What are market
access challenges?

Market access refers to the process of ensuring that patients have timely, consistent, and affordable access to drugs and medical products. Pharmaceutical manufacturers often negotiate reimbursement terms with payers to secure a favorable formulary position, or inclusion on medical policies. However, several challenges can impact successful market access.

Key Market Access Challenges

1. Pricing and Reimbursement Hurdles

• Price Controls and Cost Containment: Governments and insurers impose strict pricing regulations to manage healthcare budgets (e.g., Medicare drug price negotiations in the U.S.).
• Health Technology Assessment (HTA) Requirements: Agencies like NICE (UK), ICER (U.S.), and CADTH (Canada) conduct evidence-based reviews of specific therapies to help determine a fair price.
• Budget Impact Considerations: Payers may limit access if a drug is deemed too costly relative to its clinical benefits, or if the drug has insufficient differentiators from its competitors.
  
  

2. Regulatory and Compliance Barriers

• Variability Across Markets: Each country or region has different regulatory pathways and reimbursement processes.
• Post-Marketing Requirements: Some approvals come with real-world evidence (RWE) obligations, which require ongoing data collection on effectiveness and safety.
• Data and Evidence Standards: Payers demand high-quality HEOR (Health Economics and Outcomes Research) data to justify reimbursement.
  
  

3. Competitive Landscape

• Biosimilars and Generics: Lower-cost alternatives can challenge the adoption of branded drugs.
• Existing Standard of Care: If a strong competitor exists, payers may resist covering new, more expensive treatments unless there is clear differentiation.
• Therapeutic Class Crowding: Multiple new drugs in the same category may lead to pricing pressure and access restrictions.
  
  

4. Payer and Provider Engagement

• Limited Payer Budgets: Payers prioritize treatments that offer the most cost-effective benefits, making negotiations difficult.
• Formulary Restrictions: Payers may impose step therapy, prior authorizations, or tiered pricing, limiting patient access.
• HCP Awareness & Adoption: Physicians may be reluctant to switch from familiar treatments, even if new options are available.
  
  

5. Patient Access & Affordability Issues

• High Out-of-Pocket Costs: Co-pays, deductibles, and lack of insurance coverage can limit patient uptake.
• Geographic Disparities: Rural or lower-income populations may face additional access barriers.
• Patient Adherence: Even when drugs are accessible, adherence to treatment regimens can be low without proper patient support programs.

How Companies Overcome Market Access Challenges

• Early Payer Engagement: Work with payers and pharmacy benefit managers (PBMs) early to align on evidence expectations.
• Strong HEOR and Real-World Evidence (RWE): Demonstrate both clinical efficacy and cost-effectiveness.
• Flexible Pricing Models: Explore value-based contracts, risk-sharing agreements, and affordability programs.
• Patient Assistance Programs (PAPs): Improve affordability through copay assistance and educational programs.
• Stakeholder Education: Ensure physicians, payers, and patients understand the treatment’s value proposition.
  
  

Pharma companies must work to overcome these complex access challenges when they bring a new product to market. To learn how to secure favorable coverage for your therapy, read our ebook, The Essentials of Market Access.