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      Is pricing of dolutegravir equitable? A comparative analysis of price and country income level in 52 countries

      editorial
      1 , 2 , *
      Journal of Virus Eradication
      Mediscript Ltd
      dolutegravir, efavirenz, price, costs, cost-effectiveness

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          Abstract

          Objectives

          Differences in marketed prices of antiretrovirals raises questions about the fairness of pricing medicines of significant public health importance such as dolutegravir (DTG). In view of the reduced prices of generically available efavirenz (EFV), there is a need to determine if previous conclusions on DTG's cost-effectiveness need to be re-assessed

          Methods

          Lowest list prices of DTG were extracted from national drug price or reimbursement databases for 52 countries. Price was recorded as US$ per person-year (ppy). We compared the price of DTG to minimum costs of production and reduced prices of EFV, as well as assessed the correlation with gross domestic product (GDP) per capita and HIV epidemic size in three income classification groups (‘high’, ‘upper middle-income’, ‘lower middle or low-income’).

          Results

          Annual prices of DTG ranged from $27 per person-year in Georgia to $20,130 in the USA. Within each income group, there was no observable relationship between DTG prices, GDP per capita and HIV epidemic size. Median price in countries excluded from voluntary licensing agreements ($8718) was >140 times higher than countries included ($60). Price of DTG was >500% higher than EFV in many countries. Three full economic evaluations from high-income settings that compared DTG against EFV all used branded drug prices of EFV-based regimens as cost inputs to evaluate DTG's cost-effectiveness.

          Conclusions

          This study highlights the wide disparity in prices of DTG across countries, even when segregated by similar income levels. The cost-effectiveness of DTG versus EFV should be re-evaluated now that low-cost generic EFV has become widely available.

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          Most cited references19

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          Brief Report: Dolutegravir Plus Abacavir/Lamivudine for the Treatment of HIV-1 Infection in Antiretroviral Therapy-Naive Patients: Week 96 and Week 144 Results From the SINGLE Randomized Clinical Trial

          Abstract: The SINGLE study was a randomized, double-blind, noninferiority study that evaluated the safety and efficacy of 50 mg dolutegravir + abacavir/lamivudine versus efavirenz/tenofovir/emtricitabine in 833 ART-naive HIV-1 + participants. Of 833 randomized participants, 71% in the dolutegravir + abacavir/lamivudine arm and 63% in the efavirenz/tenofovir/emtricitabine arm maintained viral loads of <50 copies per milliliter through W144 (P = 0.01). Superior efficacy was primarily driven by fewer discontinuations due to adverse events in the dolutegravir + abacavir/lamivudine arm [dolutegravir + abacavir/lamivudine arm, 13 (3%); efavirenz/tenofovir/emtricitabine arm, 48 (11%)] through W144. No treatment-emergent integrase or nucleoside resistance was observed in dolutegravir + abacavir/lamivudine recipients through W144.
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            Payers' experiences with confidential pharmaceutical price discounts: A survey of public and statutory health systems in North America, Europe, and Australasia.

            Institutional payers for pharmaceuticals worldwide appear to be increasingly negotiating confidential discounts off of the official list price of pharmaceuticals purchased in the community setting. We conducted an anonymous survey about experiences with and attitudes toward confidential discounts on patented pharmaceuticals in a sample of high-income countries. Confidential price discounts are now common among the ten health systems that participated in our study, though some had only recently begun to use these pricing arrangements on a routine basis. Several health systems had used a wide variety of discounting schemes in the past two years. The most frequent discount received by participating health systems was between 20% and 29% of official list prices; however, six participants reported their health system received one or more discount over the past two years that was valued at 60% or more of the list prices. On average, participants reported that confidential discounts were more common, complex, and significant for specialty pharmaceuticals than for primary care pharmaceuticals. Participants had a more favorable view of the impact of confidential discount schemes on their health systems than on the global marketplace. Overall, the frequency, complexity, and scale of confidential discounts being routinely negotiated suggest that the list prices for medicines bear limited resemblance to what many institutional payers actually pay.
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              Estimated costs of production and potential prices for the WHO Essential Medicines List

              Introduction There are persistent gaps in access to affordable medicines. The WHO Model List of Essential Medicines (EML) includes medicines considered necessary for functional health systems. Methods A generic price estimation formula was developed by reviewing published analyses of cost of production for medicines and assuming manufacture in India, which included costs of formulation, packaging, taxation and a 10% profit margin. Data on per-kilogram prices of active pharmaceutical ingredient exported from India were retrieved from an online database. Estimated prices were compared with the lowest globally available prices for HIV/AIDS, tuberculosis (TB) and malaria medicines, and current prices in the UK, South Africa and India. Results The estimation formula had good predictive accuracy for HIV/AIDS, TB and malaria medicines. Estimated generic prices ranged from US$0.01 to US$1.45 per unit, with most in the lower end of this range. Lowest available prices were greater than estimated generic prices for 214/277 (77%) comparable items in the UK, 142/212 (67%) in South Africa and 118/298 (40%) in India. Lowest available prices were more than three times above estimated generic price for 47% of cases compared in the UK and 22% in South Africa. Conclusion A wide range of medicines in the EML can be profitably manufactured at very low cost. Most EML medicines are sold in the UK and South Africa at prices significantly higher than those estimated from production costs. Generic price estimation and international price comparisons could empower government price negotiations and support cost-effectiveness calculations.
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                Author and article information

                Journal
                J Virus Erad
                J Virus Erad
                JOURNAL OF VIRUS ERADICATION
                Journal of Virus Eradication
                Mediscript Ltd
                2055-6640
                2055-6659
                October 2018
                1 October 2018
                : 4
                : 4
                : 230-237
                Affiliations
                [ 1 ] Faculty of Medicine, Imperial College London , London, UK.
                [ 2 ] Department of Pharmacology and Therapeutics, University of Liverpool , UK.
                Author notes
                [* ]Corresponding author: Andrew M Hill, Department of Translational Medicine , University of Liverpool , 70 Pembroke Place, LiverpoolL69 3GF, UK. Email:  microhaart@ 123456aol.com
                Article
                10.1016/S2055-6640(20)30311-3
                6248837
                30515303
                f9695f47-42eb-4022-9916-f3a2c66500ba
                © 2018 The Authors.  Journal of Virus Eradication published by Mediscript Ltd

                This is an open access article published under the terms of a Creative Commons License.

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                dolutegravir, efavirenz, price, costs, cost-effectiveness

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