News Contraception

FDA Approves New IUD Designed To Be More Affordable

Martha Kempner

Liletta, an IUD just approved by the FDA, is being marketed in the United States through a unique partnership between manufacturers who hope to bring the device to more people at a lower cost. However, it is still unclear whether those savings will be felt by all women.

On March 2, the Food and Drug Administration (FDA) approved a new intrauterine device (IUD) that, among other things, was designed with affordability in mind. Liletta, which is already available in Europe, is being marketed in the United States through a unique partnership between manufacturers who hope to bring the device to more people at a lower cost. However, it is still unclear whether those savings will be felt by all women.

When released, Liletta will be the fourth IUD currently available in the United States. It joins ParaGard (also called the Copper-T), which began being sold to women in the United States in 1988; Mirena, a hormonal IUD introduced in 2000; and Skyla, a smaller version of that hormonal IUD which was released just last year with younger users in mind.

All IUDs are small T-shaped devices that are inserted into the uterus by a health-care professional and serve to block sperm from moving through the uterus toward the egg. ParaGard also releases copper, which some experts believe creates a substance toxic to sperm. In addition, Mirena, Skyla, and now Liletta all release levonorgestrel, a hormone similar to those found in birth control pills. This means that they also thicken cervical mucus (creating a barrier to sperm) and may suppress ovulation in some women. ParaGard lasts for ten years, Mirena for five, and Skyla and Liletta for three—but all can be removed by a health-care provider at any point if a woman decides she wants to become pregnant or switch methods.

Some of the primary benefits of IUDs are their ease of use and efficacy in preventing pregnancy. Unlike condoms, the pill, or other hormonal methods such as the patch or ring, once in place an IUD works for years without any thought or action on the part of the user. This doesn’t just take pressure off the user to remember their birth control; it takes user error out of the efficacy equation altogether. It’s not surprising, therefore, that IUDs have among the lowest failure rates of any contraceptive method. In clinical trials, Mirena had a failure rate of 0.2 percent; Skyla had a failure rate of 0.9 percent; and ParaGard had a failure rate ranging from 0.6 to 1.0 percent.  Liletta has a failure rate of 0.55 percent. For comparison, the pill has similar failure rates under perfect conditions, but the possibility of user error makes the typical-use failure rate a much higher 9 percent.

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The FDA approval of Liletta is based on a U.S. efficacy trial of 1,751 women, which the manufacturers say is the largest study of a hormonal method conducted in this country. The results of the study to date show that Liletta is 99.45 percent effective at preventing pregnancy for three years, and that it is safe for women regardless of their body mass index or whether or not they have had children. The study is ongoing, in part, to determine whether Liletta could continue working past its currently approved three-year lifespan.

Liletta’s manufacturers say that their partnership will make the device affordable to women of all income levels. One of the main complaints about IUDs today is their high cost. Between the price of the device itself and the provider’s fee for insertion, an IUD can cost as much as $1,000. While this is actually more cost-effective than other methods paid for on a monthly basis—a woman who uses ParaGard for its full ten-year lifespan, for example, could pay less than 30 cents a day—having to come up with the money up front is prohibitive for many women.

As Rewire recently reported, IUDs can even be difficult for Medicaid patients to access, as reimbursement rules in many states are problematic in different ways. In some states, for example, Medicaid reimbursement rates are less than the cost of the actual device, which means providers inevitably lose money. The high cost of the device also means that many providers and clinics can’t stock them in advance, so women who want IUDs will have to come back at least a second time for the insertion. Moreover, some states’ rules mean Medicaid will only pay for a device prescribed to a specific woman. This doesn’t just prevent providers from stocking them in advance of a patient request; it means if that specific patient does not return for insertion, the device can’t be used for anyone else. A number of states are working to fix this issue by loosening rules and increasing reimbursement.

Liletta may also be part of that solution, as it was designed with access in mind. Medicine 360, one of the companies marketing this new device, is a nonprofit pharmaceutical company. It will make Liletta available at a reduced price to clinics enrolled in the 340B Drug Pricing program. The 340B program is run by the U.S. Department of Health and Human Services and is available to entities that typically serve low-income women such as Title X family planning clinics, STD clinics, and Federally Qualified Health Centers. The exact pricing to these organizations will not be available until the device is actually released. It is likely—though not guaranteed—that savings will trickle down to patients who get their care at these locations.

