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Background <p>Different formulations and routes of administration (e.g. oral, intravenous [IV], subcutaneous [SC]) of the same active pharmaceutical ingredient (API) may change value by altering administration burden, adherence, setting of care and resource use. This systematic review compared the economic impact of alternative formulations or routes of the same API and assessed reporting quality.</p> Methods <p>PubMed and Embase were searched from inception to 31 January 2025 for full economic evaluations directly comparing dosage forms or administration routes of the same API in humans. Two reviewers independently screened records, extracted data, and appraised reporting quality using Consolidated Health Economic Evaluation Reporting Standards (CHEERS 2022). For cost minimization analyses (CMAs), costs were converted to 2024 US dollars (USD) and summarized as median annual total cost differences and relative changes. Mean CHEERS scores were compared between CMAs and non-CMAs.</p> Results <p>Thirty-eight studies from 17 countries met criteria, spanning 11 ICD-11 categories and 10 route comparisons. CMA was most common (<i>n</i> = 20; 52.6%); all 18 non-CMA studies were model-based. Perspectives varied: healthcare system (42.1%), societal (36.8%), payer (15.8%), provider (15.8%). Industry funding was reported in 60.5%. CHEERS reporting was generally good; non-CMA studies scored higher than CMAs (mean 22.8 ± 0.9 vs. 20.9 ± 2.0; <i>p</i> &lt; 0.001). Across indications, subcutaneous or oral administration versus intravenous were often associated with lower total costs, mainly through reductions in staff time, chair occupancy, consumables, travel, and productivity losses. In 18 CMAs with sufficient data, the median annual total cost difference was -$2,073 per patient (IQR -$3,594 to -$695), a -21.35% relative reduction (IQR − 30.96% to -5.24%). Subcutaneous versus intravenous comparisons showed a median annual difference of -$2,479 (IQR -$6,715 to -$1,943). Adherence was rarely modeled explicitly (10% of CMAs; 67% of non-CMAs), often based on assumptions; indirect and organizational costs were inconsistently captured.</p> Conclusion <p>Alternative formulations and routes of the same API, particularly SC or oral instead of IV, often lower total treatment costs. However, frequent use of CMA, strong equivalence assumptions and incomplete costing limit robustness and support the need for more rigorous cost effectiveness analyses.</p>

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Economic evidence of alternative formulations and routes of administration for identical active pharmaceutical ingredient: a systematic review

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月20日

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  • Hanqiao Shao,
  • Yunong Jiang,
  • Mingye Zhao,
  • Wenxi Tang

摘要

Background

Different formulations and routes of administration (e.g. oral, intravenous [IV], subcutaneous [SC]) of the same active pharmaceutical ingredient (API) may change value by altering administration burden, adherence, setting of care and resource use. This systematic review compared the economic impact of alternative formulations or routes of the same API and assessed reporting quality.

Methods

PubMed and Embase were searched from inception to 31 January 2025 for full economic evaluations directly comparing dosage forms or administration routes of the same API in humans. Two reviewers independently screened records, extracted data, and appraised reporting quality using Consolidated Health Economic Evaluation Reporting Standards (CHEERS 2022). For cost minimization analyses (CMAs), costs were converted to 2024 US dollars (USD) and summarized as median annual total cost differences and relative changes. Mean CHEERS scores were compared between CMAs and non-CMAs.

Results

Thirty-eight studies from 17 countries met criteria, spanning 11 ICD-11 categories and 10 route comparisons. CMA was most common (n = 20; 52.6%); all 18 non-CMA studies were model-based. Perspectives varied: healthcare system (42.1%), societal (36.8%), payer (15.8%), provider (15.8%). Industry funding was reported in 60.5%. CHEERS reporting was generally good; non-CMA studies scored higher than CMAs (mean 22.8 ± 0.9 vs. 20.9 ± 2.0; p < 0.001). Across indications, subcutaneous or oral administration versus intravenous were often associated with lower total costs, mainly through reductions in staff time, chair occupancy, consumables, travel, and productivity losses. In 18 CMAs with sufficient data, the median annual total cost difference was -$2,073 per patient (IQR -$3,594 to -$695), a -21.35% relative reduction (IQR − 30.96% to -5.24%). Subcutaneous versus intravenous comparisons showed a median annual difference of -$2,479 (IQR -$6,715 to -$1,943). Adherence was rarely modeled explicitly (10% of CMAs; 67% of non-CMAs), often based on assumptions; indirect and organizational costs were inconsistently captured.

Conclusion

Alternative formulations and routes of the same API, particularly SC or oral instead of IV, often lower total treatment costs. However, frequent use of CMA, strong equivalence assumptions and incomplete costing limit robustness and support the need for more rigorous cost effectiveness analyses.