In summary, our study spanning 2016 to 2022 provides, valuable insights into the evolving landscape of HIV treatment in the Netherlands. Despite the increased number of people with HIV in care, pharmaceutical expenditures for HIV treatment have slightly diminished (9.4%) over time. Our data showed that the introduction of generic substitution was highly successful, contributing largely to the reduction in ART costs (22.2% lower annual ART costs per patient in 2022 vs. 2016).
In this study, we used the SFK database for the first time to provide insights into the utilization of generic ARVs and patient populations [8]. It is worth noting that, when comparing our results with those of other national databases, some differences can occur and should be explained. For instance, when examining data from the HIV Monitoring Foundation (SHM), we observed higher patient numbers (e.g., 24,381 vs. 21,397 in 2021) [1]. There could be various sources for this difference, such as potential variations in patient registration and migration patterns. These factors may include individuals who decline registration in SHM, foreign travelers/expats, Dutch citizens with HIV living abroad, and changes in the population composition due to various factors, including global events such as the conflict in Ukraine, which could have led to shifts in the demand for ART. It is important to acknowledge that these potential factors may contribute to the differences in patient numbers between databases [14]. Data from the National Institute for Public Health and the Environment (Dutch: Rijksinstituut voor Volksgezondheid en Milieu, RIVM) indicated lower HIV treatment costs, possibly because of the exclusion of certain non-reimbursed provisions [2]. By contrast, the SFK database offers a more inclusive perspective (mentioned above), capturing all prescriptions of ARVs, which may explain the difference in cost between the two sources.
Generic substitution of ARVs was highly successful, which is consistent with international observations in other cohorts. Similar studies in countries such as France, Germany, and Italy have demonstrated comparable trends, indicating the potential generalizability of our findings across certain European contexts [4, 15–17]. For instance, research conducted in Italy and France demonstrated that generic medication utilization led to significant cost savings in overall HIV expenditures [4, 15]. Germany’s research has exhibited similar patterns regarding generic drug adoption and cost savings. Furthermore, they highlighted the additional cost-saving potential of splitting medication regimens, potentially reducing total expenditures by nearly 10% [17].
One of our objectives was to assess the impact of generic substitution on ARV costs. This is rather complex because many factors contribute to the overall expenditure on ARVs. For instance, we noticed large differences in costs/DDD after the introduction of a generic, ranging from 90% for TDF/FTC to 33% for ATZ. We assume that this is caused by limited competition between generic manufacturers for ATZ, whereas TDF/FTC was much more attractive for multiple generic manufacturers, probably because of its use in PrEP [18, 19]. Another confounding factor was the change in prescription patterns over time [1]. Generic ARV formulations reflect agents developed some time ago, while branded formulations often have better tolerability profiles, contain boosters less frequently, and have the advantage of low pill burden [20, 21]. Our data reflect some of these changes in prescription patterns as the number of DDDs prescribed as generics decreased over time, from approximately 6 million DDDs of ARVs that could be prescribed as generic in 2016 to approximately 2.6 million DDDs in 2022. Consequently, cost savings by generic substitution will be less pronounced because of the transition to prescribing novel ARVs.
Nonetheless, the TDF/FTC case offers valuable insights into the impact of generic substitution on ARV costs. This combination remains a cornerstone of antiretroviral therapy, and our analysis underscores its evolution. The monthly prices for branded TDF/FTC have substantially decreased, dropping from €526 to €217. By contrast, the availability of generic TDF/FTC at a mere €28 per month contributed significantly to cost savings. In 2022 alone, with approximately 1 million DDDs of TDF/FTC dispensed, this transition resulted in a remarkable cost reduction of approximately €6.3 million, making generic TDF/FTC the largest contributor to overall expenditure reduction.
