596 10 sildenafil citrate (Revatio)
SMC ISSUES ADVICE ON NEW DRUGS
The Scottish Medicines Consortium (SMC) today (Monday) accepted the following new drug for use within NHSScotland:
- sildenafil citrate (Revatio) for treatment of patients with pulmonary arterial hypertension (PAH)
Further Details:
SILDENAFIL CITRATE (REVATIO)
- Sildenafil citrate (Revatio) is accepted for restricted use within NHS Scotland for treatment of patients with pulmonary arterial hypertension (PAH) classified as WHO functional class II (F C II), to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease.
- It is restricted to initiation by specialists working in the Scottish Pulmonary Vascular Unit or similar specialists.
- This is an orphan indication for sildenafil with limited clinical evidence from post-hoc analysis of a short-term clinical trial.
- The manufacturer estimated that 35% of FC II patients receive sildenafil already with the remainder receiving ambrisentan. If it were assumed that all ambrisentan patients were switched to sildenafil 20mg three times per day the saving would be £331k in year one, rising to £474k by year 5. The manufacturer estimated that 33 patients would be treated with sildenafil in year one rising to 47 by year five. However, expert opinion suggests patient numbers will be lower, especially in year 5, and hence the savings may be an overestimate.
Notes for editors – Glossary:
- Pulmonary arterial hypertension (PAH) – A rare and debilitating disease where there is severe narrowing of the blood vessels of the lungs causing abnormally high pressure in the vessels taking blood from the heart to the lungs.
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.