A clinical-stage biopharmaceutical company was planning to launch a novel treatment delivered via infusion indicated for patients with a neurological condition. Within three years of product approval and launch, the number of active patients was expected to exceed 100,000. To ensure as many patients as possible would have access to this treatment option, the manufacturer was seeking to develop a patient access strategy that included financial support offerings to specifically address this goal – primarily through copay financial assistance and PAP (Patient Assistance Programs which provide free product for patients with inadequate or no insurance coverage).
Our client wanted to evaluate existing industry offerings to ensure their proposed patient support programming would be competitive and provide appropriate levels of assistance. At the same time, they sought to effectively use their resources to launch a program that was beneficial to as many patients as possible, and to accurately assess the budget impact before launching the programming.
Our plan was designed to help our client assess the market environment and provide the tools they needed to effectively develop their patient support programming in three main steps.
Conduct secondary research to gauge competitive program offerings within the therapeutic category and establish marketplace relevance
Conduct primary research with payers to assess the reimbursement landscape
Develop a customized financial exposure modeling tool with multiple input capabilities designed to help evaluate various patient support program scenarios and forecast budget impacts
Throughout each step, we collaborated with our client’s market access, finance and executive leadership teams to ensure the financial exposure modeling tool could effectively meet their needs.
We used both primary and secondary research findings to inform and establish multiple input scenarios required to develop the customized financial exposure modeling tool. Once completed, the modeling tool enabled our client to conduct simulations that generated outputs used to forecast financial outcomes for planning purposes and develop program eligibility criteria. These outputs included patient forecasts by service, program utilization and associated financial impacts among others. We helped our client assess these modeling outputs and guided them to develop effective patient support programming strategies and tactical program offerings. The model was also used to inform decisions pertaining to the development of business rules and standard operating procedures (SOPs) for each program. Once program strategies and tactics were established, we then worked with the client’s service providers to help them effectively implement the strategies, allowing our client to realize their goal of optimized post-launch access for most of the anticipated patient population.
It is anticipated that within the next 8 years up to 50% of all drugs in development will be biopharmaceuticals. As the development and subsequent use of biopharmaceuticals rise, so does the impact of their relatively high costs on the individuals who need them, and the resources required for manufacturers to provide the products affordably. With many biopharmaceuticals carrying annual costs in excess of $50,000 for a year of treatment, manufacturers must plan upfront for the financial exposures they may face. To help get these products in the hands of the patients who need them, manufacturers must establish effective strategies that can be used to develop robust patient support programs that enhance accessibility.