Drug pricing and valuation, particularly in the United States, is becoming an increasingly contentious topic as prices rise and patients and payers struggle to pay for new treatments. Frameworks for assessing the value and fair price of drugs, both for patients and payers, have been the topic of much recent discussion in the United States. We have written extensively on the topic of measuring the value of drugs in the United States and even conducted a webinar on the topic earlier this year. In the last month alone, the American Society for Clinical Oncology (ASCO) published a new version of their value framework and JAMA published two different articles comparing various frameworks and investigating their utility.
Three relatively new U.S. frameworks in particular are drawing a lot of attention, praise, and criticism. The Institute for Clinical and Economic Review (ICER) has developed a framework aimed at informing payers and policymakers and better tying drug prices to value. Two oncology organizations, ASCO and the National Comprehensive Cancer Network (NCCN), have released frameworks aimed at helping patients and physicians work together to compare and select the best treatments based on effectiveness and affordability to the patient. Though they take different approaches, all three hope to solve the same problem: ensuring that patients receive effective, high-quality drugs at a cost, both to patients and payers, that results in a high level of value for the money.
While these value frameworks are relatively new in the United States, many countries have Health Technology Assessment (HTA) agencies that have been conducting detailed effectiveness and cost-effectiveness assessments of drugs for the last decade or more. These agencies, such as the National Institute for Health and Care Excellence (NICE) in the UK, the Federal Joint Committee (G-BA) in Germany, and the Canadian Agency for Drugs and Technologies in Health (CADTH), have been fine-tuning their frameworks and assessment methods for years. They have also published assessments of hundreds of different drugs, producing a great deal of data that could inform the development of other value frameworks.
Context Matters has been collecting and analyzing data from these HTA agencies for years. Based on our extensive experience with these agencies, we are confident that the organizations developing value frameworks in the United States could learn a great deal from the structure of and data generated by HTA agencies in other countries. We’ve assembled a table to compare and contrast three U.S.-based value frameworks (ASCO, NCCN, and ICER) with three HTA agencies (CADTH, G-BA, and NICE).
While there is much to learn by comparing these agencies, we have a few key observations:
- The aims and methods of the U.S. value frameworks are not new: HTA agencies have been pursuing some of the same goals for more than a decade. For example, NICE and CADTH both conduct similar cost-effectiveness analyses to those of ICER, and have been doing so for much longer. More generally, HTAs have been using clinical evidence for decision-making purposes for years and have sophisticated methods for doing so. In spite of their different aims, the HTA agencies’ younger U.S.-based counterparts stand to learn a lot from their methods.
- Some of the key differences between and among U.S. value frameworks and international HTA agencies involve patient involvement. NCCN and ASCO aim to equip patients and physicians with the tools to make their own decisions and to exercise their personal preferences based on their individual circumstances—the frameworks themselves are made to inform patient choice instead of society-level decision making. ICER and the HTA agencies, on the other hand, solicit feedback from patient and professional groups, but ultimately direct their advice toward payers and policymakers. They are less concerned with guaranteeing individual choice than with achieving effective, affordable, and equitable drug access at the population level.
- To understand the new U.S. value frameworks properly, it is essential to understand their intended audience and use. These frameworks have different goals – ICER is focused on providing information to payers and policymakers while NCCN and ASCO aim to provide decision making tools for patients and physicians to use in individual cases.
- While HTA agencies use many similar tools and methodologies, they differ significantly based on the specific needs of their specific healthcare systems. For example, NICE and CADTH both conduct cost-effectiveness analyses while G-BA does not. G-BA and NICE decisions are both legally binding in their respective countries, while CADTH offers non-binding recommendations to federal, provincial, and territorial drug plans.
Many different value frameworks are showing up in the U.S., but it isn’t always clear who is using them or how they are being used. Many HTA agencies are well-integrated in their countries’ healthcare systems, so their decisions and/or recommendations are implemented in a predictable and transparent way. With so many different frameworks in the US representing different stakeholders and lacking a clear and transparent path to implementation, it is difficult to tell how these frameworks are affecting decision making, whose interests they are ultimately serving, and whether they are resulting in greater value in the US system. This is not likely to change until one or more of these frameworks takes on a more formal role in the US healthcare system, either through legal mandate or large-scale industry buy-in.
Furthermore, the emergence of frameworks intended for use by patients and physicians indicates serious policy-level problems in American healthcare spending. Should patients be put in the position of trying to understand clinical trial results well enough to make tremendously important decisions about their health and finances? Do these frameworks empower patients to make their own decisions? Or do they indicate that patients are currently being saddled with a decision-making burden they are ill-equipped to handle, especially in times of extreme physical, emotional, and financial stress?
We still lack a unified language to talk about value in the US. We lack any formal, integrated review process. We lack transparency. Only when these issues reach some form of resolution will we be able to make meaningful observations about the performance of these frameworks and determine if they are providing some value.