In Clinical Leader, Lorenzo D’Angelo discusses how to mitigate risks and maximize the benefits of pre-launch access programs to meet the intended goal to support patient access to treatment. Pre-launch programs can be be structured to provide additional safety and efficacy data that can support regulatory requirements, and can increase awareness of both a disease and progress in research among patients and clinicians and can highlight and reinforce a company’s commitment to patients. There are, however, some risks associated with pre-launch access programs, such as high costs and efficacy concerns. It is important that companies carefully assess both the potential benefits and risks associated with pre-launch access programs to determine the best structure to optimize benefit.
Read the full piece in Clinical Leader here.
Part 4: Inflation Reduction Act: The indirect effects and implications of IRA price negotiations
Since passage of the Inflation Reduction Act (IRA) in August 2022, the focus of many industry analysts and pharmaceutical companies has been on two important...