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“Market withdrawals” of medicines in Germany after AMNOG: a comparison of HTA ratings and clinical guideline recommendations

Overview of attention for article published in Health Economics Review, September 2018
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Title
“Market withdrawals” of medicines in Germany after AMNOG: a comparison of HTA ratings and clinical guideline recommendations
Published in
Health Economics Review, September 2018
DOI 10.1186/s13561-018-0209-3
Pubmed ID
Authors

Thomas R. Staab, Miriam Walter, Sonja Mariotti Nesurini, Charalabos-Markos Dintsios, J.-Matthias Graf von der Schulenburg, Volker E. Amelung, Jörg Ruof

Abstract

According to the AMNOG act, the German Federal Joint Committee (G-BA) determines the additional benefit of new medicines as a basis for subsequent price negotiations. Pharmaceutical companies may withdraw their medications from the market at any time during the process. This analysis aims to compare recommendations in clinical guidelines and HTA appraisals of medicines that were withdrawn from the German market since the introduction of AMNOG in 2011. Medications withdrawn from the German market between January 2011 and June 2016 following benefit assessment were categorized as opt-outs (max. 2 weeks after start of price negotiations) or supply terminations (during or after further price negotiations). Related guidelines were systematically analyzed. For all withdrawals, therapeutic area, additional benefit rating and recommendation status in relevant clinical guidelines were assessed. Among 139 medications, 10 opt-outs and 12 supply terminations were identified. Twenty-one out of 22 withdrawn medicines (95%) received 'no additional benefit' appraisal by the G-BA (average 'no additional benefit' rating for all AMNOG products: 47%). Of the 22 medicines, 15 (68%) were recommended by at least one guideline at the time of benefit assessment and 18 (82%) on 1 June 2016. Heterogeneity among guidelines was high. Acceptance of clinical trial endpoints was different between G-BA appraisals and clinical guidelines. Our analysis revealed considerable differences across clinical guidelines as well as between clinical guidelines and HTA appraisals of the medicines that were withdrawn from the German market. Better alignment of the clinical perspective and close collaboration between all involved parties is required to achieve and maintain optimization of patient care.

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Mendeley readers

Mendeley readers

The data shown below were compiled from readership statistics for 22 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 22 100%

Demographic breakdown

Readers by professional status Count As %
Student > Master 3 14%
Researcher 3 14%
Student > Doctoral Student 3 14%
Other 2 9%
Unspecified 1 5%
Other 1 5%
Unknown 9 41%
Readers by discipline Count As %
Business, Management and Accounting 3 14%
Economics, Econometrics and Finance 3 14%
Pharmacology, Toxicology and Pharmaceutical Science 2 9%
Biochemistry, Genetics and Molecular Biology 1 5%
Unspecified 1 5%
Other 3 14%
Unknown 9 41%
Attention Score in Context

Attention Score in Context

This research output has an Altmetric Attention Score of 2. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 07 September 2022.
All research outputs
#14,254,095
of 23,283,373 outputs
Outputs from Health Economics Review
#199
of 442 outputs
Outputs of similar age
#185,147
of 342,253 outputs
Outputs of similar age from Health Economics Review
#13
of 15 outputs
Altmetric has tracked 23,283,373 research outputs across all sources so far. This one is in the 37th percentile – i.e., 37% of other outputs scored the same or lower than it.
So far Altmetric has tracked 442 research outputs from this source. They typically receive a little more attention than average, with a mean Attention Score of 5.8. This one has gotten more attention than average, scoring higher than 50% of its peers.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 342,253 tracked outputs that were published within six weeks on either side of this one in any source. This one is in the 44th percentile – i.e., 44% of its contemporaries scored the same or lower than it.
We're also able to compare this research output to 15 others from the same source and published within six weeks on either side of this one. This one is in the 13th percentile – i.e., 13% of its contemporaries scored the same or lower than it.