However, for those obtaining Liletta through private providers, it is unclear whether Liletta will be cheaper than the three IUDs already on the market. wrote that we should “expect it to be markedly more wallet-friendly than the existing IUDs on the market when it launches this spring.” But when Rewire reached out to Actavis, the Dublin-based pharmaceutical company that will be handling the commercial sales of Liletta, the company gave no specifics. In an email, a spokesperson said: “Actavis is committed to providing access to IUDs in the private sector. More information on patient programs will be provided when LILETTA is available.” She added: “Information about pricing will be provided when LILETTA is commercially available.”

After their near-extinction in the 1980sIUDs continue to increase in popularity—the latest National Survey of Family Growth shows that 6.4 percent of women ages 15-to-44 are relying on this method of contraception. These numbers may very well go up when Liletta becomes available and helps at least some women overcome the price barrier to accessing this safe and effective form of contraception.

CORRECTION: This piece has been updated to reflect the correct daily price of an IUD when used for ten years.

News Contraception

Affordable Care Act in Action: IUDs Become More Affordable

Martha Kempner

A new study finds that the ACA has brought down the out-of-pocket costs of intrauterine devices (IUDs), one of the most effective—and often most cost prohibitive—methods of contraception.

A new study by researchers at the Guttmacher Institute found that the Affordable Care Act has been helpful in bringing down the out-of-pocket costs of intrauterine devices (IUDs), one of the most effective—and often most cost prohibitive—methods of contraception.

The study found that in 2014, 87 percent of insured women who inquired about a hormonal IUD would not have had to pay anything out of pocket, up from 42 percent of women in 2012. The study concludes that the ACA’s contraceptive coverage guarantee is reducing the cost barrier.

IUDs are small, T-shaped devices that are inserted into the uterus by a health-care professional and work by blocking sperm from moving through the uterus toward the egg. Once inserted they stay in place for between three and ten years, though a woman can have her IUD removed sooner if she dislikes it for any reason or decides she wants to become pregnant. Researchers have found that IUDs are safe for women of all ages regardless of whether they have or have not given birth.

IUDs are one of the most effective methods of contraception on the market. In fact, they are more than 99 percent effective in preventing pregnancy. One of the reasons they are so effective is that once they are in place, a woman does not need to do anything to prevent pregnancy. Unlike a pill that has to be taken every day or a patch that needs to be replaced each month, the IUD works without any action on the part of the user.

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A significant barrier to IUD use, however, has been the upfront costs. Between the price of the device itself and the provider’s fee for insertion, an IUD can cost as much as $1,000 on day one. In the long run this is likely more cost effective than methods such as the pill, which have to be purchased each month. A woman using ParaGard, for example, which lasts ten years, could pay just 30 cents a day. Still, coming up with the money upfront has been a challenge for many women.

A new IUD called Liletta was approved by the FDA in March, as Rewire reported. Medicine 360—one of the companies marketing Liletta—is a nonprofit pharmaceutical company. It plans to work with clinics enrolled in the U.S. Department of Health and Human Services’ 340B Drug Pricing program to make sure Liletta is more affordable for its patients. Clinics in this program include Title X family planning clinics, STD clinics, federally qualified health centers, and typically serve low-income women.

It is unclear whether Liletta will be any less expensive than other IUDs for those women with private insurance.

The new study, however, suggests that even without a low-cost option, women with health insurance are already seeing relief because of the ACA’s contraceptive coverage guarantee. To determine this, researchers at Guttmacher analyzed inquiries made to Bayer, which manufacturers two of the four IUDs on the market.

The pharmaceutical company offers a service that allows health-care providers to check what a patient’s insurance will and will not cover. The study included more than 444,000 inquiries made between January 2012 and March 2014. This new report looks at potential costs for women considering IUDs, whereas other research has been limited to those who ultimately chose the method.

