Estimated generic prices for novel treatments for drug-resistant tuberculosis

Gotham, Dzintars; Fortunak, Joseph; Pozniak, Anton; Khoo, Saye; Cooke, Graham; Nytko, Frederick E.; Hill, Andrew

doi:10.1093/jac/dkw522

Cited by 20 publications

(16 citation statements)

References 10 publications

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“…The current price for rifabutin per 150 mg tablet is $0.94 . Estimated generic prices for rifabutin regimens were calculated using a previously validated cost estimation algorithm . Per‐kilogram price of active pharmaceutical ingredient exported from India was collected from the http://www.infodriveindia.com database.…”

Section: Cost Considerationsmentioning

confidence: 99%

Global access of rifabutin for the treatment of tuberculosis – why should we prioritize this?

et al. 2019

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Introduction Rifabutin, a rifamycin of equivalent potency to rifampicin, has several advantages in its pharmacokinetic and toxicity profile, particularly in HIV co‐infected patients on combined antiretroviral therapy (cART). In this commentary, we evaluate evidence supporting increased global use of rifabutin and highlight key recommendations for action. Discussion Although extrapolation of data from HIV uninfected patients would suggest non‐inferiority, there has been no randomized controlled study comparing rifabutin versus rifampicin in the outcomes of relapse‐free cure, in drug susceptible tuberculosis (TB), in HIV co‐infected patients on currently utilized cART regimens or in paediatric populations. An important advantage of rifabutin is that compared to the dose adjustments required with rifampicin, it can be co‐administered with the integrase strand transfer inhibitors raltegravir or dolutegravir without the need for dose adjustments. This strategy would be easier to implement in a programmatic setting and would save costs. We have assessed cost incentives to utilize rifabutin and have estimated generic costs for a range of rifabutin dosage scenarios. Where facilities are present for drug re‐challenge and monitoring for drug toxicity and cross‐reactivity, rifabutin offers a switch alternative for adverse drug reactions (ADR)s attributed to rifampicin. This would negate the need to prolong treatment in the absence of a rifamycin as part of short‐course multidrug therapy. There is evidence of incomplete cross‐resistance to rifampicin and rifabutin. Rifabutin may be useful in rifampicin‐resistant TB, in an estimated 20% of cases, based on phenotypic or genotypic rifabutin susceptibility testing. Conclusions Rifabutin should be available globally as a first‐line rifamycin in HIV co‐infected individuals and as a switch option in cases of rifampicin associated ADRs. Further studies are needed to ascertain the utility of rifabutin in rifampicin‐resistant rifabutin‐susceptible TB.

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Section: Cost Considerationsmentioning

confidence: 99%

Global access of rifabutin for the treatment of tuberculosis – why should we prioritize this?

et al. 2019

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“…Data on API exported from India were retrieved from an online database of customs declarations (www.infodriveindia.com), a source that we have used in numerous previous analyses of manufacturing costs 3 6 8–12. API shipments in the date range from 1 July 2014 to 1 July 2016 were included, extending the range 2 years into the past if <100 records were returned, and repeating this until at least 100 records were available, or until the timeframe spanned 6 years.…”

Section: Methodsmentioning

confidence: 99%

“…We have previously estimated cost-based prices that could be achieved in a competitive market for various SOF medicines3 8–12 as well as insulins 6. The cost estimation formula is given in figure 1 and explained further below.…”

Section: Methodsmentioning

confidence: 99%

Estimation of cost-based prices for injectable medicines in the WHO Essential Medicines List

2019

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ObjectivesChallenges remain in ensuring universal access to affordable essential medicines. We previously estimated the expected generic prices based on cost of production for medicines in solid oral formulations (ie, capsules or tablets) on the WHO Model List of Essential Medicines (EML). The objectives of this analysis were to estimate cost-based prices for injectable medicines on the EML and to compare these to lowest current prices in England, South Africa, and India.DesignData on the cost of active pharmaceutical ingredients (APIs) exported from India were extracted from an online database of customs declarations (www.infodriveindia.com). A formula was designed to use API price data to estimate a cost-based price, by adding the costs of converting API to a finished pharmaceutical product, including the cost of formulation in vials or ampoules, transportation and an average profit margin.ResultsFor injectable formulations on the WHO EML, medicines had prices above the estimated cost-based price in 77% of comparisons in England (median ratio 2.54), and 62% in South Africa (median ratio 1.48), while 85% of medicines in India had prices below estimated cost-based price (median ratio 0.30). 19% of injectable medicines in England, 9% in South Africa, and 5% in India had prices more than 10 times the estimated cost-based price. Medicines that appeared in the top 20 by ratio of lowest current price to estimated cost-based price for more than one country included numerous oncology medicines—irinotecan, leuprorelin, ifosfamide, daunorubicin, filgrastim and mesna—as well as valproic acid and ciclosporin.ConclusionsEstimating manufacturing costs can identify cases in which profit margins for medicines may be set significantly higher than average.

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“…As another example, a new medicine to treat multidrugresistant tuberculosis, bedaquiline, was priced by Janssen-a subsidiary of Johnson & Johnson in South Africa-at $400 for the six-month course, which makes it unaffordable for most who need it, especially galling when researchers estimate a generic equivalent of the medicine could be made available for only $48. 34 In recognition of the global nature of this crisis in access to medicines, the UN Secretary-General set up a High-Level Panel on Access to Medicines that produced a report containing important recommendations to ensure innovation and access to medicines. 35 37 The average compensation for a drug company CEO in 2015 was $18.5 million, 71 percent greater than the median earned by executives in all industries.…”

Section: Profits and Innovationmentioning

confidence: 99%

Prescription for Poverty: Drug companies as tax dodgers, price gougers, and influence peddlers

Fried¹

2018

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Estimated generic prices for novel treatments for drug-resistant tuberculosis

Abstract: Competitive large-scale generic manufacture could allow supplies of treatment for 5-10 times more MDR-TB cases within current procurement budgets.

Cited by 20 publications

References 10 publications

Global access of rifabutin for the treatment of tuberculosis – why should we prioritize this?

Global access of rifabutin for the treatment of tuberculosis – why should we prioritize this?

Estimation of cost-based prices for injectable medicines in the WHO Essential Medicines List

Prescription for Poverty: Drug companies as tax dodgers, price gougers, and influence peddlers

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