Technology Appraisal Guidance No. 64
Source: National Institute for Health and Care Excellence
1.1 Recombinant human growth hormone (somatropin) treatment is recommended for the treatment of adults with growth hormone (GH) deficiency only if they fulfil all three of the following criteria.
- They have severe GH deficiency, defined as a peak GH response of less than 9 mU/litre (3 ng/ml) during an insulin tolerance test or a cross-validated GH threshold in an equivalent test.
- They have a perceived impairment of quality of life (QoL), as demonstrated by a reported score of at least 11 in the disease-specific 'Quality of life assessment of growth hormone deficiency in adults' (QoL-AGHDA) questionnaire.
- They are already receiving treatment for any other pituitary hormone deficiencies as required.
1.2 The QoL status of people who are given GH treatment should be re-assessed 9 months after the initiation of therapy (an initial 3-month period of GH dose titration, followed by a 6-month therapeutic trial period). GH treatment should be discontinued for those people who demonstrate a QoL improvement of less than 7 points in QoL-AGHDA score.
1.3 Patients who develop GH deficiency in early adulthood, after linear growth is completed but before the age of 25 years, should be given GH treatment until adult peak bone mass has been achieved, provided they satisfy the biochemical criteria for severe GH deficiency (defined as a peak GH response of less than 9 mU/litre (3 ng/ml) during an insulin tolerance test or a cross-validated GH threshold in an equivalent test). After adult peak bone mass has been achieved, the decision to continue GH treatment should be based on all the criteria in Section 1.1.
1.4 Patients currently receiving GH treatment, for the management of adult onset GH deficiency, whether as routine therapy or as part of a clinical trial, could suffer loss of well being if their treatment were to be discontinued at a time they did not anticipate. Because of this, all NHS patients who are on therapy at the date of publication of this guidance should have the option to continue treatment until they and their consultant consider it is appropriate to stop.
1.5 Children with GH deficiency should be treated as outlined in the Institute's guidance on the use of GH in children (NICE Technology Appraisal Guidance No. 42). At completion of linear growth (that is, growth rate < 2 cm/year), GH treatment should be stopped for 2 - 3 months, and then GH status should be re-assessed. GH treatment at adult doses should be re-started only in those satisfying the biochemical criteria for severe GH deficiency (defined as a peak GH response of less than 9 mU/litre (3 ng/ml) during an insulin tolerance test or a cross-validated GH threshold in an equivalent test), and continued until adult peak bone mass has been achieved (normally around 25 years of age). After adult peak bone mass has been achieved, the decision to continue GH treatment should be based on all the criteria set out in Section 1.1.
1.6 Initiation of GH treatment, dose titration and assessment of response during trial periods should be undertaken by a consultant endocrinologist with a special interest in the management of GH disorders. Thereafter, if maintenance treatment is to be prescribed in primary care, it is recommended that this should be under an agreed shared care protocol.
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://www.nice.org.uk/guidance/ta64
Copies of the document can also be obtained by contacting 0845 003 7783 or emailing email@example.com and quoting reference number N0265.
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.
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Human Growth Hormone (Somatropin) in Adults with Growth Hormone Deficiency.
Issue Date: August 2003
Review Date: July 2006