Availability of ulipristal acetate: A secret shopper survey of pharmacies in a metropolitan area on emergency contraception.

OBJECTIVES: To assess levonorgestrel (LNG) and ulipristal acetate (UPA) availability in pharmacies in a metropolitan area. METHODS: A cross-sectional survey was conducted of all identified pharmacies within 25 miles of an urban medical center in Kansas City, KS. We categorized the pharmacies as dedicated commercial (national chains), store-associated (affiliated with a general merchandise or grocery store), or independent. We assessed LNG and UPA availability or time to availability if not currently stocked. RESULTS: We contacted 165 pharmacies. Of the 165 pharmacies, few stocked UPA (12/165, 7%) whereas the majority stocked oral LNG (128/165, 78%). Dedicated commercial pharmacies were more likely to carry UPA than store-associated and independent pharmacies (11/84 [13%] vs. 1/61 [1%] vs. 0/20, respectively; P = 0.016). Most pharmacies that did not stock UPA reported that they could obtain it within 24 hours (94/153, 62%). Dedicated commercial pharmacies were most likely report the ability to obtain UPA in 24 hours (P = 0.016). CONCLUSION: Few pharmacies stock UPA, the most effective form of oral emergency contraception. Enhanced communication between medical providers and pharmacists within current laws and regulations could enhance patient access to UPA.

Update on emergency contraception.

PURPOSE OF REVIEW: Emergency contraception provides a critical and time-sensitive opportunity for women to prevent undesired pregnancy after intercourse. Both access and available options for emergency contraception have changed over the last several years. RECENT FINDINGS: Emergency contraceptive pills can be less effective in obese women. The maximum achieved serum concentration of levonorgestrel (LNG) is lower in obese women than women of normal BMI, and doubling the dose of LNG (3 mg) increases its concentration maximum, approximating the level in normal BMI women receiving one dose of LNG. Repeated use of both LNG and ulipristal acetate (UPA) is well tolerated. Hormonal contraception can be immediately started following LNG use, but should be delayed for 5 days after UPA use to avoid dampening the efficacy of UPA. The copper intrauterine device (IUD) is the only IUD approved for emergency contraception (and the most effective method of emergency contraception), but use of LNG IUD as emergency contraception is currently being investigated. Accurate knowledge about emergency contraception remains low both for patients and healthcare providers. SUMMARY: Emergency contraception is an important yet underutilized tool available to women to prevent pregnancy. Current options including copper IUD and emergency contraceptive pills are safe and well tolerated. Significant gaps in knowledge of emergency contraception on both the provider and user level exist, as do barriers to expedient access of emergency contraception.

Emergency Contraception.

Emergency contraception (EC) may help prevent pregnancy in various circumstances, such as contraceptive method failure, unprotected sexual intercourse, or sexual assault, yet it remains underused. There are 4 approved EC options in the United States. Although ulipristal acetate requires a provider's prescription, oral levonorgestrel (LNG) is available over the counter for women of all ages. The most effective method of EC is the copper intrauterine device, which can be left in place for up to 10 years for efficacious, cost-effective, hormone-free, and convenient long-term primary contraception. Ulipristal acetate tends to be more efficacious in pregnancy prevention than is LNG, especially when taken later than 72 hours postcoitus. The mechanism of action of oral EC is delay of ovulation, and current evidence reveals that it is ineffective postovulation. Women who weigh more than 75 kg or have a body mass index greater than 25 kg/m(2) may have a higher risk of unintended pregnancy when using oral LNG EC; therefore, ulipristal acetate or copper intrauterine devices are preferable in this setting. Providers are often unaware of the range of EC options or are unsure of how to counsel patients regarding the access and use of EC. This article critically reviews current EC literature, summarizes recommendations, and provides guidance for counseling women about EC. Useful tips for health care providers are provided, with a focus on special populations, including breast-feeding women and those transitioning to long-term contraception after EC use. When treating women of reproductive age, clinicians should be prepared to counsel them about EC options, provide EC appropriately, and, if needed, refer for EC in a timely manner.

Repeated-intermittent use of ulipristal acetate for the management of uterine fibroids: an Italian pharmacoeconomic evaluation.

