NICE Technology Appraisal Guidance

The products Genotropin GoQuick®, Genetropin MiniQuick®, and Genetropin Pen contain somatropin for the treatment of growth disturbance.1

The National Institute for Health and Care Excellence (NICE) has issued technology appraisals on the use of somatropin (recombinant growth hormone) in the treatment of growth failure in children2 and the treatment of growth hormone deficiency in adults.3

Children with growth failure2

Read the NICE guidance and technology appraisal on the use of human growth hormone (somatropin) for the treatment of children with growth failure in full here.2

Summary of recommendations for somatropin use in children2

Somatropin is recommended as an option for treatment in 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. 

Treatment with somatropin should be discontinued in children if any of the following apply: 2

  • 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.
     

Prader-Willi syndrome2
In Prader Willi syndrome, evaluation of response to therapy should also consider body composition.
 

Cessation of treatment2

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.

Adults with growth hormone (GH) deficiency3

Read the NICE guidance and technology appraisal on the use of human growth hormone (somatropin) in adults with growth hormone deficiency in full here.3

Summary of recommendations for somatropin use in adults3

NICE has recommended that somatropin should be used for adults with severe GH deficiency that is severely affecting quality of life.1,3

A severe growth hormone deficiency in patients is explicitly defined as patients who:

  • Have a peak growth hormone response of less than 9 mU/litre in the ‘Insulin tolerance test’ or a cross-validated growth hormone threshold in an equivalent test.
  • Have an impaired quality of life (QoL) because of growth hormone deficiency, 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.
  • Are already receiving replacement hormone treatment for any other pituitary hormones deficiencies.

Patients on somatropin should have their quality of life re-checked 9 months after starting treatment using the QoL-AGHDA to decide if treatment should be continued.

Choice of delivery device2

NICE recommends that clinicians work with patients to choose a GH product on an individual basis.

  • NICE recommends “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.
  • Advantages and disadvantages of available products should be discussed.
  • If more than one product is suitable after a patient/clinician discussion, NICE state that the least costly product should be chosen.

NICE recommendations2,3

The National Institute for Health and Care Excellence (NICE) provides national guidance and advice to improve health and social care.

Somatropin is recommended in NHS England, NHS Scotland, NHS Wales and NHS Northern Ireland. Healthcare Improvement Scotland (HIS) has adopted NICE guidance.4,5

References

1. Genotropin SmPC. Available here - Accessed March 2018.

2. NICE guidance TA188. Technology appraisal on the use of human growth hormone (somatropin) for the treatment of children with growth failure. Available here - Accessed March 2018

3. NICE guidance TA64. Human growth hormone (somatropin) in adults with growth hormone deficiency.  Published August 2003. Available here - Accessed March 2018

4. SMC Somatropin (Genotropin) Injection. 10 February 2006. Available here - Accessed March 2018

5. Health Improvement Scotland. Available here - Accessed March 2018

 
PP-GEN-GBR-0370. March 2018