Evidence map›Paper›PMID 34690785›Full record

ArticleFrontiers in pharmacology2021

Health Technology Assessment of Advanced Therapy Medicinal Products: Comparison Among 3 European Countries.

Lucia Gozzo, Giovanni Luca Romano, Francesca Romano, Serena Brancati, Laura Longo, Daniela Cristina Vitale, Filippo Drago

Abstract read
In one paragraph

Article in Frontiers in pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
–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

16 citing papers in PubMed.

  1. Review
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  9. Shaping a suitable EU HTA dossier template: why the German template is not fit for purpose.The European journal of health economics : HEPAC : health economics in prevention and care · 2024
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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.

Lucia GozzoClinical Pharmacology Unit/Regional Pharmacovigilance Centre, University Hospital of Catania, Catania, Italy.
Giovanni Luca RomanoDepartment of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy.
Francesca RomanoDepartment of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy.
Serena BrancatiClinical Pharmacology Unit/Regional Pharmacovigilance Centre, University Hospital of Catania, Catania, Italy.
Laura LongoClinical Pharmacology Unit/Regional Pharmacovigilance Centre, University Hospital of Catania, Catania, Italy.
Daniela Cristina VitaleClinical Pharmacology Unit/Regional Pharmacovigilance Centre, University Hospital of Catania, Catania, Italy.
Filippo DragoClinical Pharmacology Unit/Regional Pharmacovigilance Centre, University Hospital of Catania, Catania, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Even for centrally approved products, each European country is responsible for the effective national market access. This step can result in inequalities in terms of access, due to different opinions about the therapeutic value assessed by health technology assessment (HTA) bodies. Advanced therapy medicinal products (ATMPs) represent a major issue with regard to the HTA in order to make them available at a national level. These products are based on genes, tissues, or cells, commonly developed as one-shot treatment for rare or ultrarare diseases and mandatorily authorized by the EMA with a central procedure. This study aims to provide a comparative analysis of HTA recommendations issued by European countries (France, Germany, and Italy) following EMA approval of ATMPs. We found a low rate of agreement on the therapeutic value (in particular the "

Indexed as

accessadded therapeutic valueadvanced medicinal productshealth technology assessmentregulatory issue

Identifiers

PMID34690785
PMCPMC8531540

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.