On July 13, 2022 2021, ICER released its draft evidence report, “Medications for Obesity Management.” This is the first step in ICER’s process that is expected to conclude with the release of a final report in October 2022.
ICER’s report reviews four medicines currently approved by the FDA to treat obesity:
- subcutaneous semaglutide (Wegovy®)
- liraglutide (Saxenda®)
- phentermine/topiramate (Qsymia®)
- naltrexone/bupropion (Contrave®)
Obesity is a complex disease that is very common. At least 40% of adults in the U.S. are obese, and another 30% are overweight. Obesity is generally measured by Body Mass Index (BMI), which is a calculation based on height and weight. Obesity is defined as a BMI of ≥30.0, while a BMI of 25 to 29.9 is considered overweight.
Obesity has many significant negative impacts on people’s lives that are not captured by the normal medical assessment of obesity as a disease. In the report’s “Patients Perspective” section, there is some discussions about how obesity produces “considerable physical and mental burden on patients with obesity; the broad recognition that the social stigma associated with obesity can begin at a young age and affect an individual throughout their life; the need for better treatment options; the impact on all aspects of life including education, work and social/family relationships.”
ICER’s review of clinical effectiveness of the four treatments is divided between people with obesity (or who are significantly overweight and have obesity-related medical conditions) who also have diabetes, and those who don’t have diabetes. However, for its calculations of long-term cost effectiveness, ICER’s model is based upon people with obesity who do not have diabetes (see below).
Unfortunately, ICER does not present data or insights about what percentages of people with obesity don’t have diabetes, or other information about what might distinguish people with obesity who also have diabetes from those who don’t have diabetes. Research indicates that all people with obesity are not the same, so such information is necessary to have a complete picture. For example, people with abdominal (or visceral) obesity may have greater health risks than so-called “metabolically fit” people with obesity, who unfortunately may not be “cardiovascularly fit.”
Overall, ICER’s review finds that all four of the medicines are effective in treating obesity – with semaglutide being the most clinically effective – with minimal potential harms or adverse effects. That lack of adverse effects is especially important because as a chronic condition, obesity often involves long-term and potentially life-long treatment, as people who discontinue treatment generally regain weight.
The figures below display ICER’s summary of how the four medicines compare in reducing weight in people with obesity, both overall and for those with diabetes.
In ICER’s analysis and summary, these medicines all seem to be more effective in reducing weight for people with obesity who do not have diabetes. This may reflect the different types of obesity and the related underlying causes or associated metabolic irregularities, which as mentioned above, ICER does not discuss in the draft report.
ICER’s review also does not explore all possible medical treatments for obesity. For example, the Cleveland Clinic’s website lists 12 potential medicines to treat obesity. In addition, ICER’s review does not explore the potential use of oral semaglutide, which was recently approved by the FDA for the treatment of diabetes, or extensively discuss the potential use of tirzepatide for treating obesity, which was recently approved by the FDA to treat diabetes. Specifically in a recent ICER review that Patients Rising Now analyzed, ICER found that tirzepatide produced greater weight loss (10kg v. 5.7 kg) compared to the 1.0mg dose of semaglutide, rather than the 2.4mg dose approved for treating obesity. Further, that weight loss seemed to continue after 40 weeks.
In addition, ICER’s review did not include consideration of the combination of IBT with any pharmaceutical treatments. Such analyses are important because IBT has been demonstrated to be effective, it has been a Medicare covered benefit since 2011, and recently shown to be beneficial in an evidence-based review.
All those clinical factors and considerations are related to share decision-making. ICER’s report notes that shared decision-making between patients and their clinical team is an important component of treating obesity. The report goes on to provide an example, saying, “Shared decision-making involving patients and providers is seen as a fundamental aspect of weight management” within the VA/Department of Defense clinical guidelines. Similarly, Canadian clinical guidelines indicate that “Pharmacotherapy is meant to be [used] for weight loss and weight loss maintenance in addition to medical nutrition therapy, physical activity, and psychological interventions.”
