NHS England Reimburses Optilume® Urethral Drug Coated Balloon as Part of the Specialised Services Device Programme

PORTSMOUTH, N.H., April 30, 2024 /PRNewswire/ -- Laborie Medical Technologies Corp. (Laborie), a leading diagnostic and therapeutic medical technology company, welcomed the inclusion of Optilume^® Urethral Drug-Coated Balloon (DCB) into the National Health Service (NHS) Specialized Services Device Programme (SSDP) as of April 1, 2024. This national payment scheme ensures NHS Hospitals in England will be reimbursed for the cost of the Optilume Urethral DCB, enabling patients to benefit from wider access to the technology.

The SSDP, formerly the High-Cost Tariff Excluded Devices programme (HCTED), reimburses innovative healthcare technologies that meet specific clinical and economic criteria separately from the core payment mechanism for medical treatments and interventions in the NHS.

Optilume^® Urethral DCB combines balloon dilation of the urethra with the delivery of an anti-proliferative drug to prevent the recurrence of urethral strictures. This minimally invasive technology is expected to have a significant impact in the urology community, offering a breakthrough treatment option for urethral strictures that would traditionally require major surgery or need frequent retreatment¹.

"The Optilume Urethral DCB has been clinically and economically proven through randomized clinical trials and economic evidence^2,3,4, and has been evaluated by the National Institute for Health and Care Excellence (NICE)," said Kyle Knauf, Vice President and General Manager of Interventional Urology at Laborie.

In November 2022, Optilume received National Institute for Health and Care Excellence (NICE) guideline recommendations that it is safe, effective, and cost saving to use in clinical practice in the NHS for the treatment of anterior urethral stricture, providing improved clinical and economic benefits to patients versus the existing endoscopic standard of care⁵.

"The inclusion as part of national funding provides all clinically eligible patients in England access to treatment that is a more clinically effective and durable solution while providing cost efficiencies to the NHS," Knauf continued. "We look forward to continuing to provide the NHS and its patients with clinically proven technologies that preserve and restore human dignity."

About Laborie Medical Technologies

Headquartered in Portsmouth, New Hampshire, Laborie is a global medical technology company focused on Urology, Urogynecology, Gastroenterology, Obstetrics, Gynecology & Neonatal Health. We manufacture and deliver high-quality, high-impact diagnostic and therapeutic products that help clinicians and hospitals preserve and restore patient dignity. Clinicians and hospitals look to us as the market-leading experts in our business segments, and we support our products with a world-class Clinical Education & Information program. Laborie is a portfolio company of Patricia Industries. For more information visit www.laborie.com.

References

1. Heyns CF, Steenkamp JW, De Kock ML, Whitaker P. Treatment of male urethral strictures: is repeated dilation or internal urethrotomy useful? J Urol. 1998 Aug;160(2):356-8. doi: 10.1016/s0022-5347(01)62894-5. PMID: 9679876.
2. VanDyke ME, Morey AF, Coutinho K, Robertson KJ, D'Anna R, Chevli K, et al. Optilume drug-coated balloon for anterior urethral stricture: 2-year results of the ROBUST III trial. BJUI Compass. 2024; 5(3): 366?373. 
3. Mann, Rachel; Delong, Jessica; Virasoro, Ramon; Elliott, Sean PD35-08?4 YEARS OF THE OPTILUME^® DRUG COATED BALLOON FOR RECURRENT ANTERIOR URETHRAL STRICTURES: A SUMMARY OF ROBUST I, II AND III, Journal of Urology: April 2023 - Volume 209 - Issue Supplement 4
4. Kelly L, Shore J, Wright J, Patrick C, Holmes H. Economic evaluation of Optilume, a drug-coated balloon for recurrent anterior male urethral stricture. BJUI Compass. 2023 Apr 10;4(4):430-436.
5. Optilume for treating recurrent bulbar urethral strictures (MTG73). ISBN: 978-1-4731-4803-1. https://www.nice.org.uk/guidance/mtg73 

SOURCE Laborie Medical Technologies