Abstract

BackgroundRecent 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.MethodsData 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.ResultsThroughout 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.ConclusionThe 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.

Highlights

  • 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 total cost-saving through the distribution of generic ARV showed a steep increase from 1.2 million € (< 1% of total revenues) in 1/2017 to 17.3 million € (10% of total revenues) in 2/2019 (Fig. 2)

  • A detailed overview of the cost-savings achieved by each generic ARV can be found in Supplementary Table S2

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Summary

Introduction

Recent patent losses for antiretroviral drugs (ARV) have led to the debate of cost-saving through the replacement of patented drugs with generic drugs. 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. Important regulations have been introduced by the German legislation with the aim of curbing prices of patented drugs as well as the increasing expenditures on pharmaceuticals incurred by sickness funds These include, firstly, the German Act of reinforcing SHI competition that was passed in 2007 in order to facilitate the use of generic drugs after the patent expiration of branded drugs which is usually 20 years after the filings of patent applications [11,12,13,14]. As per the Social Code Book, German sickness funds are permitted to negotiate discount agreements with drug manufacturers [17]

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