Pollock Richard F, Kappelgaard Anne-Marie, Seitz Lisa
Ossian Health Economics and Communications GmbH , Bäumleingasse 20, 4051 Basel , Switzerland +41 61 271 6214 ;
Expert Opin Drug Deliv. 2015 Mar;12(3):353-60. doi: 10.1517/17425247.2015.1003805. Epub 2015 Jan 22.
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.
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.
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.
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.
人生长激素(hGH)给药系统在患者可设定的剂量增量大小方面存在差异,这会影响与可达到的目标(即规定)剂量的接近程度。我们研究了诺德笔Flex®、优伴笔FlexPro®、诺和笔NordiPen®(均为多剂量装置)和速秀笔MiniQuick®(单剂量)给药系统在剂量增量粒度上的差异。
开发了一个模拟模型,以预测生长激素缺乏症、小于胎龄儿或特纳综合征儿科患者的hGH给药情况,计算每个装置在典型欧盟和美国队列中可给予的高于目标剂量的最接近剂量,并预测在典型使用的1年期间的过量剂量(hGH浪费量)。
预测剂量增量最小的装置(优伴笔FlexPro 5mg;剂量增量为0.025mg)在所有适应症中给予的剂量比目标剂量高不到1%。速秀笔MiniQuick(剂量增量为0.2mg)预计给予的剂量比目标剂量高5%至6%。敏感性分析均未改变较大剂量增量会导致更多hGH浪费这一结论。
除了提高给药准确性外,更精细的剂量增量可能会减少不必要的hGH使用量,这反过来可能会降低医疗保健支付方承担的hGH治疗成本。