Issue date: May 2010 NHS

Review date: May 2013

National Institute for
Health and Clinical Excellence
Quick reference guide

Human growth hormone (somatropin) for the

treatment of growth failure in children
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.

Guidance
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
treatment. If, after that discussion, more than one
product is suitable, the least costly product should
be chosen.
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

• chronic renal insufficiency • final height is approached and growth velocity

is less than 2 cm total growth in 1 year
• born small for gestational age with
subsequent growth failure at 4 years of age • there are insurmountable problems
or later with adherence

• short stature homeobox-containing gene • final height is attained.

(SHOX) deficiency.
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 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.

NICE technology appraisal guidance 188

The guidance was developed using the NICE multiple technology appraisal process.
NICE technology appraisal guidance is about the use of new and existing medicines and treatments in the NHS in England and Wales.
Implementation tools Related NICE guidance
NICE has developed tools to help organisations put this There is no related guidance.
guidance into practice (listed below). These are available
on our website (www.nice.org.uk/guidance/TA188).
Updating the appraisal
• Costing tools:
This technology appraisal will be considered for review in
– costing report to estimate the national savings and May 2013. Information about the progress of a review will
costs associated with implementation be available at www.nice.org.uk/guidance/TA188
– costing template to estimate the local costs and
savings involved.
• Audit support for monitoring local practice.

Further information
Ordering information
You can download the following documents from
www.nice.org.uk/TA188
• A quick reference guide (this document) – the
recommendations.
• ‘Understanding NICE guidance’ – a summary for
patients and carers.
• The NICE guidance.
• Details of all the evidence that was looked at and other
background information.
For printed copies of the quick reference guide or
‘Understanding NICE guidance’, phone NICE publications
on 0845 003 7783 or email publications@nice.org.uk
and quote:
• N2159 (quick reference guide)
• N2160 (‘Understanding NICE guidance’).

This guidance represents the view of NICE, which was arrived at after careful consideration of the available evidence. Healthcare
professionals are expected to take it fully into account when exercising their clinical judgement. However, the guidance does not
override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual
patient, in consultation with the patient and/or guardian or carer.
Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are
reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to avoid unlawful
discrimination and to have regard to promoting equality of opportunity. Nothing in this guidance should be interpreted in a way
which would be inconsistent with compliance with those duties.
© National Institute for Health and Clinical Excellence, 2010. All rights reserved. This material may be freely reproduced for
educational and not-for-profit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed
without the express written permission of NICE.
National Institute for Health and Clinical Excellence ISBN 978-1-84936-228-3
MidCity Place, 71 High Holborn, London, WC1V 6NA; www.nice.org.uk N2159 9k 1P May 10