Theranostic Differences Between the United States and the Rest of the World

Objectives: The landscape for Nuclear Medicine is undergoing a transformation and the main driver is the emergence of Theranostics. Currently, the two main therapies are 177Lu-DOTATATE which is FDA-approved for the treatment of neuroendocrine tumors (NETs) and 177Lu-PSMA which is not FDA approved but in clinical trials for the treatment of metastatic castration-resistant prostate cancer. However, these therapies have been standard of care for many parts of the world leaving the United States to play catch-up. The objective of this study is to compare and contrast the differences of these therapies between the US and other parts of the world.

Methods: Protocols, patient selection and pricing were reviewed through published literature for treatment with 177Lu-DOTATATE in the United States and compared to Australia. The same was then done with Lu-PSMA comparing the United States with Germany.

Results: Comparing literature review for 177Lu-DOTATATE, we found that the FDA approved treatment for patients with NETs affecting the pancreas or gastrointestinal tract whereas in Australia all NETs can be treated. In addition, the US has a standard protocol for all treatments which does not take into account the tumor aggressiveness measured by Ki-67, does not do dosimetry, and requires only 68Ga-DOTATATE PET-CT prior to therapy. On the other hand, Australia has a more personalized treatment for the patient as it will tailor therapy based on the aggressiveness of the tumor, performs dosimetry, and may require both 68Ga-DOTATATE and 18F-FDG PET-CTs prior to therapy. The price of the study also varies significantly costing $50,000 USD per dose in the US vs $5,500 USD in Australia.Comparing the literature for 177Lu-PSMA is not as straightforward since it is still undergoing clinical trials in the US. Nevertheless, in Germany the total cost of the treatment is $16,000 USD which includes admission into the hospital for 5 days and all labs/imaging. If it is assumed the US follows the same pattern with pricing as with 177Lu-DOTATATE, it will be significantly more expensive than the German counterpart. Conclusion: The United States continues to trail behind the rest of the world in Theranostics. The therapies in the US lack personalization and are offered at a significantly higher cost. The counterparts across the world are able to tailor these therapies to their patients at a fraction of the cost. Differences such as these may leave the United States with lower success rates while having some of the highest healthcare costs in the world.