Role of biosimilar introduction on insulin glargine prices: a retrospective analysis in 28 European countries

Abstract

Objective

Quantify insulin glargine prices following the market introduction of biosimilars. Examine price levels and price changes for originator and biosimilars, by country.

Methods

Retrospective quantitative analysis using insulin glargine pricing data, both of the originator product and its biosimilars. Segmented regression analysis using a dual-model approach: pooled and country-specific.

Setting

28 European countries using data from the European Medicine Price Database for the period 2013–2023.

Main outcome measures

Price variations between countries were analysed to assess trends and correlations before and after biosimilar market entry.

Results

In the 28 countries studied, cost of insulin glargine underwent a median 21.6% decrease overall in the last decade (p<0.001). In 2022, the median price was €9.0 for the originator (first to market) Lantus (IQR €8.1–€10.4), €8.9 for the biosimilar Abasaglar (IQR €7.6–€10.1) and €7.0 for the biosimilar Semglee (median €7.0; IQR €6.8–€7.5). The originator price was higher than biosimilars (p=0.009). Biosimilar market entry was associated with an overall significant price reduction of the originator, both immediately after entry (p<0.001) and in the long-term postentry (p<0.001). No significant correlation was observed between the price of insulin and the countries’ economic indicators.

Conclusion

This is the first study to show the price trend of insulin glargine and its correlation with the introduction of biosimilars, in Europe. A significant price reduction of the originator was observed after biosimilars entered the market. The median cost of biosimilars was lower than the originator, although with substantial differences between individual countries and producers.

STRENGTHS AND LIMITATIONS OF THIS STUDY.

• This is the first analysis of the impact of biosimilar introduction on insulin prices in Europe.

• The analysis is based on official data from 28 European countries from the European Medicine Price Database which contains list prices of publicly reimbursed medicines.

• While price reductions are logically expected to result in cost savings, it was beyond the scope of this study to obtain data on volumes of use and market share to quantify this.

• We show how the introduction of biosimilar affected originator and biosimilar prices over time but did not asses for other possible events, such as national policy changes.

• Net retail prices were used instead of reimbursement prices because most countries do not report reimbursement data.

Introduction

Biologics are macromolecular pharmaceuticals manufactured through biological processes, rather than chemical synthesis, due to their structural complexity.¹ The architecture of biologics has the potential to afford greater pharmacodynamic specificity and therapeutic efficacy. These advantages far exceed their drawbacks, which include challenges associated with their manufacturing, medium to long-term stability, delivery and higher costs.²

In Europe, biological medicines represent 35% of the total pharmaceutical expenditure, a rapidly growing market whose costs are threatening equitable access to medicines and the sustainability of healthcare systems.³ Europe is the second-leading region in the global market for biologics, with a market value of US$57 billion in 2021, projected to reach US$85 billion by 2030 at a compound annual growth rate of 5%.⁴ Insulin is among the most widely used biological medicines. This is a peptide hormone responsible for regulating blood glucose levels and an essential, life-saving treatment for diabetes mellitus. Of the more than 500 million people worldwide living with diabetes, an estimated 71 million rely on insulin, and many more are expected in the next decades.⁵ Insulin, both human and long-acting analogue, is included in the WHO Model List of Essential Medicines, and most of the key patents on its formulations have expired.⁶ However, many global barriers hinder access to insulin, with pricing being one of the most relevant issues.⁷

The global insulin market is dominated by three multinational companies, Novo Nordisk, Eli Lilly and Sanofi, who represent 88% of insulin product registrations; together, they control 99% of the market by value and 96% by volume. This market was worth US$2 billion in 1995, US$7.3 billion in 2005 and US$36 billion in 2020. This unprecedented market expansion, together with the established domination of the aforementioned companies, globally has kept the price of insulin high.^{8 9} On the one hand, in low-to-middle-income countries, the cost of insulin is predominantly paid out of pocket by individuals and frequently this cost is out of reach.10,12 On the other hand, in Europe, a variety of government-funded insurance schemes provide financial protection to people, shifting the affordability burden from the individual to the community.¹³

As in the case of generics with traditional small molecule medicines, the loss of exclusivity and the expiry of patents on the originator biological product, hereinafter referred to as the originator, allows entry into the market of biosimilar products. The major difference between a generic and a biosimilar is that the natural variability and more complex manufacturing of biological medicines do not allow an exact replication, as is the case with generics. Consequently, biosimilars are subjected to a more comprehensive regulatory pathway to ensure that minor differences do not affect safety or efficacy.^{14 15}

