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1 mg estradiol/2 mg drospirenone (Angeliq®) as hormone replacement therapy

The Scottish Medicines Consortium issues advice on 1 mg estradiol/2 mg drospirenone (Angeliq) as hormone replacement therapy, for use within NHS Scotland.

The Scottish Medicines Consortium (SMC) has completed its assessment on the above product. The SMC advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) that 1 mg estradiol/2 mg drospirenone (Angeliq) is not recommended for use within NHS Scotland as hormone replacement therapy for oestrogen deficiency symptoms in postmenopausal women more than 1 year post-menopause.

It is effective in reducing the frequency of hot flushes and other symptoms of the menopause but comparative data versus other low dose continuous combined treatment are lacking.  The cost-effectiveness has not been demonstrated and there are cheaper alternatives.

(ENDS)

Notes for editors

1. Estradiol is a form of oestrogen involved in the female reproductive system. Drospirenone is a form of progesterone, a hormone important in the regulation of ovulation and menstruation. Together, drospirenone and estradiol are used to treat symptoms of the menopause.

2. There is a wide range of alternative hormone replacement therapies licensed for this indication.

3. The SMC advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) in Scotland about the use of all newly licensed medicines, all new formulations of existing medicines and any major new indications for established products. It does this after new medicines have been licensed by the Medicines and Healthcare products Regulatory Agency/European Medicines Evaluation Agency.

4. The SMC has formed a New Drugs Committee (NDC) to advise it and make recommendations on the issues surrounding newly licensed products.

5. The SMC process requires pharmaceutical companies to make a submission before a product is launched. The aim is to make a recommendation as soon as possible after the launch of a product.

6. Membership of the SMC has been derived from NHS Boards across Scotland. Membership is wide ranging across multi-disciplines of NHS Scotland and also includes members of the Association of British Pharmaceutical Industry (ABPI), and patient and voluntary group representatives.

7. This recommendation represents the views of the Scottish Medicines Consortium and was arrived at after careful consideration of the available evidence. Health professionals are expected to take due account of this recommendation when exercising their clinical judgement. This recommendation does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.

Contact: Colin McAllister on 07813 095930