Prices versus costs of production for molnupiravir as a COVID-19 treatment

Background Molnupiravir has been recently approved in the United Kingdom for the treatment of COVID-19 for showing promising survival benefits in clinical trials. This analysis will estimate and compare potential generic minimum costs of molnupiravir as well as observe countries eligible for pricing discounts as agreed by Merck and The Medicines Patent Pool (MPP). Methods Drug prices were searched for molnupiravir 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. Trends of molnupiravir drugs prices were also evaluated for the last 6-month period. Mean daily COVID-19 diagnosis rates were calculated for the countries eligible for voluntary licensing. Results Molnupiravir can be generically manufactured at the very low per-course cost of $9.00. Over the past 6 months, prices of molnupiravir have fallen significantly, and when comparing reported international prices, we found wide variations between countries. Only 9% of diagnosed patients worldwide were in the countries eligible for voluntary licensing. Conclusions Prices of molnupiravir range from $20 to $750 per course. Only 9% of worldwide COVID-19 diagnoses are made in countries covered by voluntary licenses. Middle income countries not eligible for voluntary licensing may need to issue compulsory licenses to secure access to molnupiravir at affordable prices.

OP440 Comparison Of Evidence Supporting Cancer Drug Approvals And Prices In The US And Brazil

IntroductionCancer drug prices are high on the policy agenda worldwide. Previous research found no association between cancer drug benefits and prices at the time of regulatory approval. Drugs approved in the US with uncertain benefits may have spill-over effects in other settings. Our objective was to compare the evidence supporting cancer drug approvals in the US and Brazil, and to examine the association between cancer drug prices and availability of added therapeutic benefit.MethodsWe matched all novel cancer drugs approved in the US from 2010–2019 to approvals in Brazil. We extracted data on pivotal study design characteristics and outcomes in the US and Brazil, and evidence supporting price approval in Brazil, including availability of added therapeutic benefit.ResultsFrom 2010–2019, fifty-six cancer drugs with matching indications were approved in US and Brazil and had their prices authorized in Brazil by December 2020. Drug were available in Brazil following a median 522 days after US approval (IQR: 351–932). In the US, thirty-four (60.7 percent) of the drugs had pivotal randomized controlled trials (RCTs) and Twelve (21.4 percent) had overall survival benefit. By the time of Brazilian approval, forty-one (73.2 percent) drugs had pivotal RCTs and twenty-two (39.3 percent) had overall survival benefit. A total of twenty-eight (50 percent) drugs did not demonstrate added therapeutic benefit over other authorized drugs for the same indication and had a median reduction from requested to approved price of 6.1 percent (IQR: 0–27.8 percent) in Brazil. The twenty-seven (48.2 percent) drugs with added therapeutic benefit had a median price reduction of 2.0 percent (IQR: 0–9.2 percent).ConclusionsHalf of new cancer drugs approved in Brazil failed to demonstrate added therapeutic benefit. The Brazilian pricing system secured considerable price reductions, ensuring that prices for medicines with no added therapeutic benefit were not higher than existing treatments for the same approved indication. Although evidence was more mature by the time of Brazilian review, pivotal studies often lacked randomization and overall survival endpoints.

Implementation of Halal Product Assurance in the Pharmaceutical Sector in Indonesia

The goal of this research is to determine and assess the implementation of halal certification for the pharmaceutical business in accordance with Law Number 33 of 2014 on Halal Product Assurance, as well as the variables that hinder and support its implementation. The impact of the JPH Law on the process value chain and supply chain of drugs and vaccines results in a total change in the pharmaceutical industry, including changes in ingredients resulting in reprocessing of quality, safety, and efficacy, changes in the distribution process, addition of personnel or staff, decreased economic capacity of the industry due to increased production costs, and there is a decrease in the industry's economic capacity due to increased costs of production. The halal status of a product has become a must-have for all consumers, particularly Muslims. Some parties, particularly the pharmaceutical business, continue to oppose to the existence of Law No. 33 of 2014 concerning Halal Product Guarantee. The supply of special facilities, such as rooms, equipment, and human resources, will significantly raise costs, resulting in higher drug prices and a reduction in people's access to the items they truly require for health care. Currently, the pharmaceutical sector must import 95 percent or more of its raw materials, totaling 150,000 items, in order to make about 30,000 different types of pharmaceuticals in the country.