The market share of biosimilar insulins is slowly rising but little evidence is available on their impact on prices. In research conducted by Gotham et al, it was estimated that widespread availability of biosimilar insulin analogues could significantly reduce cost globally and allow substantial savings for both governments and individuals.¹⁶ Data on the biosimilar market at a multinational level in Europe are lacking. The aim of this paper was (1) to assess whether the introduction of insulin glargine biosimilars was associated with originator’s price changes; (2) to quantify this variation over time, the impact on insulin market dynamics and the differences between individual countries under study and (3) to identify possible correlations with national economic indicators.

Methods

Study design

We conducted a retrospective, quantitative, longitudinal study of the price changes of insulin glargine on the national market of 28 European countries over the decade 2013–2023. Raw data were obtained on request from the European Medicine Price Database (EURIPID), voluntary and non-profit cooperation between competent authorities on building up and maintaining a database with information on national prices of medicines in a standardised format.¹⁷ The 28 countries included in this study were: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom. All countries are a member of the European Union except Iceland, Norway, Switzerland and the UK. No data were available for Germany, Malta and Luxembourg. The EURIPID database contains data on prices of publicly reimbursed medicines that are published by national authorities in line with the European Commission Transparency Directive.¹⁸ The countries included in this study are listed in online supplemental appendix A.

Price levels and changes were analysed in two perspectives. First, at each individual national market level, the price relationship over time between the originator product and its biosimilars was studied before and after market entry of the biosimilar(s). Second, at the international level, relative and absolute price differences between the member countries of EURIPID were explored (where available).

To identify a potential relationship between insulin prices and the country’s income level, in order to explain—at least in part—the observed differences across the national markets, the originator net retail price was correlated with the following economic indicators: gross domestic product (GDP) per capita (€), current health expenditure as share (%) of GDP and healthcare expenditure (€) as purchasing power standard (PPS) per inhabitant. The data used were from 2020, the most recent year with complete data on economic indicators.

Data collection

Quarterly net prices from January 2013 to March 2023 were extracted from the EURIPID dataset which is based on national authorities. When net prices were not available, wholesale prices (Croatia, Netherlands and Slovenia) and reimbursement prices (Austria and Ireland) were used. All insulin glargine formulations had the same strength (100 IU/mL) and all countries under study experienced market entry with the same drug strength. Prices were shown in Euro (€) and analysed in reference to a standard 3 mL prefilled pen with a strength of 100 IU/mL.

We retrieved data on three insulin glargine formulations: vials, cartridges and prefilled pens. After noting that no glargine biosimilar vials were marketed and that cartridges were marketed in very few countries, we focused exclusively on insulin glargine prefilled pens. Data on economic indicators were obtained from the open-access database of the European Statistical Office (Eurostat, 2020).

Statistical analysis

The price of the originator prefilled insulin glargine pen (Lantus) was considered over a 10-year observation period in order to evaluate its change before and after biosimilar market entry. Continuous data were summarised as median and IQR; categorical data were summarised as numbers and percentages. Wilcoxon signed-ranks test was used to compare the price differences between the originator and its biosimilars in the last observed quarter with complete data (Q4, 2022). The relationship between prices and economic indicators was evaluated with Spearman’s rank correlation test.

The effect of the biosimilar market entry on the price of the reference product was estimated by an interrupted time series analysis. We used a segmented linear regression analysis. The primary variables included the price of the originator product (dependent variable), a binary indicator for the event of biosimilar entry (event) and a continuous variable representing time since the biosimilar entered the market (postentry time). Two distinct models were employed: a pooled analysis combining data from all countries, and individual analyses for each country. This dual-model approach was designed to provide both a broad understanding of overall trends and a detailed view of country-specific variations. The first model (pooled analysis) estimated the average effect of biosimilar entry across all countries, accounting for baseline differences in price levels between markets using fixed effects. The regression equation for this model was:

$${\displaystyle \mathrm{P}\mathrm{r}\mathrm{i}\mathrm{c}{\mathrm{e}}_{\mathrm{i}\mathrm{t}}={\beta }_0+\mathrm{C}\mathrm{o}\mathrm{u}\mathrm{n}\mathrm{t}\mathrm{r}{\mathrm{y}}_{\mathrm{j}}+{\beta }_1\times \mathrm{E}\mathrm{v}\mathrm{e}\mathrm{n}{\mathrm{t}}_{\mathrm{i}\mathrm{t}}+{\beta }_2\times \mathrm{P}\mathrm{o}\mathrm{s}\mathrm{t}\mathrm{E}\mathrm{n}\mathrm{t}\mathrm{r}{\mathrm{y}}_{\mathrm{i}\mathrm{t}}+{ϵ}_{\mathrm{i}\mathrm{t}}}$$

