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579 09 fentanyl (Instanyl) 0.5mg/ml, 1mg/ml and 2mg/ml Nycomed

Attn: Newsdesks
 Health Correspondents

SMC ISSUES ADVICE ON NEW DRUGS

The Scottish Medicines Consortium (SMC) today (Monday) accepted the following new drugs for use within NHSScotland:

  • fentanyl nasal spray (Instanyl) for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain

Further Details:

FENTANYL NASAL SPRAY (INSTANYL)

  • Fentanyl nasal spray (Instanyl) is accepted for restricted use within NHSScotland for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain.
  • In an open-label comparative study intranasal fentanyl was superior to another fentanyl formulation used in the treatment of breakthrough pain in terms of time to onset of pain relief, although more episodes using the intranasal formulation required a second dose.
  • Use of fentanyl nasal spray should be restricted to patients who are unsuitable for other short-acting oral opioids (e.g. oral morphine) as an alternative to other buccal and sublingual fentanyl preparations. It should be noted that the doses of fentanyl nasal spray are significantly lower than doses of fentanyl given by other routes of administration for this indication.
  • The manufacturer estimated a net drug budget impact of £11k in year 1 rising to £418k in year 5. These figures assume some displacement of oral morphine and other fentanyl preparations. Given the niche position proposed, the budget impact should be less than estimated by the manufacturer as there would be no displacement of oral morphine. The manufacturer estimated 8 patients would be eligible in year 1 rising to 309 in year 5.

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.