Novel oral iron therapy for iron deficiency anaemia: How to value safety in a new drug?

Allbwn ymchwil: Cyfraniad at gyfnodolynErthygladolygiad gan gymheiriaid

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Novel oral iron therapy for iron deficiency anaemia: How to value safety in a new drug? / Culeddu, Giovanna; Su, Li; Chen, Yafeng et al.
Yn: British Journal of Clinical Pharmacology, Cyfrol 88, Rhif 3, 03.2022, t. 1347-1357.

Allbwn ymchwil: Cyfraniad at gyfnodolynErthygladolygiad gan gymheiriaid

HarvardHarvard

Culeddu, G, Su, L, Chen, Y, Pereira, DIA, Powell, JJ & Hughes, D 2022, 'Novel oral iron therapy for iron deficiency anaemia: How to value safety in a new drug?', British Journal of Clinical Pharmacology, cyfrol. 88, rhif 3, tt. 1347-1357. https://doi.org/10.1111/bcp.15078

APA

Culeddu, G., Su, L., Chen, Y., Pereira, D. I. A., Powell, J. J., & Hughes, D. (2022). Novel oral iron therapy for iron deficiency anaemia: How to value safety in a new drug? British Journal of Clinical Pharmacology, 88(3), 1347-1357. https://doi.org/10.1111/bcp.15078

CBE

Culeddu G, Su L, Chen Y, Pereira DIA, Powell JJ, Hughes D. 2022. Novel oral iron therapy for iron deficiency anaemia: How to value safety in a new drug?. British Journal of Clinical Pharmacology. 88(3):1347-1357. https://doi.org/10.1111/bcp.15078

MLA

VancouverVancouver

Culeddu G, Su L, Chen Y, Pereira DIA, Powell JJ, Hughes D. Novel oral iron therapy for iron deficiency anaemia: How to value safety in a new drug? British Journal of Clinical Pharmacology. 2022 Maw;88(3):1347-1357. Epub 2021 Medi 12. doi: 10.1111/bcp.15078

Author

Culeddu, Giovanna ; Su, Li ; Chen, Yafeng et al. / Novel oral iron therapy for iron deficiency anaemia: How to value safety in a new drug?. Yn: British Journal of Clinical Pharmacology. 2022 ; Cyfrol 88, Rhif 3. tt. 1347-1357.

RIS

TY - JOUR

T1 - Novel oral iron therapy for iron deficiency anaemia: How to value safety in a new drug?

AU - Culeddu, Giovanna

AU - Su, Li

AU - Chen, Yafeng

AU - Pereira, Dora I.A.

AU - Powell, Jonathan J.

AU - Hughes, Dyfrig

PY - 2022/3

Y1 - 2022/3

N2 - AimsNovel oral iron supplements may be associated with a reduced incidence of adverse drug reactions compared to standard treatments of iron deficiency anaemia. The aim was to establish their value-based price under conditions of uncertainty surrounding their tolerability.MethodsA discrete-time Markov model was developed to assess the value-based price of oral iron preparations based on their incremental cost per quality-adjusted life year (QALY) gained from the perspective of the NHS in the UK. Primary and secondary care resource use and health state occupancy probabilities were estimated from routine electronic health records; and unit costs and health state utilities were derived from published sources. Patients were pre-menopausal women with iron deficiency anaemia who were prescribed oral iron supplementation between 2000 and 2014.ResultsThe model reflecting current use of iron salts yielded a mean total cost to the NHS of £779, and 0.84 QALYs over 12 months. If a new iron preparation were to reduce the risk of adverse drug reactions by 30–40%, then its value-based price, based on a threshold of £20 000 per QALY, would be in the region of £10–£13 per month, or about 7–9 times the average price of basic iron salts.ConclusionsThere are no adequate, direct comparisons of new oral iron supplements to ferrous iron salts, and therefore other approaches are needed to assess their value. Our modelling shows that they are potentially cost-effective at prices that are an order of magnitude higher than existing iron salts.

AB - AimsNovel oral iron supplements may be associated with a reduced incidence of adverse drug reactions compared to standard treatments of iron deficiency anaemia. The aim was to establish their value-based price under conditions of uncertainty surrounding their tolerability.MethodsA discrete-time Markov model was developed to assess the value-based price of oral iron preparations based on their incremental cost per quality-adjusted life year (QALY) gained from the perspective of the NHS in the UK. Primary and secondary care resource use and health state occupancy probabilities were estimated from routine electronic health records; and unit costs and health state utilities were derived from published sources. Patients were pre-menopausal women with iron deficiency anaemia who were prescribed oral iron supplementation between 2000 and 2014.ResultsThe model reflecting current use of iron salts yielded a mean total cost to the NHS of £779, and 0.84 QALYs over 12 months. If a new iron preparation were to reduce the risk of adverse drug reactions by 30–40%, then its value-based price, based on a threshold of £20 000 per QALY, would be in the region of £10–£13 per month, or about 7–9 times the average price of basic iron salts.ConclusionsThere are no adequate, direct comparisons of new oral iron supplements to ferrous iron salts, and therefore other approaches are needed to assess their value. Our modelling shows that they are potentially cost-effective at prices that are an order of magnitude higher than existing iron salts.

KW - Iron-defiency anaemia

KW - iron

KW - cost and cost analysis

KW - Cost Effectiveness

U2 - 10.1111/bcp.15078

DO - 10.1111/bcp.15078

M3 - Article

VL - 88

SP - 1347

EP - 1357

JO - British Journal of Clinical Pharmacology

JF - British Journal of Clinical Pharmacology

SN - 0306-5251

IS - 3

ER -