Effect of Removing Financial Barriers on Use of Long-acting Reversible Contraceptives


Jack McCain

Long-acting reversible contraceptives (LARCs), which include intrauterine devices (IUDs) and subdermal implants, are the most effective method of contraception currently available, with failure rates comparable to those of male (vasectomy) or female sterilization (tubal ligation, fallopian tube inserts). LARCs are an easy contraceptive method to use. Once a LARC has been inserted, a woman need do nothing else to avoid pregnancy for 3 to 5 years for most devices and up to 10 years if she selects the copper IUD. Despite these advantages, LARCs are not yet widely used in the United States, trailing sterilization, oral contraceptives, and male condoms in popularity (Figure 1). One reason the U.S. lags behind other developed countries in LARC use is that memories of the Dalkon Shield still linger from the 1970s, when a design defect in that IUD resulted in infections that led to infertility, ectopic pregnancies, and death. Lawsuits and discontinuation of the product followed, as did limited use of IUDs for many years thereafter. However, the Dalkon debacle led to FDA regulation of medical devices, and a copper IUD, ParaGard, in 1984 became the first IUD whose safety and efficacy was ascertained by the FDA.

Table
Long-acting reversible contraceptives currently available in the United States
Brand name
(generic name)
Company FDA approval Device lifespan Active ingredient and device characteristics*
Copper IUD
ParaGard T 380A
(intrauterine copper contraceptive)
Teva Pharmaceuticals USA 1984 10 years Copper—176 mg of copper wire coiled along 36 mm stem of T-shaped device (32 x 36 mm) plus 68.7 mg copper collar on each arm; exposed surface of 380 mm2 continuously releases copper into uterine cavity
Hormonal IUDs
Mirena (levonorgestrel-releasing intrauterine system) Bayer 2000 5 years Levonorgestrel 52 mg, released from reservoir in 32 x 32 mm T-frame at initial rate of about 20 mcg/day, progressively falling to half that value after five years
Skyla
(levonorgestrel-releasing intrauterine system)
Bayer 2013 3 years Levonorgestrel 13.5 mg, released from reservoir in 28 x 32 mm T-frame at rate of about 14 mcg/day after 24 days, 10 mcg/day after 60 days, and 5 mcg/day by end of third year
Liletta
(levonorgestrel-releasing intrauterine system)
Medicines360, Actavis Pharma 2015 3 years Levonorgestrel 52 mg, released from reservoir in 32 x 32 mm T-frame at initial rate of 18.6 mcg/day, about 16.3 mcg/day by end of first year, 14.3 mcg/day by end of second year, and 12.6 mcg/day by end of third year
Subdermal implant
Nexplanon Radiopaque
(etonogestrel implant)
Merck 2006 3 years Etonogestrel 68 mg, released from reservoir in 4 cm x 2 mm implant at initial rate of 60–70 mcg/day in Week 5–6 after insertion, falling to 35–45 mcg/day at end of first year, 30–40 mcg/day at end of second year, 25–30 mcg/day at end of third year
*Each device incorporates barium sulfate to make it radiopaque.
Source: Manufacturers’ package inserts
Figure 1

Contraceptive methods used by U.S. women

About one third of women in the United States who seek to prevent pregnancy report using sterilization (gray shades) as their method of birth control. About one quarter of these women use oral contraceptives, and about one fifth rely on their male partner to wear a condom or withdraw before ejaculation (blue shades). Only about one tenth use a long-acting reversible contraceptive (green shades).

Injection: (depot medroxyprogesterone acetate); female sterilization: (tubal ligation, fallopian tube inserts); male sterilization: (vasectomy), implants: (etonogestrel).

Source: Guttmacher 2015

Most non-LARC methods of birth control are highly effective if they are used properly. Two thirds of women use contraceptives consistently and correctly, and they account for only 5% of unintended pregnancies (Figure 2). The remaining third who use contraceptives incorrectly, inconsistently, or not at all account for 95% of the unintended pregnancies and, therefore, they are the women who could derive the greatest benefit by selecting a LARC as their method of birth control.

Figure 2

Relationship between patterns of contraceptive use and unintended pregnancies

The one third of women who use contraceptives improperly, inconsistently, or not at all (red/pink shades, left pie chart) account for 95% of unintended pregnancies (right). Lapsed use is defined as a gap of 1 month or more in contraceptive use during a 12-month span.

Source: Guttmacher 2015

As recently as 2002, however, LARCs were used by only about 2% of U.S. women who used some method of birth control (Guttmacher 2015). Since then, that rate has more than doubled and is likely to increase further because of projects supported by the Susan Thompson Buffett Foundation (Weise 2015) and a provision of the ACA that requires insurance coverage of FDA-approved contraceptives.

