Healthcare
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Oncology science evolves rapidly and any static framework quickly becomes outdated by technology changes.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.
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