This analysis, therefore, potentially includes women who were put off by the upfront cost.

“As this study documents, the ACA is making these more expensive methods a realistic option for many women. More women can now choose a birth control method based on what works best for them as opposed to what they can afford,” Megan Kavanaugh, a senior research scientist at the Guttmacher Institute and one of the authors of the article, said in a press release.

The study did find some gaps in coverage still remain. Even in 2014 with the ACA in place, 13 percent of women said they had to pay at least something if they wanted to get an IUD. This may be explained in part by exemptions to the contraceptive mandate extended to some religious employers.

Commentary Human Rights

Improving Reproductive Care for Women in Jail Is Not an Impossible Task

Kyl Myers

Women in city and county jails frequently face barriers to accessing contraception, abortion, prenatal care, and disease screening and treatment. But preventive family planning can be improved in jails around the United States by implementing a few core tenets for those incarcerated there.

Millions of the most medically underserved women in America enter local jails each year, where their reproductive health care and family planning needs are grossly overlooked. Women in city and county jails frequently face barriers to accessing contraception, abortion, prenatal care, and disease screening and treatment. But preventive family planning can be improved in jails around the United States by implementing a few core tenets for those incarcerated there.

Although the direct results of improving such care have not yet been studied, it seems a safe guess that releasing healthier, more empowered women with control over their fertility would have positive outcomes for them and the families and communities to which they return.

The U.S. Department of Justice reports that the female jail population has been the fastest-growing correctional population. In 2012, women accounted for more than 26 percent of all persons arrested, primarily for drug-related charges. Regardless of the growing rate of female incarceration, the National Commission on Correctional Health Care has stated that women’s sex-specific health-care needs remain unmet due to their minority status in a male-dominated jail population.

There are no federally mandated guidelines for women’s health care in jails. Correctional health-care arrangements vary; contracted providers may deliver health services at jails on site, or incarcerated persons may be transported to local hospitals or clinics for care. Often, these health care arrangements do not include appointments with obstetrics and gynecological health providers. The scholar and lawyer Kendra Weatherhead argues that the medical inadequacies incarcerated women face infringe on their rights established in the Eighth and 14th Amendments.

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Although some members of the public may believe that contraception and other reproductive care needs aren’t necessary because of facilities’ sex-segregation, discontinuing women’s birth control and not providing contraceptives before release may increase the likelihood of women experiencing an unintended pregnancy post-incarceration. Jails are different than prisons in that they are designed for short-term stays of people in pretrial detention or who have been sentenced to less than one year for low-level felonies. The average length of stay in America’s jails is around 30 days, but while jail time is short, it is also frequent. Recidivism rates are alarmingly high in the United States—half of women who have been incarcerated return to jail at least once within three years after their release.

Unfortunately, many women have a revolving-door experience with incarceration. An unintended pregnancy may further complicate a woman’s efforts to meet her probation or parole requirements; thus, helping women avoid unintended pregnancies may lead to a reduction in recidivism, or at least a reduction in women returning to jail with unwanted pregnancies, for which they may be unable to decide the outcome.

Overall, most women in jail are between the reproductive ages of 18 and 45; are sexually active; and already have children, for whom they are the primary caregivers. It is also estimated that 25 percent of incarcerated women are either pregnant or gave birth in the year prior to their arrest. Compared to women who have never been arrested, women with a history of involvement in the corrections system experience higher rates of unintended pregnancies, abortion, sexually transmitted infections, and domestic and sexual violence—again displaying the need for improved health care in jails.

To assess women’s family planning needs and desires for contraception, the following recommendations should be initiated in all local jails housing women.

Upon booking into jail, all women should be asked if they are sexually active with men and currently using a method of birth control.

