News

Non-inferiority of PVP with the GreenLight XPS™ laser compared to TURP considered to be sufficiently proven based on new clinical data

We are happy to announce that the Federal Joint Committee (G-BA) has published a final, positive benefit assessment decision on photoselective vaporization (PVP) for the treatment of benign prostatic syndrome (BPS) on February 15, 2018. New clinical data has thus provided sufficient evidence that PVP is non-inferior to the standard treatment TURP (transurethral resection of the prostate). Furthermore, PVP demonstrates clinical benefits regarding secondary endpoints.

Boston Scientific welcomes the latest G-BA decision and the consequences resulting from it for clinical practice: G-BA will adopt changes to the guidelines “Methoden Krankenhausbehandlung (Hospital Care Methods, KHMe-RL)” and “Methoden vertragsärztliche Versorgung (Ambulatory Care Methods, MVV-RL)” for PVP. The well-tried minimally invasive procedure will therefore be established in ambulatory care and will continue to remain a necessary treatment option for in-patient care. For urological clinics and centers this means that the important reimbursability is guaranteed in the long run for performing a PVP. This also applies to the thulium laser enucleation in both settings, since the G-BA also issued a final decision to change the respective guidelines here.

G-BA decision and justification documents for PVP:

• Guideline „Methoden Krankenhausbehandlung (KHMe-RL)“
  
• Guideline „Methoden vertragsärztliche Versorgung (MVV-RL)“
  
  

G-BA decision and justification documents for thulium laser enucleation:

• Guideline „Methoden Krankenhausbehandlung (KHMe-RL)“
• Guideline „Methoden vertragsärztliche Versorgung (MVV-RL)"

Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) confirms benefit of thulium laser resection (TmLRP) for patients with benign prostatic syndrome (BPS)

Boston Scientific welcomes the G-BA’s recent decision to adopt changes to both the “Methoden vertragsärztlicher Versorgung“ (ambulatory care methods, MVV-RL) and “Methoden Krankenhausbehandlung“ (hospital care methods, KHMe-RL) guidelines for thulium laser resection (TmLRP) for the treatment of benign prostatic syndrome (BPS).

There are several methods of treatment for BPS that are authorized in Germany, transurethral resection of the prostate (TURP), adenectomy, holmium laser resection (HoLRP) and holmium laser enucleation (HoLEP). Prostate resection by means of the thulium laser (TmLRP) procedure is another method for the treatment of BPS and can be deployed as an alternative to the previously mentioned treatment options for patients with an appropriate medical indication.  The laser’s vaporizing effect is used to cut out tissue from the enlarged prostate using a continual stream of energy, rather than the pulsed energy output provided by holmium laser resection.

The text of the G-BA decision and the main justifications are available online on the G-BA website at https://www.g-ba.de/.