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Published on: December 9, 2015
Overcoming regulatory and economic challenges facing pharmacogenomics
1Tufts Center for the Study of Drug Development, 75 Kneeland Street, Suite 1100, Boston, MA 02111, United States. Joshua.cohen@tufts.edu
New Biotechnology
|February 29, 2012
Summary
Personalized medicine adoption faces barriers despite growth. Simultaneous development of therapeutics and companion diagnostics is hindered by regulatory and reimbursement challenges, limiting clinical utility evidence.
Area of Science:
- Biotechnology
- Genomics
- Pharmacology
Background:
- Personalized medicine and companion diagnostics have seen gradual growth since 2001.
- Despite advancements, adoption has not met the full potential envisioned after the human genome project.
- Significant clinical, regulatory, and economic hurdles impede widespread implementation.
Purpose of the Study:
- To examine the barriers to the clinical adoption of personalized medicines and companion diagnostics.
- To identify regulatory and economic challenges affecting the development and reimbursement of these targeted therapies.
- To propose strategies for overcoming obstacles to increase clinical integration.
Main Methods:
- Analysis of the current landscape of personalized medicine and companion diagnostic development.
- Review of regulatory processes for therapeutics and diagnostics.
- Examination of payer reimbursement policies and evidence requirements.
Main Results:
- Most personalized medicines are developed post hoc with separate companion diagnostics, not simultaneously.
- Complex regulatory pathways for diagnostics and lack of clear guidance contribute to this separation.
- Payer restrictions on reimbursement due to insufficient clinical utility evidence are a major barrier.
Conclusions:
- Simultaneous development of therapeutics and companion diagnostics is not the current norm.
- Clearer regulatory guidance and robust clinical utility evidence are crucial for increased adoption.
- Overcoming reimbursement barriers requires demonstrating the value of personalized approaches in clinical practice.
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