From our Corporate Partner, Pharmanovia: Ghryvelin NICE approved

NICE provide advice for use of macimorelin in diagnosing adult growth
hormone deficiency¹

The National Institute for Health and Care Excellence has provided a new Medtech Innovation Briefing (MIB)
that reviews and provides advice on the new oral adult growth hormone test, macimorelin.

What is a Medtech Innovation Briefing (MIB)²?

Medtech Innovation Briefings (MIBs) are NICE advice. They are designed to support NHS and social care
commissioners and staff who are considering using new medical devices and other medical or diagnostic
technologies. They are designed to be fast, flexible and responsive to the need for information on innovative
technologies. They help avoid the need for organisations to produce similar information locally, saving staff
time and resources.

What is macimorelin?

Macimorelin is a synthetic growth hormone secretagogue receptor agonist stimulating release of growth
hormone from the pituitary gland.
It is the first and only oral agent for use in AGHD test, which is likely to reduce the resources required to
perform a growth hormone stimulation test compared current standard tests such as the Insulin tolerance
test (ITT) and Glucagon Stimulation test (GST)³. Additionally, the macimorelin test can also significantly
reduce the negative impact on patients by having a more favorable and tolerable safety profile2
Macimorelin is available as granules that are dissolved in water and taken by mouth. The recommended
dose is 0.5 mg per kg body weight which the patient should take once. The Healthcare professional then
takes 3 blood samples at 45, 60 and 90 minutes to measure the concentration of GH produced after
stimulation.

Sherwin Criseno, Nurse Consultant at Queen Elizabeth Hospital Birmingham, is optimistic that macimorelin is
a safe and more practical option for growth hormone stimulation testing, especially for Endocrine centres
that don’t have adequate facility and expertise to perform regular insulin tolerance tests. Sherwin
highlighted though that macimorelin test is an additional option from the array of currently used GH
stimulation tests and will not replace ITT in all cases as it can only assess the growth hormone axis (and not
the cortisol axis), nonetheless, the availability of an oral agent is a step forward to making the assessment
and diagnosis of GHD in at risk group more practical and safer for patients.

The macimorelin MIB can be found here https://www.nice.org.uk/advice/mib320Product specific information can be found https://www.macimorelin.co.uk/prescribing-information

The NHS list price of macimorelin is £300.00 plus VAT per 60mg sachet.

3 References:
1. Macimorelin for diagnosis growth hormone deficiency, Medtech Innovation Briefing, NICE March
2023, https://www.nice.org.uk/advice/mib320
2. Jose M Garcia JM, Biller BMK, Korbonits M, et al. Macimorelin as a diagnostic test for adult GH
deficiency. J Clin Endocrinol Metab. 2018;103:3083-3093. https://doi.org/10.1210/jc.2018-00665.
3. Macimorelin SmPC
https://mhraproducts4853.blob.core.windows.net/docs/53ce2b92d08629a659baf9d9f81b47fe3fc5f
1a0