Extended coverage expands access to iTind for BPH-related LUTS

Several coverage updates have expanded patient access toiTind, a temporary nitinol device used to treat lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH).¹

Olympus, the developer of iTind, explained in a news release that the CVS Health company Aetna has updated its coverage to include iTind for patients with a “prostate volume between 25 and 75 g and no obstruction in the median lobe.”¹ The company also reported in the news release that 3 regional health plans updated their polices to include iTind, expanding coverage in the states of Delaware, Florida, North Carolina, Pennsylvania, South Carolina, and Washington, DC. Olympus noted that Aetna and the other coverage expansions affect nearly 30 million individuals.¹

Olympus previously reported that the American Urological Association had added iTind to its clinical practice guideline for the management of LUTS attributed to BPH.² 

"We are very pleased to see these positive coverage updates for the iTind procedure," Paul Skodny, PharmD, executive director for Health Economics and Market Access at Olympus Corporation, stated in the news release.¹ "Olympus is committed to supporting physicians and patients in accessing recommended and proven BPH therapies like the iTind procedure."

Olympus previously reported that the American Urological Association had added iTind to its clinical practice guideline for the management of LUTS attributed to BPH.² 

Data on iTind

Data from the MT02 study (NCT02145208) evaluating the long-term efficacy of the iTind device in patients with BPH-related LUTS showed a significant and durable reduction in symptoms and improved quality of life (QoL) for more than 48 months following treatment.³

In total, 41 patients were followed for 50 to 79 months following treatment with an average follow-up time of 60.2 months. Patients included in the long-term study spanned across 3 international sites in Italy, Switzerland, and Belgium.

Data showed a durable improvement in patient symptoms, with an International Prostate Symptom Score (IPSS) reduction of 45.2% from baseline to 79 months following treatment (P < .0001). The average IPSS score was 11.26 (standard deviation = 7.67) among all patients. Similarly, data showed an IPSS-QoL reduction of 45.1% among all patients over the same time period (P < .0001), with an average score of 2.10 among all those included in the study (standard deviation = 1.41).

Further, there were no post-operative complications reported from 36 to 79 months, and no patients required additional medication. Only 4% of patients required surgical retreatment after 36 months. In total, 11.1% of patients from the original study cohort (n = 81) required surgical retreatment from baseline to 79 months.

References

1. iTind™ Procedure Available to More Patients through Extended Commercial Payer Coverage. Published online and accessed April 16, 2023. https://www.prnewswire.com/news-releases/itind-procedure-available-to-more-patients-through-extended-commercial-payer-coverage-302118255.html

2. Novel iTind procedure now included in treatment guideline for lower urinary tract symptoms caused by enlarged prostate. News release. Olympus Corporation. Published online September 28, 2023. Accessed April 16, 2023. https://www.prnewswire.com/news-releases/novel-itind-procedure-now-included-in-treatment-guideline-for-lower-urinary-tract-symptoms-caused-by-enlarged-prostate-301941709.html

3. Amparore D, De Cillis S, Schulman C, Kadner G, Fiori C, Porpiglia F. Temporary implantable nitinol device for benign prostatic hyperplasia-related lower urinary tract symptoms: over 48-month results. Minerva Urol Nephrol. Published online June 23, 2023. doi:10.23736/S2724-6051.23.05322-3