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OBJECTIVE To highlight the challenges and differences regarding the reimbursement of breakthrough medical device technologies, by example of a novel cancer treatment using Tumor Treating Fields (TTFields). BACKGROUND TTFields is a breakthrough cancer treatment modality. The treatment is delivered through a medical device with the brand name Optune. Its efficacy was first established in glioblastoma multiforme. Reimbursement challenges for medical devices vary by. Common issues for novel device technologies like Optune however, are the difficulties to classify the treatment in the respective country’s health care system with the ability to develop a value-based reimbursement pathway. MATERIALS/METHODS We reviewed reimbursement decisions of payers for Optune from a total of 6 countries. We assessed their classification of the device, the flexibility of their health care framework and how Optune was implemented. RESULTS All 6 countries implemented Optune in their respective health care systems. 3 countries consider Optune to be an outpatient treatment delivered by durable medical equipment, one country classifies Optune as a hospital dispensed medical device, one country classifies Optune as an extended medical service and the last country as rehab services.The differential fitting of Optune in the respective country’s health care system allows each of the countries to take a positive, value-based reimbursement decision for this breakthrough technology. Generally, the speed of payer adoption for Optune varied based on the ability to assess the clinical data, rather than the more technical aspects of how the device is delivered to patients. CONCLUSIONS Classification of a breakthrough technology like Optune in the traditional framework of health care systems is challenging and handled differently by each country. Countries with a flexible approach regarding this novel oncological treatment modality however, were able to reach positive reimbursement decisions by classifying Optune in the category most suitable in the respective country’s health care system.

HOUT-24. CHALLENGES AND SUCCESSES IN THE GLOBAL REIMBURSEMENT OF A BREAKTHROUGH MEDICAL TECHNOLOGY FOR TREATMENT OF GLIOBLASTOMA MULTIFORME