BACKGROUND: The aim of this paper was to evaluate an Italian pharmacoeconomic profile of repeated-intermittent (from 4 to 10 cycles) use of ulipristal acetate 5 mg (UPA 5 mg) in comparison with the use of UPA 5 mg before surgery (2 cycles) for the management of symptomatic uterine fibroids. METHODS: The pharmacoeconomic analysis was performed in two steps: 1) estimating an incremental cost-effectiveness ratio (ICER); 2) assuming a nationwide prediction of future expenditure in the Italian scenario. Effectiveness data were derived from the randomized-controlled trial, whilst quality of life and costs data were retrieved from the published literature. RESULTS: In comparison with the use of UPA 5 mg before surgery, the values of ICER per patient were the following: 1) €20,600 euros (UPA 5 mg 4 cycles); 2) €26,884 (UPA 5mg 6 cycles); 3) €30,244 (UPA 5 mg 8 cycles); 4) €31,906 (UPA 5 mg 10 cycles). In comparison with the use of UPA 5 mg before surgery plus subsequent surgery, the saving per patient for the National Healthcare System (NHS) by adding repeated-intermittent use of UPA 5 mg were the following: 1) €26 million (UPA 5 mg 4 cycles); 2) €17.6 million (UPA 5mg 6 cycles); 3) €8.9 million (UPA 5 mg 8 cycles); 4) €0.2 million (UPA 5 mg 10 cycles). CONCLUSIONS: The results showed that repeated-intermittent use of UPA 5 mg for the long-term treatment of uterine fibroids has a favourable pharmacoeconomic profile up to 10 repeated cycles and may be a cost-saving treatment option for the NHS. Although the data are encouraging, more data are needed regarding the benefits and risks of long-term treatment with UPA.

The Cost-Effectiveness of Emergency Hormonal Contraception with Ulipristal Acetate versus Levonorgestrel for Minors in France.

OBJECTIVE: To evaluate the cost-effectiveness of ulipristal acetate and levonorgestrel in minors in France, and analyze whether it is worthwhile to provide ulipristal acetate to minors free of charge. METHODS: The cost-effectiveness of two emergency contraceptive methods was compared based on a decision-analytical model. Pregnancy rates, outcomes of unintended pregnancies, and resource utilization were derived from the literature. Resources and their costs were considered until termination or a few days after delivery. Deterministic and probabilistic sensitivity analyses were performed. RESULTS: The cost of an unintended pregnancy in a French minor is estimated to be 1,630 € (range 1,330 € - 1,803 €). Almost 4 million € (3.1 € - 13.7 € million) in unintended pregnancy spending in 2010 could have been saved by the use of ulipristal acetate instead of levonorgestrel. The incremental cost of ulipristal acetate compared to levonorgestrel is 3.30 € per intake, or 418 € per pregnancy avoided (intake within 72 hours). In the intake within 24 hours subgroup, ulipristal acetate was found to be more efficacious at a lower cost compared to levonorgestrel. CONCLUSIONS: Ulipristal acetate dominates levonorgestrel when taken within 24 hours after unprotected intercourse, i.e., it is more effective at a lower cost. When taken within 72 hours, ulipristal acetate is a cost- effective alternative to levonorgestrel, given that the cost of avoiding an additional pregnancy with ulipristal acetate is less than the average cost of these pregnancies. In the light of these findings, it is worthwhile to provide free access to minors.

An emergency contraception algorithm based on risk assessment: changes in clinicians' practice and patients' choices.

OBJECTIVES: When ulipristal acetate (UPA) was introduced into the Contraceptive and Sexual Health Services service in June 2011 an algorithm was developed to guide method selection. The aim was to encourage clinicians to assess risk and to offer a copper intrauterine device (IUD) as first-line choice with hormonal methods as second-line choice. METHODS: UPA was the second-line choice for presentations up to 120 hours after high-risk episodes (i.e. around the time of ovulation). Women at lower risk were also offered UPA if presentation was between 72 and 120 hours after unprotected intercourse unless the risk was very low, in which case levonorgestrel 1.5 mg was the second-line choice. RESULTS: Prior to the protocol only 49% of women were offered an IUD compared with 61.6% afterwards. This improved further in the subgroup of women at high risk where 93.3% were offered an IUD compared with 59% initially. After the introduction of UPA the percentage of women accepting the IUD fell from 30% to 14.1%. Overall 14.5% of women received UPA compared to 7.8% receiving an IUD. CONCLUSIONS: Introduction of a standardised protocol for the provision of emergency contraception has significantly increased the proportion of women offered an IUD as postcoital contraception, particularly in women at high risk of conception. Introduction of UPA has seen a halving of the number of women accepting the IUD. This is cause for concern. Further investigation into the reasons behind this decrease in IUD uptake needs to be undertaken.

The price of emergency contraception in the United States: what is the cost-effectiveness of ulipristal acetate versus single-dose levonorgestrel?

