The Impact of Reimbursement Practices on the Pharmaceutical Market for Off-Patent Medicines in Slovakia

Background: The aim of this study was to investigate the impact of selected legislative initiatives and their implementation for off-patent medicinal products in Slovakia compared with the rest of the Visegrád Group (V4 countries).Methods: We analyzed the development of applications for the reimbursement of generic and biosimilar drugs. Particular emphasis was placed on a) the availability and penetration of biosimilars from 2006 to 2020 in Slovakia, b) a comparative analysis of biosimilars in V4 countries based on the national reimbursement lists of medicinal products for August 2021. Data relating to the sales of generic and biosimilar medicines in Czechia, Hungary, Poland, and Slovakia were based on the IQVIA MIDAS MAT July 2021.Results: The number of applications for the reimbursement of generic drugs decreased from 296 in 2016 to 165 in 2020. In financial terms, the sales of generic medicines in Slovakia increased from 21.7% in 2015 to 22.3% in 2020. Over the same period, the sales of generic drugs in Poland fell from 40.4% in 2015 to 35.0% in 2020, from 26.2 to 22.1% in Hungary, and from 29.6 to 20.4% in Czechia. When considering the 66 biosimilars registered by the European Medicines Agency 38 drugs (58%) were available on the Slovak market as of August 1, 2021; this compared to 32 drugs (48%) in Poland, 38 drugs (58%) in Hungary, and 40 drugs (61%) in Czechia. In financial terms, the sales of biosimilars in Slovakia increased from 0.94% in 2015 to 2.00% in 2020. Over the same period, the sales of biosimilars in Poland increased from 0.59% in 2015 to 1.29% in 2020, from 0.72 to 2.23% in Hungary, and from 0.76 to 2.15% in Czechia.Conclusion: To intensify the use of generic and biosimilar medicines, we suggest the comprehensive re-evaluation of combinations of the three-threshold entry, the amount of mandatory price reductions, and external reference pricing requirements (as the average of the three lowest prices among the official prices of a medicinal product in other Member States) for generic and biosimilar drugs. We also suggest cancellation of the exception from the fixed co-payment of the insured.

A case for external reference pricing to regulate drug costs in low- and middle-income countries

Amirul Ashraf and Siew Chin Ong discuss external reference pricing as a possible method of navigating the complex issue of drug pricing in Malaysia.

Reference Pricing for Healthcare Services

Problem definition: The traditional payment system between an insurer and providers does not incentivize providers to limit their prices, nor patients to choose less expensive providers, hence contributing to high insurer expenditures. Reference pricing has been proposed as a way to better align incentives and control the rising costs of healthcare. In this payment system, the insurer determines the maximum amount that can be reimbursed for a procedure (reference price). If a patient selects a provider charging more than the reference price, the patient is responsible for the entire portion above it. Our goal is to understand how reference pricing performs relative to more traditional payment systems. Academic/practical relevance: Our results can help healthcare leaders understand when reference pricing has the potential to be a successful alternative payment mechanism, what its impact on the different stakeholders is, and how to best design it. Methodology: We propose a game-theoretical model to analyze the reference pricing payment scheme. Our model incorporates an insurer that chooses the reference price, multiple competing price-setting providers, and heterogeneous patients who select a provider based on a multinomial logit choice model. Results: We find that the highest-priced providers reduce their prices under reference pricing. Moreover, reference pricing often outperforms the fixed and the variable payment systems both in terms of expected patient utility and insurer cost but incurs a loss in the highest-priced providers’ profit. Furthermore, we show that in general the insurer utility is often higher under reference pricing unless the insurer is a public nonprofit insurer that weighs the providers’ utility as much as its own cost. Managerial implications: Overall, our findings indicate that reference pricing constitutes a promising payment system for “shoppable” healthcare services as long as the insurer does not act similar to a public nonprofit insurer.

FORENSIC PHARMACY: ANALYSIS OF COMPLAINTS ABOUT THE PHARMACEUTICAL PROVISION FOR PRIVILEGED CATEGORIES OF PATIENTS IN UKRAINE (EXPERIMENTAL RESEARCH)

The article presents the results of the research from position of forensic pharmacy concerning analysis of complaints about the pharmaceutical provision for privileged categories of patients in Ukraine. Analyzed world experience of the reimbursement system (reference pricing) in pharmaceutical provision for privileged categories of citizens comparing to existing system in Ukraine. Studied complaints of privileged contingents of patients concerning pharmaceutical supply in various health care facilities. Based on results created a matrix of complaints of privileged contingents of patients regarding unsatisfactory pharmaceutical provision. Based on the matrix of complaints, three regional lists of drugs were developed with the further development of organizational and legal measures to increase the level of pharmaceutical provision of privileged contingents of patients.

Managing Pharmaceutical Expenditures: Estimating the Effect of Internal Reference Pricing for Three Pharmacological Categories

Background: Internal reference pricing (IRP) is one of the pharmaceutical pricing approaches, which is widely favored by health policymakers in different countries as a cost-containment tool for managing medicine expenditure. Evidence related to the implementation of this method confirms its usefulness in reducing pharmaceutical costs. Accordingly, the purpose of this study was to calculate potential changes in pharmaceutical expenditure using the IRP method for products belonging to three pharmaceutical categories in the pharmaceutical system of Iran. Methods: This routine data study assessed the potential effect of IRP in three pharmaceutical categories including statins, non-steroidal anti-inflammatory drugs, and proton pump inhibitors (PPIs). Two scenarios for reference groups (levels 4 and 5 of the ATC code) and four scenarios for the reference price (i.e., the minimum, median, mean, and the mean of three minimum prices in the reference group) were considered in this regard, and the price and sales data source was the report published by the Iranian Food and Drug Administration. Then, cost changes were calculated with each hypothetical scenario. It was assumed that other intervening factors remain unchanged, including consumers and prescribers’ behavior. Results: Based on the results, the two largest potential saving effects belonged to the minimum price scenario and the mean of the scenario of the three minimum prices, respectively. However, the results showed that the consequence of using a price scenario other than the minimum price as the reference price is highly related to the details of the distribution of prices in the related reference group. In addition, appropriate decisions regarding outlier products (e.g., imported products) might have extremely important effects on the result, especially for the mean price scenario. The minimum price scenario concomitant with a premium for superior products can also be considered, but part of it is outside the scope of this study and requires independent research. Conclusion: Thus if an appropriate scenario is selected for the reference price and group, the IRP method has the potential to reduce the costs of medicines. Therefore, pharmaceutical policymakers must pay enough attention to the details of planning this system and the needed procedure for updating the details of this system.