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>> In fact, this regulation paves the way for the introduction of exclusive discount agreements in the biosimilar market. This pharmaceutical policy development, which can be seen as foreseeable for the time being, gives reason to critically assess some of the experiences and insights that have been gained (in particular) with exclusive discount agreements in the generics market in recent years. Discount agreements can and must be viewed from two different perspectives. On the one hand, the health insurance companies are forced for financial reasons and are also obliged under social law to ensure the cost-effectiveness and efficiency of care. Against this background, discount agreements have been seen as one of the most successful instruments for reducing the statutory health insurance's pharmaceutical expenditure in recent years. Thanks to the discount agreements in Germany, health insurance companies have so far been able to save up to four billion euros per year [1].
On the other hand, the nature of discount agreements is to induce repeated medication changes that are not based on medical reasons. For the majority of patients, such a change had no negative consequences. They were not confused by the different packaging or appearance of the tablets, nor did they experience any side effects or lack of effect when taking the discounted medicine. However, this medically unnecessary change had serious consequences for many other affected patients.
In one of our studies, we found that the risk of hospitalization was 57% higher in depression patients who switched to a discounted drug than in patients who did not switch. Extrapolated to the national level, this corresponded to around 35,000 additional hospital patients and direct inpatient costs of more than 350 million euros per year in Germany alone [2]. These costs are significantly lower than the amount that the health insurance companies saved due to the discount agreements, so a direct cost comparison makes no sense. However, this matter concerns the suffering of many patients, and this suffering cannot be expressed in the form of euros.
Another analysis we conducted highlights the association between the introduction of discount contracts and a negative impact on compliance among breast cancer patients undergoing adjuvant hormone therapy. The analyzes revealed a significant increase in risk of treatment discontinuation of approximately 27% in patients who were switched to a discounted drug compared to patients who did not undergo such a switch [3].
The current study showed that in previously seizure-free patients, a discount contract-related change in the antiepileptic medication they were taking was associated with a higher risk of seizure recurrence [4]. Based on the results of this publication, the Swiss Epilepsy League has issued a warning regarding drug switching. This warning urges healthcare decision-makers, neurologists, pediatric neurologists and pharmacists to avoid unnecessary drug switching when treating epilepsy.
However, the problem of switching medications without a medical reason also occurs regardless of discount agreements. We examined prescription data for patients treated with specific TNF blockers for severe autoimmune diseases between 2015 and 2017. Within one year, 30 percent of patients who were switched from an original product to a biosimilar switched back to the original [5]. This result is probably not due to the lack of effectiveness of the new drug, but rather to the uncertainty of patients who were prompted to make such a switch. If patients have information about a product that they do not like and are then prescribed that product, they may experience what they perceive to be adverse effects. Whether the drugs exchanged actually have relevant and objective differences on a medical and pharmaceutical level or whether the patients' compliance problems are rationally understandable is irrelevant when evaluating the therapy changes triggered by the discount agreements. What is important is what influences the patient's therapy under real conditions and what consequences this has.
Discount agreements in the generics market can also be questionable in terms of competition policy. For example, delivery bottlenecks are increasingly occurring in the German market. These can be an indication that economic undesirable developments and concentration processes have already taken place. However, the data currently available is ultimately insufficient to provide scientific evidence.
As outlined at the beginning, the introduction of exclusive discount agreements in the biosimilar market is currently not unlikely. Meanwhile, the initial economic and market conditions here differ significantly from those in the generics market. Exclusive tenders (discount contracts/offers) are problematic in the biosimilar market because they make it more difficult or even impossible for new providers to enter the market and can thus hinder sustainable competition in this market segment [6-8]. Therefore, the fact that German legislation has currently opened the door to aut-idem regulation for biosimilars in pharmacies through the Act for Greater Security in the Supply of Medicines (GSAV), which promotes the implementation of discount agreements, must be viewed critically. As with prescription generics, pharmacists must then dispense the discounted biosimilar. We conducted an expert survey at Fresenius University and came to the conclusion, among other things, that the legal framework in Germany, particularly with regard to the introduction of discount contracts, represents a negative incentive for the market launch of biosimilars throughout Europe [6].
When assessing savings based on rebate agreements, all health economic impacts must be taken into account. Calculating the savings based on a pure price comparison of Aut-idem products is insufficient. An expanded approach must include all socially relevant factors as well as all factors with a direct or indirect impact on the health system. As a result, not only is the assumed savings potential to be put into perspective, but for some indications, additional effort is to be expected in conjunction with a decreasing quality of care.
Last but not least, it must be demanded that the effects of exclusive discount agreements in the biosimilar market on the quality and cost-effectiveness of the supply process are not only reflected in the short-term cost-
damping aspects, but also in terms of a sustainable competitive framework. <<

Citation note:

literature
1 Rücker D. Discount agreements relieve pressure on cash registers. Pharmaceutical newspaper. 2019. Accessed at https://www.pharmazeutische-zeitung.de/versandvertraege-entlasten-kassen/
2 Kostev K., May U, Ott C, Paul M, Schetschok K, Tingelhoff M, Claus C, Waehlert L. Frequency of hospitalizations before and after conversion to a rebate pharmaceutical in depression patients in Germany. Int J Clin Pharmacol Ther. 2013 May;51(5):416-22. doi: 10.5414/CP201912.
3 Kostev K, May U, Hog D, Eisel J, Kremmers T, Kosteic M, Waehlert L, Hadji P. Adherence in tamoxifen therapy after conversion to a rebate pharmaceutical in breast cancer patients in Germany. Int J Clin Pharmacol Ther. 2013 Dec;51(12):969-75. doi: 10.5414/CP201969.
4 Lang JD, Kostev K, Onugoren MD, Gollwitzer S, Graf W, Müller T, Olmes DG, Hamer HM. Switching the manufacturer of antiepileptic drugs is associated with higher risk of seizures: A nationwide study of prescription data in Germany. Ann Neurol. 2018 Dec;84(6):918-925. doi: 10.1002/ana.25353. Epub 2018 Nov 8.
5 Reuber K, Kostev K. Prevalence of switching from two anti-TNF biosimilars back to biologic reference products in Germany. Int J Clin Pharmacol Ther. 2019 Apr 16. doi: 10.5414/CP203474. [Epub ahead of print]
6 Kramer N, Ziebe A, May U. Company expectations and strategies in the biosimilar market. Results of a survey against the background of the current regulatory discussion. Pharm. Ind. 2017; 79 (12): 1–7
7 Bauer C, May U, Ziebe A. Competitive analysis of biosimilar-capable markets in the context of regulation and adequate pricing. 2018. Accessed at https://www.wiwi.uni-due.de/fileadmin/fileupload/WIWI/forschung/IBES_Diskussionbeitraege/IBES_2018_Nr224.pdf
8 Altin S, Bauer C, May U, Walendzik A, Wasem J, Ziebe A. Regulation and adequate pricing in the biosimilars market. 2017. Accessed at https://www.wiwi.uni-due.de/fileadmin/fileupload/WIWI/pdf/Events/IBES_2017_nr220.pdf