BACKGROUND: Ulipristal acetate (UPA) is a novel form of emergency contraception (EC) that appears to be more effective than the prevailing method, single-dose levonorgestrel (LNG). This study examines the cost-efficacy of UPA compared with LNG. STUDY DESIGN: A decision-analytic model was developed to compare the cost-effectiveness of UPA versus LNG in preventing unintended pregnancy when taken within 120 h of unprotected intercourse. Univariate and bivariate sensitivity analyses, as well as Monte Carlo simulation and threshold analyses, were performed. RESULTS: Utilizing UPA instead of LNG would result in 37,589 fewer unintended pregnancies per 4,176,572 estimated US annual EC uses (UPA 54,295 pregnancies; LNG 91,884 pregnancies) and a societal savings of $116.3 million annually. Cost-effectiveness acceptability curve analyses suggest a 96% probability that UPA is more cost-effective at a willingness to pay $100,000 per quality-adjusted life year. CONCLUSIONS: UPA is cost-effective in preventing unintended pregnancy after unprotected intercourse. Efforts should be promoted to increase access to UPA.

Emergency contraception: an underutilized resource.

This emergency contraception update and telephone triage guide can help ensure that your patients get the help they need, when they need it.

Ulipristal acetate: review of the efficacy and safety of a newly approved agent for emergency contraception.

BACKGROUND: Emergency contraception (EC) is used to prevent unintended pregnancies. The current gold standard for oral EC is levonorgestrel (LNG) administered as a single 1.5-mg dose or in 2 doses of 0.75 mg separated by 12 hours. LNG has shown to be effective up to 72 hours after coitus. Ulipristal acetate (UPA) is a selective progesterone receptor modulator approved for EC use in the United States in August 2010. UPA is administered as a one-time, 30-mg dose within 120 hours of intercourse. OBJECTIVE: The goal of this review was to provide a summary of the available literature on the use of UPA for EC. METHODS: PubMed, Cochrane Library, ClinicalTrials.gov, International Pharmaceutical Abstracts, EBSCO, and Iowa Drug Information Service were searched from February 2011 through September 2011 to identify relevant articles. Search terms included ulipristal acetate, CDB-2914, VA 2914, and emergency contraception. RESULTS: In an open-label study, UPA was effective in preventing pregnancy in 1241 women who presented for EC up to 120 hours (5 days) after unprotected intercourse, with an observed pregnancy rate of 2.1% (95% CI, 1.4%-3.1%) versus 5.5% (ie, the expected pregnancy rate without EC). The efficacy of UPA did not decrease significantly (P = 0.44) over time, with pregnancy rates at intervals between >48 and 72 hours at 2.3% (95% CI, 1.4%-3.8%), >72 and 96 hours at 2.1% (95% CI, 1.0%-4.1%), and >96 and 120 hours at 1.3% (95% CI, 0.1%-4.8%). In a single-blind, comparative noninferiority study of 1696 women, UPA was at least as effective as LNG when used within 72 hours for EC, with 15 pregnancies in the UPA group and 22 pregnancies in the LNG group (odds ratio = 0.68 [95% CI, 0.35-1.31]). In addition, UPA prevented significantly (P = 0.037) more pregnancies than LNG when used between 72 and 120 hours after unprotected intercourse, with 0 pregnancies in the UPA group and 3 pregnancies in the LNG group. In a meta-analysis, UPA prevented a greater percentage of pregnancies than LNG at intervals up to 24 hours (0.9% UPA vs 2.5% LNG; P = 0.035), up to 72 hours (1.4% UPA vs 2.2% LNG; P = 0.046), and up to 120 hours (1.3% UPA vs 2.2% LNG; P = 0.025). The most commonly (>10%) reported adverse events included headache, nausea, and abdominal pain. In addition, UPA delayed onset of menstruation by a mean of 2.1 to 2.8 days. CONCLUSIONS: Based on clinical trials, UPA seems to be a reasonably tolerable and effective method of EC when used within 120 hours of intercourse. UPA is at least as effective as LNG when used within the first 72 hours after unprotected intercourse. However, UPA may be more effective than LNG when used between 72 to 120 hours after unprotected intercourse, extending the window of opportunity for EC. UPA may provide a new option for women who require EC up to 5 days after unprotected intercourse.

Adolescents and emergency contraception: update 2011.

PURPOSE OF REVIEW: This review presents the most up-to-date information regarding available methods, safety, efficacy, and availability of emergency contraception for adolescents. RECENT FINDINGS: Recent reanalysis suggests that previously reported efficacy rates for the levonorgestrel-only method emergency contraception were probably overestimated. A newer and more efficacious method of emergency contraception, ulipristal acetate, was FDA approved in August 2010. SUMMARY: Emergency contraception provides young women with an opportunity to prevent pregnancy in the event of unprotected sexual intercourse. Several dedicated products are available commercially in the USA with varying efficacy rates. Barriers, including cost and accessing emergency contraception within the designated time frame, often prevent use among young women.

