New Anti-Obesity Medications Should Be Considered Preventive Health Care
- eskramer2
- Jul 27, 2024
- 7 min read
JULY 5, 2024
TL;DR: Federal policymakers are evaluating new GLP-1 drugs, which show promise for treating type 2 diabetes and obesity, potentially reducing healthcare costs and improving lives. The U.S. Preventive Services Task Force is considering grading these drugs as preventive medications, while the Congressional Budget Office studies their financial impact on Medicare. With significant weight loss and health benefits, GLP-1s could be a groundbreaking preventive intervention. Ensuring coverage without cost sharing could enhance access and yield substantial societal benefits.
Federal policy makers are trying to wrap their heads around a new class of drugs for managing and preventing the symptoms of type 2 diabetes. The surprising success of their use for weight loss has the potential to curb the US’s high rates of obesity, change lives for those struggling with cardiovascular diseases and metabolic disorders, and generally facilitate a shift to healthier living and reduced long-term health care costs.
Glucagon-like peptide 1 or GLP-1—a class of receptor agonists—are innovative new medicines that yield significant benefits to the patient populations for which they are indicated, including many benefits that are still being realized through additional study and widespread use. As new benefits are being discovered, and the value of known benefits still being determined, where GLP-1s fit within our health care paradigm, and which federal entity will oversee their access and cost issues, remain open questions.
The US Preventive Services Task Force (USPSTF or Task Force) is reportedly developing a draft research plan that will consider whether to grade anti-obesity medications (AOMs) as preventive medications for chronic weight management. Meanwhile, the Congressional Budget Office has laid out the new research it needs to assess the budgetary effects were Medicare to widely cover AOMs, specifically asking for data on near- and long-term clinical impacts, factors affecting use of the drugs and the expectations around the price and effectiveness as they are being developed.
Promising clinical and real-world evidence suggests that GLP-1s should be positioned as a clinical preventive intervention. By preventing the potential complications of living with obesity and type 2 diabetes, GLP-1s are poised to improve lives while reducing costs to our health care system and society.
GLP-1s Are An Exceedingly Successful Clinical Intervention
Nearly 42 percent of adults are considered obese, and the chronic condition is estimated to cost the health care system $173 billion annually, according to peer-reviewed research cited by the Centers for Disease Control and Prevention. Between 90 percent and 95 percent of the 38 million Americans living with diabetes have type 2 diabetes, and the medical costs and lost wages associated with living with diabetes are upwards of $413 billion annually.
While GLP-1s are not a magic wand that can erase the complications and medical costs of living with obesity and type 2 diabetes, they have had startlingly widespread success in treating the conditions. Traditionally, obesity treatments sought to sustain a 5 percent weight loss to be considered effective, with a 10 percent weight loss leading to increased cardiometabolic health. GLP-1s, meanwhile, consistently produce 12 percent to 18 percent weight loss.
When used in tandem with lifestyle changes such as a healthier diet and increased exercise, individuals have experienced much more significant weight loss than those who only changed their lifestyle, including one study in which more than 52 percent of participants lost 15 percent of their bodyweight, and 36 percent of participants lost more than 50 percent of their bodyweight.
There are a host of other benefits to GLP-1 treatment that are not yet fully understood. After studies found that GLP-1 treatment can reduce alcohol consumption in individuals living with obesity, Novo Nordisk, the manufacturer of Ozempic and Wegovy, is planning a study to determine the extent to which the medications can help people drink less. Because GLP-1s have reportedly reduced inflammation in organs including the brain, it is possible that they could be used to treat conditions such as Alzheimer’s disease and Parkinson’s disease. While not yet the subject of clinical trials, some have reported unexpected fertility, birthing “Ozempic Babies” after GLP-1 treatment.
It is a safe bet that there are more, yet to be realized benefits to GLP-1 medications. Ongoing studies may lead to additional, not yet considered indications. Nonetheless, GLPs are an extraordinary intervention—one with the opportunity not just to save and change countless lives, which on its own should be considered a miracle, but one that can turn the tide against the exorbitant human and capital costs associated with poor cardiometabolic health.
A Milliman study commissioned by Novo Nordisk analyzed Medicare Part D costs associated with GLP-1 coverage and found that, should AOM coverage be added to Part D, upwards of $8 billion in medical costs could be prevented over a 10-year period. Another study found that Medicare coverage of AOMs would save the entire Medicare program between $175 billion to $245 billion over a 10-year period, and the cumulative social benefits of Medicare coverage of AOMs over that 10-year period would reach nearly $1 trillion. And as is typical of economic analyses, this does not even consider the improvement in the lives of the millions of Medicare beneficiaries who may benefit.
