Estimated Economic Impact of the Levonorgestrel Intrauterine System on Unintended Pregnancy in Active Duty Women

ABSTRACT Unintended pregnancy is reportedly higher in active duty women; therefore, we sought to estimate the potential impact of the levonorgestrel-containing intrauterine system (LNG-IUS) could have on unintended pregnancy in active duty women. A decision tree model with sensitivity analysis was used to estimate the number of unintentional pregnancies in active duty women which could be prevented. A secondary cost analysis was performed to analyze the direct cost savings to the U.S. Government. The total number of Armed Services members is estimated to be over 1.3 million, with an estimated 208,146 being women. Assuming an age-standardized unintended pregnancy rate of 78 per 1,000 women, 16,235 unintended pregnancies occur each year. Using a combined LNG-IUS failure and expulsion rate of 2.2%, a decrease of 794, 1588, and 3970 unintended pregnancies was estimated to occur with 5%, 10% and 25% usage, respectively. Annual cost savings from LNG-IUS use range from $3,387,107 to $47,352,295 with 5% to 25% intrauterine device usage. One-way sensitivity analysis demonstrated LNG-IUS to be cost-effective when the cost associated with pregnancy and delivery exceeded $11,000. Use of LNG-IUS could result in significant reductions in unintended pregnancy among active duty women, resulting in substantial cost savings to the government health care system.

INTRODUCTION

Nearly half of all pregnancies in the United States are unin- tended,1 which is defined as any pregnancy either mistimed, unplanned, or unwanted.2,3 Prior studies on unintended preg- nancy in the military estimated the rate of unintended pregnancy to be around 55%.4-6 Recently, Grindlay et al demonstrated women in the military have an age-standardized rate of unin- tended pregnancy 50% higher (78 per 1,000 women) than the general population rate (52 per 1,000 women). Subgroups such as those less educated, non-white, and married or cohabiting women have even higher rates of unintended pregnancy.7 These investigations imply the military unintended pregnancy rate is significantly higher than the U.S. national average.

A review of military demographic statistics demonstrated the potential impact of these high-unintended pregnancy rates. Currently, approximately 20% of new military recruits, 15% of active duty, and 17% of Reserve and National Guard service members are women.8 The large majority of these women give their military service while in their peak repro- ductive years, and approximately 75% of new military recruits are younger than age 22.9 There are a number of negative consequences resulting from unintended pregnancy, which are unique to the military, including effects on the unit, mission readiness, and evacuation of pregnant women from combat theater. These factors do not include loss of duty hours and the health care costs for the pregnancy.

To identify strategies to address the military unintended pregnancy rates, it is important to examine possible etiologies. Active duty women have low percentages of contraceptive use and this nonuse increases during deployment despite having readily accessible health care.10-13 Given that active duty women and Department of Defense (DoD) beneficiaries have access to no cost contraception, this population could potentially serve as a model for an enhanced access to care environment. The impact of unintended pregnancy on mission readiness makes it a women's health issue of paramount importance.

Effective contraception, which combines maximal patient compliance with minimal patient error in use, is a characteristic of long-acting reversible contraception (LARC) and may rep- resent the best strategy for decreasing unintended pregnancy. The levonorgestrel-containing intrauterine system (LNG-IUS) is a form of LARC, which has the additional noncontraceptive benefit of markedly decreasing menstrual blood loss. LARCs require no daily user maintenance, have a much lower typical use failure rate, have been well studied, and have been demon- strated to help reduce unintended pregnancy.14-16

We therefore selected the LNG-IUS as the contraceptive method in our model, analyzing the impact of LARC on unin- tended pregnancy rates in the military. A cost analysis was also performed to identify the potential annual savings associated with the use of a LNG-IUS system. We hypothesized that with modest use of the LNG-IUS, a dramatic decrease in unin- tended pregnancy and their related costs could be achieved.

MATERIALS AND METHODS

A decision tree model with sensitivity analyses was per- formed to estimate the number of unintentional pregnancies in active duty women that could be prevented annually by the use of a LNG-IUS. The U.S. DoD 2013 report on service members was used to ascertain the total number of service members.17,18 Previous reports have estimated the number of new female military recruits, active duty, and Reserve or National Guard members.8 Fifteen percent was used for our calculations. Unintended pregnancy rates of 105 per 1,000 women, with an age-standardized rate of 78 per 1,000 were estimated using prior reports.7

The reported failure rate of the LNG-IUS ranges from 0.0 to 1.1 failures per 100 women years.19-21 Expulsion rates for the intrauterine devices (IUD) are around 2% to 3% for women using an IUD solely for contraceptive purposes.22,23 Currently, it is estimated that roughly 5.5% of American women use an IUD for contraception.24 Sensitivity analyses were performed over a range of usage rates for the LNG-IUS (5% to 25%), and over a range of failure and expulsion rates of the LNG-IUS (2.2% to 5%).

