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Cost-Efficient Transcriptomic-Based Drug Screening
Published on: February 23, 2024
Clinical and economic challenges facing pharmacogenomics
J Cohen1, A Wilson, K Manzolillo
1Tufts University School of Medicine, Tufts Center for the Study of Drug Development, Boston, MA 02111, USA. joshua.cohen@tufts.edu
The Pharmacogenomics Journal
|January 11, 2012
Summary
Personalized medicine faces challenges in companion diagnostic reimbursement and evidence generation. Increased comparative effectiveness research is recommended to address these gaps and support pharmacogenomic growth.
Area of Science:
- Pharmacogenomics
- Health Economics
- Regulatory Science
Background:
- Personalized medicine and companion diagnostics offer tailored treatments but face clinical and economic hurdles.
- Existing research highlights regulatory and reimbursement complexities for these innovations.
Purpose of the Study:
- To examine clinical, regulatory, and reimbursement challenges for personalized drugs and companion diagnostics.
- To assess Medicare reimbursement for selected personalized medicines and companion diagnostics.
- To survey stakeholders on diagnostic reimbursement, evidence impact, and pharmacogenomics challenges.
Main Methods:
- Review of clinical, regulatory, and reimbursement issues for eight personalized medicines and companion diagnostics.
- Analysis of Medicare Parts B and D reimbursement data.
- Surveys of payers, drug/diagnostic developers, and pharmacogenomic analysts.
Main Results:
- Medicare Part B drugs show broad access; Part D drugs face more restrictions (prior authorization, quantity limits).
- Companion diagnostics lack comprehensive reimbursement, even when FDA-approved and labeled.
- Payers are skeptical of diagnostic utility due to insufficient evidence linking tests to health outcomes.
Conclusions:
- Lack of clinically useful diagnostics and evidence on effectiveness hinders personalized medicine growth.
- Post-hoc companion diagnostic development is expected to grow moderately; co-development is limited.
- Comparative effectiveness research is crucial for closing evidence gaps and advancing pharmacogenomics.
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