Advice
Estimated impact for the NHS
Likely place in contraceptive choice
The Faculty of Sexual & Reproductive Healthcare clinical guidance on combined hormonal contraception (2011) advises that healthcare professionals prescribing combined hormonal contraceptives should be guided by the woman's personal preference, risk of venous thromboembolism, any contraindications, possible non-contraceptive benefits, and experience with other contraceptive formulations. See the Faculty of Sexual & Reproductive Healthcare guidance for more information.
In Mansour et al. (2011) and Westhoff et al. (2012) acne, irregular withdrawal bleeding and weight gain were reported more often with nomegestrol/estradiol than with drospirenone/ethinylestradiol. However, withdrawal bleeds were lighter and shorter with nomegestrol/estradiol than with drospirenone/ethinylestradiol, which may be seen as an advantage by some women. The more common absence of withdrawal bleeding with nomegestrol/estradiol may be seen as an advantage or disadvantage.
A Faculty of Sexual & Reproductive Healthcare statement on the use of nomegestrol/estradiol notes that combined oral contraceptives that have extended regimens (for example, 24/4 or 26/2) or that contain hormones similar to endogenous hormones may appeal to some women. It states that current evidence suggests that nomegestrol/estradiol is acceptable and safe. However, until more data are available the indications and contraindications for nomegestrol/estradiol must be assumed to be the same as for other combined hormonal contraceptives.
Localities making formulary decisions about nomegestrol/estradiol will need to take this evidence into account, bearing in mind that user preference is an important factor in contraceptive choice. A reduction in or absence of withdrawal bleeding may be attractive to some women, but seen as a disadvantage to others. Acquisition cost may be another important factor: a 3-month pack of nomegestrol/estradiol (Zoely) is £16.50, which is in the middle of the range of combined oral contraceptives (£1.80 to £29.25 for a 3-month supply).
The manufacturer of nomegestrol/estradiol (Zoely, Merck Sharp & Dohme) has suggested that, in the UK, nomegestrol/estradiol will usually be prescribed as a second- or third-line option, as an alternative to products such as drospirenone/ethinylestradiol (Yasmin, the fixed-dose combined oral contraceptive used as a comparator in the studies assessed in this evidence summary) or dienogest/estradiol (Qlaira, currently the only other combined oral contraceptive that contains estradiol and has a pill-free interval of less than 7 days).
Estimated usage
The manufacturer of nomegestrol/estradiol (Zoely, Merck Sharp & Dohme) and the specialists involved in the production of this evidence summary have suggested that nomegestrol/estradiol is likely to be used as a second- or third-line option in only a small subgroup of women who have found alternative combined hormonal contraceptives unsuitable.
Costs of combined oral contraceptives range from £1.80 to £29.25 for a 3‑month supply. Possible alternatives to nomegestrol/estradiol (Zoely) include drospirenone/ethinylestradiol (Yasmin) and dienogest/estradiol (Qlaira). The cost of a 3-month pack is £16.50 for Zoely, £14.70 for Yasmin and £25.18 for Qlaira (MIMS, October 2013).