Uterine Perforation

Data showed similar costs at year one and year five for hormonal and non-hormonal IUD use, including when incorporating duration of use and surgical management of uterine perforations ROSWELL, Ga., March 21, 2023 /PRNewswire/ -- Sebela Women's Health Inc, a part of Sebela Pharmaceuticals, will present findings from a post-hoc comparison of payer costs for hormonal and non-hormonal intrauterine devices (IUDs) during the Academy of Managed Care Pharmacy Congress, March 21-24, 2023, in San Antonio, TX. Seven years of U.S. commercial claims data were analyzed to improve estimates of long-term, real-world costs, with specific attention to costs related to IUD complications and device removals. The study included paid claims from individuals aged 12-45 years who had an IUD inserted in 2014 and were continuously enrolled for one year prior and after the insertion of a new IUD. The cohort included 45,709 (72.1%) individuals with a hormonal IUD (13.5mg [Skyla®] or 52mg levonorgestrel (LNG)-releasing [Mirena®]) and 8,035 (12.7%) with a non-hormonal (copper-based [Paragard®]) IUD. The data—obtained from MarketScan®, a commercial claims database from Merative™—were examined using diagnosis codes for procedures and services related to IUD use. This approach allowed the researchers to evaluate factors impacting real-world IUD costs, such as imaging costs during device insertion/removal, the duration of device use, and procedures utilized in the management of complications. "While IUDs are one of the most effective forms of contraception available to women today, they may be underutilized. These data begin to appropriately reposition these long-acting reversible contraceptives as important options for patients, with limited meaningful economic impact to the healthcare ecosystem and payers," said study author Dr. Brian T. Nguyen, Program Director, Fellowship in Complex Family Planning, Associate Professor, Department of Obstetrics & Gynecology, Keck School of Medicine of the University of Southern California. The study showed that excluding insertion costs, the mean cumulative five-year costs were similar between the two IUD types: $1,548 for those with the hormonal (n=9,992) and $1,389 for the non-hormonal IUDs (n=1,509). Notably, half of all IUDs were removed within 4 years, which is shorter than the FDA-approved lifespan at the time of the study for the 52 mg LNG and copper IUDs. Costs due to complications incorporated any paid claims associated with known adverse events during the time of IUD use. In the study, surgical management of uterine perforations occurred slightly more frequently with the non-hormonal (3.5%) versus the hormonal (2.8%) IUD in the first year after insertion; cumulative five-year perforation rates were similar between the two IUD types (non-hormonal 4.8% vs. hormonal 4.4%). The incidence and costs of these complications warrant future investigation to inform future payer programs on the provision of adequate contraceptive coverage. Dr. Nguyen continued: "This comprehensive comparison of real-world utilization and costs associated with non-hormonal and hormonal IUDs identifies a need for continued innovation with IUDs, particularly now in the U.S. with the current dialogue." About Sebela Pharmaceuticals® Sebela Pharmaceuticals is a US pharmaceutical company with a market leading position in gastroenterology and a focus on innovation in women's health. Sebela Women's Health has two next-generation intrauterine devices (IUDs) for contraception in the final stages of clinical development. Braintree, a part of Sebela Pharmaceuticals, is the market leader in colonoscopy screening preparations for over 35 years, having invented, developed and commercialized a broad portfolio of innovative prescription colonoscopy preparations and multiple gastroenterology products. Braintree also has several gastroenterology programs in late-stage clinical development. Sebela Pharmaceuticals has offices/operations in Roswell, GA; Braintree, MA; and Dublin, Ireland; has annual net sales of approximately $200 million; and has grown to over 320 employees through strategic acquisitions and organic growth. Please visit sebelapharma.com for more information or call 844-732-3521. Forward Looking Statements This press release and any statements made for and during any presentation or meeting contain forward- looking statements related to Sebela Women's Health Inc. under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. These statements may be identified by the use of forward-looking words such as "anticipate," "planned," "believe," "forecast," "estimated," "expected," and "intend," among others. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the development, launch, introduction and commercial potential of IUDs as described herein; growth and opportunity, including peak sales and the potential demand for these IUDs, as well as their potential impact on applicable markets; market size; substantial competition; our ability to continue as a growing concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third-party payer reimbursement; dependence upon third parties supply and manufacturing uncertainties; our financial performance and results, including the risk that we are unable to manage our operating expenses or cash use for operations, or are unable to commercialize our products, within the guided ranges or otherwise as expected; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Sebela Women's Health Inc. does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances except as required by law. SOURCE Sebela Pharmaceuticals Inc