GLP-1s Should Be Recommended As A Preventive Service
The USPSTF last considered whether to recommend a weight-loss intervention to prevent obesity-related morbidity and mortality in adults in 2018. Notably, the Task Force has only reviewed behavioral interventions, providing them with a Grade B recommendation. The Task Force has not yet considered any biopharmaceutical interventions for obesity. Prior to the development of GLP-1s, lifestyle interventions such as increased exercise and a healthier diet were considered the best anti-obesity preventive options available.
That the Task Force is reportedly developing a research plan to consider whether to grade AOMs as preventive medications for chronic weight management is indicative of the shift in the standard of anti-obesity preventive care. Recently, however, the Task Force announced a recommendation for intensive counseling for children and adolescents living with obesity. Task Force Chair Wanda Nicholson said in an interview that there was not enough evidence to assess the value of GLP-1 usage in children and adolescents six years and older, and that “We’re calling for more research into both the benefits and potential harms of medication therapy for kids and teens.”
As found in the studies mentioned above, GLP-1s prevent many conditions from manifesting in those living with obesity and type 2 diabetes. These studies catalogue a significant magnitude of benefits of GLP-1s for those who use them, consistently finding the benefits far outweighing any harms associated with GLP-1s as a preventive intervention. While the Task Force is required to weigh the available evidence when considering a recommendation, for many individuals at risk of complications from obesity and type 2 diabetes, a timely recommendation is essential.
Arguing along a similar line, we have previously suggested that the Task Force has laid the framework for recommending insulin as a preventive service for insulin-dependent individuals based upon its recommendation for statins for a limited population of adults ages 40–75 years who have one or more risk factors for cardiovascular disease, and its recommendation for aspirin as a preventive medication to prevent preeclampsia and related morbidity and mortality in high-risk pregnant individuals.
Until GLP-1s are properly reviewed and recommended as a clinical preventive intervention, they will remain subject to coverage barriers and lapses, diluting the promising benefits of GLP-1s for both individuals and the health care system at large. The Task Force is taking an important first step toward issuing a recommendation by developing a research plan. Once it reviews the available evidence on GLP-1s, the Task Force should provide a recommendation for GLP-1s as a preventive service for those living with obesity.
Coverage Of GLP-1s Once Recommended As A Preventive Service
Commercial insurers are required by Section 2713 of the Public Health Service Act (Section 2713) to cover preventive services with a rating of A or B from the USPSTF without cost sharing. Cost sharing is a known barrier to preventive interventions. Removing it as an obstacle will pave the way for patient access.
States that have expanded Medicaid eligibility under the Affordable Care Act must also provide first dollar coverage of all USPSTF-recommended preventive services with a rating of A or B. States that have not expanded Medicaid are not required to cover all preventive services with an A or B rating without cost sharing but will receive a 1 percent Federal Medical Assistance Percentage increase should they choose to do so. Therefore, an A or B USPSTF recommendation would go far in assuring access for millions of low-income Americans who may be living with type 2 diabetes or obesity.
For Medicare beneficiaries, as noted, there is a statutory bar against coverage for drugs to treat “anorexia, weight loss, or weight gain.” The Centers for Medicare and Medicaid Services (CMS) has issued guidance clarifying that, while Medicare Part D plans are statutorily barred from covering AOMs, Part D plans may elect to cover GLP-1s that have received Food and Drug Administration approval for an indication other than weight loss, including type 2 diabetes. That Medicare may cover a GLP-1 when indicated for conditions such as type 2 diabetes but may not cover the same GLP-1 when indicated for weight loss, stands to deprive millions of seniors of perhaps the most promising weight loss intervention of their lifetime.
Yet, there is a provision of the Social Security Act, Section 1861(ddd), which authorizes the secretary of the Department of Health and Human Services to add preventive services to Medicare coverage via a national coverage decision (NCD) conducted by CMS when those services are: reasonable and necessary for the prevention or early detection of an illness or disability; recommended with a grade of A or B by the USPSTF; and appropriate for beneficiaries covered by Medicare Parts A and B.
According to our own analysis, CMS has issued a total of 15 NCDs relating to preventive services, 11 of which were issued pursuant to Section 1861(ddd). A recommendation from the USPSTF and rating of A or B for GLP-1s as a preventive service to prevent the long-term effects of living with obesity would provide the necessary predicate for the service to be added to Medicare coverage.
During the NCD process, CMS can waive cost sharing for preventive services, as it has proposed to do in the draft NCD for Pre-exposure Prophylaxis (PrEP) for HIV. Once properly considered as a preventive intervention, CMS should also waive all cost sharing for GLP-1s when used as a clinical preventive intervention.
Conclusion
For the individuals who take GLP-1s, the possible increase in quality of life approaches the immeasurable. For the health care system, the savings to be realized from GLP-1s are readily measurable, and staggeringly large. Like other preventive interventions recommended by the USPSTF, GLP-1s should be made available to those who need them without cost sharing.
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