Cost-savings and potential cost-savings through the distribution of generic antiretroviral drugs within the statutory health insurance market of Germany between January 2017 and June 2019

Abstract

Background Recent patent losses for antiretroviral drugs (ARV) have led to the debate of cost-saving through the replacement of patented drugs with generic drugs. The split of recommended single-tablet regimens (STR) into their single substance partners is one of the considerations mentioned in said debate. Particularly, generic tenofovir disoproxil/emtricitabine (TDF/FTC) is expected to hold untapped cost-saving potential, which may curb increasing overall expenditures for combined antiretroviral therapy (cART) within the statutory health insurance (SHI) of Germany. Methods Data of ARV reimbursed by the SHI were used to describe the trends of defined daily doses (DDD) as well as the revenue within the German ARV market. They were also used to determine the cost-savings of moving to generic drugs. The time period observed was between January 2017 and June 2019. The potential cost-savings were determined with following assumption in mind: the maximum possible use of generic ARV, including 1) the split of STR and replacing all substance partners with generic ones, and 2) replacing patented tenofovir alafenamide/emtricitabine (TAF/FTC) with generic TDF/FTC. Results Throughout the observation period, the DDD of generic ARV increased nearly five-fold while their revenue increased more than four-fold. Total cost-saving showed a sharp increase over the same period, with generic TDF/FTC accounting for a share of around 70%. The largest potential cost-saving could have been achieved through replacing patented TAF/FTC with generic TDF/FTC, peaking at nearly 10% of total revenue, but showing decreasing trends in general. Conclusion The progressive distribution of generic ARV ensured increasing cost-savings, but consequently curbed the potential cost-savings. Unique price reductions of generic TDF/FTC have played a pivotal role for these effects. In any case, substituting with generic ARV should not fail to adhere to the treatment guidelines and continue to consider the medical requirements for the treatment.

Impact of Generic Antiretroviral Drugs Introduction on Pharmaceutical Expenditure Patterns in the Netherlands: A Six-Year Retrospective Database Analysis from 2016 to 2022

“…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 ndings across certain European contexts [4,[15][16][17]. For instance, research conducted in Italy and France demonstrated that generic medication utilization led to signi cant 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].…”

Negative impact of a health insurer-mandated de-simplification from a single-tablet regimen to a two-tablet regimen

“…Worldwide, the increasing costs of ARTs and the introduction of generic alternatives have led to a number of different strategies for cost reductions [15][16][17][18]. One of these methods is too de-simplify an STR to a TTR, usually containing a generic NRTI backbone [9,19].…”

Transmitted drug resistance and subtype patterns of viruses from reported new HIV diagnoses in Germany, 2017–2020

“…Approximately 40% of cases with primary resistance showed reduced susceptibility to older drugs that are rarely used in Germany and that are no longer recommended for initial therapy [ 4 , 16 , 30 ]. This resistance is primarily based on the TAMs and the polymorphic E138A variant in NRTI resistance and the K103NS mutation in NNRTI resistance.…”

“…The prevalence of resistance due to substitutions at the K103 position is steadily increasing, a trend that has been observed and analyzed since 2014 in Germany [ 15 ]. Among drugs used in initial regimens, mutations that lead to pronounced resistance to the frequently prescribed non-TAM NRTIs (especially TDF/TAF, FTC, 3TC, ABC), as well as to PIs and INIs, are much more significant [ 30 ]. The frequency of these mutations is much lower and largely stable, ensuring sustained efficiency of the currently recommended primary regimens in the near future.…”