Factors Contributing to the Rising National Cost of Glucose-Lowering Medicines for Diabetes During 2005-2007 and 2015-2017.

OBJECTIVE: We examined changes in glucose-lowering medication spending and quantified the magnitude of factors that are contributing to these changes. RESEARCH DESIGN AND METHODS: Using the Medical Expenditure Panel Survey, we estimated the change in spending on glucose-lowering medications during 2005-2007 and 2015-2017 among adults aged ≥18 years with diabetes. We decomposed the increase in total spending by medication groups: for insulin, by human and analog; and for noninsulin, by metformin, older, newer, and combination medications. For each group, we quantified the contributions by the number of users and cost-per-user. Costs were in 2017 U.S. dollars. RESULTS: National spending on glucose-lowering medications increased by $40.6 billion (240%), of which insulin and noninsulin medications contributed $28.6 billion (169%) and $12.0 billion (71%), respectively. For insulin, the increase was mainly associated with higher expenditures from analogs (156%). For noninsulin, the increase was a net effect of higher cost for newer medications (+88%) and decreased cost for older medications (-34%). Most of the increase in insulin spending came from the increase in cost-per-user. However, the increase in the number of users contributed more than cost-per-user in the rise of most noninsulin groups. CONCLUSIONS: The increase in national spending on glucose-lowering medications during the past decade was mostly associated with the increased costs for insulin, analogs in particular, and newer noninsulin medicines, and cost-per-user had a larger effect than the number of users. Understanding the factors contributing to the increase helps identify ways to curb the growth in costs.

Reflections on the Formulary System from 1997 to the Present.

DISCLOSURES: No funding was received for the writing of this reflection. Avey is a member of the AMCP Foundation and has recently retired from MedImpact Health Systems, where he served as Vice President of Specialty Clinical Solutions.

By the numbers: global oncology drug spending, 2010-2014.

Global spending on oncology drugs hit $100 billion in 2014, an increase of 10.3% over 2013. The United States accounts for 42.2% of total spending.

Medicines produced in Telsiai pharmacy (Vilnius governorate): analysis of prescription book from 1830.

The Museum of the History of Lithuanian Medicine and Pharmacy has a prescription book by a pharmacist Teodor. Geldner from Telsiai (the tsarist Russia's Lithuanian Vilnius Governorate), dated 1830. Each medication that was produced at the pharmacy had to be registered in this book. The entries included the composition of the drug, its form, usage, price, the physician's name, and (sometimes) the method of production. This paper presents the content analysis of this book. The study revealed which medicines were used for the treatment of patients back then, which principles of therapy predominated, and what the social status of the patients was.

The market dynamics of generic medicines in the private sector of 19 low and middle income countries between 2001 and 2011: a descriptive time series analysis.

This observational study investigates the private sector, retail pharmaceutical market of 19 low and middle income countries (LMICs) in Latin America, Asia and the Middle East/South Africa analyzing the relationships between volume market share of generic and originator medicines over a time series from 2001 to 2011. Over 5000 individual pharmaceutical substances were divided into generic (unbranded generic, branded generic medicines) and originator categories for each country, including the United States as a comparator. In 9 selected LMICs, the market share of those originator substances with the largest decrease over time was compared to the market share of their counterpart generic versions. Generic medicines (branded generic plus unbranded generic) represent between 70 and 80% of market share in the private sector of these LMICs which exceeds that of most European countries. Branded generic medicine market share is higher than that of unbranded generics in all three regions and this is in contrast to the U.S. Although switching from an originator to its generic counterpart can save money, this narrative in reality is complex at the level of individual medicines. In some countries, the market behavior of some originator medicines that showed the most temporal decrease, showed switching to their generic counterpart. In other countries such as in the Middle East/South Africa and Asia, the loss of these originators was not accompanied by any change at all in market share of the equivalent generic version. For those countries with a significant increase in generic medicines market share and/or with evidence of comprehensive "switching" to generic versions, notably in Latin America, it would be worthwhile to establish cause-effect relationships between pharmaceutical policies and uptake of generic medicines. The absence of change in the generic medicines market share in other countries suggests that, at a minimum, generic medicines have not been strongly promoted.

How phenobarbital revolutionized epilepsy therapy: the story of phenobarbital therapy in epilepsy in the last 100 years.

Phenobarbital (phenobarbitone) was first used as an antiepileptic drug 100 years ago, in 1912. This article tells the story of the discovery of its antiepileptic action, its early development, and the subsequent course of its clinical use over the 100-year period. The side effects, pharmacokinetics, and misuse of barbiturates are considered, along with the more recent clinical trials and the drug's current clinical utilization. The introduction of controlled drug regulations, the comparative cost of phenobarbital, and its inclusion on the World Health Organization (WHO) essential drug list are discussed. It is one of the few drugs on the formulary in 1912 that is still listed today, and remarkably its efficacy in epilepsy has not been significantly bettered. The current recommendation by the WHO is that phenobarbital should be offered as the first option for therapy for convulsive epilepsy in adults and children if availability can be ensured. This is rated as a strong recommendation because of the proven efficacy and low cost of phenobarbital, and despite its perceived side-effect profile and the practical problems of access. Whether this recommendation puts "a hierarchy on the brain," as has been suggested, is arguable. Much still needs to be learned about the drug's effects, and the issues raised by phenobarbital have lessons for all antiepileptic drug therapy.

Pharmaceutical high profits: the value of R&D, or oligopolistic rents?

