Indication
Growth disturbance caused by growth hormone deficiency in children
RAG rating
Red
Document type
Decision document
Place
Hertfordshire and West Essex ICB
Output type
Pharmacy / Prescribing
Document
Download

Somatrogon (Ngenla)

HERTFORDSHIRE AND WEST ESSEX AREA PRESCRIBING COMMITTEE (HWE APC)

Somatrogon for treating growth disturbance in children and young people aged 3 years and over

RED

Recommended for restricted prescribing by specialist only.

Not recommended for primary care prescribing.

Name generic (trade) Somatrogon (Ngenla®)

What it is Recombinant human growth hormone

Indication Licensed for the treatment of children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone.

Date decision last revised March 2023

Decision status Interim*

NICE / SMC Guidance NICE TA 863 recommended, SMC accepted for use

HWE APC recommendation:

Somatrogon is recommended, within its marketing authorisation, as an option for treating growth disturbance

in children and young people aged 3 years and over in line with the recommendations in NICE TA 863.

Somatrogon treatment should be reviewed in line with discontinuation criteria already agreed across HWE ICB for somatropin treatment:

Poor response: growth velocity in the first 3 years of treatment <50% above baseline value for year 1, 2, 3 of treatment.

Growth velocity is less than <2cm total growth in 1 year

Final height is attained. Confirmation of final height: bone age is >14yrs (girls) or >16yrs (boys)

Insurmountable problems with adherence

National tariff excluded.

If somatrogon is considered one of a number of suitable treatments (including any preparation of somatropin),

the least expensive (taking into account administration costs, dosage, price per dose and commercial arrangements) should be chosen.

RED STATUS*:

NOT RECOMMENDED FOR PRIMARY CARE PRESCRIBING.

RECOMMENDED FOR RESTRICTED PRESCRIBING BY SPECIALISTS

* Prescribing RAG recommendation to be reviewed at a future HWE APC meeting following consultations with

local specialists and tertiary centres

NICE TA 853 recommendations:

Somatrogon is recommended, within its marketing authorisation, as an option for treating growth disturbance caused by growth hormone deficiency in children and young people aged 3 years and over.

If people with the condition and their clinicians, consider somatrogon to be 1 of a range of suitable treatments (including any preparation of somatropin) discuss the advantages and disadvantages of the available treatments. After that discussion, if more than 1 treatment is suitable, choose the least expensive. Take account of administration costs, dosage, price per dose and commercial arrangements.

Review date: The recommendation is based upon the evidence available at the time of publication. This recommendation will be reviewed upon request in the light of new evidence becoming available.

Back