– Scenario Script: Module 3 Week 1
Saba Pharmaceuticals Ltd. is an international drug company with manufacturing sites in locations in Europe and the USA. The CEO and board of directors are responsible for managing overall operations in the company. The company has three manufacturing sites managing an expanding drug portfolio. The manufacturing and production of drugs involve various departments: Production, Engineering, Quality assurance, Quality Control, Validation and Operations.
Sam is a pharmacist in the Dublin manufacturing plant and the manager of the production team. This team consists of six pharmacists and ten technicians who manufacture drugs using validated processes and machinery. The company was recently successful in obtaining marketing authorisation from the EMA for a new drug that addresses an unmet need in a condition affecting a significant number of individuals worldwide. The Dublin manufacturing plant, specifically Sam’s team, has been chosen as one of the production sites for end-product manufacturing of the new drug. The manufacture will require a significant change to existing processes and the operation of new machinery.
Sam is responsible for managing his team to maintain efficiency and productivity whilst introducing a change to the current work process.
2. Answer the following questions. Refer to Task 2 of the individual rubric for guidance.
– Discuss how the Health Outcomes Unit prepares a cost-effectiveness analysis for a new drug application.
– Discuss the impact the increased cost will have on the original cost-effectiveness analysis and the potential decision of the healthcare payer.
– Discuss implications of the increased cost on clinicians and patients, and any actions they may take