606/10 ketoprofen omeprazole (Axorid)
SMC ISSUES ADVICE ON NEW DRUGS
The Scottish Medicines Consortium (SMC) today (Monday) accepted the following new drug for use within NHSScotland:
- ketoprofen/omeprazole (Axorid) is accepted for use within NHS Scotland.for the symptomatic treatment of rheumatoid arthritis, ankylosing spondylitis and osteoarthritis in patients with a previous history or who are at risk of developing NSAID associated gastric ulcers, duodenal ulcers and gastroduodenal erosions in whom continued treatment with ketoprofen is essential.
Further Details:
KETOPROFEN/OMEPRAZOLE (AXORID)
- Ketoprofen/omeprazole (Axorid) is accepted for use within NHS Scotland.
- Licensed indication under review: the symptomatic treatment of rheumatoid arthritis, ankylosing spondylitis and osteoarthritis in patients with a previous history or who are at risk of developing NSAID associated gastric ulcers, duodenal ulcers and gastroduodenal erosions in whom continued treatment with ketoprofen is essential.
- Studies in healthy volunteers demonstrated the bioequivalence of this combination product to the reference products, modified-release ketoprofen and omeprazole.
- Other nonsteroidal anti-inflammatory drugs can be co-prescribed with proton pump inhibitors at lower cost.
- The net medicines budget impact was estimated to be a saving of £1,175 in year 1 rising to a saving of £9,085 by year 5. The budget impact was based on 149 patients in year 1 rising to 165 in year 5 as the prevalence of arthritis increases over time. These figures were derived from an estimate of patients currently receiving ketoprofen MR in Scotland and an assumption that of these 28.5% would be co-prescribed gastro- protection. The share of the market, when ketoprofen MR and omeprazole were used together as Axorid, was assumed to rise from 10% in year 1 to 100% in year 5.
Notes for editors – Glossary:
- Ankylosing spondylitis – Ankylosing spondylitis is the persistent inflammation of the spine and sacroiliac joints (joints that lie at the junction of the spine and the pelvis) in the pelvis eventually causing fusion of the spine.
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 Agency (EMA).
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.