The Implementation of Lutathera® Therapy

Introduction: Significant data can be found on the safety and efficacy of Lutathera® therapy as well as the price of treatment, which averages at $50,000 per dose in the United States (Bjork, et al., 2020). As patients, treating and referring physicians learn more about the benefits of this life-saving treatment it follows that the number of medical institutions that will open their doors to offer theranostic services will only increase over time. This research aims to explore answers to the central question of: Where is the cost and time going in starting and running a Lutathera® therapy program?

Methods: Two methods were used in this research: (1) Review and analysis of published literature on Lu-177 dotatate Lutathera®; and (2) qualitative inquiry, where in-depth interviews of key participants in medical institutions involved in Nuclear Medicine and Lutathera® therapy program were conducted.

Results: A major portion of the cost and time in running a Lutathera® program goes to labor. Data from the interviews reveal that a Radiologist or Nuclear Medicine Physician, Nuclear Medicine Technologist, and an Infusion Registered Nurse need to be present during therapy. The amount of time required can vary anywhere from six to eight hours. The second category is pharmacy and radio-pharmacy. Antiemetics, two 500-ml bags of amino acids, long-acting octreotide 30 mg, and the Lutathera® dose comprise the items going into the cost. However, the cost for each item may depend upon different variables. One variable can be the hospital’s participation in Section 340B of the Public Health Service Act. This is legislation that allows medical institutions that serve patients who are considered low-income and those who lack insurance to purchase outpatient drugs at lower costs (American Hospital Association, March 2021). Another variable is the physician’s choice of antiemetic and amino acids, which can affect the cost. An added variable, and perhaps the primary one is patient insurance. Medicare and Medicaid services as well as numerous insurance providers have different reimbursement policies for each Lutathera® dose and associated pharmaceuticals (Advanced Accelerator Applications, January 2019). Equipment such as infusion pumps, an acrylic container to hold the Lutathera® dose, a GM survey meter for frequent monitoring, and items such as intravenous catheters, tubing, pre-filled normal saline syringes, PPE, protective floor covering are in the bathroom as spill precaution are essential materials in each procedure. The fourth contributor to the cost is the private suite where therapy is performed. The interviews reveal that a single therapy session is typically billed as an outpatient procedure. Note there is a difference in cost and Medicare reimbursements depending upon whether the therapy is performed in a single site operator (SSO) facility, or in a multi-platform operator (MPO) facility set by the Center for Medicare Services (CMS) (VMG Health, April 2021). Additionally, for a facility to offer this service, it must have a radioactive material (RAM) license, which is an annual expenditure that is an added component to the total cost. Finally, the department requires a gamma camera with low-energy collimators in order to pick up the low-energy photons.

Conclusions: Determining the cost of running a theranostic program can be divided into two categories: structured and variable. This research has shown that the structured cost can be categorized into five parts: labor, pharmacy/radiopharmacy, materials for delivery, private hospital suite, and SPECT/CT Camera. Variables to the cost, on the other hand, are a demonstration of the complexities of the healthcare delivery system. Theranostic therapy is a multidisciplinary practice, and by analyzing each step of the process, this study has revealed additional data to help nuclear medicine technologists and associated medical professionals educate themselves on the new and exciting potential of theranostic medicine.