Adenomyosis in women undergoing hysterectomy for abnormal uterine bleeding associated with uterine leiomyomas.

BACKGROUND: Uterine leiomyomas and adenomyosis are both common and often associated with abnormal uterine bleeding (AUB), including the symptom of heavy menstrual bleeding (HMB). Understanding the prevalence of adenomyosis in women with uterine leiomyomas could inform clinicians and patients in a way that may improve therapeutic approaches. OBJECTIVE: To explore the prevalence of adenomyosis in a group of women who underwent hysterectomy for AUB-L, to determine the prevalence of submucous leiomyomas, and to examine the utility of preoperative ultrasound to detect the presence of adenomyosis. METHODS: The Kaiser Permanente Hysterectomy Database (KPHD) was searched for women aged 18-52 undergoing hysterectomy for leiomyoma-associated chronic AUB (AUB-L) in 2018 and 2019. A target sample of 400 comprised those with at least 3 years in the Health System. Radiologists evaluated preoperative pelvic ultrasound images to determine leiomyoma size and level 2 FIGO type (submucous or other), and the linked electronic medical record abstracted for clinical features, including histopathological evidence of adenomyosis. RESULTS: Of the 370 subjects that met the study criteria, adenomyosis was identified via histopathology in 170 (45.9%). There was no difference in the adenomyosis prevalence with (47.1%) and without (43.0%) at least one submucous leiomyoma. Subgroup analysis of ultrasound images by an expert radiologist for the presence of adenomyosis demonstrated a positive predictive value of 54.0% and a negative predictive value of 43.4%. CONCLUSIONS: Adenomyosis was present in almost half of this AUB-L cohort undergoing hysterectomy and was equally prevalent in those with and without submucous leiomyomas as determined by sonographic evaluation. The imaging findings are in accord with prior investigators and demonstrate that 2-D ultrasound is insensitive to the presence of adenomyosis when the uterus is affected by leiomyomas. Further research is necessary to determine the impact of various adenomyosis phenotypes on the presence and severity of the symptom of HMB.

Health Care Costs and Treatment Patterns Associated with Uterine Fibroids and Heavy Menstrual Bleeding: A Claims Analysis.

Background: Heavy menstrual bleeding (HMB) is one of the most common distressing complications of uterine fibroids (UF); however, data on the health care costs for treatments in women experiencing HMB associated with UF are lacking. The objective of this study was to compare the direct costs and treatments patterns for women diagnosed with UF+HMB, UF only, and HMB only in the United States. Materials and Methods: The study design was retrospective matched cohort study using claims data. Women, aged 18-51 years, comprising four cohorts (HMB only, UF only, UF+HMB, and controls) were identified in the IBM MarketScan® Commercial Claims and Encounters Database (October 1, 2007‒September 30, 2018) and matched by demographics and Charlson Comorbidity Index score. Baseline characteristics and treatments during the 12 months post-diagnosis were summarized descriptively. Costs (2018 U.S. dollars) during the post-diagnosis year were compared using analysis of variance. Results: Before matching, women with UF+HMB represented 54% of UF cases. Following diagnosis, 32% in the matched UF+HMB cohort had no treatment, 49% underwent surgeries/procedures with (12%) or without (37%) medications, and 18% received medications only. The mean all-cause total costs for UF+HMB ($16,762) exceeded that for UF only by 24% ($13,506) and HMB only by 50% ($11,135), and almost tripled the mean cost for the control cohort ($6,691) (all, p < 0.001). The mean diagnosis-related costs were significantly higher for UF+HMB ($8,741) than for UF only ($4,550) and HMB only ($3,081) (all, p < 0.0001). Surgery/procedure costs comprised 80% of diagnosis-related medical costs for UF+HMB. Conclusions: UF with HMB were associated with significant economic burden, driven primarily by surgical/procedural costs and treatment patterns.

Impact of pain and nonpain co-morbidities on opioid use in women with endometriosis.

Aim: To evaluate impact of co-morbidities on opioid use in endometriosis. Patients & methods: This was a retrospective analysis of data obtained from the Symphony Health database (July 2015-June 2018), which contains medical and pharmacy claims information on 79,947 women with endometriosis. Relative risk (RR) of postdiagnosis opioid use and supply duration associated with baseline co-morbidities were determined. Results: Women with endometriosis using opioids at baseline were 61% more likely to receive opioids postdiagnosis (RR: 1.61; 95% CI: 1.59-1.63). Risk of prolonged opioid supply postdiagnosis was highest for those with prolonged supply at baseline (RR: 21.14; 20.14-22.19), and was 1.32 (1.26-1.38) for patients with ≥1 co-morbidity, 1.37 (1.31-1.43) for pain co-morbidities and 1.07 (1.04-1.11) for psychiatric co-morbidities. Conclusion: Risk of opioid use after endometriosis diagnosis was greater in patients who used opioids before diagnosis. Risk of prolonged opioid use was greater if co-morbidities existed before diagnosis.

Real-World Characterization of Women with Diagnosed Endometriosis Initiating Therapy with Elagolix Using a US Claims Database.