The endeavors of the foundation (named for Warren Buffett’s first wife) involved, among other activities, providing Washington University in St. Louis with substantial financial support for a longitudinal study of the contraceptive choices well-informed women would make if the financial cost of contraceptives is removed as a factor when women select a method of contraception.

LARCs can be popular

Grants of $20 million from the Buffett Foundation to Washington University have provided most of the financial support the university’s researchers needed to conduct the Contraceptive CHOICE Project (NCT01986439) in greater St. Louis (Weise 2015). CHOICE was launched in 2007 with Jeffrey F. Peipert, a professor of obstetrics and gynecology at the Washington University School of Medicine, as the principal investigator. CHOICE eventually enrolled 9,256 adolescents and women between the ages of 14 and 45 years who were at risk for unintended pregnancy. Most of the study volunteers were recruited from public health clinics whose patients tended to be at high risk for sexually transmitted infections (STIs) and unintended pregnancies, but some subjects learned about CHOICE through advertisements and word of mouth. The project provided all participants with education about contraceptives, access to contraceptives, and their desired contraceptive without cost for two to three years.

The study is no longer enrolling new participants, but data collection is expected to continue through the end of this year. Since its first major results were published in 2010, this multifaceted study already has generated at least 70 peer-reviewed studies yielding insights into women’s knowledge, beliefs, and behaviors regarding contraceptives in general and LARCs in particular.

One important finding of CHOICE is that when LARCs are made available without cost to the patient and when women are fully informed of the risks and benefits of their options for contraception, including the efficacy of each method in preventing pregnancy, three-fourths of women selected a LARC (Figure 3) (Peipert 2012). If the category is broadened to include injectable contraceptives (depot medroxyprogesterone acetate), then more than four fifths of women in the CHOICE study selected a LARC.

Figure 3

Initial choices of contraceptives in CHOICE

In the Contraceptive CHOICE Project, when contraceptives were provided to women at risk of unintended pregnancy (N=9,256), 75% of subjects selected a long-acting reversible contraceptive (green shades). Although injectable contraceptives (depot medroxyprogesterone acetate) sometimes are regarded as LARCs, the injections require an office visit every three months (vs. every 3 to 10 years for insertion of an IUD or subdermal implant), and the injections do not compare well with IUDs and implants in terms of rates of long-term use, patient satisfaction, and effectiveness in preventing pregnancy.

Source: Peipert 2012, Reeves 2016

In CHOICE, however, pregnancy rates among women who selected an injectable contraceptive were comparable to those of women who chose oral contraceptives and substantially higher than those of women who selected a LARC as more narrowly defined, i.e., IUD or implant (Reeves 2016). In the intent-to-use analysis, based on the contraceptive choice participants made at enrollment, pregnancy rates per 100 person-years were 5.3 and 5.5 for oral and injectable contraceptives, respectively, versus 2.0, 1.9, and 1.7 for implants, hormonal IUDs, and copper IUDs, respectively. In the as-used analysis, based on the method actually used, the pregnancy rates per 100 person-years were 6.7 and 1.6 for oral and injectable contraceptives, respectively, vs. 0.2, 0.2, and 0.6 for implants, hormonal IUDs, and copper IUDs, respectively.

Another important finding was that continuation rates were substantially higher among women who selected a LARC compared with those who chose a non-LARC method (Birgisson 2015). After 12 months, the continuation rates were 87% and 57% in the LARC and non-LARC groups, respectively; after 24 months, 77% and 41%. The 12-month continuation rate for injectable contraceptives, which require an office visit every three months, was 57% [CHOICE 2016].

In the CHOICE study, women in both the LARC and the non-LARC groups received the same information about contraceptive methods and neither form of contraceptive cost them anything, indicating that various nonfinancial factors influenced their initial choice of contraceptives. However, whatever the factors were that led to the initial selection of non-LARCs by 25% of the women, they were not sufficient to lead to long-term use of those methods, as shown by the higher discontinuation rate in that group. After a year, the satisfaction rate of LARC users was higher than the rate of non-LARC users. About 80% of LARC users were satisfied with their method of contraception compared with only about 50% of women who selected injections, oral contraceptives, or vaginal rings, and about 40% of transdermal patch users (CHOICE 2016).

To disseminate information about contraception and CHOICE’s findings to audiences beyond the readers of peer-reviewed journals and conference attendees, CHOICE devised an outreach strategy incorporating community events (e.g., health fairs), formal presentations to local and national groups, social media (Facebook, YouTube, Twitter), and the general news media (Broughton 2016).