Ulipristal acetate: a review of its use in emergency contraception.

Ulipristal acetate (ellaOne®; ella®) is the first of a new class of selective progesterone receptor modulators, and is indicated for emergency contraception within 120 hours after unprotected sexual intercourse or contraceptive failure. The principal effect of ulipristal acetate is to inhibit or delay ovulation. This effect may result from the drug's ability to delay the onset of luteinizing hormone (LH) surge or postpone LH peak if LH surge has started, or possibly by a direct inhibitory effect on follicular rupture, when administered in the follicular phase (including just before ovulation). In clinical trials, a single oral dose of ulipristal acetate 30 mg was effective in preventing pregnancies in women requesting emergency contraception after unprotected sexual intercourse and provided sustained efficacy throughout the 120-hour postcoital period in which it is indicated. When compared with levonorgestrel in well designed noninferiority trials, it was no less effective in preventing pregnancies when administered within 72 hours of unprotected intercourse, but was more effective when administered later (within 72-120 hours). Results of a meta-analysis suggest that ulipristal acetate may be more effective than levonorgestrel from day 1 and throughout the entire 5-day period following unprotected sexual intercourse. Ulipristal acetate is generally well tolerated, with a similar tolerability profile to that of levonorgestrel. In general, the onset of menses is delayed by 2-3 days following treatment. Although, ulipristal acetate is more expensive than levonorgestrel, it may represent a cost-effective alternative to levonorgestrel for women requesting emergency contraception within 120 hours of unprotected intercourse. Thus, ulipristal acetate provides effective, sustained and well tolerated emergency contraception when taken within 120 hours of unprotected sexual intercourse, thereby offering an extended treatment window compared with levonorgestrel, which should be administered within 72 hours.

Ulipristal - a new emergency contraceptive pill.

Until recently, women in the UK who wanted emergency contraception had two options: an oral hormonal method (levonorgestrel), which is licensed for use up to 3 days after unprotected sexual intercourse; or a copper-bearing intrauterine device (IUD), which can be inserted up to 5 days after unprotected intercourse or up to 5 days after the earliest likely calculated ovulation. Now ulipristal acetate (ellaOne - HRA Pharma), a new oral hormonal emergency contraceptive, has been licensed in the European Union for use within 120 hours (5 days) of unprotected intercourse. Here we assess whether it is an advance for emergency contraception.

Cyclic progestin administration increases energy expenditure and decreases body fat mass in perimenopausal women.

OBJECTIVE: The menopause transition is characterized by luteal phase defect anovulatory cycles, and changes in body weight and body composition. Resting metabolic rate (RMR) is increased in the luteal phase of the menstrual cycle. We evaluated whether progestin administration increases RMR and influences body composition of perimenopausal women. DESIGN: Thirty-six perimenopausal women were randomly allocated to receive either calcium (1 g/day) continuously plus the progestin nomegestrol acetate (NOMAc; 5 mg/day for 10 days x month for 12 months) or calcium alone. Body composition, RMR, energy intake, and climacteric and psychological symptoms were evaluated at baseline and after 12 months. In the NOMAc group, body composition and RMR analyses were performed twice during the first month of treatment. One evaluation was performed after almost 8 days of NOMAc adjunct, and an another before or almost 15 days after NOMAc administration. RESULTS: Resting metabolic rate was increased by NOMAc administration of 54.5 +/- 73.8 kcal/24 h (P < 0.01). In women treated with NOMAc, fat mass decreased by 1.2 +/- 0.6 kg (P < 0.001). In comparison with controls, body weight (P < 0.05) and body mass index (P < 0.05) were also reduced after 12 months of therapy with NOMAc. CONCLUSIONS: In perimenopausal women the use of NOMAc increases RMR. During the menopause transition, cyclic NOMAc administration may contribute to reduce negative modification of body composition.

Further experience with quingestanol acetate as a postcoital oral contraceptive.

PIP: The experiences of 4 clinical research groups, 1 each in Mexico, Peru, Chile, and Argentina, using quingestanol acetate as a postcoital oral contraceptive is described. 2702 patients accumulated 18,531 cycles of postcoital therapy. In Mexico with a 800 mcg dose, the pregnancy rate was .6. In Chile and Peru at a dose of 750 mcg, pregnancy rates were over 20. Differences in selection of patients may account for part of the difference.^ieng