Urolift is a device for minimally invasive procedure of treatment of benign hyperplasia of prostate.
In France, the technology was first assessed for add-on reimbursement via LPPR List in January 2016, when evidence was found sufficient to adopt technology, but the level of added value was found absent in comparison with transurethral resection of prostate (TURP). Because as of today, almost 1.5 years since the first assessment, the add-on reimbursement is not established, it is likely that Neotract Inc. and Economic Committee for Healthcare Products (Comité Economique des Produits de Santé, CEPS) at HAS did not agree on the pricing for the device, so the case was not taken forward.
However, in May 2017 National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) at HAS issued second assessment of the Urolift device, in which added value was found to be minor in comparison with TURP, which is a progress compared with the first assessment.
In the first assessment, the evidence included:
- Randomized controlled trial of 206 patients vs “phantom” procedure (the same procedure, but with no sutures) with one year of follow-up
- Three case series studies including 147 patients with follow-up between 3 and 24 months
- Assessment by the National Institute for Health and Care Excellence (NICE) in the UK in 2014
- Assessment of Urolift by the FDA in 2013
In the second assessment, additional evidence included:
- 3-year follow-up of previously available study
- Randomized controlled trial of 91 patients vs TURP
- Recommendation from the European Association of Urology
Recommended criteria for reimbursement include:
- Age above 50 years old
- Uncomplicated symptomatic benign hyperplasia of prostate
- Volume of prostate less than 80 ml
- No history of prostatic surgery
- No signs of infection
CNEDiMTS estimated annual size of eligible population between 3250 and 6500 patients. In the submission to the National Institute for Health and Care Excellence (NICE) in the UK, Neotract Inc. estimated average cost of device per patient at £1,320. It means that overall annual market potential for Neotract Inc. in France is between £4.2 mln. and £8.5 mln., if the same price is established.
If established, add-on reimbursement will be valid for 5 years. CNEDiMTS has requested a pragmatic, real-world study to support reevaluation of registration in 5 years, including characteristics of patients, specifics of use of Urolift, long-term outcomes in relation to symptoms of hyperplasia, rate and nature of re-interventions, and evolution of sexual function/symptoms.
The next key step in the process is pricing negotiation with Economic Committee for Healthcare Products. If successful, add-on reimbursement can be expected within 1-1.5 years.
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