A new, more affordable IUD enters the market
Eisenberg DL, Schreiber CA, Turok DK, Teal SB, Westhoff CL, Creinin MD. Three-year efficacy and safety of a new 52-mg levonorgestrel-releasing intrauterine system. Contraception. 2015;92(1):10–16.
Programs such as the Contraceptive CHOICE Project and the Colorado Family Planning Initiative relied on private foundations for financial support, largely because of the high cost of the IUDs and implants currently available in the United States. Even with the Affordable Care Act (ACA) reducing the costs of LARC products and other contraceptives for patients, there are still many women not covered by these programs. For example, “grandfathered” health insurance plans do not need to follow some aspects of the ACA.
Just as important, the high cost of LARC products takes a toll on providers and clinics that must finance the cost per unit to have stock on hand and then wait for months for reimbursement by insurance companies. As a result, some providers do not stock IUDs and implants and only order them as they are needed and approved by insurance for a particular patient. These barriers limit access to LARC methods and reduce the number of women who receive the products.8
Liletta is less expensive than other IUDs
Enter Liletta, a new levonorgestrel-releasing, 52-mg intrauterine system (IUS) that has been in clinical trials since 2009.9 ACCESS IUS (A Comprehensive Contraceptive Efficacy and Safety Study of an Intrauterine System) was initiated by Medicines360, a unique nonprofit pharmaceutical company committed to ensuring access to reproductive health products for all women (private and public sector).
ACCESS IUS is the largest IUD approval study ever performed exclusively in the United States. The Phase 3, open-label clinical trial was conducted at 29 sites around the United States, enrolling healthy, nonpregnant, sexually active women aged 16 to 45 years with regular menstrual cycles. Both nulliparous and parous women were included, with no weight or body mass index (BMI) restrictions applied. The study is ongoing and will continue for as long as 7 years. Eisenberg and colleagues published the data used for initial approval for 3 years of use in the United States and Europe.9
Details of the trial
A total of 1,600 women aged 16 to 35 years comprised the group in which efficacy was evaluated. An additional 151 women aged 36 to 45 years were evaluated for safety only. Of the enrolled women, 1,011 (58%) were nulliparous, making ACCESS IUS the largest product approval study of nulliparous women. In addition, 438 women (25.1%) were obese, and 5% of these women had a BMI greater than 40 kg/m2.
Liletta was placed successfully in 1,714 women (97.9%). Fifteen women did not have placement attempted due to uterine factors (the uterus could not be sounded, or the sound was <5.5 cm) or factors unrelated to the product or inserter. In women in whom placement was attempted, the success rate was 98.7%.
The first-year Pearl index for Liletta was 0.15. Life-table pregnancy rates were 0.14 through year 1 and 0.55 through year 3. Four of the 6 pregnancies reported through 3 years of use were ectopic. Adverse events and their incidence, occurring in more than 2% of users, were acne (6%), expulsion (3.5%), dyspareunia (2.8%), and mastalgia (2.0%). The most common adverse events leading to discontinuation were expulsion (3.5%), bleeding complaints (1.5%), acne (1.3%), and mood swings (1.3%).
Uterine perforation with Liletta was diagnosed in 2 participants (0.11%). Expulsion occurred in 62 users (3.5%) and was more frequent among parous than nulliparous women (5.6% vs 2.0%, respectively; P<.001). Most (80.6%) of the expulsions were reported in the first year of product use. Pelvic infection was reported in 10 participants (0.6%), and all cases resolved with outpatient antibiotic treatment.9
Keep in mind that this is an ongoing study—not all women have reached a full 3 years of use. Updates on efficacy and adverse events will be published in the future. This current publication demonstrates the high efficacy and safety of the product through 3 years of use, permitting its approval for contraception in the United States.
In Europe, the product is approved for both contraception and the treatment of heavy menstrual bleeding, based on a European study.10
What this EVIDENCE means for practice
Liletta is a branded product (not generic) designed to be similar to Mirena, with the same size, frame, hormone content, and hormone release rate.11 Medicines360 has entered a groundbreaking marketing partnership with Actavis to make Liletta widely available and affordable. For most public sector providers and clinics in the United States, Liletta costs only $50, significantly less than other LARC methods available in the United States. Actavis also has a program that ensures that any woman lacking insurance coverage for an IUD and not receiving care at a public sector clinic will not be charged more than $75 for her IUD. However, the price of the device is only one aspect of its overall cost, as women still need to pay for any office visit or insertion fees.
For society, this unique business partnership has to include providers and patients as well. Sales of Liletta in the private sector will support the very low price in the public sector. As a health care community, even if we do not directly care for women in public-sector settings, we can all help poor women access very affordable highly effective contraception.
For providers, Liletta is a lower-cost alternative to currently available hormonal IUDs and should perform well over the long term. The highly successful use of Liletta in nulliparous women demonstrates its safety in this population. The 3-year approval is the first step, as the Phase 3 study continues. In the future, Liletta is expected to be approved for 5 years or longer.
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