Abstract
Introduction
Drug-test (RxDx) companion products pair a drug and a diagnostic test that can
tell physicians which patients will benefi t most from treatment with the
drug. This report examines whether it is appropriate to ask
pharmaceutical/biotech and diagnostics companies to develop these products
when they may question what benefit they will receive from such development;
after all, these companies are already developing good drugs and good tests to
treat many people. We examine the FDA' s efforts to encourage development of
RxDx products, possible incentives to both drug and diagnostics companies, the
companies that we believe are currently suited to fi nd success, and what
factors will likely play into this success.
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The benefi ts of RxDx companion products could be very high for individual
patients and society. However, decisions in the drug and diagnostics
industries are based on economics. What will development of such tests
cost? How will companies know when it makes fi nancial sense to develop
them?
Technology now exists to exploit the information in human genes to make better
medicines that treat not just large patient populations but also individual
patients through personalized medicine. How can drug and diagnostics
companies best benefi t from this new knowledge? How can they strike a balance
between public benefi t and company profit? Try as the FDA might to
encourage the codevelopment of RxDx products, a lack of obvious economic
benefi t to the pharmaceutical and diagnostics industries has caused these
industries to drag their feet in the development of personalized medicine and
RxDx products specifi cally. What incentives are being considering to
encourage development of these products? Can the cost of development be
decreased? Should pricing/reimbursement for RxDx products be increased? What
other incentives are reasonable?
Decision Resources, Inc. 5-2
The goal of incentives to encourage development of RxDx products must be to
balance the needs of many stakeholders-including patients, doctors, and payers
as well as diagnostics and pharmaceutical/biotech companies. What monetary
or legislative incentives can benefi t most stakeholders? Aside from economic
considerations, what factors could stand in the way of development of these
tests?
Scope
- Key codevelopment concepts: April 2005 FDA paper "Drug-Diagnostic
Co-Development Concept Paper," and ownership and role of biomarkers.
- Benefi ts and incentives for stakeholders: detailed coverage of
four incentive possibilities.
- Case study: Herceptin, HER-2 tests, and a pharmaceutical company
executive' s perspective on the value of RxDx.
- Outlook: DxRx partnering challenges, parallel and nonparallel RxDx
partnerships, and companies to watch.
Mentioned in This Spectrum Report
Companies
- Abbott
- Applera
- Arup Laboratories
- AstraZeneca
- Bayer
- BioGenex
- Biogen Idec
- Bristol-Myers Squibb
- Celera Genomics
- Chugai
- Clinical Data
- Dainippon Sumitomo
- Dako
- Elan
- Eli Lilly
- Genentech
- Genomic Health
- Genzyme
- Genzyme Genetics
- GlaxoSmithKline
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- Hoffmann-La Roche
- ImClone
- Johnson & Johnson
- MedImmune
- Merck KGaA
- Novartis
- Merck & Co.
- Perlegen
- Pfi zer
- PGx Health
- Prometheus Laboratories
- Riken
- Roche
- Schering AG
- Schering-Plough
- Serono
- Tanabe
- Ventana Medical Systems
- Vysis
- Wyeth
- Zenyaku
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