EUnetHTA project plan for regional hyperthermia for high-risk soft tissue sarcoma treatment has been published

In mid-May 2019, the network of European HTA agencies, EUnetHTA, announced the final plan of the project OTCA18 “Regional hyperthermia for high-risk soft tissue sarcoma treatment.”

This project is being executed by The Norwegian Institute of Public Health (NIPHNO) and the Italian Region of Emilia Romagna. The dedicated reviewers are Swiss Network for HTA (SNHTA), State Health Care Accreditation Agency (VASPVT, Lithuania) and Health Institute Carlos III, AETS-ISCIII, the Spanish HTA body.

The rationale of this assessment is to collaboratively produce structured (rapid) core HTA information on regional hyperthermia for high-risk soft tissue sarcoma. In addition, the aim is to apply those collaboratively created assessments in the national or regional context.

This rapid assessment addresses the research question whether, for oncological patients with high-risk soft tissue sarcoma, the regional application of non-invasive external hyperthermia administered in addition to chemo- and/or radiotherapy is more effective and/or safer than radio- and/or chemotherapy alone.

This topic was chosen based on a request from the National System for Introduction of New Health Technologies within the Specialist Health Service in Norway. They proposed the topic to the Norwegian Institute of Public Health. The relevance of the topic lies in the fact that the therapy is already in use for selected patients, but it is very resource demanding and not a generally accepted treatment modality. Regional hyperthermia could be especially useful for patients where it is not possible to remove the entire sarcoma surgically or when surgery would be mutilating (for example requiring amputation).

The Core Model® for Rapid Relative Effectiveness Assessment Version 4.2 will be used as the reference framework for the selection of the assessment elements per domain. Within the Rapid Relative Effectiveness Assessment, the technical characteristics of technology (TEC) under assessment (i.e., type of device, procedure) will be described, Health problem and current use of the technology (CUR) (i.e., target condition, target group), Clinical Effectiveness (EFF) (i.e., relative benefits) and Safety (SAF) (i.e., unwanted or harmful effects) will be assessed.

The devices planned to be assessed include, inter alias, BSD 2000 devices produced by Pyrexar Medical, EHY devices produced by Oncotherm, ALBA 4D devices produced by Med-logix, Celsius TCS device produced by Celsius 42, Synchrotherm devices produced by Synchrotherm, HYDEEP devices produced by Andromedic.

The final version of this rapid assessment is expected to be published at the beginning at the end of September 2019.

See the whole plan in English here.

EUnetHTA also published the experts’ and manufacturers’ comments, which can be found here and here.

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