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¹ This list is the rapporteur’s summary of points made by the individual speakers identified, and the statements have not been endorsed or verified by the National Academies of Sciences, Engineering, and Medicine. They are not intended to reflect a consensus among workshop participants.

The third session examined cost and value considerations of expanded coverage of AOMs with a focus on microsimulation modeling, cost and benefit assessment, and suggestions for employers. The session featured presentations, a panel discussion, and workshop closing remarks. David E. Arterburn, Kaiser Permanente Washington Health Research Institute, and Anand K. Parekh, Bipartisan Policy Center, moderated the session.

EXPANDING MEDICARE COVERAGE FOR ANTI-OBESITY MEDICATIONS

Alison Sexton Ward, University of Southern California Schaeffer Center for Health Policy and Economics, discussed the prevalence of obesity and value of treatment, presented findings from a microsimulation model analyzing the benefits of broader access to new AOMs, and considered pricing and policy implications of broader AOM coverage.

may affect individual and societal outcomes, said Ward. She outlined reasons why such modeling is particularly appropriate for AOMs. Benefits of weight loss are accrued over many years of improved health, but current real-world data are limited to short-term treatment. Although AOMs result in rapid effects, the value and benefit of fewer comorbid conditions and higher health-related quality of life are seen over a lifetime, she explained. Additionally, a sizable portion of the AOM market is paying for treatment out of pocket; therefore, claims data capture only a subset of patients. Given that no available data source includes the cash pay market, analysis based on real-world data reflects bias by access method. The absence of randomization in access generates selection bias even within claims data analyses, Ward asserted. The microsimulation model uses nationally representative data sources to estimate the relationship between BMI, patient characteristics, health conditions, medical spending, and economic outcomes. Researchers can simulate different scenarios in a manner that more closely resembles an RCT than real-world data allow, said Ward. She added that FAM draws upon data sources including the Panel Study of Income Data and numerous other nationally representative surveys and predicts responses in 10, 20, and 30 years based on these.

To assess the potential social benefits and medical cost offsets of passing TROA and thereby ensuring universal Medicare access to new AOMs, Ward and colleagues used the FAM to examine different insurance coverage scenarios and their effects: (1) status quo, (2) Medicare coverage, (3) Medicare and private coverage, and (4) universal access. The first scenario involves no intervention, current coverage levels, and the natural weight trajectory. The second scenario models a therapy that reduces BMI by 20 percent, a figure based loosely on clinical trial results for Wegovy (semaglutide) and tirzepatide, Ward noted. It models Medicare coverage only, representing a potential outcome in which TROA passes but does not influence coverage by private insurers. It also assumes that patients maintain BMI reduction over their lifetime, with natural fluctuation capped at plus or minus 5 percent of their initial weight loss until age 75. Ward highlighted that nationally representative data suggest that average BMI begins to decline for people aged 65–75. Therefore, lifetime AOM treatment should consider the natural weight loss in older adults, she added. The Medicare and private coverage and the universal access scenarios also model a 20 percent BMI reduction maintained within 5 percent of initial weight loss until age 75. The former envisions TROA leading to both Medicare coverage of AOMs and private insurers following suit, enabling AOM access to any person with Medicare or private insurance who meets the label criteria. The latter extends coverage to individuals with Medicaid or who are uninsured, noted Ward.

Modeling of the four scenarios indicates that broader access to AOM treatment would generate substantial social benefits, including reduced medical spending, said Ward. For example, in comparison to the status quo, Medicare coverage would generate $176, $479, and $704 billion in cost offsets within 10, 20, and 30 years, respectively. These figures demonstrate growth over time, with the reduction of comorbid conditions increasing the rate of benefit in successive decades. She specified that these figures include cost offsets associated with Medicare Part A, Part B, and Part D and noted the importance of this distinction in budget impact conversations about the solvency of Medicare. The cost of AOMs will largely come from Part D, and the majority of savings will accrue to Part A. Ward clarified that the benefit calculations do not include treatment costs and that Part A is most critical to Medicare solvency. Modeling indicated that cumulative social benefits, derived from improvement in health-related quality of life, would total over $1 trillion within 10 years for the Medicare coverage scenario.

