Building Pricing Discipline in Gene Therapy: How SOPs Strengthened Global Market Access

In the fast-moving world of gene therapy, science often takes center stage. But behind every launch, there’s another layer of complexity: ensuring that global pricing and market access operations run smoothly, consistently, and compliantly. For one biotech, operational inconsistencies in its Global Market Access and Pricing (GMAP) function were putting compliance and launch readiness at risk.

This case study explores how a structured assessment and the development of Standard Operating Procedures (SOPs)transformed pricing governance into a competitive advantage.

The Challenge

The biotech’s GMAP function was struggling with:

• Inconsistent workflows: Teams across regions and functions were managing pricing activities differently.

• Variable communication: No standard process for information flow, leading to misalignment.

• Governance gaps: Key decisions lacked clarity on ownership and escalation paths.

• Compliance risks: Without structure, pricing and HTA submissions risked running afoul of regulatory expectations.

The Head of GMAP recognized the need for a comprehensive situation assessment as the first step toward building standardized SOPs that would bring clarity, consistency, and compliance.


The Approach

The project unfolded in three stages, combining stakeholder insights with structured process design:

1. Listening to the Organization

Semi-structured interviews with stakeholders across R&D, Medical Affairs, Regulatory Affairs, Commercial, and HEOR provided a ground-level view of current practices. These conversations surfaced:

• Pain points in workflows

• Bottlenecks in governance

• Suggestions for improvement from those closest to the work

2. Assessing the Situation

Insights were synthesized into a diagnostic report outlining:

• Operational inefficiencies

• Governance gaps

• Both immediate fixes and longer-term structural needs

3. Defining and Building SOPs

Priority was given to SOPs covering:

• Global Pricing Committee (GPC) operations: Establishing clear rules for decision-making, documentation, and escalation.

• Implementation & Change Management: Training sessions were delivered virtually to ensure consistent understanding across geographies.

• Compliance Monitoring: Mechanisms were put in place to track adherence and ensure sustainability.
  
  The Impact
  
  

  The rollout of SOPs created a measurable shift in how the GMAP function operated:

  • Efficiency gains: Streamlined workflows reduced duplication and delays.

  • Regulatory confidence: Compliance in HTA and pricing submissions was strengthened.

  • Strategic alignment: Teams across functions and geographies worked from a single playbook.

  • Launch readiness: With structured governance in place, the organization was better prepared for upcoming launches and external stakeholder engagements.
    
    Why It Matters
    
    

    For gene therapy companies, where pricing can determine patient access and commercial viability, operational excellence is not optional. This case highlights how even breakthrough science can falter if pricing governance isn’t clear, consistent, and compliant.
    
    
    By investing in SOPs, the biotech turned pricing from a source of risk into a source of strategic strength, ensuring that every future launch is backed by disciplined, transparent, and aligned processes.
    
    
    Takeaway: In advanced therapies, operational discipline is as critical as scientific innovation. SOPs are not bureaucracy, they’re the backbone of sustainable global access.