An analysis of product wastage arising from dosing increment granularity in four modern growth hormone administration devices

Abstract

Objective: Human growth hormone (hGH) delivery systems differ in the size of the dose increments that can be set by the patient, affecting proximity to the target (i.e., prescribed) dose which can be attained. We investigated differences in dosing increment granularity in NordiFlex®, FlexPro®, NordiPen® (all multiple dose devices) and MiniQuick® (single dose) delivery systems.

Methods: A simulation model was developed to project hGH dosing in pediatric patients with growth hormone deficiency, small for gestational age or Turner syndrome, calculating the nearest dose above the target dose administrable by each device in typical EU and US cohorts and projecting the excess dose (hGH wastage) over 1 year of typical use.

Results: The device with the smallest dosing increment (FlexPro 5 mg; 0.025 mg dosing increment) was projected to administer doses < 1% above the target across all indications. MiniQuick (0.2 mg dosing increment) was projected to deliver between 5 and 6% above the target dose. None of the sensitivity analyses changed the conclusion that larger dosing increments result in more hGH wastage.

Conclusions: In addition to increasing dosing accuracy, finer dosing increments may result in reductions in unnecessary hGH usage, which may in turn result in reductions in the cost of hGH treatment borne by the health-care payer.

Keywords:

• computer simulation
• drug delivery systems
• growth hormone
• injections
• subcutaneous

Declaration of interest

This study was funded by Novo Nordisk A/S, which manufactures FlexPro, NordiPen and NordiFlex devices. Novo Nordisk A/S paid consultancy fees to Ossian Health Economics and Communications GmbH to conduct the analysis and prepare the manuscript. RF Pollock is a full-time employee of Ossian Health Economics and Communications GmbH. A-M Kappelgaard and L Seitz are full-time employees of Novo Nordisk Pharma GmbH, a wholly owned subsidiary of Novo Nordisk A/S, and of Novo Nordisk A/S, respectively. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Parts of this work have been presented as poster MON-0151 at the 16th International Congress of Endocrinology (ICE/ENDO), Chicago, 2014.

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