The scenario in which both Medicare and private insurers cover AOMs results in higher Medicare cost offsets, totaling $245 billion within 10 years, $832 billion within 20 years, and $1.4 trillion in 30 years, said Ward. She explained that the increased cost offsets result from patients having access to weight loss at an earlier age, thereby avoiding comorbid conditions. If obesity is not treated until people are 65 and eligible for Medicare, some will have already developed diabetes, heart disease, or other comorbid conditions. However, early access to AOMs prevents more cases of obesity-related diseases. Modeling indicated that Medicare and private insurer coverage of AOMs would lead to a 9 percent decrease in the prevalence of diabetes and a 5 percent decrease in disability within a decade. Within 20 years, diabetes would decrease by 17 percent, equating to 4.4. million fewer people with diabetes in 2044 given widespread access to AOMs today. Ward emphasized that this equates to 45 million person-years (total years people would be spared from living with this disease). Modeling universal access to AOMs for all people who meet medical criteria, including those on Medicaid or without insurance, indicates even greater values; Ward highlighted that the cumulative social benefits would total almost $4 trillion within 10 years, over $10 trillion within 20 years, and over $17 trillion in 30 years.

Ward underscored that the social benefits of AOM treatment are not homogeneous and vary by age, BMI, and other characteristics. For instance, the annual social benefit of treatment for a person aged 25–34 years is almost $12,000, but this decreases with age and falls to less than $3,000 for a person aged 75+. She reiterated that the earlier a person begins treatment, the more likely they are to prevent comorbid conditions and accompanying pain and disability. The annual social benefit associated with

AOM treatment by BMI is greatest for moderate obesity BMIs (35–40 and 30–35), followed by severe obesity BMIs (40–45 and greater than 45). Treatment for people with BMIs of 27–30 generated annual social benefits, but these were lower than for higher BMI ranges, Ward noted.

Considerations and Policy Implications

Outlining AOM drug price considerations, Ward acknowledged that GLP-1 medications are expensive, but average rebates are high. For example, the list price is $936–1,349 per month, but the net price is $215–701 after rebates. Furthermore, the development pipeline is robust, and FDA approval of new AOMs will increase competition and drive price reductions, she predicted, citing the hepatitis C and HIV medication markets as examples. Ward reiterated that broad access to AOMs could generate $17.5 trillion in social benefits over 30 years, with the greatest gains stemming from increased longevity and reduced disability. Moreover, these benefits would grow over time, so predicting the full benefit requires long-term modeling. Ward said that AOM treatment could help to alleviate health disparities in racial minority populations, given that research indicates that racial minority and lower-income patients are less likely to respond to behavioral weight-loss interventions than wealthier, White counterparts. She underscored that breakthroughs in medical technologies that simplify the treatment regimen, such as GLP-1 drugs, can also reduce health disparities.

FEDERAL PERSPECTIVE ON EXPANDING COVERAGE OF ANTI-OBESITY MEDICATIONS

Noelia Duchovny, Congressional Budget Office (CBO), considered how expanding Medicare’s coverage of AOMs would affect the federal budget. She described the role and function of CBO, reviewed its assessment of the economic effects of Medicare coverage of AOMs, and outlined factors that could affect future costs and benefits associated with AOMs.

The Role of CBO in Policy Making

Created by the Congressional Budget and Impoundment Control Act of 1974, CBO was established to give Congress a stronger role in budget matters, said Duchovny. The agency provides objective, impartial, and strictly nonpartisan analysis of budgetary and economic issues. She emphasized that it does not make policy recommendations. Following processes specified in statute or developed with the budget committees and Congressional leadership, it chiefly assists budget committees with the matters under their jurisdiction. CBO provides Congress with different types of information,

including baseline projections, cost estimates, identification of federal mandates (requirements that legislation imposes on state, local, or tribal governments or private-sector entities), scorekeeping, and estimates of economic and budgetary effects of policy options. Baseline projections pertain to federal spending and revenues under current law that help Congress formulate its budget plan. Duchovny stated that projections assume that laws about federal spending and revenues will remain in place. This approach allows the baseline to serve as a benchmark for measuring the effects of proposed legislation. CBO provides cost estimates of these effects on the federal budget and identifies and estimates the cost of federal mandates. Scorekeeping information includes estimates of the effects of proposed and enacted legislation on the major categories within the budget. Furthermore, CBO provides estimates of the economic and budgetary effects of policy options. For example, CBO typically produces reference volumes every 2 years that examine a wide range of options for reducing budget deficits, whether by decreasing spending or increasing revenues.

