The Market Access Puzzle: Beyond Traditional Pricing Models

Historically, generics competed on cost, with pricing wars defining market access strategies. VAMs, however, require a different approach. These products improve existing therapies by enhancing bioavailability, reducing side effects, or offering more convenient administration routes—all of which add value beyond mere cost savings.

But how do you price value? This is the core challenge for pharmaceutical companies today. Unlike novel drugs, which often benefit from high pricing due to exclusivity, VAMs need to justify their added value in a cost-conscious healthcare environment. Regulatory agencies and payers are increasingly looking for real-world evidence (RWE) and health economic outcomes before granting premium reimbursement rates.

Evidence-Based Value Proposition

Market access for VAMs depends on proving clinical and economic benefits. At SK-Pharma, we invest in real-world data collection, post-marketing studies, and health economic models to showcase how our VAMs provide:

• Better patient adherence(e.g., reduced pill burden, once-daily dosing).
• Lower hospitalization rates (by reducing side effects or improving disease management).
• Faster or more effective treatment outcomes (precision medicine approaches).

By presenting compelling health-economic data, we strengthen our case for higher reimbursement tiers and inclusion in national and private healthcare formularies.

Unlike traditional generics, which rely on volume-driven sales, VAMs require a strategic partnership with payers. We engage early with insurers, health authorities, and pharmacy benefit managers to:

• Develop risk-sharing agreements(pay-for-performance models based on patient outcomes).
• Advocate for alternative reimbursement models(e.g., subscription-based access for chronic disease treatments).
• Work with healthcare providers to align VAM adoption with value-based healthcare initiatives.

Payers are more likely to support VAMs that reduce overall healthcare costs, even if they come at a slightly higher drug price. This means demonstrating long-term benefits, not just short-term savings.

While traditional generics follow a well-defined regulatory pathway, VAMs fall into a gray area. These products often require additional clinical trials or new regulatory classifications, depending on the jurisdiction.

K-Pharma actively works with regulatory agencies to:

• Streamline approval processes by leveraging real-world data and existing clinical research.
• Position VAMs within the right regulatory framework(whether as an improved generic, a new therapeutic entity, or an orphan drug).
• Ensure compliance with evolving regulatory requirements around patient safety, pharmacovigilance, and digital health integration.

Navigating these regulatory complexities ensures that our VAMs enter the market faster and with strong credibility.

Even if a VAM is clinically superior, physician and pharmacist adoption is not automatic. Many healthcare professionals are accustomed to traditional generics and may hesitate to switchwithout clear incentives.

SK-Pharma tackles this by:

• Conducting targeted medical education programsto showcase the clinical advantages of our VAMs.
• Collaborating with key opinion leaders (KOLs)to influence treatment guidelines and prescribing behaviors.
• Offering digital health tools that support personalized treatment regimens and improve adherence.

By ensuring that healthcare professionals recognize and trust the added value of our medicines, we accelerate adoption and market penetration.