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Reimbursement & Market Access

Development with approval and access in mind

It has become apparent that regulatory success does not automatically equate to commercial success. Companies want to develop products with a competitive advantage when compared to competing products and alternative treatments. Doing so will allow access to the greatest potential population of users.

Developing with reimbursement and market access (RMA) in mind has become the new "make or break" of product commercial success. By understanding "market access" implications during development companies can design the right trial, create an optimal label, better leverage "evidence-based" or "outcome-based" medicine, and eliminate "access hurdles" by demonstrating patient, payer and provider value. Your company can also align clinical investment to payer reimbursement and patient access trends.

PAREXEL Consulting is uniquely positioned in its approach, fusion of expertise and integrated services to support product commercial success.

Clinical Trial Protocol Integration

  • Optimal Clinical Trial Design
  • Development of an Optimal Label
  • Comparative Effectiveness Research (Phase III/IIIb/IV)
  • Analysis of Clinical Endpoints
  • Quality of Life (QoL) and Patient Reported Outcomes (PRO)

Market Analysis and Access Assessment

  • Competitive Product Reimbursement Analysis
  • Payer Coverage Analysis
  • Health Policy Review and Implications to Commercialization
  • Setting of Care Considerations and Associated Payment Values
  • Review of Patient Access Hurdles
  • Product Coding Requirements and Strategy Development (HCPCS/CPT)
  • Compendia Coverage Analysis and Submissions

Economic Modeling

  • Cost Effectiveness
  • Cost Utility
  • Budget Impact
  • Quality Added Life Year (QALY)

Economic and Clinical Value Messaging

  • Local and Global Dossier Preparation and Submission
  • Local Dossier Translations: EU and AMCP (US)
  • Pricing and Reimbursement Committee Negotiations

Payer Strategy and Communications

  • Virtual Health Economies
  • Payer Advisory Boards
  • Mock P & T Committees
  • Journal Publications
  • Congress and Symposia Presentations and Posters

HelpLine™ Contact Centers

  • Reimbursement
  • Patient Assistance Program (PAP)
  • Risk Evaluation and Mitigation Strategy (REMS)
  • Product Information

More information at: www.parexelconsulting.com