Duchovny emphasized that CBO does not participate in specific activities. Strictly nonpartisan, CBO does not make policy recommendations or judgments about the merits of legislative proposals. It does not write legislation but rather analyzes various proposals and options. Additionally, CBO does not enforce budget roles or implement programs or regulations. Those tasks are the responsibility of budget committees, other federal agencies, and the Office of Management and Budget. Moreover, Duchovny noted that CBO does not audit operations of government programs, a responsibility designated to the Government Accountability Office.

Outlining characteristics of CBO estimates, Duchovny stated that they typically focus on the next 10 years, but in some cases, the focus extends 20+ years. The agency provides supplemental information about effects beyond the first decade to the extent possible. She highlighted that this is particularly important when longer-term budgetary effects are anticipated to occur in magnitude relative to the first decade. Developing estimates involves researching potential effects of proposals from a variety of data sources. Ultimately, CBO synthesizes potential effects of a policy to reflect the middle of the distribution of likely outcomes. Cost estimates incorporate behavioral responses to the extent possible, based on available evidence. For instance, the effects of a policy such as Medicare coverage for AOMs depend on how providers and beneficiaries respond, such as whether providers will prescribe AOMs and which specific AOMs beneficiaries will take. Duchovny stated that CBO policy assessments may change if new data or information—for example, from experts and stakeholders—become available. She said that CBO strives to be transparent, so cost estimates include clear, concise explanations and list key components of their basis.

Duchovny described that CBO bases its assessments on a detailed understanding of federal programs and revenue sources. For example, analyzing a Medicare policy requires understanding how Medicare operates under current law. CBO assessments analyze a variety of data sources, such as research literature, data reported by federal statistical agencies and other groups, and consultation with outside experts in academia, think tanks, industry groups, the private sector, and federal, state, and local agencies. Analysis may include discussion with CBO’s Panel of Economic Advisers and Panel of Health Advisers. Duchovny outlined that CBO makes its work transparent by testifying, publishing answers to questions, explaining analytic methods, releasing data, analyzing the accuracy of its estimates, comparing current and previous estimates, comparing its estimates with those of other organizations, estimating the effects of policy alternatives, characterizing uncertainty of estimates, creating data visualizations, and conducting outreach.

The Potential Effects of Medicare Coverage of AOMs on the Federal Budget

The focus of CBO assessments is on budgetary effects of policy, but lawmakers base decisions on considerations aside from effects on the federal budget, Duchovny specified. In analyzing the potential budgetary effects of Medicare coverage of AOMs, CBO analysts first consider obesity treatments covered under law. Medicare covers bariatric surgery, behavioral counseling by PCPs, obesity screenings, and intensive behavioral therapy (IBT). Medicare Part D plans cover retail prescription drugs and are prohibited from covering AOMs as part of the standard benefit, according to the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. GLP-1 drugs originally developed to treat diabetes can be covered by Part D for patients with Type 2 diabetes, Duchovny said. Recently introduced in the 118th Congress, TROA would allow Medicare Part D to cover drugs indicated for weight loss. Duchovny outlined that two main provisions would (1) expand AOM coverage to beneficiaries who have obesity or overweight with one or more related comorbidities and (2) permit Medicare payment for IBT for obesity to other health care providers or counseling programs.

Duchovny explained that CBO analysis of any policy expanding Medicare AOM coverage has two primary components: the direct costs of the medications and the potential offsetting budgetary savings associated with improved health outcomes. The net effect of such a policy would be equal to the sum of these two components, one increasing and one potentially decreasing federal spending. CBO relies on the best available evidence and considers the full range of effects resulting from AOMs in conducting

analyses. At current prices, CBO assessment found that coverage over the next 10 years would generate federal spending more than the total savings that it would generate by reducing other health care costs. However, Duchovny noted that this could change in later decades, depending on drug prices and the long-term effects of AOMs on utilization of other health care products and services.

