As we enter a new and exciting era of medicine, there is an important question we need to answer: What if we could measure the efficacy of a medicine, and more broadly, the value a specific medicine will have on patients and society as a whole? To find an answer, efforts like the Innovation Value Initiative (IVI) are underway to develop value-assessment frameworks aimed to assess the worth of pharmaceuticals and other technologies. And as we are learning, not all value assessments are created equal.
In new blog featured in Health Affairs, Peter Neumann and Joshua Cohen of the Tufts University School of Medicine examine the Institute for Clinical and Economic Review (ICER), which has crafted its own way to measure the cost-effectiveness of drugs and technologies, but has come under scrutiny in recent years for their questionable processes and flawed methodology. Here’s why:
Doesn’t Reflect the Full Value of Treatments
Appropriately and accurately measuring value is increasingly important as our health care system seeks to reward quality over quantity and ensure patients have access to the medicines they need. These tools can help us better understand how biomedical innovations can improve the lives of patients and society more broadly, and these findings can help inform future health care decisions. However, ICER’s past ties to the insurance industry make us question who will ultimately benefit from their work. As Neumann and Cohen point out:
“[P]rivately funded assessment … raises questions, and given ICER’s expanding profile, it is important to consider them. A central one is: to whom is ICER accountable? As a private entity with private payers as a key target audience, ICER, however well intentioned, may downplay the “social good” aspect of health care—i.e., spillover effects on caregivers, families, and society at large. For example, treating a person’s cancer, Parkinson’s disease, or substance abuse can have broad benefits for society. Privately-led value assessments tend to ignore or discount such effects, as do private payers, a key audience of ICER’s reports, because the effects fall outside of their budgets.”
Patient-Stakeholder Perspective Missing
One of ICER’s greatest flaws is its lack of sufficient input from the full breadth of stakeholders and patient advocates, which paints an incomplete picture of value. And while it’s true that ICER has made an effort to incorporate these voices more prominently in their work, the group must do more to ensure these viewpoints are included in the value measurement process. In a recent letter, BIO applauded these efforts as an encouraging step forward, yet groups like the Partnership to Improve Patient Care (PIPC) have noted that ICER’s use of the information these groups have provided is not consistent and their role is not formal.
Barriers to Critical Cures and Medicines Evident
By neglecting the full value and potential of a medicine and ignoring third-party perspectives, ICER’s flawed processes and methodology can detrimentally impact patient care by encouraging insurers to impose higher cost sharing requirements (or outright coverage denials) for some treatments. As Neumann and Cohen explain:
“[B]y identifying cost-effectiveness benchmarks (e.g., $100,000 to $150,000 per QALY) and budget thresholds to which a technology can be compared, ICER weighs in on what level of spending is appropriate. However, judgments about proper spending are better rendered by actual decision makers (payers and their enrollees) in consideration of specific budget constraints, preferences, and tradeoffs.”
Greater Transparency Needed
Believe it or not, until recently ICER had “no formal policy for updating its evaluations based on the availability of important new data,” PIPC found in a new report. And just this week, a report released by the President’s Cancer Panel highlighted this flaw and others in ICER’s work:
“Some efforts are under way, including those by the Institute for Clinical and Economic Review (ICER) … to develop value frameworks for use in the United States, but none of these is yet widely accepted or used. Limitations noted for one or more of these frameworks include lack of patient-centeredness, lack of systemwide perspective, inadequate provisions for updates as new data are obtained, lack of transparency about methodologies, and failure to engage all stakeholders.”
For a better approach, we should look at value-assessment tools like the IVI’s Open-Source Value Project (OSVP) – a transparent and holistic approach for estimating the value of medical technologies in a way that allows for a broad range of perspectives, incorporates the latest available evidence, and considers the full value of cures and treatments.