Pharmaceutical firms attribute high prices and high profits to costs associated with researching and developing the next generation of life-saving drugs. Using data from annual reports, this article tests the validity of this claim. We find that while pharmaceutical firms do invest in R&D, they also enjoy strong rents; between 1988 and 2009, pharmaceuticals enjoyed profits of 3 to 37 times the all-industry average, depending on the years, while investing proportionately less in R&D than other high-R&D firms. Costs of pharmaceutical drugs have successfully flown below the radar in much of the current health care debate, with producers managing to obstruct alternative sourcing as well as payment cuts. While health care is examined for savings in other areas, sustained high pharmaceutical profits suggest that as a new health care policy develops in the U.S., the pharmaceutical industry should not be excluded from examination for significant savings in health care costs.

A global subsidy: key to affordable drugs for malaria?

The global fight against malaria has been continually challenged by poor access to affordable, effective medicine. Growing resistance to chloroquine, the traditional treatment, has worsened the situation. Artemisinins, the successor therapy to chloroquine, are at least ten times more costly than the older drug. In developing countries, most malaria medicines are purchased in the private sector, where traditional aid mechanisms do not reach. So a new aid approach was needed. The Affordable Medicines Facility-malaria (AMFm) will efficiently supply publicly subsidized drugs to meet public- and private-sector demand in malaria-endemic countries. If artemisinins are priced more competitively, resistance to them will be delayed.

"Who's winning the human race?"Cold war as pharmaceutical political strategy.

Between 1959 and 1962, Senator Estes Kefauver led a congressional investigation into the pricing practices of U.S. drug firms. As part of its defense, the industry mobilized the rhetoric of cold war and promoted the industry as a critical national asset in the global war against communism. The industry argued that any effort to undermine corporate innovation by inviting, as Kefauver proposed, greater government involvement in drug development threatened the public's health and invited socialism-in the form of socialized medicine-into the domestic political economy. This strategy proved critical to the industry's efforts to build political support for itself, particularly among the medical profession, and undermine Kefauver's reform agenda.

"Couldn't live without it": diabetes, the costs of innovation and the price of insulin in Canada, 1922-1984.

This article traces insulin prices in Canada from 1922, just after its discovery at the University of Toronto, to 1984 when production fell out of Canadian control. Connaught Laboratories (part of the University of Toronto from 1914 to 1972) was the first to manufacture insulin and remained the sole Canadian producer. As a public trust, Connaught remained committed to providing insulin at the lowest possible price despite increasing economic pressures. This article analyzes the context surrounding the price of insulin preparations and how they fell from 1922 to 1942, remained unchanged until 1967, and rose during the 1970s.

Economic manifestations of opiate addiction: evidence from historical data from colonial Indonesia.

The aim of this paper is to demonstrate, using an example, the utility of historical data to illuminate important questions in the field of drug dependence research. The literature on the consumption of addictive substances often characterizes users as being one of two types: "addicts" and "casual users." An econometric characterization of the responses of opium consumers in the late-colonial Netherlands Indies to changes in the price of opium and other important variables is provided, which explicitly acknowledges the existence of different types of opium smokers, as modeled in the underlying theory. The results reveal systematic differences between the behavior of groups of high-intensity consumers and groups of low-intensity consumers. While the findings show that both groups showed similar total price elasticities, the high-intensity consumers were affected predominantly via changes in the number of users rather than in per capita consumption. In the course of the analysis, various analytic methods that are new to the field of drug dependence research are introduced.

Assessment of the pharmaceutical market in Poland after accession to the European Union.

The Republic of Poland joined the European Union (EU) on 1 May 2004. The EU accession brought new opportunities to the Polish health care system and the pharmaceutical market. However, there are still barriers to overcome such as bureaucracy, lack of transparency in pricing and reimbursement, decision-making processes, the short period of data exclusivity, respect for intellectual property rights, favorisation of local companies and low health care investment. Additionally, drug costs outpace overall economic development, a trend which is universally valid for almost all EU countries and which forms one of the most serious factors in health care expenditure. A systematic cost-effective assessment, the so-called fourth hurdle (after quality, efficacy and safety), of prescription drugs seems a necessity in most EU countries. The Polish Ministry of Health has defined aims for the future health care system in the National Drug Policy 2004-2008, including health economical criteria and instruments. However, it is to be expected that for some time there will be more a reimbursement hurdle instead of a fourth hurdle in controlling drug expenditure. This review focuses on the Polish pharmaceutical market with special consideration of the history of the Polish health care system. It will highlight the present situation of the Polish health care system after EU accession and provide an outlook to its possible future.

The Trading with the Enemy Act of 1917 and synthetic drugs: relieving scarcity, controlling prices, and establishing pre-market licensing controls.

The "Trading with the Enemy Act" (TWEA) was enacted in October 1917 after America's entry into World War I and during a period of wartime scarcity and rising prices of synthetic drugs and dyestuffs that began in 1914. It was described as "An Act to define, regulate, and punish trading with the enemy, and for other purposes." The act and subsequent executive orders authorized an "Alien Property Custodian" to take control of all enemy property within the United States. Also, The Federal Trade Commission (FTC) was authorized to issue licenses for the use of enemy owned patents, which covered a range of industrial and consumer products. Significantly, the FTC was given the power to set the conditions for use of the patents and to fix the price for those products necessary for health. The effect of these measures was to bring federal pre-marketing control over the production, testing, and pricing of the most therapeutically significant synthetic drugs of the day. Enactment of the TWEA and the events preceding and surrounding it are significant parts of the history of the American pharmaceutical industry and federal regulation.