Critical Connection: Patient Services and Product Launch

To begin, based on your product strategy, potential patient pool, and planned services to be built into your program, assess the infrastructure needs of hosting and managing a patient services support program, spanning: * Technology and data management, such as the systems and technology to support secure handling of patient information, the complexity of business rules, and workflows associated with patient services administration. * Legal and regulatory compliance, such as organizational structure and bandwidth to support oversight of patient services in-house, regular monitoring, and remediation processes. * Human capital and staffing, considering that patient services generally rely on people resources and an investment in ongoing recruiting, hiring, and support for hub staff, as well as leadership and management for oversight. * Training and quality management, e.g., the structure and ongoing support needed to implement and maintain hub programs. * Facilities, including the infrastructure for the necessary equipment (computers, phones, etc.) and space to support a hub program, as well as secure areas to keep patient information safe. * Patient service management, considering the expertise needed to support the design, development, and ongoing operations of patient service programs. * Product service, such as the necessary processes and controls to meet a product's specific requirements, e.g., Risk Evaluation and Mitigation Strategy (REMS). [...]in a recent case, the manufacturer preferred to keep the customer relationship management in-house, so it decided to focus on front-end customer support and outsource payer-related services like benefits verification and prior authorization. Depending on the therapy, key service offerings might include: * Reimbursement support to help patients navigate insurance coverage. * Fast-start or bridge programs to help patients initiate therapy quickly while working through access challenges. * Patient financial assistance in the form of free product for uninsured patients, financial assistance, or copay assistance for underinsured patients, or referrals to charitable organizations for government-funded insured patients. * Nurse educator support to provide individualized education and product support to patients and their caregivers. * Adherence support to help patients initiate and stay on their therapy. * REMS support to meet FDA-directed requirements to prevent, monitor, and/or manage a specific serious risk by info