In 2009, Joint Federal Committee (G-BA) received an application for review of non-medical procedures for treatment of benign prostatic hyperplasia (later this term was changed to “benign prostatic syndrome (BPS)”). Then in December of 2010, the Joint Federal Committee (G-BA) suspended the review of thulium laser resection (TmLRP) till the end of December 2016.
Additionally, the consultation process regarding procedures for treatment of BHP was initiated on 16 July 2015 and the Institute for Quality and Efficiency in Health Care (IQWiG) performed rapid assessment where three laser procedures were evaluated, including:
- Thulium laser resection of prostate (TMLRP)
- Thulium laser enucleation of the prostate (TmLEP)
- Laser photo-vaporization of the prostate (PVP)
This benefit assessment by IQWiG showed following results:
- TMLRP: Perioperative endpoints showed a shorter length of stay and a shorter duration of catheterization in comparison to standard treatment. Moreover, in the case of the adverse events, it was shown that blood transfusions are less frequently required in the case of TmLRP and that severe bleeding during treatment is less frequent than in the standard treatment;
- TmLEP could not be conclusively assessed due to insufficient evidence;
- PVP did not demonstrate higher benefit than standard treatment in relation to efficacy and safety outcomes.
Therefore G-BA came to the conclusion that the use of TmLRP for the treatment of BHP is adequately documented.
Thus, in the middle of June 2017 based on evaluated benefit and medical needs, G-BA approved TMLRP for coverage within statutory health insurance treatment of patients with the benign prostatic syndrome. The current decision was submitted to the Federal Ministry of Health (BMG) for examination and will enter into force after the announcement in the German Federal Gazette (Bundesanzeiger).
See rapid report developed by IQWIG here.
See press release in German here.
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