599 10 ulipristal acetate (EllaOne)
SMC ISSUES ADVICE ON NEW DRUGS
The Scottish Medicines Consortium (SMC) today (Monday) accepted the following new drug for use within NHSScotland:
- ulipristal acetate (EllaOne) for emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure
Further Details:
ULIPRISTAL ACETATE (ELLAONE)
- Ulipristal acetate (EllaOne) is accepted for use within NHSScotland for emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure.
- When administered within the licensed time frame for ulipristal or an active comparator for emergency hormonal contraception, contraceptive efficacy with ulipristal was non-inferior to that with the comparator in individual studies and statistically superior in a meta-analysis of two studies.
- Other treatments are available at lower drug acquisition cost.
- The manufacturer provided estimates of the total cost of emergency hormonal contraception (EHC) prescribing (ulipristal and levonorgestrel combined) under different scenarios, ranging from £146k in year 1 if ulipristal were used for women presenting after 72 hours to £193k if ulipristal were used for women presenting after 48 hours.
- The manufacturer estimated 40,491 to 48,589 women would require EHC in 2010 with the figures falling very slightly over time as the demographic structure of the Scottish population changes. Around 43% of these women were assumed to require a prescription, therefore 21,031 women would be potentially eligible for ulipristal.
Notes for editors – About SMC:
1. 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 (MHRA) / European Medicines Evaluation Agency (EMEA).
2. The SMC process encourages pharmaceutical manufacturers to make a submission before a product is launched. The aim is to issue advice as soon as possible after the launch of a product.
3. 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.
4. This advice 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.
For further information, contact Stephen Ferguson on 07779 329 689.