A Review of the Development of Companion Diagnostic Assays and their Relationship to Public Health translation missing: zh.hyrax.visibility.files_restricted.text

Sullivan, Ryan (2017)

Permanent URL: https://etd.library.emory.edu/concern/etds/m039k565z?locale=zh
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Abstract

Bringing a companion diagnostic (CDx) to market is a complex process involving several stakeholders including the pharmaceutical industry, regulatory bodies, health financing entities (payers) and healthcare providers. In order to capitalize on synergies between public health policy makers and CDx developers, both groups should better understand the motivations of the other. Policy makers interested in maximizing the public health impact of CDxs through increased development, adoption and use should take into account financial and investment decisions affecting CDx development.

This SSP presents a synthesis of existing literature to educate/inform public health policy makers about the motivations of developers responsible for CDx generation. This information can assist public health decision makers responsible for guidelines and public finance to make such decisions with an appreciation of the dynamic environment in which developers of companion diagnostics operate in the private sector.

Table of Contents

TABLE OF CONTENTS

CHAPTER ONE: INTRODUCTION 1 1.1 CONTEXT 1 1.2 PURPOSE / PROBLEM STATEMENT 3 CHAPTER TWO: METHODS 3 2.1 SEARCH PROCEDURE 3 2.2 INCLUSION/ EXCLUSION CRITERIA 5 CHAPTER THREE: RESULTS REVIEW 6 3.1 ASSESSMENT OF KEY STAKEHOLDERS 6 3.2 BIOMARKER STATUS / FDA MEDICAL DEVICE: 9 3.3 REGULATORY AVENUES TO MARKET 10 3.4 FDA RECCOMENDATION FOR PARALLEL DEVELOPMENT 13 3.5 PHARMACEUTICAL DEVELOPMENT PROCESS 15 3.6 CO-APPROVAL PROCESS 16 3.7 LABELING 18 3.8 INTERNATIONAL REGUALTION 18 3.9 REIMBURSMENT 19 3.10 COMPANION DIAGNOSTIC MARKET EVALUATION 25 3.11 MARKET GROWTH 27 3.12 SPECIALTY GROWTH AREAS 28 3.13 ONCOLOGY MARKET 33 3.14 TYPES OF CDX TESTING 34 3.15 INTERNATIONAL MARKETS 36 CHAPTER FOUR: DISCUSSION 37 4.1 PUBLIC HEALTH IMPACT 37 4.2 STRATEGIC BUSINESS MODEL 40 4.3 DECREASED CLINICAL TRIAL COSTS 40 4.4 INCREASE IN TO MARKET SUCCESS RATE 43 4.5 PHYSICIAN UPTAKE 45 4.6 DIFFERENTIATION 46 4.7 CDX VALUE PROPOSAL FOR DEVELOPERS 47 4.8 CASE STUDY KEYTRUDA & OPTIVO 48 4.9 CONCLUSION 50 SOURCES 53

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