A cost analysis was performed to examine the cost savings with different usage rates. The decision tree (Fig. 1) started with IUD usage rate and allowed for unintended pregnancy for those using or not using LNG-IUS. Within the IUD usage arm, we modeled for unintended pregnancy (failure rate) and nonpregnant arms. In those with an unintended pregnancy, we then took into account those who may choose to elec- tively abort the pregnancy. Elective abortion is not autho- rized to be performed in any government facility (except in special circumstances) and is not covered by TRICARE unless the abortion is medically indicated. As such, tracking the total numbers of elective abortions is difficult to ascertain in the military population.11 Estimations into the number of women seeking abortions from vary from 19% to 40%.25,26 A range of percentages from 19% to 40% was used to take into account the number of unintended pregnancies, which may be aborted and therefore, excluded from our final analy- sis. The cost of abortion and time off is not covered by the government and is the sole responsibility of the individual. As such, the cost of an abortion and the leave time used for this procedure were not factored into our model. In those continuing with an unintended pregnancies there were three possible outcomes: (1) pregnancy loss, (2) vaginal delivery, and (3) cesarean section. For those not using LNG-IUS, the same modeling and outcome trees were used. The model included the usage rate and failure/expulsion rates as previ- ously described. A pregnancy loss rate (miscarriage) of 10%, a vaginal delivery rate of 60%, and a cesarean section of 30% were utilized based on published literature.27

A one-way sensitivity analysis was also performed using a constant usage rate, set at the lowest rate of 5%, while vary- ing the cost of delivery. The cost for vaginal delivery and cesarean section were taken from a recent Marketscan analy- sis of delivery charges. The average charge for "normal" pregnancy and delivery was $31,093 for vaginal delivery and $51,125 for cesarean delivery.28 There are currently two available LNG-IUS devices approved and used in the United States. We chose to use estimates for the Mirena (Bayer, Pittsburgh, Pennsylvania) in our calculations. The cost of the LNG-IUS was determined from the manufacturer's web site to be $843.29 This only reflects the fixed cost of the device and does not take into account the insertion fee as no fee is charged in this health care system. It also does not reflect the contracted purchase price as this price is negotiated and not available for the authors. We performed a second analysis using a lower IUD cost ($500) to evaluate the impact this lost cost has on the model.

Decision tree modeling and statistical analysis were per- formed using Microsoft Office Excel. Given that the study was comprised of a literature review and mathematical model without the use of patient data, no institutional board approval was required.

RESULTS

The total number of men and women serving in the Armed Services in 2013 was over 1.3 million,17 with an estimated 208,000 being women. Using the age-standardized unin- tended pregnancy rate (78 per 100 women) results in a projected 16,235 unintended pregnancies among active duty women annually. Decreases in unintended pregnancy were calculated using different failure and usage percentages for the LNG-IUS. Using a combined expulsion and failure rate of 2.2%, the projected decrease in unintended pregnancies would be 794, 1588, and 3970 with 5%, 10%, and 25% usage, respectively. Increasing the failure rate to 3.5%, the projected decreases in unintended pregnancy would be 783, 1567, and 3917 with the same usage rates. Finally, we examined the decreases in unintended pregnancy using a 5% failure rate. At this higher rate, unintended pregnancies would still be decreased by 771, 1542, and 3856 with 5%, 10%, and 25% usage, respectively (Fig. 2).

Cost analysis demonstrated significant potential savings impact with LNG-IUS use even at the lowest usage rates. Using the national average abortion percentage of 19% demonstrates an annual cost savings of $7,645,453 to $38,227,266. Even when using a higher abortion percentage of 40%, which has been described for those with unintended pregnancies, annual cost savings are non-trivial at $3,387,107 to $16,935,533 (Fig. 3A). Using a lower IUD purchase price of $500, with the same usage, failure, and abortion rates, we saw even further increases in cost savings. A 5% usage, 2.2% failure, and 40% abortion rate demonstrated cost savings of $6,963,005, whereas a 25% usage, 2.2% failure, and 19% abortion rate produced annual cost savings of $56,107,008.

One-way sensitivity analysis of the cost-effectiveness of the LNG-IUS, varying costs for delivery demonstrated the IUD remained cost-effective across a broad spectrum of costs. The LNG-IUS was cost-effective in all situations, using a 5% IUD usage and 19% abortion percentage, where the costs of pregnancy and delivery were more than $11,000 (Fig. 3B). When using the lower IUD cost, keeping the usage and abortion percentages the same, this cut point changes to $6600.

