Siegmeier Florian, Büssgen Melanie
Hamburg Center for Health Economics, University of Hamburg, Hamburg, Germany.
J Pharm Policy Pract. 2022 Aug 29;15(1):53. doi: 10.1186/s40545-022-00451-x.
Pharmaceutical spending has been increasing rapidly for years and is higher than ever before. To control the rising costs, countries are implementing regulatory frameworks such as (internal) reference pricing, price cuts or generics substitution. Internal reference pricing establishes a reference price within a country which serves as the maximum level of reimbursement for a group of pharmaceuticals. Price setting in the German market is especially relevant for many European countries, which use Germany as a reference country for their own price setting.
We evaluate pharmaceutical price dynamics for not reference priced pharmaceuticals (NRPs) as well as for reference priced pharmaceuticals (RPs) in Germany-referring to the internal reference price system. 64,862 medication packs have been extracted from the German pharmaceutical pricing register Lauer-Taxe. For each pack, we extracted detailed data on the company, manufacturer rebates, pharmacy retail prices, reference prices, co-payments, import quotas, and discount agreements. We then investigated price setting and dynamics of NRPs vs. RPs for all 14 indication areas by ATC code level 1.
The average manufacturer price per pack was 604.84€ for NRPs and 112.11€ for RPs. Similar differences were found for the wholesale price and the pharmacy retail price. The reference price was-as expected-0.00€ for NRPs, and 154.40€ for RPs. NRP packs were imported in 42.38%, while RP packs were imported only in 24.62%. Highest average pharmacy retail prices could be found in the therapeutic areas 'antineoplastic and immunomodulating agents' (1711.47€), 'systemic hormonal preparations' (1331.95€), and 'blood and blood forming organs' (1260.58€). We detected high fluctuations in pharmacy retail prices per indication, as well as for reference prices per indication. The indications with the highest number of reference price regulated medical packs are 'cardiovascular system', 'musculo-skeletal system', and 'nervous system'. Highest co-payments were found in the indications 'antineoplastic and immunomodulating agents', 'blood and blood forming organs', and 'antiinfectives for systemic use'.
Price setting and price dynamics vary substantially between NRP and RP medication packs. Further, we saw major differences across all indication areas as well as when comparing medication packs launched by top 20 pharma companies vs. the rest.
多年来药品支出一直在快速增长，且高于以往任何时候。为控制成本上升，各国正在实施监管框架，如（内部）参考定价、降价或仿制药替代。内部参考定价在一个国家内设定一个参考价格，作为一组药品的最高报销水平。德国市场的定价对许多欧洲国家尤为重要，这些国家将德国作为自身定价的参考国家。
我们参照德国的内部参考价格体系，评估未参考定价药品（NRP）以及参考定价药品（RP）的价格动态。已从德国药品定价登记册Lauer-Taxe中提取了64,862个药品包装的数据。对于每个包装，我们提取了有关公司、制造商回扣、药房零售价、参考价格、共付额、进口配额和折扣协议的详细数据。然后，我们按ATC一级代码级别，研究了所有14个适应症领域中NRP与RP的定价和动态。
NRP每个包装的平均制造商价格为604.84欧元，RP为112.11欧元。批发价和药房零售价也存在类似差异。如预期的那样，NRP的参考价格为0.00欧元，RP为154.40欧元。42.38%的NRP包装是进口的，而RP包装的进口比例仅为24.62%。在“抗肿瘤和免疫调节药物”（1711.47欧元）、“全身性激素类制剂”（1331.95欧元）和“血液及造血器官”（1260.58欧元）治疗领域可发现最高的平均药房零售价。我们检测到每个适应症的药房零售价以及每个适应症的参考价格都有很大波动。参考价格监管的医疗包装数量最多的适应症是“心血管系统”、“肌肉骨骼系统”和“神经系统”。共付额最高的适应症是“抗肿瘤和免疫调节药物”、“血液及造血器官”和“全身用抗感染药”。
NRP和RP药品包装之间的定价和价格动态差异很大。此外，我们在所有适应症领域以及比较前20大制药公司推出的药品包装与其他公司时都发现了重大差异。
