Healthcare costs, specifically those related to prescription drugs, are a major election issue for many Americans. According to the August 2016 Kaiser Health Tracking Poll, two-thirds of Americans say Medicare access and healthcare affordability are top election issues, and 53 percent of voters say that prescription drug costs in particular are top priorities. Many of the efforts to address these issues concern the use of comparative efficacy and cost-effectiveness research. These forms of research, widely used integrated in the healthcare systems of many countries in Europe and elsewhere, are only recently gaining traction in the United States. Policy efforts and election outcomes could have a major impact on how these forms of research are used in the future.
Using data from the Context Matters Market Access Platform (MAP), the GetReal team analyzed mentioned uncertainties in regulatory and reimbursement assessments and evaluated when RWE could be included in the drug development process to reduce these uncertainties.
The recent and frequent outcry over expensive drugs has made evident the gap in the United States’ healthcare system. While no perfect system exists, other countries have health technology assessment (HTA) agencies to evaluate efficacy and/or cost-effectiveness and inform reimbursement decisions.
What might the U.S. learn from countries like England, Germany, and France in structuring a methodology for evaluating drugs?
When the New York Times recently published an article, "For Big Data Scientists 'Janitor Work' Is Key Hurdle to Insights" it struck a chord with us. Context Matters is not a "Big Data" company, but in the process of curating and standardizing disparate sources of drug development data, we confront many of the same issues and challenges.
There has been a lot of discussion about the high price of Gilead's Hepatitis C drug Sovaldi, and a variety of strong opinions expressed. But are agencies around the world asking the right questions when evaluating its cost-effectiveness?
Peter Pitts is a member of our Advisory Board and the President of the Center for Medicine in the Public Interest. He is also a former FDA Associate Commissioner, advisor to the Obama administration and currently serves as an Associate Editor of the DIA journal, Therapeutic Innovation & Regulatory Science. His work has been published in New York Times, The Washington Post, Wall Street Journal, and The Economist. Peter also has a fantastic blog drugwonks.com, so if you’re not already a reader, you should definitely check it out! In part One of our interview with Peter, he spoke about a variety of topics including his take on the FDA’s expedited review program, comparing the approaches taken by the FDA and the EMA (European Medicines Agency), and his overall impression of the current state of drug development.
On June 17th we attended the HTAi conference in Washington, DC. At the conference we presented research on three topics, including one that was a collaboration with PhRMA (The Pharmaceutical Research and Manufacturers of America). Our collaboration focused on clinical variability across Heath Technology Agencies (HTAs), and highlighted some of the challenges for countries that may be considering utilizing technology assessment as a budgetary tool, but which may have consequences on patient access to important medicines. We examined trends in global HTA, with a specific focus on established global HTA models that are often referenced in U.S. policy conversations regarding access and reimbursement. To that end, we paid particular attention to The United Kingdom’s (UK) National Institute for Health and Care Excellence (NICE), given their high level of activity and amplified presence in global HTA.