Several determinants factor into CBO estimates of direct costs from Medicare AOM coverage, including use of medications and current and future drug prices, said Duchovny. Regarding use of medications, CBO expects that Medicare coverage would result in considerable demand, which is a function of the number of eligible enrollees, AOM use among the eligible population, and treatment duration. In determining the number of eligible enrollees, CBO estimated how many meet the indications for AOMs—those with obesity or a BMI 27–30 kg/m² with related comorbidities—and subtracted those with type 2 diabetes, given that they already have access to these medications under law. She noted that the size of the population could decrease further if FDA approves—and Medicare allows—new indications. For instance, 2 weeks before this workshop, FDA approved Wegovy for certain patients with cardiovascular disease, noted Duchovny, which illustrates the importance and implications of keeping abreast of new information. Next, CBO projected the share of this newly eligible population that would take AOMs and their treatment duration. Given that studies indicate that most people who discontinue AOMs regain weight, treatment duration affects both direct costs and offsetting effects from improved health. Duchovny stated that these figures demonstrate that, without other changes, estimates of direct costs are higher when (1) the number of newly eligible individuals is larger, (2) use rates are higher, and (3) treatment duration is longer.

Current drug prices constitute another component of direct costs, said Duchovny. The price of a 4-week supply of GLP-1 medications is $1,000–1,300, although the amount received by the manufacturer is often reduced by discounts it pays to insurance plans and other payers. She stated that if a GLP-1 were covered by Medicare as an AOM, some of its costs would be paid by enrollees through higher premiums and cost-sharing. Reiterating that CBO estimates of policies typically cover a 10-year period, she noted that its assessment of drug coverage policies requires expectations about future prices, and the price trajectory of AOMs is highly uncertain. Some factors are expected to drive prices lower. For instance, CBO expects semaglutide to be selected for price negotiation by the Secretary of the U.S. Department of Health and Human Services (HHS) in the coming years, which would lower its price and potentially that of other AOMs, and generic competition for semaglutide and tirzepatide to substantially increase in the second decade of a policy enabling

Medicare Part D coverage of AOMs. However, future prices could also increase as new AOMs become available. Duchovny described that hundreds of AOMs are in the pipeline, and new drugs might be more effective, have fewer side effects, or be taken less frequently or more easily, which could translate to higher average prices even if the prices for currently approved AOMs decline.

Duchovny described CBO’s approach to assessing the effects of Medicare AOM coverage on other health care spending, noting that greater use of AOMs by people with obesity could improve their health, reduce the use of other health care products and services, and lower spending for other types of health care. She stated that CBO is not aware of empirical evidence that directly links AOMs to reductions in other health care spending. Given that GLP-1s for weight management indications and other AOMs are relatively new, the data needed to make these determinations may not yet be available. However, CBO is examining other types of evidence, including simulation models used to estimate how a decrease in BMI affects spending on other types of health care. Duchovny highlighted that this evidence indicates reduced spending as BMI decreases. Additionally, CBO is reviewing evidence of the effects of bariatric surgery, an intervention that can result in significant weight loss, on other health care spending.

Given the rapidly evolving nature of this area of medical development and research, a CBO team is analyzing studies and communicating with experts, said Duchovny. As CBO continues to monitor trends in AOM use, prices, effects on health, and coverage by insurance plans, specific research would be especially valuable. In an October 2023 CBO blog post, the agency called for new obesity research (Swagel, 2023). Duchovny outlined that CBO is requesting research on (1) factors affecting the use of AOMs, such as takeup rates and patient adherence to drugs on the market; (2) expectations about the prices and effectiveness of AOMs being developed; and (3) near- and long-term clinical impacts—including health benefits or complications—and their effects on patient use and spending on other medical services.

THE EMPLOYER PERSPECTIVE: ENSURING COMPREHENSIVE CARE FOR THE WORKFORCE

Shawn Gremminger, National Alliance of Healthcare Purchaser Coalitions (National Alliance), reviewed employer survey results of obesity treatment coverage and trends and outlined the National Alliance obesity treatment employer position statement, recommendations, and guide for AOM coverage. A nationwide nonprofit organization, National Alliance represents 45 individual employer purchaser coalitions composed of private-sector purchasers, union organizations, and purchasers for public-sector

institutions, such as school districts and city, state, and federal governments. These coalitions spend more than $400 billion annually on health care for approximately 45 million people. In fall 2023, National Alliance conducted an annual survey of approximately 175 large and medium-sized employers nationwide that included a battery of questions regarding AOM coverage. Gremminger noted that although this panel is not fully representative of all U.S. employers and purchasers, it indicates some practices and trends regarding AOMs. The survey found that 80 percent of employers offer lifestyle programs for obesity, and 68 percent offer coverage for bariatric surgery. Coverage of GLP-1 medications was lower, at 36 percent, with an additional 20 percent considering adding it within the next 3 years. Gremminger underscored that nearly one half of employers indicated they are not considering GLP-1 coverage or need more information before considering it.

