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Facts Are Stubborn Things: The Medicare Part B Experiment, a Patient Advocate's Perspective (Part II)

Debra Madden is a 2-time cancer survivor who was diagnosed with Hodgkin's lymphoma as a young adult and breast cancer nearly 20 years later, which was thought to be secondary to the radiation she had received for her original cancer treatment. Debra became an active Cancer Research Advocate following her second cancer diagnosis at the age of 42 years. She is currently a member of the ECOG/ACRIN Cancer Research Group and the Patient-Centered Outcomes Research Institute's Advisory Panel on the Assessment of Prevention, Diagnosis, and Treatment Options. She also serves on multiple grant review panels, including the Congressionally Directed Medical Research Program Breast Cancer Research Program. Debra blogs at "Musings of a Cancer Research Advocate", ( and you can follow her on Twitter at @AdvocateDebM.
The reality is that, of course, reasonable people may have very different opinions concerning the optimal approach to evaluating the value of medications and other health interventions.  It is critical to respect such differences and to engage with them openly. ICER consistently demonstrates this through the structure used in the development of its reports and its public meetings, which ensures ongoing opportunity for these differing voices to be heard. It’s also understandable that any efforts to evaluate the evidence and provide guidance can lead to strong reactions. But it’s concerning when different perspectives, again whether due to passionately held opinions or interests or facts that do not fall into place with one’s mission, result in loud reactions that are colored by false narratives, lack of understanding, and/or misrepresentations. For example, in recent days, ICER has been said to “clearly be inspired” by the UK’s National Institute for Health and Care Excellence (NICE), to base their analyses solely focused on drug costs, to use “opaque methods” to review and assess the value of specific medications, and to represent the interests of the insurance industry.  And who could miss former Arkansas’ Governor, Mike Huckabee’s, deft revisiting of the term “death panels” as he loudly misinterpreted ICER’s mission and its work?

That is why it’s so important to break through the noise and clearly stress the following: ICER’s work is focused on improving the use of evidence as a foundation for open, transparent, public dialogue—something that has been lacking for far too long—concerning clinical effectiveness, innovation, cost, and sustainability in today’s healthcare system. Rather than “representing the interests of the insurance industry” or following popular opinion, political ideologies, or biases, ICER and its reports follow the evidence. Each ICER report includes full analyses of the drugs’ clinical comparative effectiveness, including efficacy, toxicity, potential benefits, and potential harms and the value these treatments represent to patients and the healthcare system.

Yes, some ICER reports have found that the comparative effectiveness of a new medication is extremely limited (eg, ICER’s report on insulin degludec (Tresidba), a new long-acting insulin analog to meet the basal insulin needs of patients with type 1 or 2 diabetes mellitus) while other reports have found that the evidence is persuasive (such as its review of mepolizumab (Nucala), a humanized monoclonal antibody against interleukin-5, found to demonstrate a net health benefit when added to standard of care for the treatment of patients with severe eosinophilic asthma). And in some cases, ICER reports have found that the exceptional value of a new medication improves patient outcomes while also saving overall healthcare costs (eg, its review of Entresto, a combination of the angiotensin II receptor blocker valsartan and the neprilysin inhibitor sacubitril), which found evidence of clinical effectiveness and high value  as compared with usual care with ACE inhibitors, due to improvements in clinical outcomes and quality of life and reduction in costly hospitalizations and other complications). These evidence-based reports support ICER’s overall goal of getting excellent, high-value drugs to market quickly, at a cost that is affordable to patients, without hindering the development of new and effective drugs.

So, importantly, ICER’s primary focus is its assessment of clinical efficacy—but its secondary focus on value and cost should not be thrown out with the bathwater.

Be sure to tune in to Part III tomorrow, where Ms Madden discusses the increasing financial struggles many patients with cancer or chronic conditions are experiencing, and the approaches several groups are now taking to bring greater awareness and a higher level of science to considerations of cost and overall value of care.

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