EUnetHTA project plan for biodegradable rectum spacers to reduce toxicity for prostate cancer published

In late November 2019, the network of European HTA agencies, EUnetHTA, announced the final plan of the project OTCA23 “Biodegradable rectum spacers to reduce toxicity for prostate cancer.”

This project is being executed by the Norwegian Institute of Public Health (NIPHNO) together with the Romanian National School of Public Health, Management, and Professional Development (NSPHMPDB). The dedicated reviewers are Swiss Network for HTA (SNHTA), Lithuanian State Health Care Accreditation Agency (VASPVT) and National Institute of Care and Excellence in health (NICE, UK).

The rationale of this assessment is to collaboratively produce structured (rapid) core HTA information on biodegradable rectum spacers for prostate cancer radiotherapy. Also, the aim is to apply those collaboratively produced assessments in the national or regional context.

This rapid assessment addresses the research question of whether for adult oncological patients with prostate cancer receiving curative radiotherapy, the application of biodegradable rectum spacers is more effective and/or safer for rectum toxicity than no rectum spacer.

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. The relevance of the topic lies in the fact that due to the close proximity of the prostate to the rectum wall when curative radiotherapy is indicated to patients, the rectum can be damaged and cause unwanted consequences to patients.

The HTA core model® for Rapid Relative Effectiveness (REA) will be used, focusing on the technical characteristics of technology (TEC) under assessment (i.e., type of device, procedure), 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).

It is planned to identify manufacturers that have devices (hydrogel, balloon, hyaluronic acid) that are relevant for rectum protection for prostate cancer treatment. The manufacturers will be invited to provide the description and technical characteristics of the technology, information regarding health problem and current clinical practice, current use of the technology, and investments and tools required.

The final version of this rapid assessment is expected to be published at the end of May 2020.

The full details in English can be found here.

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