Additional analysis was performed in which we doubled the cost of the IUD for this analysis to take into account potential costs for extra clinical visits for education, counsel- ing, etc. We found that across usage rates of 5% to 25% that the IUD was always cost-effective, even when the cost of the IUD was estimated to be double than what we considered in our original analysis. In this setting, when varying the cost of labor and delivery, the cut point at which the IUD became more cost-effective was at a labor and delivery cost of approx- imately $27,000, which is comparable to normal charges as discussed previously.

DISCUSSION

In this study, we propose increased reductions in unintended pregnancy are attainable with increased utilization of intrauter- ine contraception. Even when calculating the decrease using the highest failure and lowest utilization percentages, 771 unintended pregnancies could be prevented annually. If LNG- IUS usage approached levels seen in Europe, or levels com- parable to female sterilization in the United States, just under 4,000 unintended pregnancies could be prevented annually. These reductions would have a profound impact on the socio- economic and medical care costs, pregnancy outcomes, and military mission readiness factors associated with unintended pregnancy. It has been well documented that family planning results in tremendous cost savings as a result of prevention of unintended pregnancies. On average, one dollar invested in family planning saves about two dollars in expenses related to antenatal, maternal, and newborn health care.30

Significant cost savings by preventing unintended preg- nancy can be realized in the military health care system, although there are no direct costs to the patient. Our cost analysis model demonstrated IUD usage would always result in a beneficial cost impact at any usage rate above 0%. As the usage rate increased, the cost savings dramatically increased as well. The cost savings of preventing unintended pregnan- cies, even with a usage rate at the U.S. average, demonstrates a profound economic impact on the military health care system. These cost savings are only increased when factoring a lower purchase price for the IUD, as one would expect.

The IUD remained cost-effective across a range of costs for delivery when the charges for delivery were $11,000 or higher. This cost-effectiveness is even more dramatic when using a lower purchase cost IUD. The cost-effectiveness cut point changes to $6600 for delivery charges in this analysis, further supporting LNG-IUS cost-effectiveness in decreasing unintended pregnancy. To put these numbers in prospective, the average commercial insurance payment in the United States is $18,329 per vaginal delivery and $27,866 per cesar- ean section. The use of LNG-IUS (and other LARC) is a very cost-effective and sustainable model for decreasing unin- tended pregnancy, specifically in the military.

Unintended pregnancies are common among women in America, especially among teens and young, reproductive- aged women2 and place a tremendous burden on both the individual and society in terms of pregnancy outcomes and socioeconomic costs.31-33 It has been demonstrated that unin- tended pregnancies are associated with negative birth outcomes for both the mother and child, including low birth weight, preterm birth (PTB), postpartum depression, and decreased breastfeeding.34-36 In 2012, 11.5% of all births were preterm and 7.99% were classified as low birth weight (LBW).37 On average, PTB/LBW deliveries stay in the NICU 12.9 days and add an additional $151,000 to the cost of delivery.38 These figures further emphasize the importance of decreasing unin- tended pregnancy, as eliminating just a small number of these deliveries will have a profound economic impact. In addition, unintended pregnancy has a great influence on mission readi- ness and the general quality of life for the Armed Forces ser- vice members. Decreasing unintended pregnancy is of great importance in counteracting these effects.

A recent study performed in St. Louis demonstrated the effectiveness of the LNS-IUS in decreasing unintended preg- nancy and abortion in adolescent and young women.14 In this study, participants were offered LARCs at no cost. Failure was defined as pregnancy while on the chosen mode of con- traception. In those subjects choosing no contraception or contraception other than IUD or subdermal implant, the fail- ure rate was, respectively, 4.8%, 7.8% and 9.4% for years 1, 2, and 3 of use. Conversely, for the group choosing either an IUD or subdermal implant the failure rate was 0.3%, 0.6%, and 0.9% (p < 0.001) for the same respective time periods. This study also demonstrated a marked decrease in abortions among users of LARC. This type of model would be readily and easily adaptable to the military health care system. Lack of contraception use, either intentionally or through contraception failure, is the primary reason for unintended pregnancy. Roughly half of service women with an unin- tended pregnancy were not using contraception at the time they conceived and the other half report contraception fail- ure.5 It has been estimated that 12% of all women experience a contraceptive failure within the first year of use.39 There are other reports, however, which suggest the actual method fail- ure is less than 10% with the remainder being attributed to poor method adherence.40

