Ospemifene versus local estrogen: adherence and costs in postmenopausal dyspareunia
Publication: Journal of Comparative Effectiveness Research
Abstract
Aim: Objective was to compare adherence and persistence, as well as direct healthcare costs and utilization, of ospemifene to available local estrogen therapies (LETs). Patients & methods: This retrospective database study used integrated medical and pharmacy claims data from the IQVIA Real-World Data Adjudicated Claims – US Database. Results: Ospemifene patients had significantly greater adherence and persistence compared with the other nonring LETs. Ospemifene had the lowest mean outpatient costs of any of the LET cohorts, including the estradiol vaginal ring. Total all-cause healthcare costs were also significantly less for ospemifene patients compared with all other LETs.
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References
1.
The North American Menopause Society. Menopause 101: a primer for the perimenopausal (2018). https://www.menopause.org/for-women/menopauseflashes/menopause-symptoms-and-treatments/menopause-101-a-primer-for-the-perimenopausal
2.
Mayo Clinic. Menopause (2018). https://www.mayoclinic.org/diseases-conditions/menopause/symptoms-causes/syc-20353397
3.
Mac Bride MB, Rhodes DJ, Shuster LT. Vulvovaginal atrophy. Mayo Clin. Proc. 85(1), 87–94 (2010).
4.
Lev-Sagie A. Vulvar and vaginal atrophy: physiology, clinical presentation, and treatment considerations. Clin. Obstet. Gynecol. 58(3), 476–491 (2015).
5.
Kingsberg SA, Kroll R, Goldstein I et al. Patient acceptability and satisfaction with a low-dose solubilized vaginal estradiol softgel capsule, TX-004HR. Menopause 24(8), 894–899 (2017).
6.
Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause 20(9), 888–902 (2013).
7.
Wysocki S, Kingsberg S, Krychman M. Management of vaginal atrophy: implications from the REVIVE survey. Clin. Med. Insights Reprod. Health 8, 23–30 (2014).
8.
Kingsberg SA, Krychman M, Graham S, Bernick B, Mirkin S. The Women’s EMPOWER Survey: identifying women’s perceptions on vulvar and vaginal atrophy and its treatment. J. Sex. Med. 14(3), 413–424 (2017).
9.
Sadownik LA, Smith KB, Hui A, Brotto LA. The impact of a woman’s dyspareunia and its treatment on her intimate partner: a qualitative analysis. J. Sex Marital Ther. 43(6), 529–542 (2017).
10.
Parish SJ, Nappi RE, Krychman ML et al. Impact of vulvovaginal health on postmenopausal women: a review of surveys on symptoms of vulvovaginal atrophy. Int. J. Womens Health 5, 437–447 (2013).
11.
Faubion SS, Rullo JE. Sexual dysfunction in women: a practical approach. Am. Fam. Physician 92(4), 281–288 (2015).
12.
Mattsson LA, Ericsson A, Bogelund M, Maamari R. Women’s preferences toward attributes of local estrogen therapy for the treatment of vaginal atrophy. Maturitas 74(3), 259–263 (2013).
13.
Portman D, Shulman L, Yeaw J et al. One-year treatment persistence with local estrogen therapy in postmenopausal women diagnosed as having vaginal atrophy. Menopause 22(11), 1197–1203 (2015).
14.
LePage K, Selk A. What do patients want? A needs assessment of vulvodynia patients attending a vulvar diseases clinic. Sex. Med. 4(4), e242–e248 (2016).
15.
Kingsberg SA, Wysocki S, Magnus L, Krychman ML. Vulvar and vaginal atrophy in postmenopausal women: findings from the REVIVE (REal Women's VIews of Treatment Options for Menopausal Vaginal ChangEs) survey. J. Sex. Med. 10(7), 1790–1799 (2013).
16.
Kingsberg SA, Larkin L, Krychman M, Parish SJ, Bernick B, Mirkin S. WISDOM survey: attitudes and behaviors of physicians toward vulvar and vaginal atrophy (VVA) treatment in women including those with breast cancer history. Menopause 26(2), 124–131 (2019).
17.
Duchesnay. Ospemifene full prescribing information (2019). https://files.duchesnay.com/duchesnay-usa/osphena/osphena-prescribing-information.pdf
18.
Shin JJ, Kim SK, Lee JR, Suh CS. Ospemifene: a novel option for the treatment of vulvovaginal atrophy. J. Menopausal Med. 23(2), 79–84 (2017).