ACA requires coverage

These activities, some more effective (e.g., outreach to traditional news media) than others (e.g., Facebook and Twitter, which required too much staff time to reach a small audience, as measured by number of Facebook likes and Twitter followers), led to requests for more information and technical assistance from numerous state and county health departments, hospitals, community agencies and health departments, and pharmaceutical companies, among other organizations.

Meanwhile, implementation of the ACA has started to remove out-of-pocket (OOP) expenses of IUD insertion as a barrier to IUD use. As shown by a study in a private practice, the dollar amount of OOP costs can greatly influence the rate at which women for whom a LARC is prescribed fill their prescription (Figure 4). Under the ACA, most private health insurance plans now are required to fill prescriptions for women’s FDA-approved contraceptive methods without cost-sharing. For most covered women, the mandate took effect with the benefit year beginning in January 2013. Exceptions to the ACA mandate include women whose employers claim a religious exemption. In addition, as written, the law was vague about which and how many contraceptives needed to be covered, although HHS has since issued guidances that say 18 different categories of contraceptives must be covered (CMS 2015).

Figure 4

Effect of out-of-pocket expenses on the filling of LARC prescriptions by commercially insured patients and Medicaid beneficiaries seen at a private practice

In a retrospective chart analysis of patients covered by Medicaid or private insurance and who were prescribed a LARC (N=571) by a private practice, 72% filled their prescription overall. A substantial majority of the Medicaid beneficiaries, who bore no out-of-pocket (OOP) expense, filled their prescription, as did privately insured patients whose out-of-pocket cost was under $200. In contrast, a minority of privately insured patients filled their LARC prescription if out-of-pocket costs exceeded $200.

Source: Broecker 2016

The effect of the ACA on out-of-pocket costs for IUDs prescribed for women with private insurance has been dramatic. Between 2012 and 2014, the percentage of privately insured women incurring OOP costs for an IUD dropped from 58% to 13% (Bearak 2016), and the mean OOP cost for an IUD fell from $262 in 2012 to $84 in 2013 (Becker 2015). Although the ACA has helped to make LARCs more affordable for many women, there was no increase in the initiation of LARC use during the first year of the mandate against cost (Pace 2016).

Medicines360

The ACA mandate also does not help Medicaid beneficiaries in states that did not expand their Medicaid programs, but a philanthropist has stepped forward to provide a novel solution—a not-for-profit pharmaceutical company in San Francisco called Medicines360—to help these women and other women who still cannot afford LARCs to acquire them. A study of tax returns led Bloomberg Businessweek to conclude that the same foundation that provided substantial grant support for CHOICE, the Susan Thompson Buffett Foundation, also is the anonymous donor that provided $74 million in seed money for Medicines360 (Weise 2015). This backing enabled Medicines360 to develop a hormonal IUD, sold under the brand name Liletta, that is similar to Bayer’s Mirena. The company secured FDA approval based on the results of a large clinical trial (N=1,751) (Eisenberg 2015) and formed a partnership with an established pharmaceutical company to market Liletta. Medicines360 says its mission is to “expand access to medicines, regardless of socioeconomic status, insurance coverage or geographic location.”

For patients with insurance coverage, the price of Liletta is slightly lower than that of other IUDs. If insured patients face a copayment, however, they may be eligible for a patient savings program that enables them to pay no more than $75 for Liletta, up to a maximum savings limit of $500. For public clinics participating in the 340B Drug Pricing Program, the price of Liletta is $50. The proceeds from the commercially insured population subsidize the low cost for public clinics that serve low-income women.

The low price enables public clinics to stockpile the IUDs so that they are available on the day a patient decides she wants to start using the device. Same-day availability is important, because a substantial percentage of women who need a second appointment for insertion fail to keep that appointment. In addition to underwriting the price of Liletta for 340B clinics, Medicines360 says it plans to use proceeds from its partnership for advocacy, education, and development of additional drugs and partnerships.

Conclusion

High OOP expenses have constituted a barrier to the use of LARCs in the U.S. The large longitudinal CHOICE Project has demonstrated that when costs are removed as a factor in the decision-making process by well-informed women, 75% of them choose a LARC. Women who select a LARC are much more likely to continue using it over the long term than women who choose non-LARCs, and a higher percentage of LARC users express satisfaction with their method of contraception than non-LARC users. The ACA has removed most financial barriers to the use of LARCs, mandating that prescriptions for FDA-approved contraceptives be filled without cost sharing for privately insured women. Meanwhile, a not-for-profit pharmaceutical company supported by the Buffett Foundation is attempting to remove financial barriers to a hormonal IUD it developed.

Jack McCain is a freelance medical writer in Durham, Conn. He has been writing about health care for almost 30 years.

References

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