Advanced Market Access Strategy for Specialty Medicines Training Course

Advanced Market Access Strategy for Specialty Medicines Training Course

Introduction

Specialty medicines have transformed patient care, especially for rare diseases and complex conditions. However, getting these innovative therapies to patients requires navigating a labyrinth of regulatory hurdles, pricing and reimbursement challenges, and fragmented healthcare systems. Advanced Market Access Strategy for Specialty Medicines Training Course addresses these complexities, providing an advanced toolkit for professionals to develop and execute winning market access strategies that ensure patient access and drive commercial success. We'll explore the latest trends in health technology assessment (HTA), value-based agreements, and real-world evidence (RWE), equipping you with the skills to confidently lead your organization's market access efforts in a dynamic global landscape.

This training program goes beyond traditional market access concepts to focus specifically on the unique challenges presented by specialty pharmaceuticals. We'll delve into the nuances of orphan drugs, cell and gene therapies, and oncology products, which require bespoke strategies due to their high cost, small patient populations, and often limited clinical trial data. Participants will learn how to build compelling value stories, engage with key opinion leaders (KOLs) and patient advocacy groups, and leverage digital health solutions to optimize market access. By mastering these advanced strategies, you will be prepared to overcome barriers and secure timely, broad patient access for life-changing medicines.

Course Duration

10 days

Course Objectives

Upon completion of this course, participants will be able to:

1. Craft and execute a robust global market access strategy for specialty medicines.
2. Develop a differentiated value proposition and a compelling value story for diverse stakeholders.
3. Effectively leverage real-world evidence (RWE) and health economics and outcomes research (HEOR) to support market access.
4. Navigate complex pricing and reimbursement negotiations across different healthcare systems.
5. Understand and prepare for Health Technology Assessments (HTAs) and their impact on market access.
6. Strategically engage with payers, policymakers, and patient advocacy groups.
7. Build a cross-functional market access team and foster internal collaboration.
8. Anticipate and adapt to emerging trends like value-based care and outcomes-based agreements.
9. Develop a pre-launch strategy that integrates market access from early development stages.
10. Implement digital health solutions to enhance patient support and evidence generation.
11. Manage the unique challenges of market access for orphan drugs and gene therapies.
12. Design and optimize patient support programs to ensure access and adherence.
13. Analyze and respond to competitor market access strategies in a crowded therapeutic landscape.

Organizational Benefits

• Faster time to market and broader patient access for specialty medicines.
• Maximized revenue potential by securing favorable pricing and reimbursement.
• Reduced uncertainty and risk associated with complex regulatory and payer environments.
• Built a core team with the advanced skills to lead and execute winning market access strategies.
• Gained a significant edge in a highly competitive market by mastering cutting-edge market access techniques.
• Fostered a culture of collaboration between R&D, clinical, commercial, and legal teams.
• Streamlined the market access process, saving time and resources.

Target Audience

1. Market Access Professionals.
2. Commercial Leaders.
3. HEOR and RWE Specialists.
4. Medical Affairs.
5. Senior Executives.
6. Regulatory Affairs and Public Policy.
7. Consultants.
8. Patient Advocacy and Government Affairs.

Course Modules

Module 1: Foundational Principles of Market Access for Specialty Medicines

• Understanding the evolving market access landscape for specialty drugs.
• Defining key stakeholders: payers, providers, and patients.
• The role of Health Technology Assessments (HTA) and regulatory agencies.
• The unique challenges of orphan drugs and rare diseases.
• Case Study: Analyzing a successful market access strategy for a breakthrough rare disease therapy in the EU and US.

Module 2: Strategic Value Proposition Development

• Crafting a compelling and evidence-based value story.
• Identifying and articulating the unmet medical need.
• Translating clinical data into a clear economic and patient value message.
• Tailoring the value proposition for different payer segments.
• Case Study: Reconstructing the value story for a high-cost oncology biologic to secure payer buy-in.

Module 3: Advanced Pricing and Reimbursement Strategies

• Global pricing models and their application to specialty medicines.
• Negotiating outcomes-based and value-based agreements.
• Managing pricing challenges for multiple indications and follow-on therapies.
• Navigating the nuances of formulary access and reimbursement pathways.
• Case Study: Developing a tiered pricing strategy for a gene therapy based on long-term clinical outcomes.

Module 4: Health Economics and Outcomes Research (HEOR)

• Designing and executing robust HEOR studies.
• Developing economic models (e.g., cost-effectiveness, budget impact).
• Integrating patient-reported outcomes (PROs) into evidence generation.
• Communicating complex HEOR data to non-expert audiences.
• Case Study: Building a budget impact model to demonstrate the long-term cost savings of a new cardiovascular specialty medicine.