Where Price_i represents the price of the originator in country i at time t; β₀ is the overall intercept, representing the baseline price; Country_j accounts for country-specific fixed effects; β₁ measures the immediate price change after biosimilar entry; Event_it is the binary variable indicating whether the biosimilar has entered the market, β₂ quantifies the long-term price trend after biosimilar entry (change per time unit), PostEntry_it is the continuous variable that counts the number of time periods since biosimilar market entry; ϵ_it is the error term.

The second model (country-specific analysis) analysed the effect of biosimilar entry on the price of the originator separately for each country, excluding fixed effects. The regression equation for this model was

$${\displaystyle \mathrm{P}\mathrm{r}\mathrm{i}\mathrm{c}{\mathrm{e}}_{\mathrm{i}\mathrm{t}}={\beta }_0+{\beta }_1\times \mathrm{E}\mathrm{v}\mathrm{e}\mathrm{n}{\mathrm{t}}_{\mathrm{i}\mathrm{t}}+{\beta }_2\times \mathrm{P}\mathrm{o}\mathrm{s}\mathrm{t}\mathrm{E}\mathrm{n}\mathrm{t}\mathrm{r}{\mathrm{y}}_{\mathrm{i}\mathrm{t}}+{ϵ}_{\mathrm{i}\mathrm{t}}}$$

Statistical significance was assessed using p values with a threshold of <0.05. Robustness checks were performed to evaluate the sensitivity of results to outliers and alternative model specifications. Statistical analysis and visualisations were performed using STATA V.17.0 (StataCorp), GraphPad Prism V.10 (GraphPad Software, California, USA) and Datawrapper 2023 (Datawrapper, Germany).

Patient and public involvement

Health Action International, a non-profit organisation working in the public interest to expand access to essential medicines and maintaining a global network of people in 70 countries around the world, was involved at all stages of this research. There was no direct involvement of patients.

Results

Insulin glargine, in prefilled pen formulation (strength 100 IU/mL), was marketed as originator Lantus (Sanofi) in all countries included in this study as of 2013. Two biosimilars were present in the analysed markets: Abasaglar (Eli Lilly) and Semglee (Viatris). Abasaglar was marketed in 25 (89%) countries included in this study as of 2015. Semglee was marketed in 9 (32%) countries included in this study as of 2019. Overall, 2 (7%) countries had no marketed biosimilars, 18 (64%) countries had only one marketed biosimilar and 7 (25%) countries had two marketed biosimilars.

From quarter 1 of 2013 (or at least 6 months before biosimilar market entry) to quarter 1 of 2023, a reduction in originator (Lantus) price was observed in almost all surveyed countries. The only exeption was Switzerland, which experienced a slight overall increase despite an initial downward trend in the first half of the observation period. The median price of the originator decreased by 21.6% overall in the 10-year period (p<0.001). However, this decrease varied from country to country, from a low of −4.8% in Italy to a high of −42.3% in Latvia. In countries with only one marketed biosimilar, the median price of the originator decreased by 22.2% in the same observation period (p<0.001), while in countries with two marketed biosimilars, the median price decreased by 21% (p<0.001). No significant difference was found between these two subgroups (figure 1).

Figure 1. Insulin glargine originator price change, 2013–2023. Percentages are calculated between Q1 2013 (or at least 6 months before biosimilar market entry) and Q1 2023 (or last available quarter). Net prices were set to a standard 3mL prefilled pen (100 IU/mL). Reimbursement (*) or wholesale (**) prices were used where not available. Arrow colors define countries with zero (grey), one (blue) or two (orange) marketed biosimilars.