Our sub-analysis revealed a promising cost-saving opportunity through the utilization of generic multi-tablet regimens (gMTRs). For instance, in the first year of implementation in 2019, an estimated annual potential cost-saving of 7 million euros (4% of the total) could have been achieved, highlighting the substantial potential of this strategy on a national scale. These findings underscore the importance of considering this approach in cooperation with prescribers to optimize resource allocation and enhance cost-effectiveness. Policymakers and healthcare professionals can leverage these insights to maximize cost efficiency while maintaining the quality of care, benefiting both people with HIV and the broader healthcare system.
In this study, our primary focus was on interpreting the substantial cost savings achieved through the adoption of generic formulations that have progressively become more cost-effective. Notably, the cost of STRs also decreased over the study period [22, 23]. This can be attributed to the regulatory framework governing drug pricing in the Netherlands, which binds manufacturers to the maximum prices. The Dutch Medicines Prices Act (Wet GeneesmiddelenPrijzen, WGP) requires that these prices be determined based on the average prices of equivalent drugs in nearby countries. The maximum prices are reviewed biannually [24]. Recent data from the Netherlands revealed an overall decrease in the prices of medications by an average of 0.5% in April 2022 compared with the previous month [25]. However, given this modest percentage, we anticipate that the magnitude of this price reduction in medications is minimal compared with the substantial cost reductions observed in generic ARVs.
The SFK database, as disclosed in our study, is a valuable resource that complements existing data from SHM. It offers unique insights into ARV prescriptions and pharmacy dispensation, along with real-time cost data, but with a one-month delay. Future research could benefit from the capabilities of the SFK database, exploring cost-saving strategies, and resource optimization in HIV treatment. For instance, investigating the feasibility of transitioning to equally effective, yet more cost-efficient STRs would be an interesting possibility. The database's ability to monitor real-time cost data facilitates the assessment of the economic implications of such transitions and identifies areas for savings while upholding the quality of HIV care. Our study highlights the versatility of the SFK database as a crucial tool for ongoing research aimed at enhancing the efficiency and cost-effectiveness of HIV treatment in the Netherlands.
Our study had some limitations. First, the data analyzed were specific to the Netherlands and its healthcare systems, and the findings may not be directly applicable to other regions or countries with different healthcare systems. Second, although we observed trends in the shift from branded to generic medications, the reasons behind the preferences of people with HIV and physicians for these changes have not been explored. In addition, we did not assess the clinical outcomes or side effects associated with these treatment regimens, which could have provided a more comprehensive view of their impact.
Our study has several strengths. We comprehensively examined the shift towards generic ARVs and the growing adoption of STRs in HIV treatment. Notably, we observed a substantial shift from branded to generic drugs, particularly in categories such as ABC/3TC and TDF/FTC, where generic use reached 97% in 2022. These findings highlight the cost-saving potential in HIV treatment, which can enhance healthcare economics and improve access to people with HIV. Additionally, our study revealed a substantial cost-saving strategy by opting for individual antiretroviral components over STRs, potentially resulting in substantial cost reductions, equivalent to up to 7 million euros in 2019. This study provides valuable insights into the economic considerations and cost-effectiveness of treatment choices in HIV care in the Netherlands. Although based on retrospective data, our findings are consistent with those of previous studies, emphasizing the need for further research to confirm and expand our results in a prospective context. Ongoing interventions for cost-saving and prospective research to monitor these trends are essential.Conclusion
Our six-year study highlights the substantial cost-saving potential realized through the adoption of generic antiretroviral medications, which have progressively become more cost-effective. This reduction in treatment expenditures underscores the economic benefits and cost-efficiency achieved through thoughtful treatment choices. Additionally, our findings highlight the significant cost-saving opportunities of transitioning from patented STRs to gMTRs. These outcomes underscore the importance of considering cost-saving strategies in healthcare policies to optimize resource allocation and enhance the cost-effectiveness of HIV care. Our study also introduced the SFK database as a valuable tool for real-time cost data and research opportunities in HIV treatment optimization.