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Demonstrating product value is becoming more complex across therapeutic areas and impacting biotech, specialty and larger pharma alike. The key stakeholders involved in the ultimate success of a drug, and their evidence needs, continue to evolve as the marketplace transforms from volume- to value-based performance.
Coupled with the need for time and cost efficiency in clinical development, this drives a need for cross-functional convergence through process and organizational optimization. This must focus on stakeholder inclusiveness, systems value integration and agile evidence delivery.
Recommitting to strategic and operational basics with consistent and integrated processes will be vital to enabling cross-functional teams to efficiently deliver integrated asset development programs and get high value products to the patients who need them. In addition to improved process rigor, organizations should focus on fundamentals around culture, incentives, training and communication to consistently meet evolving health system evidence needs.
As global healthcare costs continue to rise, and health systems continue to reform to contain these costs, the key stakeholders involved in the ultimate success of a drug and their evidence needs continue to evolve – requiring companies to embrace valuebased healthcare to drive improvement in population outcomes and maximize return on innovation. Nowhere is the demand for integrated valuation of biopharmaceuticals more poignant than in oncology today, with traditionally medically focused organizations such as ASCO, MSKCC and the NCCN all demanding evidence of value from oncologics. (For more on the implications of interdependent healthcare trends, please see IQVIA’s previous publication, Value to Outcomes.)
The pharmaceutical company’s mandate to collect the right evidence to demonstrate a medicine’s value to stakeholders has never been stronger, driving an evolution in Regulatory, Clinical, Market Access, Medical (including Health Economic Outcomes Research (HEOR)) and Commercial strategies in clinical development.
To align with this landscape shift and new market demands, some pharma companies have started to transform their business model from a transactional organization towards an integrated, outcomes-based approach. Evidence of this strategy can be seen across the biopharmaceutical industry under the rallying cry of selling outcomes. The systems view governing the market today warrants linking and synchronizing these components within companies to amplify health system performance. Evidence development, translation and demonstration requires a harmonized process.