Pricing and Reimbursement of Next Generation Diagnostics in the United States

Table of Contents

• Executive Summary
  • Strategic Considerations
  • Stakeholder Implications
• Introduction
• What Are Next-Generation Diagnostics?
• Next-Generation Diagnostic Tests Approved Since 2001
  • Roche/Affymetrix' s AmpliChip CYP450
  • Third Wave Technologies' UGT1A1 Molecular Assay
  • Other Approved Next-Generation Diagnostic Tests in Select Indications
    • Oncology
    • Cystic Fibrosis
    • HIV
• Current Pricing and Reimbursement Environment for Diagnostics
  • Challenges of Health Outcomes Data
  • Introducing a New IVD Test to the Market
  • Strategies for Commercialization
• Medicare' s Role in Reimbursing Diagnostics
  • Coding
  • Coverage
  • Payment
• Reimbursing Diagnostics Through Private Payers
• Outlook

Tables

• 1. Select Approved Next-Generation Diagnostic Tests, 2001-2007
• 2. Requirements for the Award of Each Category of CPT Codes

Figures

• 1. Process for Developing Local Medicare Coverage Determinations
• 2. Process for Developing National Medicare Coverage Determinations
• 3. Percentage of HMOs That Restrict Use of Select Targeted Cancer Therapies to Patients with Relevant Gene Mutations
• 4. HMO Pharmacy Directors' Views on the Importance of Positive Biomarker Test Results As a Condition for the Use of Select Targeted Cancer Therapies
• 5. HMO Pharmacy Directors' Views on the Importance of Accompanying, Validated Biomarker Tests As a Condition for Formulary Inclusion of Future Targeted Therapies for Select Cancers

Sidebars

• Value of Outcomes Data: the Experience of Genomic Health
• Aetna-Spearheading Coverage of Next-Generation Diagnostics
• Format for Formulary Submissions-a Model for the Diagnostics Industry?