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- Reimbursement Consulting, Healthcare Business Solutions
- Healthcare Market Research
- Healthcare Education, Healthcare Education And Training
- Hotline Assessments and Patient Assistance Programs
- Expanded Access Program
- Case Studies
- Market Research - Leveraging insight from Payors
- Comparative Cost Analysis - Pharmaceuticals
- Healthcare Reform Analysis
- Health Technology Assessment - Oncology
- Reimbursement Call Center and Patient Assistance Program Design - Multiple Product Classes
- Comparative Effectiveness Review - Diabetes
- Reimbursement Training and Field Reimbursement Call Tracking Tool
- Competitive Intelligence - Urology
- Product Commercialization and Reimbursement Landscape Analysis - Oncology
- Clinical Services Evaluation - Specialty Pharmacy
- Commercialization Strategy - Deep Vein Thrombosis
- Coverage Analysis - Drug Delivery System
- Reimbursement Coverage and Coding Analysis - Vascular Stents
- Health Economic Analysis - Rheumatoid Arthritis
- Health Economics Analysis - Diabetes Mellitus Blood Glucose Monitoring
- Expanded Access
- Comprehensive Clinical Analysis and Clinical Protocol Design - Migrane
- Outcomes Research Plan - Gastroenterology
- Clinical Compendium and Gap Analysis - Pain Management
- Reimbursement Landscape Analysis - Rare Bleeding Disorders (Hemophilia)
- Disease Area Review and Burden of Illness Analysis - Oncology
- Hospital Inpatient Payor Claims Analysis - Hospital Acquired Infections
- Health Economic Analysis - Orthopedics
- Market Valuation - Opioids
- Meta Analysis - HIV (Human Immunodeficiency Virus)
- AMCP Dossier - Dermatology
- Competitive Intelligence - Infectious Diseases
- Competitive Intelligence - Contraception
- Reimbursement Landscape Analysis - Urology
- Health Economics Analysis - Crohn's Disease
- Comprehensive Reimbursement and Health Economic Analysis - Neurovascular Disease
- Patient Assistance Program Design - Insulin Products
- Health Technology Assessment - Wound Therapy System
Case Studies
Expanded Access
Insight
A global pharmaceutical company had purchased a number of smaller biotech companies over the years and had legacy compassionate use and named patient programs for a number of oncology products. The company sought to make some significant decisions including Termination of the various expanded access programs Continuation of the expanded access programs as is Development of a consolidated and strategic expanded access programStrategy
The Aequitas Group assessed and analyzed all the current programs and interviewed key stakeholders in the process including the regulatory bodies of the different countries and key internal staff. Commercialization and clinical consultants at The Aequitas Group reviewed programs in similar therapeutic areas that were provided by other companies in a variety of countries as well as the regulatory framework for each country. A strategic plan was created that encompassed best practices for running an expanded access program, the consequences of terminating the existing programs and methods for developing a cost efficient model for running an improved new program in a compliant manner for each country. Recommendations were made for clinical, legal and regulatory criteria for the execution of the new program.Execution
The Aequitas Group developed a program that included many of the recommendations for best practice. The Aequitas Group worked closely with the company Program Manager to develop Standard Operating Procedures for the program and provide implementation assistance. A custom designed database was created which enabled the company to monitor, audit and successfully administer the program. The Aequitas Group provided training for internal staff as well as regular updates on regulations and feedback from stakeholders. Finally, the Aequitas Group was intimately involved in the transitional execution of the program until internal resources were fully developed.© 2009 The Aequitas Group, Inc. All Rights Reserved.