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Is NEXTSTELLIS covered by your patient’s insurer?
If it is not on the insurer’s prescription drug formulary or if the plan requires prior authorization, complete the form and send it to your patient’s insurer to request coverage of NEXTSTELLIS.
Brochure for your patients to:
If you would like more information, or have any questions, about NEXTSTELLIS, then please submit a request: for example, on our product availability, savings program, sampling, and our pre-activated Saving Cards or for details on our patient support services.
Most uncovered, insured eligible patients will pay as little as $25 for each one-month prescription fill or as little as $50 (less than $17 per month) for each three-month prescription fill.
Estetrol is the first native estrogen approved for contraceptive use in the United States. Produced during pregnancy, estetrol is found at high levels in maternal–fetal circulation. For pharmaceutical use, estetrol can be produced from plants and offers a distinct pharmacologic profile from other contraceptive estrogens. Estetrol has selective actions on nuclear estrogen receptors and is the first estrogen to be described as a NEST: a Native Estrogen with Selective actions in Tissues.1-5 Find more information about how estetrol works.
Estetrol is a Native Estrogen with Selective actions in Tissues (NEST).3 This describes several qualities that make estetrol unique. First, estetrol is an endogenous estrogen that occurs naturally during pregnancy.1,6 Second, it binds selectively to nuclear estrogen receptors while blocking estrogen receptors in the membrane. This makes estetrol pharmacologically distinct from other estrogens that bind both membrane and nuclear estrogen receptors throughout the body.7 Learn more about estetrol (E4) and its binding activity.
Tissues in the body respond differently to estrogen based on their dependence on nuclear or membrane receptor signaling.7,8
Understanding the role of nuclear and membrane estrogen receptor signaling in different tissue types helps clarify the selective actions of estetrol.11-14
In clinical trials, NEXTSTELLIS demonstrated a highly predictable bleeding profile. Unscheduled bleeding with NEXTSTELLIS occurred in <2% of women in the trial, and the average duration of spotting or bleeding episodes was <1 day.15 Learn more about the bleeding patterns in Phase III studies of NEXTSTELLIS.
Estetrol is an endogenous estrogen that occurs naturally during pregnancy. For pharmaceutical use, estetrol is produced from a plant source.2
NEXTSTELLIS pairs DRSP, a proven progestin, with the first newly approved contraceptive estrogen in 60 years—estetrol (E4).6,17,10 Estetrol binds selectively with nuclear estrogen receptor alpha (ERα) and antagonizes membrane ERα.7 Tissues in the body respond differently to estrogen based on their dependence on nuclear or membrane receptor signaling. This is what gives estetrol its unique tissue selectivity.7,8
Yes, NEXTSTELLIS is a monophasic regimen with 24 active and 4 placebo pills per 28-day cycle pack.6
Estetrol—the estrogen component in NEXTSTELLIS—was studied (Phase II studies) in combination with drospirenone and levonorgestrel.6,17 Estetrol combined with either DRSP or LNG demonstrated adequate safety and efficacy.22 However, these and other Phase II studies also evaluated18,19,20,21:
Based on the results of these studies, drospirenone was selected as the optimal progestin to combine with estetrol.
There are 3 key differences between estetrol and ethinyl estradiol that make a comparison in doses difficult:
Because of these differences, the dose of E4 cannot be translated into an equivalent dose of EE that applies to all tissues.
Ultimately, it is important to remember that estetrol is fundamentally different from synthetic contraceptive estrogens such as ethinyl estradiol. The lowest effective dose of estetrol + DRSP was established in Phase II dose-finding studies and validated in the Phase III studies that were the basis of its approval.6,15
Prescribing information for NEXTSTELLIS includes a boxed warning for women ≥35 years who are smokers.6 This is consistent with product labeling for combined hormonal contraceptives.
In the Phase III clinical studies of NEXTSTELLIS, with a combined safety population of 3,632, a VTE occurred in 1 patient in the EU/Russian trial, for an annual incidence rate of 3.66 per 10,000 women-years.6,25 The annual risk for VTE in women on any COC is estimated at 3 to 9 per 10,000 women. Longer-term studies will be needed to determine if there are differences in VTE risk with NEXTSTELLIS compared with any other COC.
NEXTSTELLIS shares the same prescribing considerations as other estrogen-containing birth control pills.6,26 For more information, please see the full Prescribing Information.
Patients new to hormonal birth control can start NEXTSTELLIS on the first day of the menstrual cycle. Patients transitioning from other hormonal birth control methods can begin taking NEXTSTELLIS the day after stopping the previous method, or the next menstrual cycle.6
Get comprehensive information about starting patients on NEXTSTELLIS. A downloadable patient brochure guide is also available for patients starting NEXTSTELLIS.