The objectives of this module are to:
- Discuss the relevant considerations for developing an effective patient access strategy
- Explain the different routes to market, and their implications for patient access
- Provide real-world examples of off-label and on-label drug use
- Review the key steps in creating a viable business case
This module describes the process of making an approved drug available to patients. From the developers side, this starts with understanding the potential value of the new Medicinal product, and creating a plan that delivers the main Value propositions to the key Stakeholders in the access chain: namely funders, investors, regulators and national payers. Without clear value for these groups, it becomes exceptionally challenging to enable wide patient access.
Market access for medicines is essential as it ensures that patients receive timely Benefitsfrom new therapies through market authorisation, Health technology assessment(HTA) and Reimbursement. Market authorisation confirms the Safety and Efficacy of a drug, while HTA and payer assessments evaluate its clinical and economic value compared to existing treatments, influencing pricing and reimbursement decisions. Reimbursement is crucial for making these medicines affordable and accessible, ultimately leading to better health outcomes.
While many of the core Market access activities occur post-authorisation, delaying all decisions and planning until this stage can result in significant delays to patient access. Consequently, it is crucial to consider the different routes to market and the strategy for maximising patient access early in the drug repurposing process.