Gremminger described coverage of AOMs, and GLP-1s in particular, as garnering tremendous interest from members. In response to the volume of questions regarding AOM coverage, National Alliance developed the National Obesity Advisory Council to sort through member queries and provide input on recommendations and considerations for self-funded health plan decision making. The council, composed of industry experts, medical advisors, and various coalitions from across the country, met throughout 2023. In February 2024, it released an employer position statement, employer recommendations across four pillars, and a guide for AOM coverage decisions. The employer position statement reaffirms that obesity is a chronic disease that affects more than 40 percent of the U.S. population and is linked to numerous comorbid conditions. He said that this framing facilitates employer understanding that obesity shares similarities with other chronic conditions that employer plans cover. Gremminger outlined that the position statement encourages employers to (1) develop comprehensive guidelines for interdisciplinary obesity care, (2) create reimbursement structures for providers offering obesity care consistent with emerging standards of practice, (3) enable individualized treatment plans and realistic expectations and goals, and (4) include behavior modification programs to support mental and physical health and well-being.

The employer recommendations are organized across four pillars, Gremminger noted. The first pillar, “Engage Through Obesity Science,” recommends that employer and purchaser coverage processes align with an evolving standard of care and the science of obesity. Gremminger said that some employers have created arbitrary lifetime caps on the total dollar amount of coverage, which is not consistent with scientific consensus. The second pillar, “Design for Affordable, Equitable, and Sustainable Impact,” includes recommendations based on the understanding that GLP-1s are expensive. Employers are concerned with maintaining a healthy workforce and offering competitive benefits packages, and the health and welfare of

people 10, 20, or 30 years into the future is not a primary focus. Contracts are short term, and employees will remain with a specific employer for a limited amount of time. Thus, considering long-term health effects is a challenge for many self-funded employers, said Gremminger. The third pillar, “Personalize for Shared Decision Making and Shared Responsibility,” recommends that employers and purchasers provide employees with access to a variety of interventions, including medications, coaching, and lifestyle changes. The emphasis on shared responsibility highlights that employees should use multiple interventions, given that AOM treatment is most effective in tandem with lifestyle interventions. The fourth pillar, “Integrate into Culture of Health and Wellbeing,” recommends creating an environment that supports healthy behaviors, Gremminger stated.

National Alliance also put forth a guide to coverage decisions for AOMs, said Gremminger. The guidance includes four approaches: full coverage for FDA-approved indications, coverage with conditions, use of centers of excellence, or no coverage. It outlines the pros and cons associated with each approach. He said that many employers are considering or opting for the coverage with conditions approach, which acknowledges the benefits of GLP-1s and allows access only for those with certain eligibility criteria. Some employers can access lower negotiated prices for GLP-1s through their pharmacy benefit managers, but other employers cannot; thus, the guide acknowledges the appropriateness of employers considering their specific conditions while encouraging a context of benefits for obesity care. Gremminger noted that some employers are considering providing coverage for AOMs when prescribed by centers of excellence, thereby ensuring treatment from a specialized network with a full range of tools. Many employers are experimenting with AOM coverage or exploring questions regarding the long-term costs, treatment duration, and cost trajectory. He commented that greater market competition will not necessarily result in decreased negotiated prices, given the involvement of pharmacy benefit managers, who may not ensure that prices are lowered, and the incentives for some parties to keep prices high. Gremminger anticipates that small proportions of employers will offer full or zero coverage of AOMs, whereas the majority are likely to offer them to specific subsets of individuals within a larger strategy of behavior modification interventions.

