Evidence map›Paper›PMID 26091709›Full record

SynthesisApplied health economics and health policy2015

The Impact of Generic Substitution on Health and Economic Outcomes: A Systematic Review.

H Gothe, I Schall, K Saverno, M Mitrovic, A Luzak, D Brixner, U Siebert

Abstract readSystematic Review
In one paragraph

Synthesis in Applied health economics and health policy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Utilisation of antibiotics in a community pharmacy: A case from north-west, South Africa.African journal of primary health care & family medicine · 2025
    Article
  3. Article
  4. Article
  5. Article
  6. Generic Drug Usage in Dentistry across Japan: Analysis Using a Japanese National Database.International journal of environmental research and public health · 2021
    Article
  7. Article
  8. Observational
  9. Generic formulations of psychotropic medications and treatment response.Journal of psychiatry & neuroscience : JPN · 2017
    Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

H GotheInstitute of Public Health, Medical Decision Making and Health Technology Assessment, Department of Public Health and Health Technology Assessment, UMIT, University for Health Sciences, Medical Informatics and Technology, Eduard Wallnoefer Center 1, 6060, Hall i.T., Austria.
I Schall
K Saverno
M Mitrovic
A Luzak
D Brixner
U Siebert

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGeneric drugs are considered therapeutically equivalent to their original counterparts and lower in acquisition costs. However, the overall impact of generic substitution (GS) on global clinical and economic outcomes has not been conclusively evaluated.

objectiveTo test whether (1) generics and original products yield the same health outcomes, and (2) generic therapies save economic resources versus original therapies.

methodsWe performed a systematic literature review in Medline, Embase, and the Cochrane Database of Systematic Reviews to identify original studies that examine clinical or economic outcomes of GS. After standardized data extraction, reported outcomes were categorized as supporting or rejecting the hypotheses. Each reported outcome was assessed and accounted for supporting and opposing GS. One publication could provide multiple outcome comparisons.

resultsWe included 40 studies across ten therapeutic areas. Fourteen studies examined patients on de novo therapy; 24 studies investigated maintenance drug therapy, and two studies considered both settings. Overall, 119 outcome comparisons were examined. Of 97 clinical outcome comparisons, 67% reported no significant difference between generic drugs and their off-patent counterparts. Of 22 economic comparisons, 64% suggested that GS increased costs. Consequently, hypothesis (1) was supported but hypothesis (2) was not. We found no major differences among studies that investigated clinical outcomes with de novo or maintenance therapy.

conclusionThe review suggests that clinical effects are similar after GS. However, economic savings are not guaranteed. More systematic research comparing clinical and economic outcomes with or without GS is needed to inform policy on the use of generic substitution.

Indexed as

Cost-Benefit AnalysisDatabases, BibliographicDrugs, GenericDrug SubstitutionHumansOutcome Assessment, Health CareDrugs, Generic

Identifiers

PMID26091709
PMCPMC4519629

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.