Economic evaluation of doravirine/tenofovir disoproxil fumarate/lamivudine for HIV-1-infected adults in Russia: a cost-minimization and budget impact analysis

ABSTRACT

Background

In Russia, before 2022, the list of vital and essential drugs for HIV-infected patients previously untreated with antiretroviral drugs included the fixed-dose combination rilpivirine/tenofovir disoproxil fumarate/emtricitabine (RPV/TDF/FTC) but not doravirine/tenofovir disoproxil fumarate/lamivudine (DOR/TDF/3TC).

Methods

An indirect comparison of the efficacy of DOR/TDF/3TC and RPV/TDF/FTC defined by virologic suppression (HIV-1 RNA of <50 copies/mL at week 48) was made. The per-patient drug costs over 1 year were compared in a cost-minimization analysis. A budget impact analysis considered the costs to the healthcare system of including DOR/TDF/3TC as a treatment option for eligible patients in Russia over a 3-year time horizon.

Results

The indirect treatment comparison of DOR/TDF/3TC and RPV/TDF/FTC in treatment-naïve patients with baseline HIV-1 RNA 100,000 copies/ml or less showed no statistically significant difference (RR 0.914, 95% CI 0.833–1.003). In the cost-minimization analysis, the per-patient cost of one year of treatment with RPV/TDF/FTC and DOR/TDF/3TC was, respectively, ₽320,975 and ₽151,192, for a saving of ₽169,783. In the budget impact analysis, the adoption of DOR/TDF/3TC into clinical practice is expected to reduce drug costs by ₽333 million (23.8%) in year 3.

Conclusions

Fixed-dose combination DOR/TDF/3TC is equally effective and cost-saving compared to RPV/TDF/FTC from Russian vital and essential drugs list perspective.

KEYWORDS:

• Antiretroviral therapy
• doravirine
• fixed-dose combination
• HIV infection
• human immunodeficiency virus
• pharmacoeconomic analysis
• rilpivirine

Article highlights

• Russia accounts for over half of all new cases of HIV infection in the WHO European region.

• Rilpivirine/tenofovir disoproxil fumarate/emtricitabine (RPV/TDF/FTC) is a standard first-line ART treatment for special cases of HIV infection in Russia.

• The fixed-dose combination, doravirine/tenofovir disoproxil fumarate/lamivudine (DOR/TDF/3TC), was registered with the Russian Federation in 2019; however, it was not included in the federal list of vital and essential drugs by the time of this analysis.

• Fixed-dose combination DOR/TDF/3TC is equally effective compared to RPV/TDF/FTC for ART-naïve HIV patients categorized as special cases.

• The data presented here indicate that inclusion of the fixed-dose combination DOR/TDF/3TC in list of vital and essential drugs is expected to reduce the costs of treating eligible HIV patients in Russia.

Acknowledgments

Medical writing assistance was provided by ScribCo and funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Declaration of interest

D Ugrekhelidze, A Lobodina, C Baxter and A Beyer are full time employees of Merck Sharp & Dohme, LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Previous presentations

The data was presented at Virtual ISPOR Europe 2020 which was held 16 – 19 November 2020.

Author contributions

All authors were responsible for the study conception and design; E Pyadushkina, E Derkach and V Rozenberg were responsible for data collection. E Pyadushkina, E Derkach, V Rozenberg, D Ugrehelidze, A Lobodina, A Beyer were responsible for the analysis of data. All authors were responsible for the interpretation of data. E Pyadushkina and E Derkach were responsible for the initial draft of the manuscript, all authors reviewed the content, revised it critically for intellectual content, and approved the final version for publication. All authors agree to be accountable for all aspects of the work described in this study.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14737167.2022.2117162

Additional information

Funding

This study was funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.