Benefit assessment in Germany: implications for price discounts

Abstract

BackgroundThe AMNOG regulation, introduced in 2011 in Germany, changed the game for new drugs. Now, the industry is required to submit a dossier to the GBA (the central decision body in the German sickness fund system) to show additional benefit. After granting the magnitude of the additional benefit by the GBA, the manufacturer is entitled to negotiate the reimbursement price with the GKV-SV (National Association of Statutory Health Insurance Funds). The reimbursement price is defined as a discount on the drug price at launch. As the price or discount negotiations between the manufacturers and the GKV-SV takes place behind closed doors, the factors influencing the results of the negotiation are not known.ObjectivesThe aim of this evaluation is to identify factors influencing the results of the AMNOG price negotiation process.MethodsThe analysis was based on a dataset containing detailed information on all assessments until the end of 2015. A descriptive analysis was followed by an econometric analysis of various potential factors (benefit rating, size of target population, deviating from appropriate comparative therapy and incorporation of HRQoL-data).ResultsUntil December 2015, manufacturers and the GKV-SV finalized 96 negotiations in 193 therapeutic areas, based on assessment conducted by the GBA. The GBA has granted an additional benefit to 100/193 drug innovations. Negotiated discount was significantly higher for those drugs without additional benefit (p = 0.030) and non-orphan drugs (p = 0.015). Smaller population size, no deviation from recommended appropriate comparative therapy and the incorporation of HRQoL-data were associated with a lower discount on the price at launch. However, neither a uni- nor the multivariate linear regression showed enough power to predict the final discount.ConclusionsAlthough the AMNOG regulation implemented binding and strict rules for the benefit assessment itself, the outcome of the discount negotiations are still unpredictable. Obviously, negotiation tactics, the current political situation and soft factors seem to play a more influential role for the outcome of the negotiations than the five hard and known factors analyzed in this study. Further research is needed to evaluate additional factors.

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

“…One the other hand, the strength of our analysis is the attempt, with the use of realistic assumptions and in absence of detailed data on health care and costs, to simulate the negotiations for the reimbursement amount. Moreover, contrary to other publications [39][40][41][42] we used in our analysis in accordance with the framework agreement the premiums on the AnTC of the ACT and not discounts on the list prices of the new pharmaceuticals when they entered the German market, as only a few recent publications have done as well [35][36][37]. The chosen approach of a premium calculation on the AnTC of the ACT is more complex, since the AnTC of the new therapies and the ACT have to be calculated.…”

Patient-reported data informing early benefit assessment of rare diseases in Germany: A systematic review

“…Although we controlled for incentives to render data on patient perspectives in a direct and systematic way considering PROs, it must also be stated that there are some factors outside the set framework that may also influence the presentation of data. For example, the benefit score and associated documents form the basis for price negotiation in Germany [40, 41].…”

Implementation of Value-based Pricing for Medicines

“…Lauenroth and Stargardt (2017) 23 Theidel and von der Schulenburg (2016) 11 Years and drugs covered 2011eJune 2016 All drugs, excluding orphan drugs drugs were found to be 32.5% lower than the price proposal submitted by the pharmaceutical company to the National Medicines Agency, compared with 27.4% for all reimbursed drugs, even if innovativeness status was not predictive of the difference between the actual price and the price proposal.…”

“…The evidence provided by 2 articles retrieved in the peer-reviewed literature (Table II) 11,23 shows a correlation between the additional therapeutic value and the price premium (net of discounts) over the comparator, whereas the role played by the additional therapeutic value on discounts is less straightforward. More in general, the empirical evidence shows that the negotiation of discounts is unpredictable: regression models that include both value-driven domains (including additional therapeutic value) and budget-driven domains (eg, target-population size) have a low explanatory power of the discount over the list price.…”

“…In France, Italy, and Spain, prices are negotiated on the basis of the drug's additional clinical value, among other elements. In France, the additional clinical value is graded according to 5 categories for price negotiation purposes: only medicines with moderate to high 9 Panteli et al, 10 Theidel and von der Schulenburg, 11 and Toumi et al 12 additional value can aspire to a price premium, provided that companies deliver a cost-effectiveness analysis if the expected budget impact is more than V20 million per year in the first 3 years. In Italy, the additional therapeutic value, along with the unmet need and the quality of the evidence, is graded to determine a medicine's "innovativeness status" (https://www.aifa.gov.it/farmaci-innovativi;last accessedOctober24, 2019): an innovative medicine is not necessarily granted a price premium, but it facilitates market access.…”