These facts seem to be compounded in the military espe- cially at times of deployment. Although surveys show over two-thirds of women have a favorable opinion of and use some form of contraception, the majority use short-acting methods that become difficult to maintain during deployment such as pills (requiring daily use and refills) or patches that fall off from dust and heat.13,41- 43 Many factors impacting the lack of contraception use among active duty women have been identified in the literature. These include lack of avail- ability of chosen method while deployed, limited space in barracks for storage and privacy of contraception, and limited health care provider knowledge of contraception.44,45 This is of increasing importance as the percentage of women serving in the military and serving in deployed status increases as unintended pregnancy remains a leading cause for service women's evacuation from combat zones.41,46

This emphasizes the point that reliable, effective contra- ception, which requires minimal daily user maintenance, is the best strategy for decreasing unintended pregnancy. There are few contraindications to the use of LARCs and almost all women are eligible for their use, including adolescents and nulliparous women. The American Congress of Obstetricians and Gynecologists in fact, specifically advocates for the increased use of LARCs in nulliparous women. The U.S. Medical Eligibility Criteria for Contraceptive Use classifies LARC usage in nulliparous women as category 2, meaning advantages of use outweigh risks.47

The strengths of this study include its use of mathematical modeling to predict outcomes of interest using different fail- ure rates of the LNG-IUS and utilization among active duty women. We were also able to examine the decrease in unplanned conceptions using both the standard unintended pregnancy and age-standardized unintended pregnancy rates. Using the age-standardized rate adjusts for any effects of age. The age-standardized rate adjusts for fewer unintended preg- nancies among older women since the military has a small percentage of older women. The advantages of using a cost analysis model is that it allows for many variables to be adjusted to evaluate the potential financial impact such alter- ations would have. Moreover, our approach utilized a data- driven approach to determine the parameters in both the unintended pregnancy and cost analysis models.

The primary weakness of any statistical modeling study is the accuracy of the numbers estimated from the literature and the validity of the model assumptions. This study relies on accurate numbers for active duty women, and assumptions of both failure and utilization rates of the LNG-IUS for the outcome of interest. We have used the most up-to-date ser- vice numbers provided by the DoD and data from recent publications to help minimize inaccuracies. We did not spe- cifically include in our model additional clinical appoint- ments for counseling and insertion, or an insertion fee. However, we evaluated the potential impact of including additional costs for these services and found that LNG-IUS remained cost-effective across usage rates of 5% to 25% even when the estimated costs of the LNG-IUS was doubled. Although only a "real world" study will prove the absolute effectiveness of this contraception intervention, a study of this type would be difficult to perform given its costly, time consuming nature. This model only includes the reported charges of pregnancy and delivery itself. It does not account for the other medical and socioeconomic costs, and likely underestimates the true overall cost saving associated with decreasing unintended pregnancy. This model also does not take into account the noncontraceptive benefits and resultant cost savings associated with LNG-IUS.

Although it would be unethical to dictate to active duty women their reproductive timing and desire, it is absolutely possible for their health care providers to help increase their knowledge of contraception and timing of pregnancy. The LNG-IUS and other LARC offer extremely effective contra- ception, which does not depend upon daily user maintenance. Through patient education and increased utilization of LARC, we can have a profound societal and economic impact on the unintended pregnancy numbers in active duty women. A large, prospective study evaluating the contracep- tive education and utilization of LARC in the female active duty population needs to be performed to further evaluate the issue of unintended pregnancy in the military.

ACKNOWLEDGMENT

This research was conducted, in part, by the intramural research program of the Program in Reproductive and Adult Endocrinology, NICHD, NIH.

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MAJ Ryan J. Heitmann, MC USA*[dagger]; Sunni L. Mumford, PhD [double dagger]; MAJ Micah J. Hill, MC USA*[dagger]; COL Alicia Y. Armstrong, MC USA (Ret.)§

*Program in Reproductive and Adult Endocrinology, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 10 CRC, Room 1E-3140, 10 Center Drive, Bethesda, MD 20892-1109.

[dagger]Walter Reed National Military Medical Center, 8901 Wisconsin Avenue, Bethesda, MD 20814.

[double dagger]Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 6100 Executive Boulevard, Rockville, MD 20852.

§Contraceptive Discovery and Development Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 10 CRC, Room 1E-3140, 10 Center Drive, Bethesda, MD 20892-1109.

This article was presented as an oral presentation at the Armed Forces District ACOG Annual Meeting in Baltimore, MD, October 27-October 30, 2013.

The views expressed in this manuscript are those of the authors and do not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. Government.

doi: 10.7205/MILMED-D-14-00055