Estimated generic prices for novel treatments for drug resistant
tuberculosis
tuberculosis
File(s)TB prices JAC accepted draft.pdf (1.6 MB)
Accepted version
Author(s)
Type
Journal Article
Abstract
Background:
Estimated annual incidence of MDR-TB is 480,000, representing 5% of TB incidence, but 20% of mortality. Multiple drugs have recently been developed or re-purposed for the treatment of MDR-TB. Currently, treatment for MDR-TB costs thousands of dollars per course.
Objectives:
To estimate generic prices for novel TB drugs that would be possible given large-scale competitive manufacture.
Methods:
Prices for linezolid, moxifloxacin, and clofazimine were estimated based on per-kilogram prices of active pharmaceutical ingredient (API). Other costs were added, including formulation, packaging and a profit margin. The costs of projection for sutezolid were estimated to be equivalent to those for linezolid, based on chemical similarit
y. Generic prices for bedaquiline, delamanid, and pretomanid were estimated by assessing routes of synthesis, costs/kg of chemical reagents, routes of synthesis, and per-step yields. Costing algorithms reflected variable regulatory requirements, efficiency of scale based on demand, and were validated by testing predictive ability against widely-available TB medicines.
Results:
Estimated generic prices were USD $8-$17/month for bedaquiline, $5-$16/month for delamanid, $11-$3 /month for pretomanid, $4-$9/month for linezolid, $4-$9/month for sutezolid, $4-$11/month for clofazimine, and $4-$8/month for moxifloxacin. Estimated generic prices were 87%-94% lower than current lowest available prices for bedaquiline, 95%-98% for delamanid, 94%-97% for linezolid. Estimated generic prices were $168-$395 per course for the STREAM trial modified Bangladesh regimens (current cost
s $734-$1,799), $53-$276 for pretomanid-based three-drug regimens, and $238-$507 for a delamanid-based four-drug regimen.
Conclusions:
Competitive large-scale generic manufacture could allow supplies of treatment for 5-10 times more MDR-TB cases within current procurement budgets.
Estimated annual incidence of MDR-TB is 480,000, representing 5% of TB incidence, but 20% of mortality. Multiple drugs have recently been developed or re-purposed for the treatment of MDR-TB. Currently, treatment for MDR-TB costs thousands of dollars per course.
Objectives:
To estimate generic prices for novel TB drugs that would be possible given large-scale competitive manufacture.
Methods:
Prices for linezolid, moxifloxacin, and clofazimine were estimated based on per-kilogram prices of active pharmaceutical ingredient (API). Other costs were added, including formulation, packaging and a profit margin. The costs of projection for sutezolid were estimated to be equivalent to those for linezolid, based on chemical similarit
y. Generic prices for bedaquiline, delamanid, and pretomanid were estimated by assessing routes of synthesis, costs/kg of chemical reagents, routes of synthesis, and per-step yields. Costing algorithms reflected variable regulatory requirements, efficiency of scale based on demand, and were validated by testing predictive ability against widely-available TB medicines.
Results:
Estimated generic prices were USD $8-$17/month for bedaquiline, $5-$16/month for delamanid, $11-$3 /month for pretomanid, $4-$9/month for linezolid, $4-$9/month for sutezolid, $4-$11/month for clofazimine, and $4-$8/month for moxifloxacin. Estimated generic prices were 87%-94% lower than current lowest available prices for bedaquiline, 95%-98% for delamanid, 94%-97% for linezolid. Estimated generic prices were $168-$395 per course for the STREAM trial modified Bangladesh regimens (current cost
s $734-$1,799), $53-$276 for pretomanid-based three-drug regimens, and $238-$507 for a delamanid-based four-drug regimen.
Conclusions:
Competitive large-scale generic manufacture could allow supplies of treatment for 5-10 times more MDR-TB cases within current procurement budgets.
Date Issued
2017-01-10
Date Acceptance
2016-11-01
Citation
Journal of Antimicrobial Chemotherapy, 2017, 72 (4), pp.1243-1252
ISSN
1460-2091
Publisher
Oxford University Press (OUP)
Start Page
1243
End Page
1252
Journal / Book Title
Journal of Antimicrobial Chemotherapy
Volume
72
Issue
4
Copyright Statement
© The Author 2017. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please email: journals.permissions@oup.com.
Subjects
Science & Technology
Life Sciences & Biomedicine
Infectious Diseases
Microbiology
Pharmacology & Pharmacy
DIRECT-ACTING ANTIVIRALS
STANDARDIZED TREATMENT
DEVELOPING-COUNTRIES
ACCESS
1115 Pharmacology And Pharmaceutical Sciences
0605 Microbiology
1108 Medical Microbiology
Publication Status
Published