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Therapeutic area: Breast cancer

"Worldwide, more than a million women are diagnosed with breast cancer every year, accounting for a tenth of all new cancers and 23% of all female cancer cases," notes Cancer Research UK. Yet all acknowledge there are too few effective treatments. And the recent treatments for the disease bring with them a high cost burden to health care systems already struggling with limited budgets.

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 challenges to developing new treatments for breast cancer, including:

  • The complexity underlying the disease – given the heterogeneity of tumor formation likely successful treatment requires a combination of different modes of attacking tumor growth and metastasis
  • Aligning views of unmet needs and shared value definitions across stakeholders as to what constitutes value in a breast cancer medicine
  • Defining regulatory and reimbursement processes for innovative drug development programs
  • Defining the quality of life (QoL) measures and collection design requirements given the lack of consensus in the field
  • Difficulty in moving chronic treatments to earlier disease stages – developing effective treatments for the adjuvant setting

To overcome some of these challenges, the working group developed a Shared Value Framework for evaluating medicines for breast cancer. 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 with demonstrated progress with the gold standard in chronic breast cancer of overall survival (OS), and where progression free survival (PFS) when linked to OS would be an acceptable endpoint. Debate on quality of life led to acknowledgement that within a chronic patient class, standards for tolerability and toxicity would be perceived differently than in an adjuvant setting.

Oncology science evolves rapidly and any static framework quickly becomes outdated by technology changes. To help drug developers and their key constituencies keep up, the working group recommended the development of early stakeholder consultations in drug development.

Explore this issue:

  • Improving health outcomes in breast cancer: recommendations of the Breast Cancer Working Group

    After developing a shared value framework focused on how new medicines can be assessed and rewarded, the Breast Cancer Working Group recommended that progress in this area should continue in the form of pilots of early multi-stakeholder consultations in drug development. The Working Group suggested that the consultations would require institutional commitment across Member States and that the objectives, structure, participants, and process details of the pilots should be fully transparent.

  • Improving health outcomes in breast cancer: advancing the shared value framework

    The Working Group completed a consensus framework for measuring the value of breast cancer medicines. Additionally, participants took initial steps to design a collaborative pilot process testing the merit of earlier consultations in drug development.

  • Multi-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.

  • A summary of the Breast Cancer Working Group’s recommendations

    After developing a Shared Value Framework focused on how new medicines can be assessed and rewarded, the Breast Cancer Working Group recommended that progress in this area should continue in the form of pilots of early multi-stakeholder consultations in drug development. The Working Group suggested that the consultations would require institutional commitment across Member States and that the objectives, structure, participants, and process details of the pilots should be fully transparent.

  • The agenda for change: opportunities for improving health outcomes in breast cancer

    The Breast Cancer Working Group re-affirmed the need for more collaboration between stakeholders to support the sustainable development of innovative medicines.

  • Setting the agenda for change: developing a shared value framework for breast cancer

    The Working Group received input from a range of constituencies that called for improved patient outcomes despite rising healthcare costs and the decreasing incremental benefits of new medicines.

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