19.
Nappi RE, Panay N, Bruyniks N, Castelo-Branco C, De Villiers TJ, Simon JA. The clinical relevance of the effect of ospemifene on symptoms of vulvar and vaginal atrophy. Climacteric 18(2), 233–240 (2015).
20.
Archer D, Goldstein S, Simon JA et al. Efficacy and safety of ospemifene in postmenopausal women with moderate-to-severe vaginal dryness: a Phase III, randomized, double-blind, placebo-controlled, multicenter trial. Menopause 26(6), 611–621 (2019).
21.
Bachmann GA, Komi JO. Ospemifene effectively treats vulvovaginal atrophy in postmenopausal women: results from a pivotal Phase III study. Menopause 17(3), 480–486 (2010).
22.
Portman DJ, Bachmann GA, Simon JA. Ospemifene, a novel selective estrogen receptor modulator for treating dyspareunia associated with postmenopausal vulvar and vaginal atrophy. Menopause 20(6), 623–630 (2013).
23.
Premarin Prescribing Information (2018). https://www.premarinvaginalcream.com/about
24.
Imvexxy Prescribing Information (2018). https://www.imvexxy.com/pi.pdf
25.
Estrace Prescribing Information (2018). https://www.estracecream.com/
26.
Estring Prescribing Information (2018). http://labeling.pfizer.com/ShowLabeling.aspx?id=567
27.
Alliance PQ. PQA adherence measures (2019). https://www.pqaalliance.org/adherence-measures
28.
Shook LL. An update on hormone replacement therapy: health and medicine for women: a multidisciplinary, evidence-based review of mid-life health concerns. Yale J. Biol. Med. 84(1), 39–42 (2011).
29.
Simon JA, Nappi RE, Kingsberg SA, Maamari R, Brown V. Clarifying Vaginal Atrophy’s Impact on Sex and Relationships (CLOSER) survey: emotional and physical impact of vaginal discomfort on North American postmenopausal women and their partners. Menopause 21(2), 137–142 (2014).
30.
Shifren JL, Gass ML. The North American Menopause Society recommendations for clinical care of midlife women. Menopause 21(10), 1038–1062 (2014).
31.
The NAMS 2017 Hormone Therapy Position Statement Advisory Panel. The 2017 hormone therapy position statement of The North American Menopause Society. Menopause 24(7), 728–753 (2017).
32.
Crandall CJ, Hovey KM, Andrews CA et al. Breast cancer, endometrial cancer, and cardiovascular events in participants who used vaginal estrogen in the Women’s Health Initiative Observational Study. Menopause 25(1), 11–20 (2018).
33.
Manson JE, Aragaki AK, Rossouw JE et al. Menopausal hormone therapy and long-term all-cause and cause-specific mortality: the Women’s Health Initiative Randomized Trials. JAMA 318(10), 927–938 (2017).
34.
Simon JA, Altomare C, Cort S, Jiang W, Pinkerton JV. Overall safety of ospemifene in postmenopausal women from placebo-controlled Phase II and III trials. J. Womens Health 27(1), 14–23 (2018).
35.
Minkin MJ, Maamari R, Reiter S. Improved compliance and patient satisfaction with estradiol vaginal tablets in postmenopausal women previously treated with another local estrogen therapy. Int. J. Womens Health 5, 133–139 (2013).
36.
Donga P, DeKoven M, Kaplan T et al. Costs of Clostridium histolyticum and fasciectomy for Dupuytren’s contracture. Am. J. Pharm. Benefits 7(1), 7–12 (2015).
37.
Kleinman NL, Rohrbacker NJ, Bushmakin AG, Whiteley J, Lynch WD, Shah SN. Direct and indirect costs of women diagnosed with menopause symptoms. J. Occup. Environ. Med. 55(4), 465–470 (2013).
38.
Soliman AM, Yang H, Du EX, Kelley C, Winkel C. The direct and indirect costs associated with endometriosis: a systematic literature review. Hum. Reprod. 31(4), 712–722 (2016).
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Pages: 1111 - 1123
PubMed: 31432687
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© 2019 Future Medicine Ltd.
History
Received: 10 July 2019
Accepted: 6 August 2019
Published online: 21 August 2019
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Ospemifene versus local estrogen: adherence and costs in postmenopausal dyspareunia. (2019) Journal of Comparative Effectiveness Research. DOI: 10.2217/cer-2019-0091
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