Trends and Innovations in Companion Diagnostics

March 2016 | | ID: T3A2C7E07CCEN
FirstWord

Abstracts

Are companion diagnostics becoming a “must have” for market access?

Companion Diagnostics (CDx) are playing an increasingly vital role in market access by supporting product value claims and improving patient outcomes. What are the upsides for developers, pharma, payers and physicians and how can the challenges around new technology adoption, reimbursement and clinician uptake be overcome?

To really understand the issues and trends that are shaping the CDx market, senior managers in diagnostic development companies and the pharma industry should turn to this report.

“Pharma companies around the world are scouring tumour cells to find something different. It’s logical that detecting those differences would in fact then be down to a companion diagnostic.” Rob Steitz, Insight Genetics Inc.

Answering key questions:

• Pharma’s benefit: Are CDx becoming essential for regulatory approval and clinical diagnosis?
• New therapy areas: Beyond oncology, what therapy areas are being targeted by CDx?
• All in the timing: At what stage should CDx be included in a drug’s development?
• New technologies: How revolutionary will next generation sequencing, liquid tumour testing, biopsies and bioinformatics be in driving future uptake of CDx?
• Engaging Physicians: Many physicians do not use approved CDx, or choose alternatives. Should the use of approved CDx be mandatory and enforced?
• Where’s the money? Reimbursement models do not reflect the wider value of advanced CDx – what are the options for change and how is this influencing developers thinking and investment?
• Point of Care: What are the future prospects for the development of PoC CDx?

With this report you will be able to:

• Identify the new CDx approaches and evaluate their benefits.
• Understand how and where they will impact the market and review the challenges they must overcome.
• Assess the activities, policies and partnerships of CDx-progressive pharma companies.
• Understand how financial and reimbursement models need to change to reflect the real value of CDx.
• Learn how advanced CDx can radically improve clinical trial research and outcomes.
• Formulate strategies that encourage physicians to use approved CDx.
• Identify the therapy areas and conditions where next generation CDx will make an impact.
• Grasp the growing importance of research consortia in the identification of biomarkers.

Key Topics Explored:

• Pharma is sometimes compelled to identify a CDx as part of securing regulatory approval, but physicians are not obligated to use it. Is it time to make their use mandatory?
• Reimbursement models do not allow for premium pricing of advanced CDx. Taking potential cost savings and improved patient outcomes into account, isn’t it time that a fair price was paid?
• Some pharma companies may see CDx as unnecessary revenue capping, while others take a more progressive view. Will the benefits of CDx mean they become key in supporting value claims and securing market access?
• Pharmaceutical companies, diagnostic companies, patients, physicians, payers, testing laboratories and regulators are all stakeholders. They should be engaged as early as possible.
• Payers have most to benefit by using CDx to ensure that expensive drugs are prescribed optimally, so why are some payers concerned?

Expert Contributors

• Frank Apostel, VP Companion Diagnostics, R-Biopharm AG, Germany
• Joachim Reischl, VP Head of Policy, Portfolio and Externalisation, Personalised Healthcare, AstraZeneca, EU
• Richard Watts, Vice President, Companion Diagnostic Partnerships, Global Business Development, QIAGEN, USA
• Rob Seitz, Chief Technology Officer, Insight Genetics Inc., USA
• William Pignato, Regulatory Affairs Consultant, Companion Diagnostic, USA
• Director, CDx Development, Japanese Pharma Company
• Director, Corporate Development, European Diagnostic Company
• Companion Diagnostic Expert, Global Diagnostic Company
• Companion Diagnostic Expert, Specialist Diagnostic Company

All respondents met FirstWord’s stringent screening criteria, and were compensated for participating. To encourage frank and forthright responses, their names have been withheld.

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Contents

1 EXECUTIVE SUMMARY

2 RESEARCH OBJECTIVES

2.1 Research Methodology
2.2 Definitions

3 SETTING THE SCENE

4 CLINICAL AND ECONOMIC BENEFITS OF DEVELOPING A COMPANION DIAGNOSTIC

5 RECENT INNOVATIONS IN PRECISION MEDICINE AND COMPANION DIAGNOSTICS

6 RECENT TECHNOLOGICAL INNOVATIONS IN COMPANION DIAGNOSTICS

7 DRIVERS AND INHIBITORS FOR THE UPTAKE OF CDX

8 FACTORS INFLUENCING SUCCESSFUL/UNSUCCESSFUL PARTNERSHIPS

9 OPTIMAL AND SUB-OPTIMAL PRACTICE FOR DEVELOPING COMPANION DIAGNOSTICS

10 REGULATORY IMPACT ON THE DEVELOPMENT AND UPTAKE OF CDX

11 MANAGING STAKEHOLDER EXPECTATIONS ON CDX PROGRAMMES

12 WHAT NEEDS TO BE DONE TO ENCOURAGE FUTURE INNOVATION IN CDX DEVELOPMENT?

13 FUTURE OPPORTUNITIES IN CDX AND PRECISION MEDICINES

14 APPENDIX