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

Tesař, Tomáš; Golias, Peter; Masaryková, Lucia; Kawalec, Paweł; Inotai, András

doi:10.3389/fphar.2021.795002

Cited by 6 publications

(10 citation statements)

References 25 publications

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“…The literature search yielded 1,037 records, of which 971 were excluded following screening. Of the 66 full-text articles that were assessed for eligibility, seven articles were included ( Value-based pricing, 2011 ; Puig-Junoy, 2012 ; Hollis and Grootendorst, 2017 ; Granlund and Bergman, 2018 ; Tesar et al, 2021 ; Medaxes, 2022 ; Moradpour et al, 2023 ). In addition, one relevant report from a consultancy agency was identified in the grey literature ( Invent, 2020 ).…”

Section: Resultsmentioning

confidence: 99%

New pricing models for generic medicines to ensure long-term sustainable competition in Europe

Francois,

Gawlik,

Mestre-Ferrandiz

et al. 2023

Front. Pharmacol.

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Background: Price erosion of generic medicines over time as a result of existing pricing policies in combination with increasing operational costs of these products due to high inflation, undermine long-term sustainable competition in European off-patent medicines markets. Therefore, the aim of this study is to identify new potential pricing models for retail generic medicines in Europe, examine their pros and cons, and illustrate them with examples inside or outside the pharmaceutical sector.Methods: A targeted literature review, one-to-one interviews and a joint advisory board meeting with experts from five European countries were carried out to assess potential pricing models for generic medicines.Results: We identified ten pricing models that can be applied to generic medicines. The tiered pricing model is viewed as a sustainable solution ensuring competitiveness, but requires market monitoring using a supportive IT infrastructure. De-linking the price of generic medicines from that of the off-patent originator medicine prevents the originator from forcing generic medicines’ prices to unsustainable levels. Higher costs due to inflation can be compensated in the automatic indexation model. Other pricing models that have less implementation potential include the one-in-one/multiple-out model, tax credits, value-based pricing, volume for savings and guaranteed margin/fee models. The hypothecated tax and cost allocation models, which add a patient fee to generic medicines prices, are not likely to be socially acceptable.Conclusion: When considering a new pricing model for generic medicines, the impact on innovative medicines and the characteristics of the healthcare system in a given country need to be taken into account. Also, there is a need to continuously follow up the level of competition in off-patent medicines markets and to identify sustainability risks.

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Section: Resultsmentioning

confidence: 99%

New pricing models for generic medicines to ensure long-term sustainable competition in Europe

Francois,

Gawlik,

Mestre-Ferrandiz

et al. 2023

Front. Pharmacol.

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“…The variations in reimbursement and national policy are discussed as the main reason [25]. Recent data revealed that sales of biosimilars increased in 2020 in Slovakia, Hungary, and the Czech Republic and that they were higher than what was found for Poland [26].…”

Section: Discussionmentioning

confidence: 98%

How Managed Entry Agreements Influence the Patients’ Affordability to Biological Medicines—Bulgarian Example

Mitkova,

Manev,

Tachkov

et al. 2023

Healthcare

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Managed entry agreements are applied in almost all European countries in order to improve patients’ access to therapy. The current study aims to evaluate the changes in the affordability of biological medicines for patients in Bulgaria during 2019–2022. The study is a top-down macroeconomic analysis of the key economic indicators and reimbursed costs of biologic therapies. Affordability was determined as the number of working hours needed to pay for monthly therapy. The average NHIF budget for pharmaceuticals increased significantly along with inflation in the healthcare sector. Bulgarian patients had to devote a large part of their income to buying medicines if a co-payment existed. The percentage of the monthly income of pensioners needed for therapy co-payment varied between 10% and 280%. The hours of work required to purchase a package of biologicals varied between 7 and 137 working hours. The global economic crisis has affected Bulgaria and led to worsening economic parameters. There are still no well-established practices to control public spending, as the measures taken to reduce the final cost of medicines mainly affect the pharmaceutical companies. This type of cost-containment policy provides an opportunity for innovative treatment with biologicals for patients with inflammatory diseases. Most of the therapies cost more than the patients’ monthly income.

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“…They found that 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. [ 45 ] Simoens analyzed the Polish generic market and concluded that Poland needs to consider moving away from competition by discount to competition by price [ 46 ].…”

Section: Discussionmentioning

confidence: 99%

The long-term effect of generic price competition on the Hungarian statin market

Répásy

Gazsó

Elmer

et al. 2023

BMC Health Serv Res

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Background Generic competition is a vital health policy tool used in regulating the pharmaceutical market. Drug group HMG-CoA reductase (3-hydroxy-3-methyl-glutaryl-coenzyme-A reductase) inhibitors, widely known as “statins,” was the first drug group in Hungary in which generic prescriptions became mandatory. Our aim is to analyze the changes in the retail and wholesale margins through the generic competition regarding “statins”. Methods Data was derived from the nationwide pharmaceutical database of the Hungarian National Health Insurance Fund Administration, the only health care financing agency in Hungary. We observed the turnover data regarding the HMG-CoA-reductase inhibitor “statins” from 2010 through 2019. As the drugs under review have a fixed price point in Hungary, we effectively calculated the margins. Results In 2010, the consumer expenditure of statins was 30.7 billion HUF ($148 million), which decreased by 59%, to 12.5 billion HUF ($42.9 million) in 2019. In 2010, the annual health insurance reimbursement of statins was 23.7 billion HUF ($114 million), which underwent a 63% decrease to 8.6 billion HUF ($29.7 million) in 2019. In 2010, the DOT turnover was 287 million days, and it increased to above 346 million days for 2019, which reflects a 20% increase over the past nine years. The monthly retail margins decreased from 334 million HUF ($1.6 million), (January, 2010) to 176 million HUF ($0.61 million), (December, 2019). The monthly wholesale margins decreased from 96.3 million HUF ($0.46 million), (January, 2010) to 41.4 million HUF ($0.14 million), (December, 2019). The most significant downturn in margins was due to the introduction of the first two blind bids. The combined DOT turnover in reference to the examined 43 products consistently increased. Conclusions The decline in retail and wholesale margin and in health insurance expenditures was largely due to a reduction in the consumer price of generic medicines. DOT turnover of statins also increased significantly.

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

Cited by 6 publications

References 25 publications

New pricing models for generic medicines to ensure long-term sustainable competition in Europe

New pricing models for generic medicines to ensure long-term sustainable competition in Europe

How Managed Entry Agreements Influence the Patients’ Affordability to Biological Medicines—Bulgarian Example

The long-term effect of generic price competition on the Hungarian statin market

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