Section 7 of the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 requires integrated care boards, NHS England and, with respect to their public health functions, local authorities to comply with the recommendations in this evaluation within 3 months of its date of publication.
The Welsh ministers have issued directions to the NHS in Wales on implementing NICE technology appraisal guidance. When a NICE technology appraisal guidance recommends the use of a drug or treatment, or other technology, the NHS in Wales must usually provide funding and resources for it within 2 months of the first publication of the final draft guidance.
When NICE recommends a treatment 'as an option', the NHS must make sure it is available within the period set out in the paragraphs above. This means that, if a patient has GH deficiency and the healthcare professional responsible for their care thinks that human growth hormone (somatropin) treatment is the right treatment, it should be available for use, in line with NICE's recommendations.
Local guidelines and care pathways on the treatment of adults with GH deficiency should incorporate the guidance.
To measure compliance locally with the guidance, the following criteria can be used. Further details on suggestions for audit are presented in the section on detail on criteria for audit.
Recombinant human growth hormone (somatropin) treatment is given to an adult with GH deficiency only if they meet the following criteria (all of the first 3, or the fourth):
the individual has severe GH deficiency, defined as having a peak GH response of less than 9 mU/litre (3 ng/ml) during an insulin tolerance test (ITT) or a cross-validated GH threshold in an equivalent test, and
the individual has a perceived impairment of quality of life (QoL), as demonstrated by a reported score of at least 11 in the disease-specific QoL-assessment of growth hormone deficiency in adults (QoL-AGHDA) questionnaire, and
the individual is already receiving treatment for any other pituitary hormone deficiencies as required, or
the individual is receiving GH treatment at the date of publication of this guidance and, following re-assessment by his or her consultant endocrinologist as part of routine follow-up, it is considered appropriate to continue the therapy, taking into account the guidance in section 1.1.
An adult who is started on GH treatment is re-assessed for QoL status 9 months after the initiation of therapy. GH treatment is discontinued if the individual has a QoL improvement of less than 7 points in QoL-AGHDA score.
For an individual who as a child has been treated for GH deficiency and who has completed linear growth, the following are done.
GH treatment is stopped for 2 to 3 months.
The GH status of the individual is re-assessed.
GH treatment at an adult dose is re-started only if the individual has a peak GH response of less than 9 mU/litre (3 ng/ml) during an ITT, or a cross-validated GH threshold in an equivalent test.
If GH treatment is re-started, GH treatment at an adult dose is continued until adult peak bone mass is achieved.
When adult peak bone mass is achieved, GH treatment is continued only if the individual meets the criteria in 7.6.
For an individual who develops GH deficiency in early adulthood, after linear growth is completed but before the age of 25, the following are done.
GH treatment should be given until adult peak bone mass is achieved if the individual has a peak GH response of less than 9 mU/litre (3 ng/ml) during an ITT, or a cross-validated GH threshold in an equivalent test.
When adult peak bone mass is achieved, GH treatment is continued only if the individual meets criteria 7.6.
The following are carried out only by a consultant endocrinologist with a special interest in the management of GH disorders.
Initiation of GH treatment.
Dose titration.
Assessment of response during the trial period.
If maintenance GH treatment is to be prescribed in primary care, there is an agreed shared-care protocol.