Insulin glargine price also varied for biosimilars that subsequently came onto the market (Abasaglar and Semglee). While the path and dynamics of these differences are quite variable across countries and do not appear to follow consistent patterns (figure 2), the median insulin glargine price of all countries under study significantly decreased over time (figure 3).

Figure 2. Insulin glargine originator and biosimilars price development, per country, 2013–2023.

Figure 3. Insulin glargine originator and biosimilars median price development, 2013–2023.

The price of the prefilled insulin glargine pen was then evaluated for all marketed brands in the latest available quarter in order to analyse price differences. Substantial price differences were found for the same product between different countries as well as between different products in the same country (figure 4). The median price of the originator Lantus was €9.0 (IQR €8.1–€10.4), ranging from a minimum of €7.7 in Poland to a maximum of €15.6 in Switzerland; the median price of Abasaglar was €8.9 (IQR €7.6–€10.1), ranging from a minimum of €6.1 in Poland to a maximum of €13.1 in Switzerland; the median price of Semglee was €7.0 (IQR €6.8–€7.5), ranging from a minimum of €6.0 in Slovakia to a maximum of €10.8 in Spain. The price of the originator Lantus was significantly higher compared with Abasaglar (p=0.009) and to Semglee. Due to the small sample size for the latter biosimilar (N=8), statistical analysis was not performed.

Figure 4. Insulin glargine originator and biosimilars prices, 2022. Net prices were set to a standard 3mL prefilled pen (100 IU/mL). Reimbursement (*) or wholesale (**) prices were used where not available.

The pooled regression analysis, which combined data from all countries, revealed how the entry of the first biosimilar (Abasaglar) was associated with a statistically significant immediate reduction in the price of the originator (figure 5). Specifically, the event coefficient (β₁) indicated an average price decrease of 0.842 units immediately following the biosimilar entry (p<0.001). Additionally, the long-term trend coefficient (β₂) showed that prices continued to decline at a rate of 0.054 units per quarter after biosimilar market entry (p<0.001). Country fixed effects included in the pooled model revealed significant baseline differences in prices among countries, reflecting variations in initial market conditions and regulatory frameworks. The model R² value of 0.896 demonstrated a high degree of explanatory power, indicating that the majority of the variability in prices was accounted for by the included predictors.

Figure 5. Insulin glargine originator median price development from 12 months before to 36 months after first biosimilar market entry.

The country-specific analysis showed wide levels and trends across countries (table 1). Immediate price changes, as indicated by the event coefficient, varied widely across countries. Significant price reductions were observed in the majority of the countries under study. In contrast, a few countries experienced immediate price increases, such as Switzerland (p<0.001) and Denmark (p=0.018). The analysis of postentry price trends also highlighted differences among countries. Most countries exhibited negative and statistically significant long-term trends, indicating ongoing price reductions after the biosimilar entered the market. However, some countries had weaker or statistically insignificant trends, such as Switzerland (p=0.094).

Table 1. Effect of first biosimilar market entry on originator price.

Country	Level change (event)	P value	Trend change (postentry)	P value
Belgium	−1.294	<0.001	−0.051	<0.001
Bulgaria	−0.520	<0.001	−0.055	<0.001
Cyprus	−1.169	<0.001	−0.067	<0.001
Czech Republic	0.287	0.314	−0.039	0.004
Denmark	0.877	0.018	−0.146	<0.001
Finland	−1.725	<0.001	−0.069	<0.001
France	−1.308	<0.001	−0.125	<0.001
Greece	−0.795	<0.001	−0.046	<0.001
Hungary	0.052	0.654	−0.066	<0.001
Italy	−0.628	<0.001	−0.006	0.042
Lithuania	−0.266	0.038	−0.013	0.095
Norway	−0.592	0.022	−0.067	<0.001
Poland	−1.985	<0.001	−0.032	<0.001
Portugal	−1.189	<0.001	−0.032	0.004
Slovakia	−0.596	<0.001	−0.038	<0.001
Spain	−3.530	<0.001	−0.010	0.003
Sweden	−0.813	<0.001	−0.049	<0.001
Switzerland	14.687	<0.001	0.017	0.094
UK	0.445	0.044	−0.106	<0.001

Results are presented with coefficients and relative p values of immediate price change after biosimilar entry (event) and change in price trend after biosimilar entry (postentry).

