Value assessment in oncology is an emerging area of interest. Multiple value frameworks have been launched in the past 5 years to help stakeholders analyze the cost-effectiveness, or affordability, of oncology treatments. However, the influx of new oncology drugs and changes to practice guidelines threaten to make value frameworks obsolete or in need of significant updating. In this article, we explore how four different frameworks—the Drug Abacus, the American Society of Clinical Oncology (ASCO) Value Framework, the National Comprehensive Cancer Network® (NCCN) Evidence Blocks™, and the Institute for Clinical and Economic Review (ICER) Value Assessment Framework—have evolved over time and the role they play in oncology value assessment.
The year 2018 was a banner year for new oncolytics, with 19 new agents gaining Food and Drug Administration (FDA) approval and many more primed for approval.1 According to IQVIA, there are nearly 850 new oncolytics in the pipeline that have advanced to at least phase 2.2 Innovation comes at a cost, however, with the median price of a new oncology agent released in 2017 coming in at $160,000.3 Rising drug costs are fueling debate around drug value and how to better align a product’s price with the value the product provides. The United States has only recently begun to critically assess the cost-effectiveness of products in the oncology space, a practice already utilized in other parts of the world. The question is: can the tools we use to measure value keep up with the pace that oncology is advancing?
In 2015, the Drug Abacus, one of the first oncology value frameworks, was launched. Created by Peter B Bach, MD, MAPP, at Memorial Sloan Kettering, the Drug Abacus allowed users to manipulate different variables to come to an “abacus price” to compare with the list price.4 Other value frameworks soon followed. ASCO released its Value Framework in 2015 as a way to educate oncologists on the net health benefit between two regimens and the associated difference in cost to achieve that benefit.5 The NCCN joined the fray in October 2015 by adding “evidence blocks” to its influential treatment guidelines.6 These evidence blocks allowed users to compare “affordability” with different cancer drugs using a simple schematic.
Lastly, ICER, founded in 2006, began gaining notoriety due to its in-depth reviews of drug classes, such as PCSK9. ICER has since conducted numerous analyses in oncology, including lung cancer, multiple myeloma, and ovarian cancer.7 ICER analyses assign medications cost-effective benchmark prices that align to quality-adjusted life-year gains. The tools were welcomed by many as a way to bridge the gap between the cost and value of oncology treatments. Their utility, of course, would depend on the tools staying up-to-date, a goal these tools have had varying success achieving.
Drug Abacus
The Drug Abacus was one of the first tools that allowed users to generate a recommended price based on an oncolytic’s evidence and compare it to the list price. When the Drug Abacus launched in 2015, it claimed to cover drugs launched since 2001 and included approximately 50 medications.8 Fast forward to 2019: the Drug Abacus has not changed much in scope or content and has not added newer products.9 For example, the four newest checkpoint inhibitors are missing, as are two of the three CDK 4/6 inhibitors. Poly ADP ribose polymerase (PARP) inhibitors, a groundbreaking class in several difficult-to-treat cancers, are absent as well. In addition, since the Drug Abacus comparison is based on the initial approval indication for each product, the tool may not be capturing the value of subsequent clinical evidence. This is particularly an issue for classes like checkpoint inhibitors where initial products have gone from a single indication to several in the last 4 years. The Drug Abacus not being updated may be intentional, satisfied to be a pioneer in a trend of generating value prices based on evidence. However, without updates, it may end up as a historical footnote.
ASCO Value Framework
By design, the ASCO Value Framework aims to avoid the common problem of obsolescence. The tool allows users to conduct an assessment on clinical trials involving two competing regimens, negating the need to constantly update. ASCO has also made important changes since the framework was introduced; in 2016, the net health benefit metric was modified to include hazard ratios and all adverse events associated with a regimen.5 This update was also done with the aim to have the framework serve as a software tool for oncologists comparing the net health benefit and cost differences of different regimens. As the Oncology Care Model and other alternative payment models begin to take hold in oncology, the ASCO Value Framework appears poised to play an important role in helping providers make cost-effective choices.
NCCN Evidence Blocks
NCCN Evidence Blocks first appeared in NCCN Guidelines for chronic myeloid leukemia and multiple myeloma.10 NCCN’s goal to incorporate Evidence Blocks into all of its guidelines by the end of 2016 appears to have been largely achieved. Scrolling through the NCCN Guidelines, one will find that nearly all now have a link to a version that includes the Evidence Blocks. In terms of methodology and information conveyed, the Evidence Blocks have evolved little. The measure of affordability may be useful in circumstances where brand drugs compete with generics or possibly biosimilars. However, for disease states dominated by recently released brand products, the affordability feature provides minimal comparative value since all the treatments generally score the same. The NCCN Evidence Blocks have kept pace with the oncology market in terms of updates but may need to provide more in-depth information in the future to stay relevant in the value-driven marketplace.
ICER Value Assessments
ICER has achieved the most notoriety over the last few years. The methodology and process of its assessments have undergone numerous updates to include more metrics, including quality of life and other refinements.11 ICER has also revisited prior analyses in categories like psoriasis to conduct updates when new therapies are released.12 ICER provides open comment periods on the analyses they conduct, with opportunities for feedback both before and after draft reports are made public. ICER panels are diverse and include payer, manufacturer, and third-party stakeholders. The overall approach results in reports that are complex but also applicable to the changing health care landscape.
ICER’s partnership with the US Department of Veteran Affairs and the use of ICER benchmarks in a CVS program on drug exclusions are examples of how ICER has evolved and grown in influence.13,14 ICER’s biggest challenge will be staying current and identifying the drug products where an analysis is most desired. In the oncology space, ICER has conducted analyses on only a handful of therapeutic categories, and many of these reports have not been updated. To keep pace, ICER may need to expand or explore ways to make analyses simpler and faster.
Valuation Outside Oncology
The frameworks described here, with the exception of ICER, are focused on oncology. Health care stakeholders may ask why more value frameworks have not been launched in other disease categories such as inflammatory diseases or diabetes; the answers are complex and varied. For one, in competitive categories like diabetes, the list price of products and the net price actually paid may be far apart due to rebates and discounts to payers. In addition, the growth and brand-centric nature of the oncology market make it an ideal target for ongoing value assessment compared with categories with fewer launches and more generics. Determining the value of endpoints in other disease states may present a further challenge. Nonetheless, as the US marketplace advances to a value-based model, it is likely that tools to assess value in nononcology categories will come to fruition.
Conclusion
The staggering pace of change in oncology therapeutics is a challenge for stakeholders interested in assessing value. As discussed here, even a few years’ time is enough to make a value assessment tool obsolete without regular updates. An optimal approach for assessing value in oncology and other disease therapies may be theorized by taking lessons from all these tools. Frameworks should be informative, focus on emerging issues of importance, and allow stakeholders to compare regimens. The cost of new technologies will necessitate assessing value in an accurate and timely way. The hope is that how we assess therapies can keep up.
References
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