598 10 somatropin (Omnitrope)
SMC ISSUES ADVICE ON NEW DRUGS
The Scottish Medicines Consortium (SMC) today (Monday) accepted the following new drug for use within NHSScotland:
- somatropin (Omnitrope) for infants, children and adolescents with growth disturbance
Further Details:
SOMATROPIN (OMNITROPE)
Somatropin (Omnitrope) is accepted for use within NHSScotland for:
Infants, children and adolescents:
- Growth disturbance due to insufficient secretion of growth hormone (GH)
- Growth disturbance associated with Turner syndrome
- Growth disturbance associated with chronic renal insufficiency
- Growth disturbance in short children/adolescents born small for gestational age, with a birth weight and/or length below -2 standard deviation (SD), who failed to show catch-up growth by four years of age or later
- Prader-Willi syndrome (PWS) disturbance due to insufficient secretion of growth hormone, for improvement of growth and body composition.
Adults:
- Replacement therapy in adults with pronounced GH deficiency. Patients with severe GH deficiency in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one known deficiency of a pituitary hormone not being prolactin.
- Somatropin (Omnitrope) is a biosimilar product and has demonstrated equivalency in terms of efficacy and safety to a reference recombinant human growth hormone (somatropin (Genotropin)).
- The manufacturer estimated savings of £103k in year 1 and £89k in year 5. It was assumed that Omnitrope would replace 10% of the Genotropin market with the market share assumed to remain constant over the 5 year period, equating to use of Omnitrope in 143 patients per year.
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.