ICER In Healthcare

Americans have access to and benefit from one of the most technologically advanced pharmaceutical systems in the world. However, this system is also very strict and tedious. The system this paper will evaluate is the United States Food and Drug Administration (FDA), more specifically, the FDA’s Center for Drug Evaluation and Research (CDER). Although, having access to this system can be frustrating to those that are in the pharmaceutical development industry or those that have illnesses and need the best drugs available in order to cope with their symptoms.

There are multiple health concerns worldwide and more and more drugs are needed every day. Many drugs however, are extremely expensive to develop, test, and produce. According to the Tufts Center for the Study of Drug Development (2002), it costs up to $802 million to bring a new drug to the market. In 2002, pharmaceutical companies spent $34 billion in research and development (Center-Watch, 2003). In addition to the costs, the overall time from the discovery to approve and market the drug can take up to 15 years.

FDA’s Center for Drug Evaluation and Research (CDER) works to ensure that the drugs release in the market are safe to be used by general public. They evaluate prescription as well as non-prescription drugs for their safety effectiveness and quality. They review the drug before being marketed to improve overall health

Improvements in health care and life sciences are an important source of gains in health and longevity globally. The development of innovative pharmaceutical products plays a critical role in ensuring these continued gains. To encourage the continued development of new drugs, economic incentives are essential. These incentives are principally provided through direct and indirect government funding, intellectual property laws, and other policies that favor innovation. Without such incentives, private corporations, which bring to market the vast majority of new drugs, would be less able to assume the risks and costs necessary to continue their research and development (R&D). In the United States, government action has focused on creating the environment that would best encourage further innovation and yield a constant flow of new and innovative medicines to the market. The goal has been to ensure that consumers would benefit both from technological breakthroughs and the competition that further innovation generates. The United States also relies on a strong generic pharmaceutical industry to create added competitive pressure to lower drug prices. Recent action by the Administration and Congress has accelerated the flow of generic medicines to the market for precisely that reason. By contrast, in the Organization for Economic Cooperation and

1 Kaiser Family Foundation Report on the Uninsured. Available at http://www.kff.org/uninsured/7451.cfm. 2 Danzon, P., et al. “The Impact of Price Regulation on the Launch Delay of New Drugs.” Health Economics, 2005; 14(3): 269-292. Available at http://hc.wharton.upenn.edu/danzon/html/Journal_Articles.htm. 3 The Boston Consulting Group. “Ensuring Cost Effective Access to Innovative Pharmaceuticals – Do Market Interventions Work?” April, 1999. Available at http://www.bcg.com/impact_expertise/publications/files/Ensuring_Cost_Effective_Access_Innovative_Pharmaceuticals_Apr1999.pdf 4 Thorpe, K. et al. “Differences in Disease Prevalence as a Source of the U.S.–European Health Care Spending Gap.” Health Affairs (Web Exclusive) Oct. 2, 2007. Available at www.healthaffairs.org.

The organization’s purpose states that it harmonizes the scientific approach of its products and services. They have also increased the production of its health technology assessments (HTAs) and rapid reviews. On the customer side, the organization has invited patient engagement, and welcomed the pan-Canadian Oncology Drug Review - one of their major key initiatives - to the organization. Their work is one of

Morgan, S. G., & Daw, J. R. (2012, August). Canadian pharmacare: Looking back, looking forward. Healthcare Policy, 8(1), 14–16. Retrieved from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3430151/

The time frame and cost to release a drug for sale into the United States market is enormous. After nearly 20 years and about one billion dollars spent, a drug manufacture can begin to market its product to consumers (Philipson & Sun, 2008). The reason behind these huge numbers is the drug approval process mandated by the Food and Drug Administration. Understanding the testing process will explain the long time frame and huge costs associated with drug approval.

A highly motivated and dedicated analyst with over two years’ experience in start-up Research Office at Huron Consulting Group. Working on developing Medicare Coverage Analysis (MCA) and study budgets for clinical research protocols in various therapeutic areas such as oncology, cardiology, pediatrics, and internal medicine for multiple clients across the country. A meticulous eye for detail in assisting clients with mitigating clinical research billing compliance risks, by interpreting and applying Medicare/Medicaid coverage decisions and national care guidelines to determine correct billing to insurance providers and research study sponsors. A confident communicator with an emphasis on utilizing the strengths of colleagues and creating an

Anyone who has purchased prescription medications has probably wondered why they cost so much, and rightfully so. Medication prices in the United States have been on a steady increase for decades, however, prices have been drastically increasing as of recent. Pharmaceutical companies have tried to justify these price increases due to the demand, the high cost of research, and the high costs of development and approval. Notwithstanding, the extent to which the prices have increased is not justifiable. Americans should be against these high medication prices and take action because pharmaceutical companies are taking advantage of our healthcare system in order to capitalize from the sick. In order shed some light on this issue, the magnitude, scope, and consequences of these prices must be examined.

The organization’s purpose outlines that it harmonizes the scientific approach of its products and services, increased production of its HTAs and rapid reviews, invited patient engagement, and welcomed the pan-Canadian Oncology Drug Review to the organization. Their work is one of their world’s leading health technology assessment (HTA) organizations and essential contributor to evidence-informed decision-making in Canada.

Prescription drug prices are on the rise in the United States. Currently, the United States does not implement a price control on prescription drugs. Every day the supply and demand for prescription drugs fluctuates. Pharmaceutical companies produce drugs that are necessary for survival. Therefore, it is necessary for research and development to continue in the United States. Those suffering the effects of exorbitant prices must do so until a generic form of a prescription drug is produced. Once approved by the FDA, new drugs will make their appearance on the market and patients will no longer suffer financially. Until then, it is necessary for pharmaceutical companies to price their drugs based on the idea of supply and demand. This produces the profit used to fund research. Price controls discourage innovation. If a price control were set in place, of course the price of prescription drugs would decrease. However, the development of new drugs decreases with it. Today’s generation would benefit from lower prices, while future generations would suffer from the loss of drug innovation.

U. S. citizens pay the highest prescription drug prices in the world. This is an injustice that must be corrected. The "U.S. forbids the import of prescription drugs by anyone other than the original U.S. manufacturer, and even then only when the drugs meet all the approval requirements of the U.S. Food and Drug Administration (FDA)" (Barlett & Steele, 2004). Prescription drug prices are outrageously high in the United States because of the influence of advertising on consumer purchasing, the misleading statements by pharmaceutical companies about the cost of research and development of new drugs, the manipulation of patent laws, the antiquated laws regarding importation of

Recently, there has been a debate about the high prescription drug prices in the United States. Accounting for 9.7% of the national health expenditure, $329.2 billion was spent on prescription medications ($931 per person) in 2011 (Linton, 2014). So what exactly is the average American getting with their $931? Well, because there is an extraordinary amount of time, effort, and energy that goes into creating, manufacturing, and distributing a new drug, it’s no wonder the prices are so high. But what other costs are folded into the prices of your prescribed medications? This review looks beyond just the research and development costs needed to take a new drug from idea to shelf by examining several journals and other credible, secondary sources, to shed some light on how much pharmaceutical companies are spending to develop, advertise, and sell their drugs.

Drug prices are set by pharmaceutical companies to cover research and development costs. While R&D costs clearly need to be covered, markets in developed countries already pay for most R&D of new products. Because of this, it makes moral and economical sense to establish a two-tiered pricing system; for R&D costs to be paid for by developed countries, allowing significantly reduced prices to be charged in developing countries.