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Therapeutic area: Type 2 diabetes

The world is experiencing an epidemic of type 2 diabetes, a complex metabolic disorder linked to obesity and sedentary lifestyles. For most people with the disease, avoiding life-threatening complications requires ongoing medical treatment.

In 2009, Tapestry brought together a working group of world-class leaders from the ranks of medical experts, regulators, health technology assessors (HTA), payers and advisers, patient representatives, and medicine developers to examine how drug development could better support improved health outcomes in this area.

Working group participants identified significant unmet needs that call for targeted innovation, including:

  • Arresting disease progression
  • Reducing cardiovascular complications
  • Reducing the side effects of treatment

Several factors hinder progress in addressing these needs, including:

  • The absence of consensus among stakeholders as to what constitutes value in a type 2 diabetes medicine
  • The complexity of diabetes as a disease affecting multiple organ systems and the lack of validated biomarkers for changes to cardiovascular risk
  • The long period of time it takes for health outcomes to manifest

To overcome these challenges, the working group developed a Shared Value Framework for evaluating medicines for type 2 diabetes. The framework is intended to drive clarity and alignment among constituencies as to what constitutes value in a new medicine and how that value should be assessed and rewarded.

Participants agreed that new treatments must show improvement over existing therapies in areas such as durability of control, improved adverse effects profile, effectiveness where other drugs fail, and ability to simplify treatment. The Working Group also laid out principles to apply when assessing the value of a new medicine based on a composite of multiple performance criteria.

Science evolves rapidly. To help drug developers and their key constituencies keep up, the Working Group recommended the development of early stakeholder consultations in drug development. Beginning in 2010, healthcare leaders, medicine developers and Tapestry have been following the working group's recommendation by piloting multi-country, multi-stakeholder consultations in drug development.

Explore this issue:

  • Improving health outcomes in Type 2 Diabetes: recommendations of the Type 2 Diabetes Working Group

    Over the course of the Working Group's meetings, participants agreed unmet needs in Type 2 Diabetes and opportunities to improve patient health outcomes, and committed to working together to overcome challenges to achieving these improvements.

  • A summary of the Type 2 Diabetes Working Group’s recommendations

    Over the course of the Working Group's meetings, participants agreed unmet needs in type 2 diabetes and opportunities to improve patient health outcomes, and committed to working together to overcome challenges to achieving these improvements.

  • Improving health outcomes in Type 2 Diabetes: putting a shared value framework into practice

    Participants agreed principles for the use of value assessment based on composites of multiple value indicators and measures. The Working Group also recommended launching pilots of early stakeholder consultations.

  • Expanding the impact of shared value frameworks

    The Working Group identified opportunities for enhanced collaboration among all of the stakeholders involved in healthcare. Participants also continued their development of a consensus framework of value indicators and measures for diabetes medicines.

  • Type 2 Diabetes Working Group – 20 May meeting summary

    At the Working Group’s first meeting, participants agreed on a Shared Value Framework for type 2 diabetes, highlighted the importance of expanded consultation among stakeholders along the drug development process, and identified behaviors that stakeholders should start and stop.

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