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

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.

A Comparative Analysis of Pricing and Reimbursement of Cystic Fibrosis Transmembrane Conductance Regulator Modulators in Europe

Objectives: Cystic fibrosis transmembrane conductance regulator (CFTR) modulators, Kalydeco® (ivacaftor), Orkambi® (lumacaftor/ivacaftor) and Symkevi® (tezacaftor/ivacaftor), have substantially improved patients’ lives yet significantly burden healthcare budgets. This analysis aims to compare pricing and reimbursement of aforementioned cystic fibrosis medicines, across European countries.Methods: Clinical trial registries, national databases, health technology assessment reports and grey literature of Austria, Belgium, Denmark, France, Germany, Ireland, Poland, Spain, Sweden, Switzerland, Netherlands, the United Kingdom were consulted. Publicly available prices, reimbursement statuses, economic evaluations, budget impact analyses and managed entry agreements of CFTR modulators were examined. Results: In Belgium, lowest list prices were observed for Kalydeco® (ivacaftor) and Symkevi® (tezacaftor/ivacaftor) at €417 per defined daily dose (DDD) and €372 per average daily dose (ADD), respectively. Whereas, Switzerland had the lowest price for Orkambi® (lumacaftor/ivacaftor) listed at €309 per DDD. Spain had the highest prices for Kalydeco® (ivacaftor) and Symkevi® (tezacaftor/ivacaftor) at €850 per DDD and €761 per ADD, whereas Orkambi® (lumacaftor/ivacaftor) was most expensive in Poland at €983 per DDD. However, list prices were subject to confidential discounts and likely varied from actual costs. In all countries, these treatments were deemed not to be cost-effective. The annual budget impact of the CFTR modulators varied between countries and depended on factors such as local product prices, size of target population, scope of costs and discounting. However, all modulators were fully reimbursed in ten of the evaluated countries except for Sweden and Poland that, respectively, granted reimbursement to one and none of the therapies. Managed entry agreements were confidential but commonly adopted to address financial uncertainties.Conclusion: Discrepancies concerning prices, reimbursement and access were detected for Kalydeco® (ivacaftor), Orkambi® (lumacaftor/ivacaftor) and Symkevi® (tezacaftor/ivacaftor) across European countries.

407. Minimum Manufacturing Costs, National Prices and Estimated Global Availability of New Repurposed Therapies for COVID-19

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, with previously promising drugs such as hydroxychloroquine and remdesivir have been shown to be ineffective. Several new candidates are now being studied in clinical trials. Safe and effective treatments will need to be both affordable and widely available. We therefore revised our original 2020 analysis to reflect recent developments. In this update we analysed the cost of production, current national list prices, and API availability for oral and IV dexamethasone, ivermectin, colchicine, dutasteride, budesonide, baricitinib and monoclonal antibodies tocilizumab and sarilumab. Methods Costs of production for new and potential COVID-19 drugs (dexamethasone, ivermectin, dutasteride, budesonide, baricitinib, tocilizumab, sarilumab and colchicine) were estimated using an established and published methodology based on costs of active pharmaceutical ingredients (API), extracted from the global shipping records database Panjiva. 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. A summary is shown in Table 1. Table 1. Summary of list prices, estimated production costs, and current availability of potential COVID-19 drugs selected for analysis. OD = Once daily, BD = twice per day, EUA = Emergency Use Authorisation (only to be given with remdesivir) *In most recent 12-month period. Conclusion Successful management of COVID-19 will require equitable access to treatment for all, not just those able to pay. Repurposed drugs can be manufactured at very low costs if shown to be clinically effective, and offers an affordable, widely available option for patients at all stages of the disease from pre-exposure prophylaxis to asymptotic and mild infections, through to critical care until vaccination coverage is expanded. Disclosures All Authors: No reported disclosures

Venetoclax (Venclexta)

CADTH recommends that Venclexta in combination with low-dose cytarabine (LDAC) should not be reimbursed by public drug plans for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) who are 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy. Evidence from 1 clinical trial demonstrated that treatment with Venclexta plus LDAC did not improve overall survival compared to treatment with LDAC alone. No conclusions could be drawn for other important outcomes including remission rates, transfusion independence, event-free survival, quality of life, and symptoms. Patients identified a need for treatments that can maintain remission, improve quality of life and symptoms (fatigue), and that have fewer side effects. It is unclear whether Venclexta plus LDAC meets these needs. Economic evidence suggests that Venclexta plus LDAC is not cost-effective at a willingness-to-pay threshold of $50,000 per quality-adjusted life-year (QALY), even at a 100% reduction in the price of Venclexta. Based on public list prices, the 3-year budget impact is $70,006,541. This estimate is larger than the value identified by drug plans as feasible for adoption.

