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ICER and the Real World

ICER’s about to get real.  Or so it says.

The Institute for Clinical and Economic Review, a controversial Boston-based drug price analysis group, recently released an updated draft of its framework.  The document outlines the methods ICER will use to evaluate drugs’ cost-effectiveness moving forward.  Among the changes are plans to use “existing” real-world evidence, as well as a plan to “benchmark” ICER’s findings with European countries’ health technology assessment systems.  

But what do these changes mean for real patients who want to access innovative medicine?

Real-World Evidence 

Real-world evidence sheds light on a treatment’s risks or benefits outside traditional clinical trials.  The evidence offers valuable insight about how a medication fares across a range of patients.  In short, it could be an important addition to ICER’s analyses. But these data require that patients first access the medication in question and use it long enough to gauge its impact.  Robust data could be years in the making.  

ICER, on the other hand, is known for its haste.  The organization has a reputation for evaluating drugs’ cost effectiveness before they even have a price, as it’s done with treatments for spinal muscular atrophy and asthma.  And ICER sees no problem with examining drugs’ clinical efficacy before they’ve even been approved by the Food and Drug Administration, as with recent therapies for Duchenne muscular dystrophy and a forthcoming analysis of cystic fibrosis medication.  

Meanwhile, patients would like ICER to incorporate another type of real-world information: quality of life.  ICER has redoubled its commitment to patient input in recent years. But that has not led the organization to incorporate meaningful patient benefits – improved sleep, the ability to remain focused at work, children being able to return to school – into its analyses.

ICER, Europe & Patient Access

A more likely change is ICER’s plan to make its findings relatable to foreign health technology assessment systems.  The updated framework notes that ICER will translate its findings into language that pares with Germany’s health technology assessment approach.  

Americans have already seen ICER’s impact on patient access.  From CVS Health to the Department of Veterans Affairs to New York’s State Medicaid system, public and private insurers have proven willing to incorporate ICER’s findings and methods into their coverage design.  And though ICER’s findings may be premature, the coverage decisions that insurers make can be “semi-permanent,” as ICER’s Steve Pearson, MD, noted in a recent ICER webinar about the updated framework. 

Does ICER see itself becoming still more like health technology organizations abroad? Just consider the UK’s National Institute for Health and Care Excellence, which gained such a reputation for rejecting cancer drugs that the UK government had to establish a standalone fund for patients’ treatment.  Or New Zealand, where coverage thresholds based on price have left patients to choose between paying thousands of dollars each month out of pocket or foregoing life-saving treatment.  

It’s a formidable prospect for patient access.  

If ICER wants to give its reports a real-world feel, the organization could start by attaching a real, quantifiable value to patients’ qualitative experiences.  That means taking into account the multi-faceted, deeply personal burden of disease, the quality-of-life benefit provided by innovative treatment options – and the all-too-real experience of access barriers that are rooted in ICER’s economics. 

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