Comments on the Recent Institute for Clinical and Economic Review (ICER) Meeting

I have extensive experience in “real world” policy-setting and decision-making and I am puzzled about the motivations regarding the attempt to transfer and recast the failed Quality Adjusted Life Years-based NICE program in the UK to the USA. Among other things, this concern is based upon the findings (Oct. 2014) of the EchOutcome Committee appointed by the European Commission whose chairman concluded that:

“The research provides robust scientific evidence that Quality Adjusted Life Years produce hugely inconsistent, wrong results on which important decisions are being made.”

I add that it has been noted that these wrong NICE-driven decisions have been correlated with decreases in OS across tumor types driving the UK to the “Bottom of the Barrel” in terms of OS across many tumor types compared to other developed Western European countries. Why do we want such a life-threatening process to be transposed to the US by ICER?

Further I note the points (OBR Green on Oct.19) made by 5 eminent Key Opinion Leaders who treat lung cancer every day.

“For us as practicing oncologists and lung cancer researchers, this report has raised serious concerns regarding ICER’s ability to interpret clinical evidence and reach conclusions on drug value that are scientific, comprehensive, and unbiased. ICER appears to represent a perspective that is less oriented toward patient benefit than toward motivations that would limit patient access to new therapeutic options. ICER’s clinic-economic methods include approaches and metrics that, due to their singular focus on population level health, would likely fail patients on an individual clinical needs basis!”

In looking at the roster (Drs. Ettinger, Schwartzberg, Otterson, Jahanzeb, Waterhouse) of experts, I am in full agreement with them. Further, I see many more points that bear extensive examination and discussion. These points include:

• Across Value Metric Frameworks, including ICER, the failure to use or at least recognize the “Real Price” (e.g., minus 340B and Medicaid discounts) leaves an important piece out of the ICER analysis.

• Making comparisons and valuations across disparate patient populations (e.g., PD-L1 expression levels) leads to almost absurdly different and misleading comparative values.

Finally, and most importantly, here is a critical lesson that I learned at Aetna making real world decisions daily that directly impacted the lives of 15 million people and that should be duly noted.

“Those who engage in the development of assessments of Evaluation and Valuation must be willing to live with, in an ABSOLUTE manner, (e.g., no appeals, no nothing) the decisions based upon their own assessments realizing that someday such assessments (e.g., ICER) may drive and direct decisions about the treatment of their mother, sister, brother, spouse, children etc.”

by William McGivney, PhD, Managing Principal for McGivney Global Advisors, and former long-time CEO of the NCCN, VP for Clinical and Coverage Policy at Aetna, and Member of the Medicare Coverage Advisory Committee

Originally posted on OBR

#ICER #QALY #Value Frameworks