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Bringing liraglutide to market: a CER case study
Gary Oderda1, S Monet Sifford-Wilson
1Pharmacotherapy Outcomes Research Center, University of Utah, College of Pharmacy, 421 Wakara Way, Salt Lake City, UT 84108, USA. Gary.Oderda@pharm.utah.edu
Journal of Managed Care Pharmacy : JMCP
|June 6, 2012
Summary
Comparative effectiveness research (CER) can strengthen new drug adoption by providing robust evidence. Ongoing real-world CER is crucial for confirming benefits and managing risks post-launch.
Area of Science:
- Health economics and outcomes research
- Pharmaceutical policy
- Clinical trial design
Background:
- Drug manufacturers face market access challenges due to competition.
- Comparative Effectiveness Research (CER) can mitigate these barriers.
- Limited examples demonstrate the effective use and impact of CER data.
Purpose of the Study:
- To evaluate how CER enhances new drug market entry and formulary integration.
- To assess the value of ongoing CER during real-world drug implementation.
Main Methods:
- A roundtable discussion with 9 health plan representatives and formulary decision-makers.
- Case study analysis of liraglutide (a GLP-1 receptor agonist) development for type 2 diabetes.
- Review of CER integration within Phase 3 clinical development programs.
Main Results:
- Pre-launch CER, integrated into Phase 3 trials, strengthens evidence for formulary decision-makers.
- Liraglutide's development incorporated CER, comparing its efficacy against established therapies.
- Participants recognized the value of both pre-launch CER and ongoing real-world research for risk management and identifying new indications.
Conclusions:
- Well-designed trials with CER yield high-quality evidence supporting formulary adoption.
- Real-world data confirming Phase 3 results can influence a drug's formulary status and utilization.
- Ongoing CER is vital for confirming benefits, managing risks, and exploring additional uses.
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