ASCO released Value Framework 2.0 yesterday. The article “Updating the American Society of Clinical Oncology Value Framework: Revisions and Reflections in Response to Comments Received” published in the Journal of Clinical Oncology makes two changes in how it values medicines.
First, it uses the hazard ratio – that is the “chance of events occurring in the treatment arm as a ratio of the hazard of the events occurring in the control arm. “ – as a measure of benefit. In other words, the ASCO framework, replaces absolute increases in benefit with one that measures the probability of benefit as the standard measure
This is a direct slap in the face to Peter Bach’s Abacus and ICER both of which measures increases in overall survival without regard to how bad a prognosis is.
Also ASCO notes: because an HR expresses a relative difference in risk, a similar HR could be derived for a modest improvement in survival that is measured in weeks or months for a tumor type with a poor prognosis or for a larger absolute gain that is produced by a highly effective therapy in a tumor type more amenable to treatment.
Third, whereas the first framework devalued progression free survival, in the revision “bonus points are awarded if the test regimen results in at least a 50% relative improvement in percentage of patients alive at a time point that is at twice the median OS or PFS point for the control regimen and if at least 20% of patients receiving the control regimen are alive at this time.”
This is likely a bar bit too high, but at least the revision framework recognizes that a month of additional average OS or PFS that is a 50 percent increase and affects 20 percent of patients is meaningful to patients. Again, neither the Abacus or ICER has this feature.
Further, the framework authors no longer publicly single out cancer drugs as the thing that will destroy the American economy. And it goes to great lengths to distance themselves from earlier goals of making the framework the tool insurers and PBMs will use to decide which drugs to cover.
In the 2015 version, the Task Force asserted:
“ASCO recognizes that this work has the potential to influence policymakers and payers as they consider preferred management options and evaluate the relative value of new treatments introduced into the cancer marketplace…As policymakers and payers seek ways to assure the best use of limited resources, they are appropriately turning to physician experts for a better understanding—and definition—of value. ASCO has dedicated significant volunteer time and resources to the issue of cost and has now turned its attention to a formal definition of and strategy for assessing value in cancer care.
…Benefit structures, adjustment of insurance premiums, and implementation of clinical pathways and administrative controls have all been employed as means of controlling cost while emphasizing value. It is in this arena that the ASCO Value in Cancer Care Task Force seeks to contribute to the effort to ensure value for patients while preserving and enhancing quality and sustaining innovation developing policy positions that will help Americans move toward more equal access to the highest-quality care at the lowest cost”.16
Now ASCO states “As currently configured, the framework is not meant to be a policy tool. It is intended for use in the clinical setting between physicians and their patients and is meant to serve as a catalyst and facilitator of individual treatment discussions.”
Ironically, these shifts in values underscores just how subjective any framework will be. And subjectivity also determines what evidence is used and how it is measured. The Task Force revisions are welcome. They don’t go far enough and the adequacy of evidence has nothing to do with it.
Hence while the Task Force still insists there is no good data to measure patient reported outcomes and drug prices net of rebates, that begs the question: why the framework accepts the lack of data to measure of Net Health Benefit?
Further, the framework still undervalues incremental benefits to specific groups of patients with limited clinical options. The tool is still biased against significant changes in outcomes that average measures of clinical benefit ignore. It is still a highly static tool that cannot take into account the impact of matching patients to combinations of treatments.
As structured the framework still ignores role of cost shifting, the pocketing of rebates and focuses obsessively on drug prices.
The Task Force had no problem asserting, “Health care costs in the United States present a major challenge to the national economic well being” and then blaming the danger on “the introduction of costly new drugs and techniques in radiation therapy and surgery.”
The Task Force still fails to acknowledge that PBM and health plan cost shifting and rebate driven formulary decisions are the principal reason patients will face high costs. ASCO supports oral parity and opposes reimbursement experiments that endanger patients.
Most important, this still NOT a patient-developed framework. The focus should be on developing one instead of tinkering with and fighting about the patient hostile approaches taken by ICER.
In sum, the ASCO value framework is an improvement over it’s first version. It is more patient-centered and less a tool for policy making and political attacks. As a recent comparison of the ICER and ASCO frameworks concluded: “ Substantial drug price reductions may be necessary in order to meet ICER thresholds even when maximum NHBs are present as assessed within the ASCO framework. “
In that important regard, it is a better value framework than those developed by ICER and Peter Bach.