A Comparative Analysis of Cost and Affordability between Veterinary and Human Pharmaceutical Drugs in India

To analyze the comparison of cost and affordability between veterinary and human drugs in India. A comparative study was conducted in two regions of Chennai based on a simple random sampling technique. Both Veterinary and human drugs were collected from private veterinary and Human drug pharmacies. Price and availability data of veterinary medicines and human medicines were collected from private sector retail pharmacies. As per the data analysis, descriptive statistics are used. The comparison of various antibiotic, anti-helminthic, anti-inflammatory, anti-fungal, anti-histamine, anti-tick drug prices used in humans and Animals. The variation of a single unit Amoxicillin drug for veterinary costs Rs.30 whereas in Humans, the same drug costs to Rs.18.6.Cephalexin, ciprofloxacin, Sulfamethoxazole, tetracycline, clindamycin drugs showed a higher cost range in veterinary than in human drugs which had a difference of Rs.9 on average. Doxycycline, Chlorpheniramine, aspirin, Clotrimazole were the only veterinary drug cheaper than their similar human combination. The veterinary drugs are too expensive and we must take certain steps to avoid those high prices. Drug Regulation policies must be implemented for a veterinary drug similar to a human drug. Keywords: Veterinary Drugs, Human Drugs, Price, Affordability.

Markups and Fixed Costs in Generic and Off-Patent Pharmaceutical Markets

There is wide dispersion in pharmaceutical prices across countries with comparable quality standards. Under monopoly, off-patent and generic drug prices are at least four times higher in the United States than in comparable Englishspeaking high income countries. With five or more competitors, off-patent drug prices are similar or lower. Our analysis shows that differential US markups are largely driven by the market power of drug suppliers and not due to wholesale intermediaries or pharmacies. Furthermore, we show that the traditional mechanism of reducing market power – free entry – is limited because implied entry costs are substantially higher in the US.

State Management of the Sphere of Circulation of Medicines in the Context of the COVID-19 Pandemic

This article analyzes the state management of the sphere of circulation of medicines in the Republic of Kazakhstan in the context of the COVID-19 pandemic, and analyzes the reasons for the shortage of medicines in the specified period. The authors conducted a sociological survey, which made it possible to identify the main problems faced by the population during the COVID-19 pandemic. All major players in the pharmaceutical market of the Republic of Kazakhstan are analyzed. The activity of «SK-Pharmacy» during the COVID-19 pandemic was considered, and measures aimed at eliminating ineffective management identified in the work of a single distributor of medicines were analyzed. The measures of the state to reduce prices for essential medicines during a pandemic are considered. Based on domestic and foreign experience, an analysis of external reference pricing for medicines was carried out. The expenditures of the population on health care, including on medicines, were considered. The study resulted in the proposed measures to improve public administration in the sphere of drug circulation in the Republic of Kazakhstan. It is concluded that the state needs to take several measures in the field of drug circulation to prevent a possible shortage of pharmaceuticals and contain drug prices during future pandemics. It is necessary to increase funding for the health care system, including for medicines, without shifting the financial burden on the population and employers. It is necessary to build an effective system of pricing for medicines, which would consider the peculiarities of the global and Kazakhstani pharmaceutical market.

Ethical Perspectives on Costly Drugs and Health Care

High drug prices have created substantial challenges for patients, physicians, health systems, and payers. High drug prices can affect patient care in many ways, including limiting access to treatment, increasing the burden of administrative tasks, and contributing to physician burnout. Exorbitant drug pricing poses direct challenges for distributive justice, which is concerned with fairly distributing benefits and burdens across society. In this position statement, we discuss ethical concerns raised by high drug costs, primarily focusing on concerns around distributive justice. We consider forms of rationing, approaches to allocation, potential complexities in real-life application, and structural forces contributing to high drug costs. Finally, we consider potential policy solutions and ramifications for individual clinicians.