Module 5: Real-World Evidence (RWE) in Market Access

• The growing importance of RWE for payers and HTAs.
• Sources of RWE: registries, electronic health records (EHRs), and claims data.
• Designing and implementing a strategic RWE generation plan.
• Addressing data quality and bias in real-world studies.
• Case Study: Using RWE to demonstrate the long-term clinical effectiveness and safety of a multiple sclerosis drug in routine clinical practice.

Module 6: Payer and Stakeholder Engagement

• Mapping and segmenting key payer organizations and decision-makers.
• Developing an effective engagement plan with HTAs and reimbursement bodies.
• Building partnerships with patient advocacy groups and KOLs.
• Mastering negotiation and objection handling with payers.
• Case Study: Simulating a payer negotiation meeting for a new orphan drug with a high list price.

Module 7: Market Access for Oncology and Hematology

• The specific challenges of oncology market access.
• Navigating complex clinical pathways and guideline recommendations.
• Managing the financial toxicity of cancer therapies for patients.
• Addressing payer concerns regarding combination therapies and biomarkers.
• Case Study: Crafting a market access strategy for an immunooncology drug facing significant competitor challenges.

Module 8: Market Access for Cell and Gene Therapies

• Addressing the unique market access barriers for CGTs.
• Exploring novel payment models like annuity payments and indication-based pricing.
• Managing the high upfront cost and uncertainty of long-term outcomes.
• Building the necessary infrastructure for supply chain and delivery.
• Case Study: A deep dive into the reimbursement challenges and solutions for a CAR-T cell therapy.

Module 9: Global vs. Local Market Access Strategy

• Developing a cohesive global strategy while allowing for local adaptation.
• Understanding the differences between major markets (e.g., US, Europe, Asia).
• Balancing global pricing strategy with country-specific needs.
• Managing multi-country HTA submissions and timelines.
• Case Study: A global pharmaceutical company's challenges in launching the same specialty medicine in Germany, France, and Japan.

Module 10: Digital Health and Patient Support Programs

• The role of digital health in enhancing market access.
• Leveraging digital tools for patient adherence and outcomes tracking.
• Designing patient support programs that are valued by payers.
• Integrating digital solutions to generate evidence and improve the patient journey.
• Case Study: Implementing a digital platform to track adherence and generate RWE for a chronic disease.

Module 11: Competitive Intelligence and Scenario Planning

• Analyzing competitor market access strategies and tactics.
• Developing a strategic response to new market entrants and biosimilars.
• Using scenario planning to prepare for future market changes.
• Identifying and leveraging competitive advantages.
• Case Study: Creating a competitive response plan for a new biosimilar launch that threatens a blockbuster specialty drug.

Module 12: Pre-Launch and Early-Stage Market Access

• Integrating market access considerations from early R&D.
• Designing clinical trials with payer needs in mind.
• The role of payer advisory boards and early scientific engagement.
• Creating a robust pre-launch strategy and timeline.
• Case Study: A biotech company's early-stage market access plan for a novel neurodegenerative drug in Phase II development.

Module 13: Market Access for Emerging Markets

• Understanding the complexities of market access in emerging economies.
• Adapting strategies for different healthcare infrastructures and payment systems.
• Navigating the challenges of local regulations and policy.
• Balancing access with sustainability and affordability.
• Case Study: Tailoring a market access strategy for a high-cost therapy in a large, but low-income, market.

Module 14: Market Access for Medical Devices and Diagnostics

• Exploring the differences between drug and device market access.
• Reimbursement pathways for innovative medical technologies.
• The role of diagnostics in personalized medicine and companion diagnostics.
• Demonstrating economic value beyond the clinical benefit.
• Case Study: Securing reimbursement for a novel diagnostic test that guides treatment selection for a specific cancer.

Module 15: Ethical Considerations and Compliance

• Understanding the legal and ethical framework for market access.
• Compliance with anti-bribery and anti-corruption laws.
• Ethical considerations in patient engagement and value communication.
• The importance of transparent and compliant interactions with stakeholders.
• Case Study: Navigating a complex ethical dilemma related to providing patient support programs.

Training Methodology

• Interactive Lectures.
• Real-World Case Studies.
• Simulations and Role-Playing.
• Group Projects.
• Expert Q&A Panels.

Register as a group from 3 participants for a Discount

Send us an email: [email protected] or call +254724527104 

Certification

Upon successful completion of this training, participants will be issued with a globally- recognized certificate.

Tailor-Made Course

 We also offer tailor-made courses based on your needs.

Key Notes

a. The participant must be conversant with English.

b. Upon completion of training the participant will be issued with an Authorized Training Certificate

c. Course duration is flexible and the contents can be modified to fit any number of days.

d. The course fee includes facilitation training materials, 2 coffee breaks, buffet lunch and A Certificate upon successful completion of Training.

e. One-year post-training support Consultation and Coaching provided after the course.

f. Payment should be done at least a week before commence of the training, to DATASTAT CONSULTANCY LTD account, as indicated in the invoice so as to enable us prepare better for you.