Cost-effectiveness of Mifepristone Pretreatment for the Medical Management of Nonviable Early Pregnancy: Secondary Analysis of a Randomized Clinical Trial.

Importance: Early pregnancy loss (EPL) is the most common complication of pregnancy. A multicenter randomized clinical trial compared 2 strategies for medical management and found that mifepristone pretreatment is 25% more effective than the standard of care, misoprostol alone. The cost of mifepristone may be a barrier to implementation of the regimen. Objective: To assess the cost-effectiveness of medical management of EPL with mifepristone pretreatment plus misoprostol vs misoprostol alone in the United States. Design, Setting, and Participants: This preplanned. prospective economic evaluation was performed concurrently with a randomized clinical trial in 3 US sites from May 1, 2014, through April 30, 2017. Participants included 300 women with anembryonic gestation or embryonic or fetal demise. Cost-effectiveness was computed from the health care sector and societal perspectives, with a 30-day time horizon. Data were analyzed from July 1, 2018, to July 3, 2019. Interventions: Mifepristone pretreatment plus misoprostol administration vs misoprostol alone. Main Outcomes and Measures: Costs in 2018 US dollars, effectiveness in quality-adjusted life-years (QALYs), and treatment efficacy. Incremental cost-effectiveness ratios (ICERs) of mifepristone and misoprostol vs misoprostol alone were calculated, and cost-effectiveness acceptability curves were generated. Results: Among the 300 women included in the randomized clinical trial (mean [SD] age, 30.4 [6.2] years), mean costs were similar for groups receiving mifepristone pretreatment and misoprostol alone from the health care sector perspective ($696.75 [95% CI, $591.88-$801.62] vs $690.88 [95% CI, $562.38-$819.38]; P = .94) and the societal perspective ($3846.30 [95% CI, $2783.01-$4909.58] vs $4845.62 [95% CI, $3186.84-$6504.41]; P = .32). The mifepristone pretreatment group had higher QALYs (0.0820 [95% CI, 0.0815-0.0825] vs 0.0806 [95% CI, 0.0800-0.0812]; P = .001) and a higher completion rate after first treatment (83.8% vs 67.1%; P < .001) than the group receiving misoprostol alone. From the health care sector perspective, mifepristone pretreatment was cost-effective relative to misoprostol alone with an ICER of $4225.43 (95% CI, -$195 053.30 to $367 625.10) per QALY gained. From the societal perspective, mifepristone pretreatment dominated misoprostol alone (95% CI, -$5 111 629 to $1 801 384). The probabilities that mifepristone pretreatment was cost-effective compared with misoprostol alone at a willingness-to-pay of $150 000 per QALY gained from the health care sector and societal perspectives were approximately 90% and 80%, respectively. Conclusions and Relevance: This study found that medical management of EPL with mifepristone pretreatment was cost-effective when compared with misoprostol alone. Trial Registration: ClinicalTrials.gov Identifier: NCT02012491.

Mifepristone (RU486) in Australian pharmacies: the ethical and practical challenges.

OBJECTIVE: The recent legalization of mifepristone has given women in Australia a new option for termination of pregnancy. Pharmacists are well positioned to provide information and supply mifepristone for patients. However, there are ethical and legal concerns in Australia regarding the supply of mifepristone, as pharmacists may choose to conscientiously object to supplying mifepristone and are subject to differing abortion laws between states and territories in Australia. The objective of this study was to explore attitudes and knowledge of Australian pharmacists about mifepristone. STUDY DESIGN: Semistructured interviews were conducted with 41 registered pharmacists working in a pharmacy or hospital in Sydney, Australia. When data saturation was achieved, audiotaped transcripts were deidentified and transcribed verbatim. Data were thematically analyzed using a framework approach for applied policy research and categorized into the following themes: contextual, diagnostic, evaluative and strategic. RESULTS: Analysis of the transcripts yielded four themes: (a) pharmacists' contextual view on pregnancy termination, the role of the pharmacist and impact on the pharmacy workplace; (b) diagnostic reasons for differing views; (c) evaluation of actual and perceived pharmacy practice in relation to the supply of mifepristone and (d) strategies to improve pharmacists' services, awareness and education. CONCLUSION: Australian pharmacists in this study perceived themselves to have a potentially important role as medicine experts in patient health care and safety in medical termination of pregnancy. However, there was a general lack of clinical, ethical and legal knowledge about medical termination of pregnancy and its legislation. IMPLICATIONS: To ensure patient safety, well-being and autonomy, there is an imperative need for pharmacist-specific training and guidelines to be made available and open discussion to be initiated within the profession to raise awareness, in particular regarding professional accountability for full patient care.

