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trabectedin (Yondelis) 634/10

The Scottish Medicines Consortium (SMC) today (Monday) did not accept the following new drug for use within NHSScotland:

  • trabectedin (Yondelis) in combination with pegylated liposomal doxorubicin (PLD) is indicated for the treatment of patients with relapsed platinum-sensitive ovarian cancer. The manufacturer’s justification of the treatment’s cost in relation to its health benefits was not sufficient to gain acceptance by SMC and in addition, the manufacturer did not present a sufficiently robust economic case to gain acceptance by SMC.

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.