Background and research question: Currently, there are about 40 facilities operating worldwide (14 in Europe) offering hadron therapy. An additional 25 facilities (9 in Europe) are under construction and will go into operation in the coming years. In 2015, the Austrian centre, MedAustron, will be opened in Wiener Neustadt and start treating patients soon afterwards. In the next 3–5 years, the capacity in Europe will approximately double. Since a supply-induced demand is to be assumed, due to the considerable expansion of capacity in Europe, the health policy issues are: for which indications (tumour entities, stages) is evidence for a better efficacy and fewer side effects respectively, through hadron therapy (proton or carbon ion therapy) already available? Which clinical trials are currently running, which indications are also mentioned in guidelines, and/or are reimbursed in other social health insurance countries?

Methods: To answer the research question on the status of evidence, only systematic reviews from HTA institutions or regulatory agencies were included (identified in the CRD database and through hand search). Secondly, 4 trial registers were searched for ongoing studies, while recommendations for the deployment of hadron therapy were sought from various professional radiooncology societies, and searched for on websites containing clinical treatment guidelines. Concerning the issue of reimbursement in other European social health insurance countries, the respective institutions (G-BA/DE, BAG/CH, CVZ/NL, KCE/BE) were contacted.

Results: The report is based on 21 reviews/HTAs from 9 institutions in 7 countries. In addition, 34 ongoing controlled trials, a few recommendations from professional societies and mentions in S3 and NCCN guidelines, as well as in UpToDate, could be identified.
Based on this information there is a wide consensus in Europe and the USA, as well as in the German Society for Radiooncology, on the following points:
• The curative (non-palliative) intention of any kind of treatment is the main focus of hadron therapy.
• Only a few (priority) standard indications are valid: paediatric tumours, spinal and paraspinal sarcomas and carcinomas, eye tumours (not indexed for brachytherapy), AVM/cerebral arteriovenous malformations, (some) head & neck and intracranial tumours. However, it is stressed that even in these tumours, plausibility is decisive, rather than proven scientific evidence.
• Reimbursement takes place – also in the case of standard indications – upon the condition of data documentation, i.e. of trial conditions (prospectively planned) and registers for adverse events and long-term side effects.
• It is repeatedly emphasised that a great need for research exists.

Conclusion: The evidence basis for an added benefit is only very moderate. Since surrogate endpoints were primarily measured and no/hardly any prospectively comparative trial results with up-to-date photon therapy are available, there is no confirmed knowledge on whether the promise of theoretical advantages can be translated into patient-relevant advantages (longer survival, quality of life through fewer side effects).

Recommendation: It is recommended that MedAustron ist to be considered primarily a scientific project for the execution of appropriate trials and to be funded accordingly.