Evidence map›Paper›PMID 28660473›Full record

ReviewPharmacoEconomics2017

Assessing the Value of Biosimilars: A Review of the Role of Budget Impact Analysis.

Steven Simoens, Ira Jacobs, Robert Popovian, Leah Isakov, Lesley G Shane

Abstract readReview
In one paragraph

Review in PharmacoEconomics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 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

17 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Review
  12. Identifying Key Benefits in European Off-Patent Biologics and Biosimilar Markets: It is Not Only About Price!BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2020
    Review
  13. Review
  14. Article
  15. Tendering and biosimilars: what role for value-added services?Journal of market access & health policy · 2020
    Review
  16. Review
  17. Review
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

5 authors.

Steven SimoensDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
Ira JacobsGlobal Medical Affairs, Pfizer Inc., 235 East 42nd Street, New York, NY, 10017-5755, USA. ira.jacobs@pfizer.com.
Robert PopovianUS Government Relations, Pfizer Inc., Washington, DC, USA.
Leah IsakovPfizer Inc., Cambridge, MA, USA.
Lesley G ShaneOutcomes and Evidence, Global Health and Value, Pfizer Inc., New York, NY, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Biosimilar drugs are highly similar to an originator (reference) biologic, with no clinically meaningful differences in terms of safety or efficacy. As biosimilars offer the potential for lower acquisition costs versus the originator biologic, evaluating the economic implications of the introduction of biosimilars is of interest. Budget impact analysis (BIA) is a commonly used methodology. This review of published BIAs of biosimilar fusion proteins and/or monoclonal antibodies identified 12 unique publications (three full papers and nine congress posters). When evaluated alongside professional guidance on conducting BIA, the majority of BIAs identified were generally in line with international recommendations. However, a lack of peer-reviewed journal articles and considerable shortcomings in the publications were identified. Deficiencies included a limited range of cost parameters, a reliance on assumptions for parameters such as uptake and drug pricing, a lack of expert validation, and a limited range of sensitivity analyses that were based on arbitrary ranges. The rationale for the methods employed, limitations of the BIA approach, and instructions for local adaptation often were inadequately discussed. To understand fully the potential economic impact and value of biosimilars, the impact of biosimilar supply, manufacturer-provided supporting services, and price competition should be included in BIAs. Alternative approaches, such as cost minimization, which requires evidence demonstrating similarity to the originator biologic, and those that integrate a range of economic assessment methods, are needed to assess the value of biosimilars.

Indexed as

Cost-Benefit AnalysisAntibodies, MonoclonalBiosimilar PharmaceuticalsHumansRecombinant Fusion ProteinsAntibodies, MonoclonalBiosimilar PharmaceuticalsRecombinant Fusion Proteins

Identifiers

PMID28660473
PMCPMC5606961

What OpenQuestion holds

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Registered trials

None linked

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.