Strategies to address the challenges of pre-approval drug access
Given the rising demand for life-saving treatments, expanded access programs (EAP) allow companies to provide investigational new drugs and devices to patients in need. However, there are different types of EAPs and many factors to be considered to determine the approach that is most appropriate for a particular drug and/or company. These factors include, but may not be limited to, the expected demand for pre-approval access to the compound, ongoing clinical development plans, resource constraints, and regulatory challenges.
MK&A (Mark Krueger & Associates, Inc.), with its decades of experience in advocacy relations and pre-approval drug access, counsels companies facing these challenges. The firm is often asked to assist companies in aligning its approach to and communication around pre-approval access.
For example, one company recognized the need for formalizing a written expanded use policy with clear guidelines for inclusion and exclusion, as positive data milestones were expected and several pre-approval requests for its drug were received. Realizing that demand would increase, the company wanted to proactively incorporate a defined review process, clear decision-making criteria, and time frame for response.
The company was well versed and understood issues surrounding pre-approval drug access, but needed to broaden and deepen its understanding of the various options and their impact. MK&A first offered a primer to educate senior staff on different approaches and how each relates to the company’s internal values as well as external expectations and realities. After this, MK&A facilitated high-level conversations on how pre-approval drug access may work in key markets and applied this information and experience to its commercial launch strategies.
These in-depth and strategic conversations created a shared understanding of potential scenarios that allowed the company to further refine its strategy and plan for effective policies that would ultimately be in the best interests of patients, healthcare providers, and the company.
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