Trends in use of medical abortion in the United States: reanalysis of surveillance data from the Centers for Disease Control and Prevention, 2001-2008.

BACKGROUND: With changing patterns and increasing use of medical abortion in the United States, it is important to have accurate statistics on the use of this method regularly available. This study assesses the accuracy of medical abortion data reported annually to the Centers for Disease Control and Prevention (CDC) and describes trends over time in the use of medical abortion relative to other methods. STUDY DESIGN: This analysis included data reported to CDC for 2001-2008. Year-specific analyses included all states that monitored medical abortion for a given year, while trend analyses were restricted to states that monitored medical abortion continuously from 2001 to 2008. Data quality and completeness were assessed by (a) examining abortions reported with an unspecified method type within the gestational age limit for medical abortion (med-eligible abortions) and (b) comparing the percentage of all abortions and med-eligible abortions reported to CDC as medical abortions with estimates based on published mifepristone sales data for the United States from 2001 to 2007. RESULTS: During 2001-2008, the percentage of med-eligible abortions reported to CDC with an unspecified method type remained low (1.0%-2.2%); CDC data and mifepristone sales estimates for 2001-2007 demonstrated strong agreement [all abortions: intraclass correlation coefficient (ICC)=0.983; med-eligible abortions: ICC=0.988]. During 2001-2008, the percentage of abortions reported to CDC as medical abortions increased (p<.001 for all abortions and for med-eligible abortions). Among states that reported medical abortions for 2008, 15% of all abortions and 23% of med-eligible abortions were reported as medical abortions. CONCLUSION: CDC's Abortion Surveillance System provides an important annual data source that accurately describes the use of medical abortion relative to other methods in the United States.

Medication abortions among New York City residents, 2001-2008.

CONTEXT: Population-level research on trends in medication abortions and the association of patient characteristics and facility type with procedure choice is limited. Surveillance is necessary to ensure accurate reporting and understanding of service availability. METHODS: New York City induced abortion data for 2001-2008 were used to calculate medication abortion prevalence among women undergoing early abortions (i.e., at nine or fewer weeks of gestation). Multiple logistic regression analysis was used to assess associations between selected characteristics and having a medication, as opposed to surgical, abortion. Proportions of patients who went to clinics or hospitals that did not offer medication abortions were also calculated. RESULTS: Five percent of early abortions were medication procedures in 2001; the proportion rose to 13% by 2008. Eighty-two percent of medication abortions in 2008 were performed at freestanding clinics, and 10% at doctors' offices. The likelihood of having had a medication abortion, rather than a surgical one, was lower among blacks and Hispanics than among whites (odds ratios, 0.5 and 0.7, respectively). Medication abortions were more likely among women with more than 12 years of education than among those with less than a high school education (2.1), and more likely among those who went to doctors' offices than among clinic patients (3.6). Throughout 2001-2008, medication abortions were not available at 50% of hospitals and 31% of clinics that provided early abortions. CONCLUSIONS: The increasing prevalence of medication abortions highlights the importance of active surveillance. Because many facilities do not offer the procedure, a better understanding of barriers to provision is needed.

Provider practice models for and costs of delivering medication abortion -- evidence from 11 US abortion care settings.

