• Health Technology Assessment (HTA):
  • Many countries have formal HTA processes to evaluate the clinical and economic benefits of a new drug or device. These bodies use RWE to understand how a product performs outside the controlled environment of clinical trials.
• Reimbursement and Pricing Negotiations:
  • Payers, like insurance companies or government bodies, are increasingly interested in outcomes-based contracts. Here, the reimbursement level is tied to the real-world performance of the drug or device.
  • RWE can provide evidence that supports the value proposition of a product, helping in negotiations with payers for optimal pricing and reimbursement conditions.
• Post-Marketing Commitments:
  • Sometimes, regulatory bodies approve a drug or device with the condition that manufacturers collect post-marketing data on its safety and efficacy.
• Label Expansion:
  • After initial approval, a manufacturer may want to expand the approved uses of a drug (indications). RWE can provide evidence for such off label use, especially when randomized controlled trials (RCTs) are not feasible.
• Patient Access Programs:
  • RWE can help design and monitor patient access programs or compassionate use programs, ensuring that patients derive real-world benefits while managing risks effectively.

Here are few examples of how Kaolel can support you in leveraging RWE to enable access:

• Economic Evaluation:
  • This helps payers and policymakers determine whether a product offers value for money compared to other treatments available.
• Comparative Effectiveness Research (CER):
  • CER compares the benefits and harms of different interventions and strategies to prevent, diagnose, treat, and monitor health conditions.
  • This provides a clearer picture of how a new product performs relative to existing ones in real-world settings.
• Patient-Reported Outcomes (PROs):
  • PROs capture patients’ experiences, including quality of life, symptom relief, and overall satisfaction.
• Value Dossiers:
  • Manufacturers create comprehensive value dossiers that consolidate clinical, economic, and patient-reported evidence to demonstrate the value of their product to payers and other stakeholders.
• Demonstrating Value Over Competitors:
  • In crowded therapeutic areas, RWE can highlight the advantages of one product over another in real-world settings, making it more attractive to payers and prescribers.
• Identifying Unmet Needs:
  • By analyzing RWE, life science companies  can identify gaps in care, patient populations that aren’t being adequately served, or areas where adherence to medication is low. This information can be used to design better access strategies.