As biosimilars to treat rheumatic diseases begin get approval from the FDA, biosimilar development remains a hot topic in drug development. Sponsors estimate a 35% growth of biosimilars in their development pipelines by 2020, but face a wide variety of regional and global markets along with shifting guidelines and recommendations, stressing the need to understand this rapidly changing landscape. What is the real potential for clinical and health-economic benefits offered by these agents? Continue reading
Our industry is witnessing increasing growth in the rare disease market, thanks to financial and regulatory incentives to develop orphan drugs. This has been good news for both sponsors and patients, but the fact remains that rare disease trials are inherently challenging to run. In addition, completing a complex study and reaching regulatory approval does not necessarily translate to market success.
John D. McDermott, Jr., Vice President of Covance Market Access Services, recently shared his insights on the market access challenges in rare disease drug development and discussed key considerations for sponsors and stakeholders.
Provide early education about the disease
Even though rare diseases as a whole are getting more attention, sponsors cannot assume that their potential payers know much about the particular condition they are targeting and its importance to patients. Continue reading
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
With the implementation of the FDA’s abbreviated biosimilar approval pathway, biosimilars have become one of the fastest-growing categories in the biopharmaceutical sector. While these lower-priced alternatives will offer value in terms of cost savings, many stakeholders have voiced concerns over switching to biosimilar products.
Three main stakeholders of market access will determine the commercial success of biosimilars: payors, providers, and patients.
Despite potential cost savings, many payors may be reluctant to aggressively steer utilization toward these agents until they have compelling data to demonstrate safety and efficacy profiles comparable to those of innovator products. Continue reading
Communications During Drug Development
Helping physicians and patients get access to new drugs and medical devices requires more than showing that a product works. In this article, we focus on the hurdles that the biopharmaceutical industry faces. Similar challenges face the medical device industry; however, as they say, the devil is in the details.
Typically, the first hurdles facing the biopharmaceutical industry are demonstrating that the product is safe and effective and that it can be consistently and reliably manufactured. However, a successful product launch also requires surmounting the hurdles of reimbursement and commercialization. Continue reading