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

Gotham, Dzintars; Barber, Melissa; Hill, Andrew

doi:10.1136/bmjopen-2018-027780

Cited by 11 publications

(12 citation statements)

References 14 publications

(20 reference statements)

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“…The AIM model is similar to other models used in cost-based pricing literature, and yet it is more extensive because it includes not only manufacturing but also R&D and sales and information costs. 14,16,17 Assumptions differ slightly from these other models but all are in the same range except for our assumption on excess, where Gotham et al assume higher excess for costs of goods than we do (10% vs 5%-7%). 16 However, the scope of Gotham et al is for injectable medicines.…”

Section: Uncertaintiesmentioning

confidence: 88%

“…14,16,17 Assumptions differ slightly from these other models but all are in the same range except for our assumption on excess, where Gotham et al assume higher excess for costs of goods than we do (10% vs 5%-7%). 16 However, the scope of Gotham et al is for injectable medicines. 16 Our assumption for an oral formulation is based on an estimation of a contract manufacturing organization applicable to mexiletine.…”

Section: Uncertaintiesmentioning

confidence: 88%

“…16 However, the scope of Gotham et al is for injectable medicines. 16 Our assumption for an oral formulation is based on an estimation of a contract manufacturing organization applicable to mexiletine.…”

Section: Uncertaintiesmentioning

confidence: 99%

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Cost-Based Price Calculation of Mexiletine for Nondystrophic Myotonia

et al. 2021

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Objectives: Mexiletine is a long-known drug used for the treatment of arrhythmias and repurposed in the 1980s for patients with nondystrophic myotonia (NDM). Recently, the price of mexiletine in Europe increased significantly after registration as an orphan drug for NDM. This led to international discussions on affordability and willingness to reimburse mexiletine in the absence of background information that would justify such a price. Our objective was to calculate a cost-based price for mexiletine for adult patients with NDM based on detailed information on development costs.Methods: We calculated a fair price based on a cost-based pricing model for commercial mexiletine to treat adults with NDM using a recent European drug-pricing model as a framework to include actual costs incurred. Three scenarios were applied: 1 with minimum estimated costs, 1 with maximum estimated costs, and 1 with costs as if mexiletine was innovative.Results: The calculated fair price of mexiletine per patient per year (PPPY) is V452 for the minimum scenario and V1996 for the maximum scenario. By using hypothetical R&D costs used for innovative drugs, the price would be V6685 PPPY. In Europe, the list price of mexiletine ranges from V30 707-60 730 PPPY, based on 600 mg daily. Conclusions:The current list price for mexiletine in Europe is manifold higher than any scenario of the cost-based models. Accounting for the reduced costs for clinical development in a repurposing scenario, the cost-based pricing model provides a fair commercial price range, which can be used as benchmark for pricing negotiations and/or reimbursement decisions.

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Section: Uncertaintiesmentioning

confidence: 88%

Section: Uncertaintiesmentioning

confidence: 88%

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Cost-Based Price Calculation of Mexiletine for Nondystrophic Myotonia

et al. 2021

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“…For injectables, an adjusted published methodology was followed to account for the cost of ampules, additional transport costs, and projected 20% API loss during formulation and filling [ 2 , 21 ].…”

Section: Methodsmentioning

confidence: 99%

Minimum Manufacturing Costs, National Prices, and Estimated Global Availability of New Repurposed Therapies for Coronavirus Disease 2019

Wang

Levi

Ellis

et al. 2021

Open Forum Infectious Diseases

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Background Currently, only dexamethasone, tocilizumab and sarilumab have conclusively been shown to reduce mortality of COVID-19. Safe and effective treatments will need to be both affordable and widely available globally to be used alongside vaccination programmes. This analysis will estimate and compare potential generic minimum costs of a selection of approved COVID-19 drug candidates with available international list prices. Methods We searched for repurposed drugs that have been approved by at least one of the WHO, FDA or NICE, or at least given emergency use authorisation or recommended for off-label prescription. Drug prices were searched for, for dexamethasone, budesonide, baricitinib, tocilizumab, casirivimab and imdevimab, and sarilumab using active pharmaceutical ingredients (API) data extracted from global shipping records. This was compared with national pricing data from a range of low, medium, and high-income countries. Annual API export volumes from India were used to estimate the current availability of each drug. Results Repurposed therapies can be generically manufactured for some treatments at very low per-course costs, ranging from $2.58 for IV dexamethasone (or $0.19 orally) and $4.34 for inhaled budesonide. No export price data was available for baricitinib, tocilizumab, casirivimab and imdevimab or sarilumab, but courses of these treatments are priced highly, ranging from $6.67 for baricitinib to $875.5 for sarilumab. When comparing international list prices, we found wide variations between countries. Conclusions Successful management of COVID-19 will require equitable access to treatment for all populations, not just those able to pay high prices. Dexamethasone and budesonide are widely available and affordable, whilst monoclonal antibodies and IV treatment courses are more expensive.

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“…For IV injectables, an adjusted and published methodology for injectable drugs was followed to account for the cost of ampules, additional transport costs, and a projected 20% API loss during formulation and filling [4,26].…”

Section: Dexamethasonementioning

confidence: 99%

Minimum manufacturing costs, national prices and estimated global availability of new repurposed therapies for COVID-19

Wang

Levi

Ellis

et al. 2021

Preprint

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Background Currently, only dexamethasone, tocilizumab and sarilumab have conclusively been shown to reduce mortality of COVID-19. No drug for prevention or treatment in earlier stages of COVID-19 are yet found; although several new candidates including ivermectin, dutasteride, baricitinib, budesonide and colchicine are being studied with some early promising results. Safe and effective treatments will need to be both affordable and widely available globally. Objectives This analysis will estimate and compare potential generic production costs of a selection of COVID-19 drug candidates with international list prices. Methods Costs of production for new and potential COVID-19 drugs (dexamethasone, ivermectin, dutasteride, budesonide, baricitinib, tocilizumab, sarilumab and colchicine) were estimated using active pharmaceutical ingredients (API) data extracted from global shipping records. This was compared with national pricing data from low, medium, and high-income countries. Annual API export volumes from India were used to estimate the current availability of each drug. Results Repurposed therapies can be generically manufactured at very low per-course costs: ranging from $2.58 for IV dexamethasone (or $0.19 orally) to $0.12 for ivermectin. No export price data was available for baricitinib, tocilizumab or sarilumab. When compared against international list prices, we found wide variations between countries. Drug API availability was generally good, with colchicine being the most available with sufficient annual API exported for 59.8 million treatment courses. Conclusions Successful management of COVID-19 will require equitable access to treatment for all populations, not just those able to pay high prices. Analysed drugs are widely available and affordable, whilst IV treatment courses are more expensive.

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

Cited by 11 publications

References 14 publications

Cost-Based Price Calculation of Mexiletine for Nondystrophic Myotonia

Cost-Based Price Calculation of Mexiletine for Nondystrophic Myotonia

Minimum Manufacturing Costs, National Prices, and Estimated Global Availability of New Repurposed Therapies for Coronavirus Disease 2019

Minimum manufacturing costs, national prices and estimated global availability of new repurposed therapies for COVID-19

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