The Strategies to Overcome and Prevent Obesity Alliance designed a comprehensive obesity benefit with input from experts and key stakeholders, including employers and payers, said Gremminger. It is consistent with emerging evidence-based standards of care and features five elements: screening and prevention, IBT, pharmacotherapy support, bariatric surgery, and weight maintenance. The Office of Personnel Management, the federal government’s chief human resources agency and personnel policy manager, has adopted this design for the 8.2 million federal employees, retirees, and family members for whom it manages health insurance benefits, he added.

both scenarios, but more stringent inputs reduce the subset of the population treated, resulting in a lowered total value compared to modeling for 100 percent uptake and adherence. She added that she and colleagues have found that weight loss generates value even if weight is regained, provided that it is regained slowly. In modeling a scenario in which patients experience a slow, steady regain through their mid-60s, then begin to experience the typical weight loss, the trajectory from the one-time shift in weight continues to yield overall value. Ward noted that value is lost when patients regain all weight within a year. This finding can inform considerations for supporting patients with a broader range of therapies at the withdrawal of AOMs. Uptake rates for AOMs are not known. Ward described how her team opted to model 100 percent uptake rather than use historical data due to the revolutionary nature of new AOMs in terms of their effectiveness and limited side effects. The team anticipates that as access to AOMs expands, people will demonstrate more eagerness to take them than has been the case for historical treatments, said Ward.

An audience member asked whether past microsimulations have correctly predicted the outcomes of health interventions. Parekh noted that the helpfulness of any model is limited to the strength of the data and assumptions it is modeling. Given that the microsimulation of AOM coverage scenarios involves overarching assumptions related to the price, uptake, and potential health benefits of the drugs and associated reductions in health care costs, Parekh asked about the factors that carry the most uncertainty or may be least understood. Ward replied that every equation is validated using in- and out-of-sample data, and the medical costs equations have been validated using historical data to examine and predict out-of-sample data, making this a strong model. She explained that she and colleagues worked to remove the least predictable elements, which informed the choice not to model uptake. The team makes no claim of modeling what the future will look like, she added, noting that uptake is uncertain. Rather than attempt to predict rates in various coverage scenarios, the model assumes 100 percent uptake as a thought exercise in examining potential value. Ward reported that the team has looked at other therapies, such as statins, to examine price, value created over time, and value proportions gained by patients, society, and manufacturers. For AOMs, future price and uptake remain highly uncertain; therefore, Ward and colleagues did not attempt to predict them by inputting estimated values.

Ward noted the availability of numerous examples of the effects of competition on drug prices. For instance, when Sovaldi was introduced for hepatitis C, the price was approximately $1,000 per pill and $90,000 per treatment course. However, one additional competitor caused prices to decrease by 50 percent within a year. She said that it is not yet known how the availability of tirzepatide will affect Wegovy (semaglutide) prices.

Furthermore, if broader AOM access is negotiated, manufacturers would desire formulary placements. Ward stated that sudden access to a much higher volume of patients deprioritizes the price per injection in favor of total revenues. Opportunities for negotiations and innovative contracting arrangements between payers and manufacturers could increase the numbers of patients on AOMs, she added.

Comorbidity Considerations in AOM Coverage Calculations

Given that additional indications for AOMs are emerging, such as kidney and liver disease, an audience member asked whether CBO considers future indications in modeling. Duchovny replied that CBO tracks RCT and FDA approvals. She noted that FDA approval for a new indication for a medication, such as with Wegovy recently for cardiovascular disease, does not affect CBO projections until the Centers for Medicare and Medicaid Services (CMS) allow coverage for it under that indication. When CMS does so, the projections account for this change by shifting people with the condition, who are now eligible for coverage, out of the population that would become newly eligible with passage of a policy such as TROA. This decreases the cost of TROA, given that fewer people will gain eligibility for GLP-1 coverage who do not already have it for other indications. However, a greater number of people taking AOMs increases Medicare baseline spending, Duchovny explained. Parekh asked when CBO expects HHS to negotiate the price of semaglutide and what effects it could trigger. Duchovny replied that Wegovy and Ozempic are both formulations of semaglutide, but sales of Ozempic have been higher; that could trigger price negotiation, which would cause the net prices for semaglutide to decrease. Moreover, CBO expects this negotiation to generate price reductions in similar drugs, and Duchovny predicted that this negotiation could occur in the next few years.