The regression analysis for the second biosimilar entry (Semglee) was not performed due to the small sample size and the limited number of observations after biosimilar market entry. To check for robustness, we ran the pooled analysis excluding countries with reported only wholesale prices (Slovenia, Croatia and Netherlands) and reimbursement prices (Austria and Ireland), finding the same results in terms of statistical significance.

We deepened the analysis by comparing the price trends over time, hereafter also referred to as price development, of both originator and biosimilars in a selection of six countries (see online supplemental material). For greater accuracy, we delved into the cases of the countries with two biosimilars and the highest time resolution. In Croatia, the price fluctuated over time without showing a significant downward trend. In the Czech Republic, fluctuations of originator and biosimilar seemed to occur in parallel over time, and over the last 3 years of the study period, the price started to rise again. In other cases, the overall trend is clearly downward: in Denmark, with wide variations; in Portugal, these variations followed the entry of a new competitor on the market; in the UK and Slovakia, there was no clear identifiable criterion. Looking at some national markets the prices of two or more products seemed to decrease, sometimes even increase, in parallel, and often it was not possible to clarify which of the two drove the price change.

Lastly, the price of the prefilled originator insulin glargine pen (Lantus) was compared with three economic indicators: health expenditure described as a share of GDP, health expenditure per capita described as PPS per inhabitant and GDP per capita. The correlation found was weak and lacked statistical significance for all of them: health expenditure described as share (%) of GDP (r=0.361; p=ns); health expenditure per capita (€) described as PPS per inhabitant (r=0.277; p=ns) and GDP per capita (€) (r=0.299; p=ns) (see online supplemental material).

Discussion

We found a significant median price reduction of 21.6% for the insulin glargine originator after the entry of up to two biosimilars in the European market. As expected, the median price of biosimilars was lower than the originator, although with substantial differences between countries, as well as between products in the same country. There was a significant association between the median originator price reduction and the two biosimilar market entry. Overall, the pooled analysis provided a general estimate of the average effect of the first biosimilar entry, suggesting an immediate and sustained price reduction. However, the country-specific analysis underscored the heterogeneity of responses across different markets. These variations likely reflect the influence of diverse regulatory environments, market competition levels and pricing mechanisms. By combining the two approaches, the analysis offers a comprehensive perspective on how biosimilar entry affects the pricing of originator products, highlighting both overarching trends and country-specific nuances. Finally, no significant correlation was observed between the price of insulin and the countries’ economic indicators, as of 2020.

The wide variability of insulin prices between European national markets was sometimes unexpected. For example, Italy and Switzerland spend twice as much as France; Greece, Portugal and the Czech Republic spend more than the UK and the Netherlands. The price difference between originator and biosimilars is sometimes high (up to 40% in Austria) and sometimes zero (Lantus, Abasaglar and Semglee have the same net price in Spain). The lack of correlation between prices and the countries’ economic indicators can be considered a lack of consideration by the manufacturers for a public health system’s ability to pay, but it could also reflect countries’ different capacities to set or negotiate prices and to adopt clear and transparent pricing policies.

With the introduction of biosimilars which fosters competition, price reductions could be expected. The introduction of biosimilars has shown positive effects in reducing the prices of pharmacological treatment of cancers and infectious, autoimmune, neurodegenerative and rare diseases in the European Union.¹⁹ Many healthcare systems have embraced biosimilars as a tool to control increasing healthcare expenses.²⁰ In a Bulgarian market analysis on biological antirheumatic medicines, Tachkov et al showed that biosimilar market entry not only reduced prices but also increased utilisation and generated competition in a therapeutic class.²¹ As of 2022, the cumulative savings at list prices from the impact of biosimilar competition in Europe reached over €30 billion.³ A recent study conducted in the USA documented a substantial change in net prices of insulin glargine with the entry of biosimilars into the market.²² Having only two biosimilars on the market may explain the relatively modest price decreases. A recent analysis in Poland showed an increasing drop in the price of the originator for each successive biosimilar introduced into the market.²³ This is similar to what has been previously described for small molecule generics where a 13% price decrease has been observed with one competitor, 23% with two and 40% with three competitors.²⁴ Similar results were also observed in the USA.^{25 26}

In the past decade, the savings potential for public budget resulting from biosimilar use has been shown, especially for monoclonal antibodies.³ However, ours is the first demonstration of a clear association between competition and price reductions for insulin analogues in the wider European market.²⁷ While the price of insulin is typically covered by governments or insurance reimbursement schemes in Europe, the increasing need for insulin and the continued high price of insulin makes its provision, in particular for analogues such as glargine, a critical expense for public health systems.⁹

