TABLE OF CONTENTS
EXECUTIVE SUMMARY
1. THE PRICING AND REIMBURSEMENT DECISION
- Overview
- Clinical Considerations
- The Clinical Development Process
- The Health Economics Process
- The Business Opportunity Assessment
- The Reimbursement Decision
- Pricing and Total Cost
- Achieving an Affordable Price
- Market Potential
- Pipeline Product Valuation
2. COST-OUTCOMES CLAIMS AND BUDGET IMPACT
- ASSESSMENTS
- The Role of the Health Economist
- Study Perspective: Traditional and Systems Approaches to Drug
- Evaluation
- What is the Case To Be Made for the New Product?
- The Systems Perspective
- The Traditional Reimbursement Case: The Australian Guidelines
- Place of the Product in Therapy
- The Comparator Product
- Preliminary Economic Evaluation
- Modelled Economic Evaluation
- Financial Impact
- Anticipating Formulary Submission Guidelines
- Guideline Evolution
- Proposed formulary submission template: the Mock
- Reimbursement submission
- The Role of Guidelines
- Proposed Template Structure
- Business Opportunity Assessments and the Mock
- Reimbursement Submission
- Overview: Modelling Inputs and Outputs
3. CLINICAL PRE-PHASE II: HEALTH ECONOMICS ACTIVITIES
- Overview
- Health Economics Activities
- Stage A: Foundation Health Economics Assessment
- Activity A1: Definition and Classification of Disease State
- Activity A2: Epidemiological Profile of Disease State
- Epidemiology: Defining our Terms
- Epidemiology: Potential Data Sources
- Activity A3: Health Economics Literature Review
- Activity A4: Preliminary Treatment Pattern Analysis
- Retrospective Chart Reviews
- Retrospective Administrative Claims Data Reviews
- Prospective Treatment Pattern Tracking Surveys
- Activity A5: Pooled Clinical Analysis of Comparator Therapies
- Activity A6: Evaluation of Treatment Guidelines and Patient Management Protocols
- Activity A7: Evaluation of Treatment Costs and Pricing Options
- Activity A8: Development of a Preliminary Business Opportunity Assessment
- Current and Projected Market Size
- Untreated Market Potential
- Treatment Pattern Analysis
- Unit Costs of Comparator Products and/or Procedures
- Development and the Probability of Success
- Resource Allocation: Supporting Stage A Health Economics Activities
- Stage B: First Revised Health Economics Assessment
- Activity B1: Update of Treatment Prevalence and Treatment
- Pattern Analyses
- Activity B2: Update of Health Economics Literature Review
- Activity B3: Update of Pooled Clinical Analysis of Comparator Therapies
- Activity B4: Review of Input Pricing Requirements
- Activity B5: Update of Treatment Costs and Pricing Options
- Activity B6: Update of Business Opportunity Assessment
- Activity B7: Allocation of Resources to Phase II Health Economics Activities
4. CLINICAL PHASE II: HEALTH ECONOMICS ACTIVITIES
- Overview
- Activities
- Stage C: Preliminary Assessment of Cost-Effectiveness Case
- Activity C1: Review of Dosage and Formulation Options
- Activity C2: Review of Outcomes Measures
- Activity C3: Review Case for a Quality of Life Measure
- Stage D: Second Revised Health Economics Assessment
- Activity D1: Update of Treatment Prevalence and Treatment Pattern Analyses
- Activity D2: Update of Health Economics Literature Review
- Activity D3: Update of Pooled Clinical Analysis of Comparator Products
- Activity D4: Update of Assessment of Treatment Costs and Pricing Options
- Activity D5: Development of Preliminary Patient Switching and Budget Impact Assessments for Health Systems
- Activity D6: Review Entry Requirements in Key Markets and Prepare Preliminary (Mock) Reimbursement Documentation
- Activity D7: Update of Treatment Guidelines, Patient
- Management Protocols and the Impact of Disease Management Programs
- Activity D8: Update of Business Opportunity Assessment
- Activity D9: Allocation of Resources to Phase IIIA Health Economics Activities
5. CLINICAL PHASE IIIA: HEALTH ECONOMICS ACTIVITIES
- Overview
- Phase IIIA: Active comparator trials
- Phase IIIA: Comparator choice
- Phase IIIA: External validity
- Health economics activities
- Stage E: Health economics input to protocol development for phase IIIA pivotal trials
- Activity E1: Update arguments for introducing health economics parameters in pivotal phase IIIA trials