Noting that untreated obesity may lead to diabetes, an audience member asked whether CBO considered that passage of TROA could decrease the number of Medicare beneficiaries who develop diabetes—who would become eligible for GLP-1 drugs under current policy. Duchovny replied that the baseline calculation under current law factors in treatment for future diabetes cases. She explained that this does not affect the cost estimate of TROA that predicts increased spending in comparison to current law. The assessment of a policy such as TROA considers populations that would gain eligibility for AOM coverage under the new law—and therefore does not include people who are covered—and includes savings from reductions in other health care spending from improved health, said Duchovny. Ward said that the efficiency of coverage should be considered as follow-on indications for AOMs to expand to include cardiovascular disease, chronic

kidney disease, or other diseases. She emphasized the value generated by treating people before they develop chronic conditions and the associated cost savings from not having to treat expensive conditions. The inefficiency of withholding access to AOMs until patients develop chronic conditions eliminates part of the value proposition of coverage, said Ward.

The Intersection of Health and Treatment Cost

Noting the focus that employers and payers place on short-term return on investment for AOM coverage, an audience member pointed out that hypertension and diabetes medications are covered without immediate cost savings from short-term health benefits and asked how to shift the narrative on obesity treatment to emphasize issues of medication affordability and health effects. Duchovny said that the focus of CBO’s role in the legislative process is on economic effects, but policy makers take other considerations into account when proposing new policies, and a chief consideration of AOM coverage is demonstrating improvements in health. Ward replied that the turnover rate among insurers is typically 4 years or less; this is often viewed as a disincentive to pay for treatments for beneficiaries, who will likely be on a different plan by the time long-term health benefits are realized. She acknowledged that access and coverage for treatment in other disease spaces, such as hypertension and diabetes, is closer to universal and that a focus on the value created by AOMs beyond cost offset could foster a shift toward broader coverage. Ward noted that policy is a mechanism for instituting change. For instance, in 2018, USPSTF assigned ratings to weight management therapies in preventing comorbid conditions. However, many of the new AOMs were not yet available to be included. A high rating from USPSTF could lead to mandated coverage for private insurers through the Affordable Care Act. Ward stated that such a development would bridge the “free rider” issue for employers.

Gremminger noted that efforts to decrease the cost of AOMs could improve the cost–benefit assessments that employers and purchasers consider when balancing plan expenses against competitive benefits and a healthier workforce. He emphasized that manufacturers and pharmacy benefit managers have substantial influence on whether AOMs are more accessible and affordable, but their priority appears to be continuing the profitability of GLP-1s. He added that the effects of increased competition on the AOM marketplace are not yet known. Without reducing prices, a policy mechanism that allows employers to offset some of their costs could address the “free rider” problem. Ultimately, downstream effects of AOMs will save taxpayers money as people move from private coverage into Medicare, said Gremminger. For instance, people who receive GLP-1s for obesity as a chronic condition at 55 will constitute a healthier subpopulation when they enroll in Medicare in 10 years, which will lower their Medicare costs.

Thus, were the federal government to help employers provide GLP-1 access to people in their 50s, it would recoup Medicare savings. In contrast, employers do not have an incentive to reduce Medicare costs when employees age into the program, Gremminger pointed out.

Given that the Medicare Part D budget for prescription drug spending exceeds $200 million—with approximately 10 percent spent on cancer drugs and 15 percent on cardiovascular disease medications—obesity treatment with new AOMs could easily become its largest spending category, said Arterburn. He asked if society should consider where obesity treatment ranks in terms of health care spending on chronic conditions. Gremminger emphasized that GLP-1s could potentially generate enormous savings by averting diseases that are expensive to treat. He said that a comparison of obesity with cancer and cardiovascular disease should focus not on parity in spending but instead on whether increased spending on obesity treatment leads to decreased spending on the other conditions. Gremminger added that the $25,000 annual cost of a family insurance plan is challenging for employers to cover and that increased medical spending will further strain budgets unless it is offset by savings. Ward said that the value of obesity treatment is tremendous and should be used as the threshold, as has been the case for other therapies, rather than a narrower threshold of cost neutrality or cost savings.

Projected AOM Utilization

Noting numerous current barriers, an audience member asked about anticipated estimated rates of AOM utilization and the time frame for achieving a steady state, a point at which more realistic assumptions could be modeled. Ward stated that expanded access may reveal that AOMs work better for some people, are more likely to cause complications in certain people, or have cross indications. Furthermore, not all people will be amenable to injections, the current route of delivery for GLP-1s. In addition to these possibilities, other aspects of AOM treatment that impede utilization rates could emerge. Ward stated that the most successful way to treat obesity is to use an array of options, because it is unlikely that all eligible people will opt for AOMs should access be made available. Parekh highlighted the importance of health care professionals, coverage, and payment policies in creating access to evidence-based innovations.