The temporal resolution of our study (prices were collected on a quarterly basis) did not allow to detect price dynamics that can occur over a few weeks, if not a few days. This made it impossible to track if the originator or biosimilar changed price first when prices of the competitors seemed to change in lockstep, a phenomenon known as shadow pricing, which has already been observed in the pharmaceutical industry in the USA within the very same market and with the long-acting insulin analogues.²⁸

In 2019, the World Health Assembly adopted a resolution on improving the transparency of markets for medicines, vaccines and other health products in an effort to expand access.²⁹ The resolution urged Member States to enhance public sharing of information on actual prices paid by governments, allowing them to make more informed decisions when purchasing health products, negotiate more affordable prices and ultimately expand access to health products for the populations. Currently, available evidence indicates that ensuring price transparency along the supply chain may be effective in managing medicine prices.³⁰ To date, hardly any national authority publishes the prices of the medicines it reimburses. Among the countries covered by this study, only Denmark publishes and updates reimbursement prices on a monthly basis and makes them easily available on the website of its national medicine agency.

Our analysis assessed the insulin glargine market over time but did not assess other potential barriers to market entry and healthy competition. Lengthy, costly and inefficient regulatory approval pathways could limit the number of companies able to bring biosimilar insulins to market. While marketing authorisation for diabetes medicines and biosimilars is centralised by the European Medicines Agency, pricing, procurement and reimbursement, as well as any measures to promote the use of generics and biosimilars, are always national responsibilities of the single states.^{31 32} Vogler et al identified and studied policy measures that target the price and uptake of biosimilar medicines in 16 European countries. They clearly demonstrated the potential savings that could be achieved by implementing specific policies, highlighting how monitoring and evaluation of these measures is key for obtaining a more comprehensive picture of their impact.³³

Insufficient acceptance and trust in biosimilar medicines as compared with the originator among physicians and people living with diabetes may limit or slow market penetration; an unfounded belief in originator superiority in terms of safety and efficacy is often reinforced through pharmaceutical communications.³⁴ A striking example is, once again, Denmark. In 2015, the infliximab biosimilar constituted 90.6% of the total amount of marketed infliximab only 4 months after patent expiration of the originator, reducing costs by two-thirds. Similar results were seen for etanercept biosimilar. One of the key elements of this successful implementation was the way the in-hospital drug sector was organised: the discussions were held with local clinicians, the shift was followed closely by the hospital pharmacies, and the biosimilar was automatically delivered to the ward unless reasons for not doing so were specifically stated.³⁵

Limitations

Net retail prices were used instead of reimbursement prices. This is because the vast majority of countries are reluctant to report reimbursement data. In most cases, there are no laws obliging governments to publish them. Where such laws exist, they are applied to a minority of medical products, among which insulin is often missing.

While price reductions are logically expected to result in cost savings, it was beyond the scope of this study to obtain data on sales volumes and respective market share to quantify this. As health expenditure in Europe is mostly covered by government or insurance, any decrease in price is expected to result in savings for the health system.

We provided graphics of time trends for a selected number of countries. In several cases, prices of originator and biosimilar seem to fall in parallel, suggesting a correlation. Assessing for other possible events in individual countries, such as policy changes, was not feasible as part of this study. Finally, individual country policies, such as reference pricing, were not analysed, although potentially relevant for assessment of market dynamic in a given country.

Conclusion

Access to biosimilars is a key element for insulin analogues price reduction, but it is not the only factor for controlling costs. The future of insulin affordability strongly relies on policy-makers and national authorities to create an adequate environment made of transparency, healthy competition, price setting and negotiations, and up-to-date education for both people and providers. More research efforts are needed to unveil potential market distortions using real-world data. Greater price transparency will support the transition towards fair access to insulin and will raise awareness of the urgency of achieving a common regulatory, pricing and reimbursement framework.

The analysis included in this paper is that of the authors alone and does not necessarily reflect the views of the Helmsley Charitable Trust. All references and conclusions are intended for educational and informative purposes and do not constitute an endorsement or recommendation from the Helmsley Charitable Trust.

Data availability statement

Data may be obtained from a third party and are not publicly available.