- Activity E2: Update comparator choice in phase IIIA trial design
- Activity E3: Update choice of outcomes measures for phase IIIA trials
- Activity E4: Update arguments for quality of life claims
- Stage F: Health economics training
- Activity F1: Implementation of manager training in health economics
- Activity F2: Implementation of a health economics awareness programme to support phase IIIA clinical results dissemination
- Activity F3: Recruitment and training of medical liaison teams
- Stage G: Third revised health economics assessment
- Activity G1: Update of treatment prevalence and treatment pattern analyses
- Activity G2: Update of health economics literature review
- Activity G3: Update of pooled clinical analysis of comparator therapies
- Activity G4: Review of patient switching and budget impact assessments for healthcare systems
- Activity G5: Update of preliminary (mock) reimbursement submissions
- Activity G6: Update of business opportunity assessment
- Activity G7: Review of options to co-operate with healthcare systems and formulary committees in drug development activities
- Activity G8: Allocate resources to phase-IIIB- and pre-market-entry-related health economics activities
- Stage H: Health economics studies based on phase IIIA trials
- Activity H1: Review modelling options to establish traditional (ICOR) claims
- Activity H2: Undertake modelled traditional (ICOR) claims for key markets and market segments
6. CLINICAL PHASE IIIB AND MARKET PRE-ENTRY
- Overview
- Phase IIIB and the Role of Effectiveness Trials
- Reimbursement Submissions
- Market Entry Strategy
- Health Economics Stages
- Activity I1: Design and Implementation of Phase IIIB
- Effectiveness Trials
- Activity I 2: Evaluation of Results of Phase IIIB Effectiveness
- Trials for Reimbursement Review Consistency in Trial Design and Outcomes
- Stage J: Finalise Health Economics Case for Product
- Reimbursement
- Activity J1: Finalise Assessment of Treatment Prevalence and Treatment Patterns Analyses
- Activity J2: Finalise Health Economics Literature Review
- Activity J3: Finalise Pooled Analyses of Comparator Therapies and Phase IIIA and Phase IIIB Clinical Trial Results
- Activity J4: Finalise Patient Switching and Budget Impact Assessments for Health Systems
- Activity J5: Agree Pricing Strategy and Prepare Reimbursement Submission Dossiers
- Activity J6: Finalise Business Opportunity Assessment to Support Market Entry Decision
- Activity J7: Allocate Resources to Reimbursement Activities
- Stage K: Develop Training Materials and Implement Sales Training for Product Health Economics Case
- Activity K1: Assess Options for Training Materials and Staffing to Support Health Economics Marketing Case
- Activity K2: Implement Publications Strategy and Key Opinion Leader Training to Support Market Entry Strategy and Reimbursement
7. FORMULARY APPROVAL, CLINICAL PHASE IV AND POSTMARKET ENTRY
- Overview
- Reviewing the Clinical Case
- Health Economics Stages
- Stage L: Submission and Monitoring of Reimbursement
- Applications
- Activity L1: Submit Reimbursement Applications
- Activity L2: Monitor Status of Reimbursement Application Process
- Activity L3: Monitor Ongoing Reimbursement Status for Agency Reviews
- Stage M: Monitoring of Product Status and Implementation of Health Economics Activities to Maintain Product Status
- Activity M1: Ongoing Assessment of Need for Phase IV Trial
- Studies to support Health Economics Case in Selected Markets
- Activity M2: Ongoing Assessment of Need for Retrospective
- Treatment Pattern Studies to support Health Economics Case in Selected Markets
- Activity M3: Ongoing Assessment of Need for Modelled Evaluations to Support Cost-effectiveness Case in Selected Markets
- Activity M4: Ongoing Assessment of Communications Strategy to support Messages Generated by Activities M1 through M3
- Activity M5: Ongoing Quality Assessment of Sales Force Activities to take Health Economics Message to Providers.
8. SUMMARY AND CONCLUSIONS
- Recommended Health Economics Activities
- Market Segmentation
- Global Perspective
- The changing face of reimbursement
- Budget Impacts
- Validation of Claims
- Targeting of Patients
- Conclusions: Basic Themes
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