Off-label usage of Lu-177 DOTATATE therapy : Challenges and Opportunities for the Theranostician

Background: Lutathera’s ( Lu-177 DOTATATE) FDA approval in 2018 in the United States for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) including foregut, midgut and hindgut neuroendocrine tumors in adults, ushered in a welcome change in the field the modern practice of theranostics. The deployment of lutathera and other similar PRRT therapies in any hospital or outpatient setting comes with its own challenges. Not many centers in the country are equipped to handle the treatment logistics including but not limited to having dedicated treatment areas, knowledgeable staff trained and equipped to handle the treatment and radiation safety contingency plans. For non-FDA approved indications, the ordeals hurdles are even larger and more complex. There are quite a few non-neuroendocrine indications not in the FDA label that Lutathera has shown promise in small cohorts outside the US. Such indications include: 1. Paragangliomas/pheochromocytomas. 2. Esthesioneuroblastomas/olfactory neuroblastomas. 3. Thymic and Pulmonary NET 4. Pediatric Neuroblastomas. 5. Intractable meningiomas refractory to conventional therapies such as multiple surgical resections and stereotactic radiation. In this educational exhibit, we examine pertinent cases and the benefits, pertinent case review, challenges, and opportunities for the nuclear medicine theranostician while dealing with matters of such off-label indications.

Objectives: To review the off-label indications of Lutathera vs the conventional standard of care for such rare indications. To examine some pertinent cases performed in our academic center and their unique circumstances that made such patients qualify for the lutathera option. To study the challenges faced by the theranostic team to get the third-party payor approval, review step-by-step approaches such as the peer review process with the insurance companies to accomplish the authorization and approval. To evaluate the role of the theranostician (nuclear medicine or the theranostic team leader) in orchestrating the team-play amongst the referring physicians/ oncologists, tumor boards, the lutathera treatment center, P&T pharmacy & therapeutics committee, hospital administration, and the third-party payors.