs

et al. 2016

The current system of biomedical innovation is unable to keep pace with scientific advancements. We propose to address this gap by reengineering innovation processes to accelerate reliable delivery of products that address unmet medical needs. Adaptive biomedical innovation (ABI) provides an integrative, strategic approach for process innovation. Although the term “ABI” is new, it encompasses fragmented “tools” that have been developed across the global pharmaceutical industry, and could accelerate the evolution of the system through more coordinated application. ABI involves bringing stakeholders together to set shared objectives, foster trust, structure decision‐making, and manage expectations through rapid‐cycle feedback loops that maximize product knowledge and reduce uncertainty in a continuous, adaptive, and sustainable learning healthcare system. Adaptive decision‐making, a core element of ABI, provides a framework for structuring decision‐making designed to manage two types of uncertainty – the maturity of scientific and clinical knowledge, and the behaviors of other critical stakeholders.

“…Adaptive Biomedical Innovation (ABI), as described in a companion article in this issue, transforms a siloed process separated by independent decisions involving few stakeholders at each point into a more holistic process, with greater stakeholder engagement throughout . ABI emphasizes prospectively planned iterations of clinical evidence development throughout the therapeutic lifespan to improve patient access and safety through staged and contingent decision‐making.…”

Section: The Challenge Of Individually Crafted Clinical Trialsmentioning

confidence: 99%

PIPELINEs: Creating Comparable Clinical Knowledge Efficiently by Linking Trial Platforms

Trusheim¹,

Shrier

Antonijevic

et al. 2016

Adaptive, seamless, multisponsor, multitherapy clinical trial designs executed as large scale platforms, could create superior evidence more efficiently than single‐sponsor, single‐drug trials. These trial PIPELINEs also could diminish barriers to trial participation, increase the representation of real‐world populations, and create systematic evidence development for learning throughout a therapeutic life cycle, to continually refine its use. Comparable evidence could arise from multiarm design, shared comparator arms, and standardized endpoints—aiding sponsors in demonstrating the distinct value of their innovative medicines; facilitating providers and patients in selecting the most appropriate treatments; assisting regulators in efficacy and safety determinations; helping payers make coverage and reimbursement decisions; and spurring scientists with translational insights. Reduced trial times and costs could enable more indications, reduced development cycle times, and improved system financial sustainability. Challenges to overcome range from statistical to operational to collaborative governance and data exchange.