Availability of new drugs for the treatment of resistant tuberculosis in Europe
The treatment regimen BPaLM (bedaquiline, pretomanid, linezolid and moxifloxacin), recently recommended by the World Health Organization (WHO), offers a safer and more effective treatment for multidrug-resistant (MDR) and rifampicin-resistant (RR) tuberculosis (TB) compared to the previous WHO standards. A major advantage of the regimen is the short treatment duration of only six months compared to the 9 to 18 months of treatment with the previous standard regimens. Shortened treatment with BPaLM is now also primarily recommended in Germany for MDR/RR-TB, provided that the requirements are met and no additional resistance complicates treatment [1].
However, the implementation of this new recommendation is difficult in Germany as well as in many other countries of the European Economic Area (EEA). In October 2023, the WHO Regional Office for Europe therefore addressed a survey to the designated national contact persons to get a picture of the availability of drugs for the treatment of MDR/RR-TB in Central and Western Europe and to investigate access barriers to treatment with BPaLM [2].
The survey included 18 of the 29 countries surveyed and the results showed that the drug pretomanid is only readily available in three of these countries. Since pretomanid is a necessary component of treatment with BPaLM, a longer and less well tolerated MDR/RR-TB therapy must be used if pretomanid is not available.
The reasons given for the limited availability of BPaLM drugs varied from country to country and reflected the conditions within the respective healthcare systems. Problems with procurement and financing within the healthcare systems were frequently mentioned. According to the survey, the high prices for bedaquiline and pretomanid play a role here.
The relatively low MDR/RR-TB case numbers in Central and Western European countries were also cited as a barrier to accessing the drugs. According to the authors, this could be a reason for a lack of interest in a national market launch or production of these drugs.
The results show that there is an urgent need to work on national or joint solutions at European level in order to achieve full availability of the necessary medicines in Central and Western Europe. Other important components of TB care, such as child-friendly formulations and rifapentine to shorten preventive therapy, are also not sufficiently available in the EEA.
Particularly with regard to the goal of eliminating TB in Europe, it must be ensured that TB treatment that meets recommendations and is patient-friendly remains possible despite falling TB case numbers. With this goal in mind and with the important support of the German Federal Ministry of Health (BMG), WHO Europe organized a European meeting in Berlin on 3-4 June 2024 to work on possible solutions. We will report on the results of the meeting in the next newsletter.
Literature
- Otto-Knapp R, Bauer T, Brinkmann F et al. Therapy for MDR, pre-XDR, XDR tuberculosis and rifampicin resistance or drug intolerance to at least rifampicin - Amendment of 19.09.2023 to the S2k guideline: Tuberculosis in adults. Pneumology 2024; 78: 35-46. DOI: 10.1055/a-2182-1609
- Otto-Knapp R, Edwards S, Kuchukhidze G et al. Rapid Communication - Availability of drugs for the treatment of MDR/RR-TB in the WHO European Region. Eurosurveillance 2024; submitted.
