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Comparative effectiveness research: the view from a pharmaceutical company
Marc L Berger1, David Grainger
1Eli Lilly and Company, Indianapolis, Indiana, USA. berger_marc@lilly.com
Pharmacoeconomics
|September 14, 2010
Summary
Comparative effectiveness research (CER) is crucial for demonstrating drug value. The innovative pharmaceutical industry must embrace CER to meet payer and agency demands for compelling evidence.
Area of Science:
- Pharmaceutical Science
- Health Policy Research
- Medical Intervention Analysis
Background:
- Comparative effectiveness research (CER) is an evolution in medical intervention knowledge development.
- The innovative pharmaceutical industry faces challenges in demonstrating drug value.
- Understanding the history of drug development provides context for current CER trends.
Purpose of the Study:
- To describe challenges facing the pharmaceutical industry regarding CER.
- To summarize the history of drug development.
- To review the international status and policy role of CER and health technology assessment (HTA).
Main Methods:
- Literature review of CER and HTA.
- Analysis of industry challenges and evolving requirements.
- Case study of a pharmaceutical company's response.
Main Results:
- CER and HTA face limitations in evidence availability and scope.
- Embracing CER is essential for pharmaceutical companies to prove pipeline product effectiveness.
- Evolving regulatory and HTA agency requirements impact drug development.
Conclusions:
- Increased understanding and alignment are emerging among drug development partners.
- Pharmaceutical companies must adapt to demonstrate compelling evidence for payers and HTA agencies.
- CER is a critical component for the future of drug development and evaluation.
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