OVERVIEW OF GLUCOSE METERS AND TEST STRIPS IN THE PHARMACEUTICAL MARKET OF THE REPUBLIC OF KAZAKHSTAN

В данной статье представлены результаты маркетингового исследования фармацевтического рынка Республики Казахстан по изделиям медицинского назначения, в том числе глюкометрам и тест-полосам. Результаты исследования представлены в виде диаграммы и списка. Также приведены цены на глюкометры и тест-полоски, зарегистрированные в Казахстане и популярные по запросу. В связи с тем, что в настоящее время в нашей стране растет число людей, страдающих сахарным диабетом, проверка уровня сахара в крови является обязательной, но не всем больным доступны зарубежные глюкометры и тест-полоски для них, поэтому стране необходимо уделять больше внимания отечественному производству This article presents the results of a marketing study of the pharmaceutical market of the Republic of Kazakhstan on medical products, including glucose meters and test strips. The results of the study are presented in the form of a diagram and a list. Prices for blood glucose meters and test strips registered in Kazakhstan and popular on request are also shown. Due to the fact that currently the number of people suffering from diabetes is growing in our country, checking the blood sugar level is mandatory, but not all patients have access to foreign blood glucose meters and test strips for them, so the country needs to pay more attention to domestic production.

Patiromer (Veltassa)

Clinical evidence suggests that Veltassa should be reimbursed to treat hyperkalemia in adult patients with chronic kidney disease and who are receiving renin-angiotensin-aldosterone system inhibitor therapy. Economic evidence suggests that at least an 85% price reduction is needed to ensure Veltassa is cost-effective at a $50,000 per quality-adjusted life-year threshold. Higher price reductions may be required if Veltassa is used long term, more patients use the maximum dose, and/or the benefit of renin-angiotensin-aldosterone system inhibitor administration is lower. Based on public list prices, the 3-year budget impact is $86,948,298.

An analytical model of the replacement costs of aircraft engine life-limited parts

Purpose The purpose of this paper is to present novel recursive expressions for modelling the replacement costs of aircraft engine life-limited parts during shop visits to assist engine operators in both evaluating their decisions regarding the applied life-limited parts management strategies and tracking the replacement costs consistently throughout the life of the engine. Design/methodology/approach The replacement costs of aircraft engine life-limited parts are modelled analytically in this research, which strives to quantify the costs of used and unused lives of the replaced parts, incurred during engine shop visit events. Inputs for this model include the list price of life-limited parts, the replacement decisions made on all previous shop visits and the number of cycles the engine has operated at different thrust ratings on all previous operating intervals. Findings The average annual escalation rate of life-limited parts list prices was shown to range from 5% to 7%. The presented model is not only suitable for calculating the costs of used and unused lives of life-limited parts during past engine shop visit events but also for application in the life-limited parts replacement cost forecasting and optimisation models. Originality/value Uniquely derived recursive expressions represent the final result of the developed model which, to the authors’ knowledge, had not been studied elsewhere in the academic literature. The analysis of aircraft engine life-limited part list prices carried out to account for the average annual escalation rate enables the prediction of replacement costs during subsequent shop visits.

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

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.

List Price Collusion

Firms sometimes collude by agreeing on increases in list prices. Yet, the efficacy of such list price collusion is subject to discussion as colluding firms might, in principle, deviate secretly from the elevated prices by granting their customers discounts. This article reviews cases of list price collusion in the USA and Europe, and it presents a theory of harm suggesting that a combination of anchoring, orientation on reference points, and loss aversion may render list price collusion effective in raising transaction prices—even if firms set transaction prices in a non-coordinated fashion.