PURPOSE: Understanding practice models and provider costs for medication abortion (MAB) provision may elucidate ways to facilitate MAB integration into a larger arena of health care services. This study provides descriptive data on the diverse MAB practice models currently being utilized by US health care providers and the costs associated with the components of those models. METHOD: Data were gathered from a sample of 11 abortion care settings, using clinic administrative records and patient satisfaction surveys. RESULTS: Practice models varied dramatically, with a wide range in the type of staff employed to provide MAB. The total episode cost for providing MAB ranged from 252 to 460 US Dollars, and patient satisfaction was high across all practices. CONCLUSION: Information from this study can be used to guide decisions regarding MAB integration into practices not currently providing abortion or which provide only aspiration abortions. The information may also be useful for providers wishing to refine their MAB services.

Early abortion in Ontario: options and costs.

OBJECTIVE: Early abortions have been predominantly surgical for many years, but medical options with comparable efficacy and safety are now available. This study compares the costs of two medical options and two surgical options. METHODS: We used a clinical model to compare the costs in Ontario of four options for early abortion: medical abortion using either mifepristone or methotrexate, and surgical abortion by vacuum aspiration in either a hospital or a free-standing clinic. The cost analysis was conducted from the perspectives of society, the health care system, and the patient. RESULTS: From all perspectives, total costs were highest for hospital surgical abortion, followed by surgical abortion in a clinic. From the patient's perspective, total costs were higher for surgical abortion but direct costs (mainly for medications) were higher for medical abortion. The total cost of mifepristone and methotrexate abortion was equal if the price of mifepristone (200 mg) was $59.52. The model was robust but was sensitive to the price of mifepristone. CONCLUSION: Early medical abortion costs less than early surgical abortion from the societal and health care system perspectives but more than surgical abortion from the patient's perspective. Surgical abortion costs more in hospitals than in free-standing clinics from the societal and health care system perspectives, but the costs are the same in both settings from the patient's perspective. No method for early abortion can be identified as best, and patients should be free to choose the option they prefer.

Patient costs for medication abortion: results from a study of five clinical practices.

PURPOSE: In 2000, the FDA approved mifepristone as a medication abortion alternative. There is limited understanding of the patient costs associated with use of this method. Our objective was to determine total patient costs for medication abortion. This information may be useful for improving counseling and patient decision making. METHODS: We surveyed 212 women who received a medication abortion from a convenience sample of 5 health care practices. Patient costs including direct medical costs (pregnancy test costs, charges), direct nonmedical costs (child care, travel, lodging), and productivity losses (value of time away from work or other activities) were determined. RESULTS: The mean total cost for medication abortion was 351 dollars (0-1,140 dollars). The average charge paid by women themselves for the procedure itself was 306 dollars. Three quarters of total costs were direct medical costs and almost one quarter was time away from work and other activities. Although nearly three quarters of the women were insured, only 1% used insurance to cover their abortion--many (44%) did not know if their insurance covered abortion. CONCLUSIONS: This study provides descriptive information on patient costs associated with medication abortion that may be integrated into patient counseling to enhance informed decision making by women. The study raises questions about why women who report having insurance are not aware of whether their insurance will cover abortion and suggests that we are unclear about women's and providers' preferences for using insurance. We should continue to develop our knowledge of the clinical and nonclinical trade-offs for women choosing between abortion methods to benefit patient decision making.

The true cost differential between mifepristone and misoprostol and misoprostol-alone regimens for medical abortion.

Our objective was to evaluate relative differences in direct and total (direct and indirect) costs for medical abortion regimens using mifepristone and misoprostol or misoprostol alone. We created formulas to evaluate relative differences in costs in the United States, Chennai (Madras), India, and a hypothetical developing country based on published protocols and efficacy data. Follow-up visits and suction aspiration procedures in the United States were evaluated over a range of costs. American indirect costs were estimated using earning data. Indirect costs in India and the hypothetical developing country were based on mifepristone cost differences between the United States and India. Although mifepristone costs US dollar 83.33 for every 200-mg tablet in the United States, the actual excess cost of using a mifepristone regimen, as compared with a misoprostol-alone regimen, is only US dollar 22 to US dollar 32. The actual cost of a mifepristone regimen is lower than that of a misoprostol-alone regimen in India. In a hypothetical developing country, a mifepristone regimen is likely to be less expensive than regimens using misoprostol alone. Because of the higher efficacy of medical abortion regimens using mifepristone and misoprostol and the need for fewer follow-up evaluations, such regimens are less expensive or only minimally more expensive than those using misoprostol alone.

