Wednesday, December 8, 2010

CER: Learn How to Love It

Comparative effectiveness: It’s a concept that payers like, and like a lot. Case in point: Britain’s National Institute for Health and Clinical Excellence. NICE has rejected paying for drug after drug over the past year, claiming it couldn’t see paying high costs for brand drugs that don’t deliver much more than other medicines of lesser value. The latest rejection was Roche’s Avastin; another rejection was Novartis’ Afinitor.

For those industry members whose attention has been riveted on other business matters – and that’s understandable – it’s important to appreciate that comparative effectiveness isn’t going away. Tucked into the health care reform bill was $1.1 billion to study comparative effectiveness research.

According to the Annals of Internal Medicine, CER is “the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care." While the point is to "assist [stakeholders] to make informed decisions that will improve health care at both the individual and population levels," all this information affords interested parties "the opportunity to address hitherto unexplored topics in clinical decision making.” In other words, how to save money.

Now, industry members could argue, and rightly so, that clinical trials produce data that come from homogenous groups. In The Health Care Blog, Norton Hadler, MD, wrote, “The science that the FDA reviews does not speak to the effectiveness of the drug, but to its efficacy… CER asks whether an intervention works better than other interventions in practice where the patients and the doctors are heterogeneous.” His argument: Redesign trials so they are more efficient. Good point, but considering industry's current reluctance to embrace this topic and FDA's current focus on safety, that argument will likely not be a top priority anytime soon.

Our advice? Take a look at PharmExec’s article The Fruits of Comparative Effectiveness

It’s a thoughtful, well conceived piece on how industry members should approach comparative effectiveness. Quoting a Lilly exec, the article says, “The companies that survive and thrive in this new environment will be those that embrace comparative effectiveness research."

Fighting CER, friends, is not helping demonstrate the value of medicine.

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