PURPOSE: Elagolix is an oral gonadotropin-releasing hormone antagonist approved in the United States for the management of moderate to severe pain associated with endometriosis. We performed a real-world evaluation of the demographic and clinical characteristics of women diagnosed with endometriosis who were initiating elagolix therapy in the United States. PATIENTS AND METHODS: This retrospective cohort database analysis included women 18-49 years of age with ≥1 pharmacy claim for elagolix between August 2018 and December 2019 from the Copyright © 2020 Truven Health Analytics LLC. All Rights Reserved. Women had continuous medical and pharmacy health plan enrollment during the baseline period (year immediately preceding the index date [date of earliest elagolix claim]) and had ≥1 medical claim with endometriosis (International Classification of Diseases [ICD]-9/10 code [617.x and N80.x]) on or before the index date. Baseline demographics, comorbidities, ICD code-based endometriosis anatomic site, endometriosis-related treatments, and pain symptoms were summarized descriptively. RESULTS: The study included 2083 patients with mean age at baseline of 33.2 ± 8.1 years. Comorbidities most commonly recorded were non-cancer, non-endometriosis pain (59.5%), including arthritis/joint pain (43.7%) and back/neck pain (31.7%), and mental disorder (40.7%), including anxiety (32.7%). The majority of endometriosis diagnosis codes recorded referred to unspecified location (52.3%) and pelvic peritoneum (23.0%); 61.0% of patients received a medical endometriosis-related treatment in the baseline period, with the most common treatments being contraceptives (various routes of administration, 40.2%) and progestins (31.7%). Additionally, 35.4% of the patients received an endometriosis-related surgery during baseline, with the most common being laparoscopy (33.2% of all patients). Opioids were used during the baseline period by 57.3% of the patients. For pain symptoms, 71.5%, 30.4%, and 19.3% of the patients had claims for pelvic pain, dysmenorrhea, and dyspareunia, respectively. CONCLUSION: Endometriosis therapies were used by a significant proportion of patients with endometriosis in the year immediately preceding elagolix initiation.

Health Care Utilization and Costs Associated with Endometriosis Among Women with Medicaid Insurance.

BACKGROUND: Endometriosis is a painful chronic inflammatory disease caused by endometrial tissue implanting and growing outside the uterus, resulting in pelvic pain symptoms and subfertility. Treatment imposes a substantial economic burden on the patient and health care system. OBJECTIVE: To evaluate direct health care utilization and costs among women newly diagnosed with endometriosis compared with age-matched controls in a U.S. Medicaid population. METHODS: This retrospective cohort study used deidentified health care claims from the 2007-2015 MarketScan Multi-State Medicaid Database. Women (aged 18-49 years) newly diagnosed with endometriosis (ICD-9-CM 617.xx) during January 2008 through September 2014 were identified (date of first diagnosis = index date). Age-matched women without endometriosis (controls) were selected from the database and assigned index dates matching the distribution for endometriosis patients. Direct health care resource utilization (HCRU) and costs (medical and pharmacy) over the 12-month post-index period (2015 U.S. dollars) were computed by service category (hospitalization, emergency room visits, outpatient services, and prescriptions) and compared between study cohorts using the chi-square test for proportions and t-test for continuous variables. RESULTS: The final sample included 15,615 endometriosis patients and 86,829 matched controls. HCRU during the 12-month post-index follow-up period was significantly higher for endometriosis cases compared with controls in all measured categories. Hospital admissions occurred among 33.1% of cases and 7.2% of controls, and 65.8% of endometriosis patients were admitted for endometriosis-related surgery. Emergency room visits occurred in 71.5% of cases, and 42.2% of controls. Mean (SD) office visits were 10.4 (8.5) for endometriosis patients and 5.1 (6.9) for controls. Endometriosis patients had significantly more prescription claims than controls, 45.9 (42.0) versus 25.1 (39.1). Mean total direct health care costs were $13,670 ($29,843) for cases versus $5,779 ($23,614) for controls. All differences between cases and controls were significant at P < 0.001. CONCLUSIONS: Health care costs and resource utilization in all measured categories were higher among endometriosis cases than controls. The economic burden of endometriosis among patients with Medicaid insurance is substantial, underscoring the unmet medical need for earlier diagnosis and cost-effective treatments. DISCLOSURES: This study was funded by AbbVie and conducted by Truven Health Analytics, an IBM Company. AbbVie participated in developing the study design, data analysis and interpretation, manuscript writing and revisions, and approval for publication. Soliman and Vora are employees of AbbVie and may own AbbVie stock/stock options. Surrey has served in a consulting role on research to AbbVie and is on the speaker bureau for Ferring Laboratories. Bonafede and Nelson are employees of Truven Health Analytics, an IBM Company, which received compensation from AbbVie for the overall conduct of the study and preparation of the manuscript. Agarwal has served in a consulting role on research to AbbVie. Preliminary results of this study were previously presented in a podium session at the 2017 American Society for Reproductive Medicine Scientific Congress and Expo; October 28-November 1, 2017; San Antonio, TX.

Cost-effectiveness of elagolix versus leuprolide acetate for treating moderate-to-severe endometriosis pain in the USA.

AIM: To assess the cost-effectiveness of elagolix versus leuprolide acetate in women with moderate to severe endometriosis pain. METHODS: A Markov model was developed. The efficacy of leuprolide acetate was derived from statistical prediction models using elagolix trial data. Model inputs were extracted from Phase III clinical trials and published literature. RESULTS: Compared with leuprolide acetate, elagolix generated positive net monetary benefit (NMB) assuming a payer's willingness-to-pay threshold of US$100,000 per quality-adjusted life year over a 1-year time horizon: US$5660 for elagolix 150 mg and US$6443 for elagolix 200 mg. The 2-year NMBs were also positive. CONCLUSION: Elagolix was cost effective versus leuprolide acetate in the management of moderate to severe endometriosis pain over 1- and 2-year time horizons. Results were robust in sensitivity analyses.