Human Growth Hormone (Somatropin) in Children with Growth Failure (TA188)

Technology Appraisal Guidance No. 188

Source: National Institute for Health and Care Excellence

NOTE: This guidance replaces ‘NICE technology appraisal guidance 42’ issued in May 2002.

The review and re-appraisal of human growth hormone (somatropin) for the treatment of growth failure in children has resulted in a change in the guidance. Human growth hormone (somatropin) is still recommended for the treatment of growth failure in children with growth hormone deficiency, Turner syndrome, Prader–Willi syndrome and chronic renal insufficiency, but there has been an extension of the guidance to include growth failure associated with either of the two following conditions:

  • born small for gestational age with subsequent growth failure at 4 years of age or later
  • short stature homeobox-containing gene (SHOX) deficiency.

1. Guidance

1.1  Somatropin (recombinant human growth hormone) is recommended as a treatment option for children with growth failure associated with any of the following conditions:

  • growth hormone deficiency
  • Turner syndrome
  • Prader–Willi syndrome
  • chronic renal insufficiency
  • born small for gestational age with subsequent growth failure at 4 years of age or later
  • short stature homeobox-containing gene (SHOX) deficiency.

1.2  Treatment with somatropin should always be initiated and monitored by a paediatrician with specialist expertise in managing growth hormone disorders in children. The choice of product should be made on an individual basis after informed discussion between the responsible clinician and the patient and/or their carer about the advantages and disadvantages of the products available, taking into consideration therapeutic need and the likelihood of adherence to treatment. If, after that discussion, more than one product is suitable, the least costly product should be chosen.

1.3  Treatment with somatropin should be discontinued if any of the following apply:

  • growth velocity increases less than 50% from baseline in the first year of treatment
  • final height is approached and growth velocity is less than 2 cm total growth in 1 year
  • there are insurmountable problems with adherence
  • final height is attained.

In Prader–Willi syndrome evaluation of response to therapy should also consider body composition.

Treatment should not be discontinued by default. The decision to stop treatment should be made in consultation with the patient and/or carers either by:

  • a paediatrician with specialist expertise in managing growth hormone disorders in children, or
  • an adult endocrinologist, if care of the patient has been transferred from paediatric to adult services.

The guidance shown above constitutes Section 1 of the full document. A copy of the full document and a summary of the evidence is available on the Internet at http://guidance.nice.org.uk/TA188

Copies of the document can also be obtained by contacting 0845 003 7783 or emailing publications@nice.org.uk and quoting reference number N2159. It is also available on the Internet at http://guidance.nice.org.uk/TA188/quickrefguide/pdf/English

This guidance represents the view of the Institute which was arrived at after careful consideration of the available evidence. Health professionals are expected to fully take it into account when exercising their clinical judgement. This guidance 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.

© Copyright National Institute for Health and Care Excellence. All rights reserved. This material may be freely reproduced for educational and not for profit purposes within the NHS. No reproduction by or for commercial organisations is permitted without the express written permission of the Institute.

Enquiries concerning the guidance should be addressed to: National Institute for Health and Care Excellence, MidCity Place, 71 High Holborn, London WC1V 6NA. email: nice@nice.org.uk

Guidance on the Use of Human Growth Hormone (Somatropin) in Children with Growth Failure.
Issue Date: May 2010
Review Date: May 2013


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