Marktdurchdringung von neuen Arzneimitteln

Millas, Christoph de; Höer, Ariane; Zimmermann, Anne; Häussler, Bertram

doi:10.1055/s-0042-122162

Cited by 3 publications

(3 citation statements)

References 2 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Our classification of the extent of added benefits as well as the score published by de Millas et al [ 12 ], which was used in the sensitivity analysis, are limited by categorically prioritizing minor benefit above unquantifiable benefit.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Predictors of negotiated prices for new drugs in Germany

et al. 2020

View full text Add to dashboard Cite

Introduction In Germany, all new, innovative medicines are subject to an early benefit assessment by the German Federal Joint Committee with subsequent price negotiation and optional arbitration. The purpose of this study was to identify drivers of negotiated (including arbitrated) prices of new, non-orphan innovative medicines in Germany. Methods The analysis considered all non-orphan drugs that underwent a benefit appraisal between January 2011 and June 2016, and displayed a reimbursement price in the German Drug Directory (Lauer-Taxe ® ) in November 2017. Negotiated annual treatment costs were analyzed with respect to 11 explanatory variables in regression models. Results The total sample included 106 non-orphan drugs. The analysis showed a significant and positive association of log-transformed negotiated annual treatment cost of new medicines with log-transformed annual treatment cost of its comparator(s), extent of added benefit, and log-transformed size of the target population. Analyzing the effects of specific endpoints instead of the overall added benefit revealed that the single endpoint with the largest impact on price is adverse events (AEs). Surprisingly, an increase in AEs significantly increased the price. Various subgroup and sensitivity analyses demonstrated the robustness of the results. The adjusted R squared for all models was above 80%. Conclusions The analysis was able to confirm that variables whose consideration is mandated by law are, in fact, the key drivers of negotiated prices. Somewhat puzzling, the analysis also found an increase in AEs to move prices significantly upward. Electronic supplementary material The online version of this article (10.1007/s10198-020-01201-z) contains supplementary material, which is available to authorized users.

show abstract

Section: Discussionmentioning

confidence: 99%

“…In a sensitivity analysis, we also considered the certainty of benefit as stated in the official G-BA resolution documents. To this end, we used a score published by de Millas et al [ 12 ], which assigns numerical values to combinations of size and certainty of benefit.…”

Section: Methodsmentioning

confidence: 99%

Predictors of negotiated prices for new drugs in Germany

et al. 2020

View full text Add to dashboard Cite

show abstract

“…Some data on market penetration of assessed pharmaceuticals is presented in de Millas et al[24] 11. Austria, Denmark, Finland, the Netherlands, Sweden, and the UK 12.…”

mentioning

confidence: 99%

The impact of additive or substitutive clinical study design on the negotiated reimbursement for oncology pharmaceuticals after early benefit assessment in Germany

Dintsios

Beinhauer

2020

Health Econ Rev

View full text Add to dashboard Cite

Background: We analysed the impact of clinical study design for oncological pharmaceuticals on the subsequent price negotiations after early benefit assessment between pharmaceutical companies and the German National Association of Statutory Health Insurance Funds. The analysis was conducted for all oncology pharmaceuticals that underwent the early benefit assessment in Germany since its introduction in 2011 up to September 2016. Methods: It was differentiated between additive (new therapy in addition to baseline therapy) and substitutive study designs (baseline therapy to be replaced). The study design was derived from the dossiers of the pharmaceutical companies submitted to the Federal Joint Committee. Subgroup specific costs in case of granted added benefit were calculated as annual therapy costs and compared with the costs of the appropriate comparators to quantify price premiums. Further price influencing factors were analysed in univariate and multivariate regression analysis considering the budget impact for the statutory health insurance as well. Results: The mean and the median of the additive premiums for substitutive designs (€50,477.68 and €49,841.24) were higher than for additive designs, if the comparator was different to best supportive care (€48,750.00 and €42,820.44). The mean multiplicative premium for the substitutive designs was 15.07 versus 2.29 for the additive designs. EU-Prices and target population size had a significant effect on the reimbursement. The adjusted R-square in the log Premium OLS-regressions reached 0.708 when including all explanatory variables and considering interaction between target population and annual costs of the comparator.

show abstract

Analyse erneuter AMNOG-Nutzenbewertungen von Arzneimitteln im gleichen Anwendungsgebiet

Rieder

Hammerschmidt

2018

Gesundheitswesen

View full text Add to dashboard Cite

LBA on a broader evidence base did not result in a significantly changed outcome. A general LBA for all drugs does not appear to be necessary because of the limited effect on the benefit assessment and the price when considering cost and administrative burden of the AMNOG benefit assessment. The selective approach of LBA for specific drugs is sufficient in cases in which the evidence base was limited at launch.

show abstract

Marktdurchdringung von neuen Arzneimitteln

Cited by 3 publications

References 2 publications

Predictors of negotiated prices for new drugs in Germany

Predictors of negotiated prices for new drugs in Germany

The impact of additive or substitutive clinical study design on the negotiated reimbursement for oncology pharmaceuticals after early benefit assessment in Germany

Analyse erneuter AMNOG-Nutzenbewertungen von Arzneimitteln im gleichen Anwendungsgebiet

Contact Info

Product

Resources

About