If she is using a hormonal birth control method, ensure it is continued. Women incarcerated in U.S. jails are subject to discontinuation of their current contraceptive methods because of an assumption that birth control is an unnecessary medication in a sex-segregated jail. Generally, women experiencing incarceration are not given previously prescribed birth control pills, or kept on schedule with other hormonal methods such as Ortho Evra (the patch), NuvaRing (the ring), or Depo-Provera (the shot). In the case of managing a health issue such as endometriosis, a woman may be allowed to remain on birth control, but even then, discontinuation is common. This practice carries risks: Because hormonal birth control can take time to become effective, this puts women at risk of unintended pregnancy if they have to reinitiate birth control after release rather than continuing on a jail’s prescription. Furthermore, women’s health insurance and income are suspended during incarceration, which could further postpone a woman’s re-initiation of birth control while she waits for her insurance to activate or a first paycheck and an appointment with a family planning provider.

All reproductive-aged women should be asked if they are interested in initiating birth control during their jail stay.

An unintended pregnancy after incarceration could hinder a woman’s ability to successfully reintegrate into her community and increase her likelihood of returning to jail. After incarceration, most women have children they need to care for or regain custody of, and they often have to find housing and jobs—things that an unintended pregnancy could make more complicated. Most incarcerated women are sexually active and plan to have sex with male partners soon after their release and hope to avoid unintended pregnancies. However, women who are incarcerated are more likely to come from poor communities where access to contraceptive education and services is limited. Because health care in jail is subsidized, women experiencing incarceration who wish to could receive free family planning counseling and services, especially effective, reversible, long-term methods such as the arm implant, Implanon, or intrauterine devices such as Mirena, Skyla, Liletta, or ParaGard—methods that are especially difficult for disadvantaged, uninsured women to access in the community. At least two jails in the United States are providing incarcerated women with access to contraception during their stay, one in Rhode Island, the other in San Francisco, California. But two facilities on opposite sides of the country are not nearly enough.

If a woman had unprotected sex within five days prior to arrest and is eligible and interested in taking emergency contraception, it should be offered to her.

A 2009 study surveyed women within 24 hours of their arrest in San Francisco. They found that 29 percent were eligible for emergency contraception based on the above guidelines, and among those women, almost half were willing to take emergency contraception if it was offered to them in jail. Additionally, 71 percent of all women surveyed said they would accept an advance supply of emergency contraception upon release from jail. The researchers estimate that access to emergency contraception at time of arrest and upon release could potentially benefit more than 750,000 women entering the criminal justice system every year.

Administrators should establish whether a woman is currently pregnant or if she would like to take a pregnancy test.

The American Congress of Obstetricians and Gynecologists states that at any given time, approximately 6 to 10 percent of incarcerated women are pregnant, many of whom find out they are pregnant in a correctional facility. Unfortunately, pregnant women in jail are inconsistently counseled on their options for pregnancy outcome and access to termination services. Incarceration impedes women’s ability to access abortion in the case of unintended pregnancy and causes additional stress to women who desire to deliver and parent. If a woman is pregnant, she should be asked what her intentions are for the pregnancy outcome and should be provided with resources to accomplish her intentions. Women’s rights to prenatal care, humane treatment, and abortion services do not cease because of incarceration; however, incarceration greatly complicates their access to such services. This may result in pregnancy and delivery complications or a woman being forced to continue an unwanted pregnancy because she was unable to access an abortion.

If women want to become pregnant after release, they should be offered preconception counseling, prenatal vitamins, and information about parenting resources, such as Children’s Health Insurance Plan (CHIP) and Women, Infants and Children (WIC).

Women with a history of incarceration often face pregnancy complications and deliver low-birth weight babies due to poor prenatal nutrition or mother’s drug use. Providing women with resources and services promoting healthy pregnancies benefits women, their children and communities.

The fight for reproductive rights is difficult enough for women who have never experienced incarceration—the millions of women who enter U.S. correctional facilities have it worse and the problem is growing. We must challenge the system of mass incarceration occurring in America and fight to keep women out of jail for nonviolent offenses through advocating for better substance abuse treatment and alternatives to incarceration. Unfortunately, women already in these facilities often have few resources to advocate for themselves. We must engage with jail administrators and local legislators to ensure incarcerated women have access to reproductive health-care services and family planning resources. Jails are our jails. People from our communities are held there, and our money funds what they do and don’t have access to.

It is our responsibility to ensure reproductive rights and autonomy for those behind bars.