As we have discussed frequently in this space, ICER’s economic modeling and analysis uses the concept of Quality Adjusted Life Years (QALYs) and “utilities” as fundamental components of its economic modeling and analysis. Using QALYs for decisions about payment, coverage, and rationing of care has been widely criticized. QALYs inherently discriminate against people with disabilities and chronic conditions like diabetes because those people will almost certainly never achieve “perfect health,” so their lives are assigned a lesser value than those of people without disabilities and/or chronic conditions.
Insurance companies and payers use ICER’s analyses to help determine coverage and payment for specific treatments. However, ICER’s approach cannot provide the kind of comprehensive assessment required to make such determinations because it uses simulations, assumptions, and limited or select information. Patients should be concerned that their access to treatment options could be limited because of this approach.
QALYs have long been criticized for their use in this manner because they discriminate against people with chronic diseases and disabilities. The National Council on Disability, an independent federal agency, issued a report in November 2019 entitled, “Quality-Adjusted Life Years and the Devaluation of Life with Disability,” explaining why patients are not well served by use of the QALY:
[S]takeholders fear that use of QALYs undervalues vital treatments that extend or improve the lives of people with disabilities. This is because the QALY calculation reduces the value of treatments that do not bring a person back to “perfect health,” in the sense of not having a disability and meeting society’s definitions of “healthy” and “functioning”; uses simplified assessments of value that do not account for the complexity of patient experience; and does not to take into account clinical expertise on rare disorders that may not have an extensive research literature available for use. Other stakeholders—often from the medical, health economics, and health insurance fields—argue that QALYs provide payers with valuable information on a treatment’s potential benefits and costs and aid them in negotiating a reasonable price with the drug (or treatment)’s manufacturers.
The Patient Access and Affordability Project (PAAP) and the Pioneer Institute have also produced reports to help illuminate the impact of the use of QALYs in analyses for patients, including “ICER uses QALYs to evaluate healthcare,” and “Study Urges Caution Before Adopting ICER Reviews to Determine Cost Effectiveness of Treatments.”
Another significant issue in the report: ICER made its “base case” population obesity patients who do not have diabetes. ICER made this choice – which clearly has an impact on the cost-effectiveness analyses – despite noting that the “effects of GLP-1 receptor agonists have not yet been well elucidated in patients without diabetes mellitus.” While that decision makes some sense because they found that all the medicines were more effective in people who do not have diabetes, the report does not clearly state this very significant limitation of its cost-effectiveness calculation. That obfuscation along with all the other exclusions and assumptions ICER made in performing its cost-effectiveness modeling means that its conclusions are of very limited utility to insurance companies, payers, and health systems looking to decide which treatments for obesity they should pay for or include on their formularies. And of course, it is likely that those conclusions would also be of negligible value to patients and their clinicians engaged in shared decision-making as suggested by best practices.
With all those limitations and caveats (and others too numerous to list here), ICER’s model concluded that phentermine/topiramate to be the most “cost effective” treatment option even though it clearly produces a smaller improvement in QALYs (see below):
Obesity is a common and very serious condition that impairs quality of life and leads to other significant health problems, such as diabetes, cardiovascular disease, and cancer. Fortunately, there are several different treatment options available today for people with obesity, including many medicines, surgical options, and intensive behavioral therapy (IBT). ICER’s report notes that shared decision-making between patients and their clinical team is an important component of treating obesity.
Unfortunately, ICER’s economic modeling – which continues to rely on QALYs – perpetuates assumptions and stereotypes about people with chronic conditions like obesity. The omission of key data and other limitations – such as only considering people who do not have diabetes and not evaluating IBT with medical treatments – in ICER’s modeling make the conclusions and presented numerical “results” suspect and of dubious utility. In addition, obesity is more common in people of color, particularly in non-Hispanic Black women. Access to better treatments for obesity would improve equity in the U.S. healthcare system. Any analysis or recommendations that fail to take those factors into account could disproportionately harm unserved or underserved populations.