A 17-year-old nulliparous woman comes to your clinic for an annual examination. She has no significant health problems, and her examination is normal. She notes that she was started on oral contraceptives (OCs) the year before because of heavy menstrual flow and a desire for birth control but has trouble remembering to take them—though she does usually use condoms. She asks your advice about switching to a different method but indicates that she has lost her health insurance coverage.
What can you offer her as an effective, low-cost contraceptive?
Long-acting reversible contraception (LARC) methods are especially suited for adolescent and young adult women, for whom daily compliance with a shorter-acting contraceptive may be problematic. Five LARC methods are available in the United States, including a new levonorgestrel-releasing intrauterine system (LNG-IUS; Liletta), which received approval from the US Food and Drug Administration (FDA) this year. Like Mirena, Liletta contains 52 mg of levonorgestrel that is released over time. Liletta was introduced by the nonprofit organization Medicines360 and its commercial partner Actavis Pharma in response to evidence that poor women continue to lack access to LARC because of cost or problems with insurance coverage.1
For providers who practice in settings eligible for 340B pricing, Liletta costs $50, a fraction of the cost of alternative intrauterine devices (IUDs). The cost is slightly higher for non-340B providers but is still significantly lower than the cost of other IUDs. For health care practices, the reduced price of Liletta may make it feasible for them to offer LARC to more patients. The reduced pricing also makes Liletta an attractive option for women who choose to pay for the device directly rather than use insurance, such as the patient described above.
Patient experience with Liletta also is key. Not surprisingly, Liletta’s clinical trial found patient satisfaction to be similar to that of Mirena users.2 The failure rate is less than 1%, again comparable to Mirena. The rate of pelvic infection with Liletta use was 0.5%, also comparable to previously published data.3
One difference between Liletta and Mirena is that Liletta carries FDA approval for 3 years of contraceptive efficacy, compared with 5 years for Mirena. In order to make Liletta available to US patients now, Medicines360 decided to apply for 3-year contraceptive labeling while 5- and 7-year efficacy data are being collected. Like Mirena, Liletta is expected to provide excellent contraception for at least 5 years.
How to insert Liletta
- With the intrauterine system (IUS) loaded at the top of the insertion tube, firmly pinch the proximal end of the insertion tube to keep the IUS in the correct position. Applying gentle traction on the tenaculum, align the cervical canal and uterine cavity.
- While still pinching the insertion tube, slide the tube through the cervical canal until the upper edge of the flange is approximately 1.5 to 2 cm from the cervix. Do not force the inserter. If necessary, dilate the cervical canal. Release your hold on the tenaculum.
- Hold the insertion tube with the fingers of one hand (Hand A) and the rod with the fingers of the other hand (Hand B).
- Holding the rod in place (Hand B), relax your pinch on the tube and pull the insertion tube back with Hand A to the edge of the second indent of the rod. This will allow the IUS arms to unfold in the lower uterine segment (FIGURE). Wait 10 to 15 seconds for the arms of the IUS to open fully.
- Apply gentle traction with the tenaculum before advancing the IUS. With Hand A still holding the proximal end of the tube, advance both the insertion tube and rod simultaneously up to the uterine fundus. You will feel slight resistance when the IUS is at the fundus. Make sure the flange is touching the cervix when the IUS reaches the uterine fundus. Fundal positioning is important to prevent expulsion.
- Hold the rod still (Hand B) while pulling the insertion tube back with Hand A to the ring of the rod. While holding the inserter tube with Hand A, withdraw the rod from the insertion tube all of the way out to prevent the rod from catching on the knot at the lower end of the IUS. Completely remove the insertion tube.
- Using blunt-tipped sharp scissors, cut the IUS threads perpendicular to the thread length, leaving about 3 cm outside of the cervix. Do not apply tension or pull on the threads when cutting to prevent displacing the IUS. Insertion is now complete.
Source: Liletta [package insert]. Actavis Pharma, Parsippany, NJ; 2015.