The accessibility of abortion services in the United States, 2001.

CONTEXT: A woman's ability to obtain an abortion is affected both by the availability of a provider and by access-related factors such as cost, convenience, gestational limits and the provision of early medical abortion services. METHODS: In 2001-2002, The Alan Guttmacher Institute surveyed all known abortion providers in the United States, collecting information on their delivery of abortion services and on the number of abortions performed. RESULTS: A minority of abortion providers offer services before five weeks from the last menstrual period (37%) or after 20 weeks (24% or fewer), but the proportions have increased since 1993. Providers estimate that one-quarter of women having abortions in nonhospital facilities travel 50 miles or more for services, and that 7% are initially unsure of their abortion decision. The majority of providers (59%) say that these clients usually receive abortions during a single visit. An average self-paying client was charged $372 for a surgical abortion at 10 weeks in 2001, up from $319 in 1997; only 26% of clients receive services billed directly to public or private insurance. Early medical abortions are becoming increasingly available but are more expensive than surgical abortions. More than half (56%) of providers experienced antiabortion harassment in 2000, but types of harassment other than picketing have declined since 1996. CONCLUSIONS: Abortion at very early and late gestations and early medical abortion are more available than before, but charges have increased and antiabortion picketing remains at high levels. Thus, many women still face substantial barriers to obtaining an abortion.

Pregnancy interruption using mifepristone (RU-486). A new choice for women in the USA.

Mifepristone (RU-486) has recently been granted approval from the Food and Drug Administration for the early termination of pregnancy. Availability is anticipated during 1997. This article describes the pharmacologic function of mifepristone and discusses its potential clinical use in the United States, including its safety, efficacy, and possible complications.

PIP: The US Food and Drug Administration's recent approval of medical abortion involving use of RU-486, in combination with misoprostol, will provide US women with a new option that offers more privacy and greater accessibility than surgical abortion. When introduced before 8 weeks of gestation, RU-486 acts as a progesterone antagonist, competitively binding with the progesterone receptor and blocking the effect of natural progesterone. Although RU-486 alone is only 64-85% successful in expelling a pregnancy, addition of a prostaglandin analogue increases this rate to 95-99%. Potential complications of medical abortion include incomplete abortion and vaginal bleeding. The cost of an RU-486-induced abortion is expected to be comparable to that of surgical abortion (US $300). The choice of surgical versus medical abortion should be based on consideration of factors such as gestational age, the greater time and clinic visits required for RU-486 abortion, whether women prefer an active or passive role in the termination, and women's comfort level with exposure to the products of conception. Medical abortion should be denied to those with ongoing miscarriage, ectopic pregnancy, allergy to prostaglandins, cardiac conditions, heavy smoking, and age over 35 years. In 1992, the American College of Nurse-Midwives rescinded its ban on nurse-midwives performing pregnancy terminations, an important step given the shortage of abortion providers in the US. Surveys conducted among both nurse-midwives and physicians have revealed a greater willingness to provide medical than surgical abortions.

[Mifepristone and misoprostol in therapeutic abortions]. / Mifépristone et misoprostol dans les interruptions médicales de grossesses.

OBJECTIVES: To report our experience with the mifepristone and misoprostol combination in second and third trimester medically induced abortion. TYPE OF STUDY: Prospective study without control group between January 1993 and december 1994. STUDY SITE: Saint-Antoine Hospital, Paris. PATIENTS: Fifty-three patients admitted for a medically induced abortion. RESULTS: Induction-to-abortion mean time was 12.9 +/- 7.5 hours (time distinctly decreased in fetal death: 8.3 +/- 4.4 hours). CONCLUSION: The combination of misoprostol with mifepristone has equivalent with the other protocol used for therapeutic pregnancy termination, is less expensive (25 to 100 times) and finally is simple and non-invasive.