Biopharmaceutical companies both big and small have witnessed the shift toward patient-centric practices in the current healthcare landscape. As a result, many are now including or planning to incorporate the voice of the patient in their drug development strategy.
How do clinical research organizations (CROs) respond and support this increasing focus on patient-centric practices? We recently spoke to Jonathan Zung, PhD, group president, clinical development and commercialization services at Covance to understand his view on the patient centricity imperative and how it impacts clinical development activities.
Covance is proud to announce that Xcellerate® Trial Design has been selected as the winner of the Fierce Innovation Awards: Life Sciences Edition in the Data Analytics/Business Intelligence category. The Fierce Innovation Awards: Life Sciences Edition recognizes outstanding innovations that are driving improvements and transforming the life sciences industry. Xcellerate Trial Design was recognized for its innovative approach to improving site selection, forecasting resource demand and optimizing of clinical trial design. Continue reading
The abuse of prescription medications is reaching epidemic proportions worldwide. Some judge prescription drug abuse to be as prevalent and as deadly as an epidemic caused by an infectious agent. Consider recent news reports about an HIV outbreak in a rural Indiana town that resulted from widespread addiction to a prescription painkiller.
The tragedy of Austin, Indiana is the tip of the iceberg. Prescription drug abuse is responsible for 16,000 deaths annually in the United States, a number that’s rising steadily. Meanwhile, 52 million people over age 12 in the US — nearly 1 in 6 — have misused prescription drugs, 6 million of them in the past month alone. Continue reading
Makers of dietary supplements are keeping a close eye on New York after several major retailers were recently accused of selling mislabeled store-branded herbal supplements.
The allegations came after testing initiated by the state’s Attorney General’s office found that supplements, such as ginseng and echinacea, apparently did not contain the labeled ingredients. Although dietary supplements do not have to be approved by the U.S. Food and Drug Administration (FDA) before being sold to consumers, they must be labeled correctly and safe for consumption. They also must, according to current good manufacturing practice, be tested using scientifically valid methods–in other words, “accurate, precise, and specific for its intended purpose.”1
The pharmaceutical, medical device and diagnostics industries are very interested in the changing market access landscape in South and East Asia because of the vast commercial potential of this area. This region has a large proportion of the world’s population (~60%), a 2011 gross domestic product (GDP) growth that is almost triple the average of Europe and North America, and a huge opportunity for improvements in healthcare.
Market access requirements
Current market access requirements vary considerably among the countries in South and East Asia. Many of them – including China and India – do not have any formal comparative effectiveness or health economic criteria for national pricing and reimbursement submissions. Health economics generally plays a minor role in their decision-making. Continue reading
Current trends in health technology assessment (HTA) indicate a shift away from the use of cost-effectiveness to value-related measures. A suite of analysis methods, collectively referred to as “risk-benefit analysis”, can be used to address these requirements. Of these, multi-criteria decision analysis (MCDA) is considered a leading candidate for practical application in HTA.
Limitations of cost-effectiveness analyses
The quality-adjusted life-year (QALY), frequently used in cost-effectiveness analyses and once the gold-standard outcome measure for economic evaluation in healthcare, is coming under heavier criticism than ever before. While appropriate in certain situations, the instruments used to generate QALYs have been shown to lack the required sensitivity to capture all benefits of interventions in some therapy areas, including hearing loss and schizophrenia. Continue reading
Geographic price disparity between pharmaceutical products exists due to the variation in national economies and the unique ways that each country determines the price of pharmaceuticals. Price disparity still exists even in areas of “free trade” or in a single combined market of multiple countries, such as the European Union. This has led to parallel trade, where products are purchased in countries with lower prices and sold in those with higher prices. The fact that such disparities can develop seems contrary to the concept of a simple, free market, and it raises the question of whether price disparity will ever truly disappear.
The principle of free trade and tariff-free access to economic goods across borders is a founding principle of the EU and other regional trade agreements. Therefore, the continued existence of legal parallel trade combined with international referencing could lead to the end of price disparity, with prices converging to an average regional price. Continue reading
A new data set has been published that paints a clear picture of who gained insurance coverage during the 2014 open enrollment period, which ended on April 15, 2014. Recently featured in the New York Times, the data come from Enroll America, a non-profit organization focused on enrolling Americans in health insurance plans, and Civis Analytics, a data analysis firm.
This data set provides insight into the 10 million previously uninsured individuals who now have health insurance. Overall, these newly-insured people reduced the national uninsured rate for adults under the age of 65 from 16.3% in 2013 to 11.4% in 2014.
The lasting image of the initial health exchange roll out is that of persistent technical problems that plagued the federal government’s insurance exchange website Healthcare.gov. At the start of the 2014 open enrollment period in October 2013, the online marketplace for federally-facilitated insurance exchanges was overwhelmed with a volume of potential customers the website was not designed to handle. A handful of state-based exchanges (e.g., Maryland, Massachusetts and Nevada) also witnessed technical glitches that hampered the enrollment process for countless applicants. It took months to fully correct these technical issues, but at the end of the open enrollment period, an estimated 7.3 million people had enrolled in an exchange nationwide. This final tally, released by Politico, is comprised of the 8 million people who signed up in the regular enrollment period less those who did not pay their premiums in time or dropped out of the exchanges for some reason. An additional 6.7 million people also enrolled in Medicaid during the open enrollment period. Continue reading
US health care is exponentially more complicated today than just 5 years ago. Even the most competent, experienced marketing teams may not anticipate or clearly understand the complex forces that are changing how we select, dispense, and reimburse for drugs and devices.
Changes in Traditional Customers
Pharmacy Benefit Managers (PBM) are your primary contracting conduit into commercial and Medicare Part D plans to assure formulary market access. The FTC approved the $29.1 billion ESI-Medco merger, further consolidating the PBM group. If your new product is not granted preferential access on a national PBM, you may be losing access to 70 million patients. Continue reading