CLOSING REMARKS

Ihuoma Eneli, University of Colorado School of Medicine and vice chair of the Roundtable on Obesity Solutions, highlighted suggested calls to action featured during the workshop. The first session explored the state of pharmacokinetics and pharmacology for obesity and future treatments

in the drug development pipeline (Chapter 2). The speakers in this session identified the need for studies on medication approaches to improving body composition. Discussion of the nonlinear nature of pharmacokinetics and the effect of lipophilic drugs on increased selective solubility in excess adipose tissue suggested that sponsors should address drug disposition and the effects of obesity early in drug development. A decision tree and MIDD can help in planning studies. Eneli noted that people with obesity should be enrolled in phase 2 and 3 clinical trials. Additionally, stakeholder engagement across sectors, including people with lived experience, clinicians, pharmacotherapy experts, and advocacy experts, should be a component of planning studies.

Speakers in the second session focused on advancing optimal obesity treatment and the intersections between various therapies, such as medical management, bariatric surgery, lifestyle modification, nutrition, and physical activity, said Eneli. Speakers suggested that obesity treatment access and education should be improved. Increasing access to pharmacotherapy and other obesity treatments for a broader number of patients will involve engaging non-specialist providers and addressing weight bias and stigma in all treatment settings. Addressing deficits in obesity and nutrition education in medical education curricula is a method of reaching medical professionals early in their development. Food noise is reduced by AOMs, such as GLP-1s, which may be a compelling reason for patients to initiate and maintain treatment, and more research is needed on this. She noted that research for adult and pediatric populations should consider including broader samples with mental health comorbidities, creating a system of screening and monitoring youth with mental health diagnoses who are prescribed AOMs, and optimizing outcomes assessment in youth with psychosocial measures. Furthermore, AOMs should be evaluated in conjunction with health lifestyle programs and other treatment options, Eneli stated, adding that the risks of AOMs should be assessed, especially regarding the rapidity and extent of weight loss.

The possibility of creating a consortium to address several AOM research areas was raised during the second session, Eneli noted. It included a discussion of the need to reframe the assessment of lean muscle mass from a focus on volume to muscle quality. The role of fitness and activity in preserving and improving the quality of lean muscle mass during AOM treatment should be considered in trials and clinical care. Valid and reliable measures of body composition are needed that include measures of lean mass, muscle mass, and bone health and proxy measures for muscle quality, such as grip strength. Eneli highlighted that AOM knowledge gaps include how to conceptualize obesity in the context of health, identifying and defining the goal of obesity therapy, circumstances in which the cost–benefit of AOMs is sustainable, the integration of older AOMs with

more recent drugs, the role of lifestyle treatment in the context of AOMs, whether AOM treatment should start early or be held until complications develop, and understanding the optimal tempo of weight loss and whether it can be too rapid or extensive.

The third session explored approaches to navigating clinical practice, economic, and policy challenges related to new obesity treatment, said Eneli. The authoritative body to define the predominant guideline or standard of care has yet to be established. Examples of regularly updated standards of care include those from the American Diabetes Association and Canadian Medical Association. She noted that the continual updates to Canadian guidelines enable them to avoid the limitations of a specific evidence time frame and the pitfalls that have been created for other recommendations. Eneli emphasized that combined pharmacotherapy and lifestyle interventions are most likely to yield optimal outcomes, and AOM treatment should not ignore environmental factors. The RE-AIM framework can be applied to obesity treatment to advance implementation and study AOM effects in pediatric populations. The third session explored modeling of AOM economic costs and benefits, the CBO assessment of TROA, and AOM data requested by CBO to improve projections. Eneli underscored the importance of encouraging a whole-person health approach and noted the need to consider reimbursement for providers offering lifestyle and behavioral treatment plans and other obesity care consistent with standards of practice. Modeling indicates that expanding Medicare coverage of AOMs would generate $176 billion in Medicare cost offsets and over $1 trillion in social benefits in the first 10 years, and these benefits would grow over time. She described this moment as an inflection point in which data collected should be acted upon in research, clinical care, advocacy, and medical education to move the field of obesity care forward. Eneli ended the workshop with a quote from Johann Wolfgang von Goethe, “Knowing is not enough; we must apply. Willing is not enough; we must do.”

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