COMMENTARY

Bartolome Burguera, MD, PhD Marcio L. Griebeler, MD W. Timothy Garvey, MD

Chief, Medical Specialty Institute, Department of Endocrinology and Associate Director, Department of Nutrition
Cleveland Clinic, Cleveland, OH; Chair, Metabolism, Cleveland Clinic, Cleveland, Sciences and the University of Alabama
Department of Endocrinology and OH; Assistant Professor, Cleveland Clinic at Birmingham Diabetes Research Center,
Metabolism, Cleveland Clinic, Cleveland, Lerner College of Medicine of Case Western University of Alabama at Birmingham,
OH; Professor, Cleveland Clinic Lerner Reserve University, Cleveland, OH Birmingham AL; Professor, University of
College of Medicine of Case Western Alabama at Birmingham, Birmingham AL
Reserve University, Cleveland, OH

Effective but inaccessible antiobesity

medications: A call for sharing
responsibility for improving access
to evidence-based care
he treatment of obesity is problematic for sev- Over the past 3 years, regulatory approval has been
T eral reasons. Obesity, obesity complications, and
obesity-related diseases are highly prevalent and exact
given to new second-generation medications with
mechanisms of action based on agonism of glucagon-
huge social costs. At the same time, we have medica- like peptide-1 (GLP-1) and other nutrient-regulated
tions of unprecedented efficacy with lifesaving poten- hormones. Two such medications, semaglutide and
tial, but these medications remain inaccessible to many tirzepatide, have achieved weight reductions of up to
patients because of high costs and other factors. This 20% in phase 3 clinical trials.5,7 Second-generation
situation is untenable and should be unacceptable to medications are more effective in preventing type 2
patients, healthcare professionals, and society at large. diabetes and improving lipids, blood pressure, and qual-
ity of life. Semaglutide also ameliorates nonalcoholic
■ THE CONUNDRUM OF OBESITY TREATMENT steatohepatitis and heart failure with preserved ejection
fraction, prevents cardiovascular disease events,8 and
Obesity exacts a huge burden of patient suffering slows the rate of the decline in renal function in patients
and social cost. Obesity affects 42% of US adults,1 and with cardiometabolic disease.9
worldwide its prevalence is rising.2 Because obesity is a Despite advances, second-generation medications
chronic condition, complications and related diseases remain unavailable to large numbers of patients.
are also common and are responsible for extensive mor- These medications have expensive price tags (approxi-
bidity and mortality. These include type 2 diabetes, mately $1,000 per month) in the United States.10 Many
hypertension, dyslipidemia, obstructive sleep apnea, healthcare systems, regulatory agencies, and the federal
osteoarthritis, cardiovascular disease, and cancer.3 In government regard obesity as a lifestyle choice and not
2016, the total cost of chronic diseases attributable to a disease, and therefore do not recognize the impact
obesity and overweight was $1.72 trillion.4 As a risk of excess adiposity on health.11 On the other hand,
factor, obesity accounts for 47.1% of the total direct many insurers and employers who sponsor insurance for
and indirect costs of chronic diseases nationwide.4 their employees regard obesity as a chronic condition
New medications to treat obesity are trans- that causes comorbidity and increases cost. The conse-
formational in terms of efficacy and safety.5 First- quences of obesity are remote, and it can take years for
generation obesity medications approved in 2014 or significant medical issues and costs to materialize. Given
earlier include phentermine, orlistat, phentermine- the current bankrupting costs of GLP-1 analogs, most
topiramate extended release, naltrexone-bupropion, insurers are waiting for the price of these medications
and liraglutide. Despite the proven clinical benefit of to drop before treating everyone who meets the broad
these drugs, average weight loss is generally less than US Food and Drug Administration (FDA) criteria.
6% to 10% in clinical trials.6 Payers and healthcare systems are unwilling to
doi:10.3949/ccjm.91a.24068 cover the cost of medications required for long-term
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ANTIOBESITY MEDICATION ACCESS

therapy of obesity. This bias runs counter to the scien- advanced care professionals, as well as dietitians, exer-
tific basis of obesity as a chronic disease with genetic cise physiologists, psychologists, and social workers,
determinants and pathophysiologic interactions that with availability of referral to sleep specialists, bariat-
involve satiety factors and central nervous system feed- ric surgeons, and other specialists as needed. Patients
ing centers that generate and sustain excess adiposity. should be encouraged to ask their physicians and other
caregivers what evidence-based therapeutic options are
■ SHARED RESPONSIBILITIES: A CALL TO ACTION available to treat their obesity.
Since publication of the American Association of Primary care physicians
Clinical Endocrinology obesity treatment guidelines Obesity is a chronic condition that requires long-term
in 2016,3 all evidence-based professional guidelines treatment and follow-up. The patient’s primary care
have advocated a complications-centric approach to physician should seek information regarding current
obesity management and have recommended that approaches to obesity management and treatment
obesity medications be available in individualized options. Consultation with colleagues who can help
care plans. address obesity in the context of multidisciplinary
Multiple headwinds prevent patients’ full access to care is also advised. Clinicians who are uncomfortable
recommended evidence-based care, including second- addressing obesity and its complications should refer
generation medications. Foremost is the problem of patients to colleagues who actively treat obesity. For
bias and stigmatization at all levels, including patients, primary care physicians who treat patients with obe-
healthcare professionals, healthcare systems, and soci- sity, effective medications should be a readily available
ety.12 Internalized bias precludes the patient from acting therapeutic option, and the clinician should be famil-
as a care partner. Bias among medical professionals iar with the pharmacology, indications, cautions, and
against obesity as a treatable disease leads to indifferent potential side effects. Consultation with the patient
engagement of patients, and as a result, healthcare should include discussion of realistic expectations and
systems are disinclined to provide infrastructure and potential weight-loss outcomes associated with each
access for coordinated multidisciplinary obesity man- medication. Importantly, all healthcare professionals
agement programs. At the level of society, bias limits should interact with patients with empathy and respect.
effective health messaging and inhibits the develop-
ment of an effective built environment and a regulatory Specialty care
environment that can ensure the viability of prepared Obesity specialists, endocrinologists, and bariatric
healthcare systems, the training of enough healthcare surgeons should address the more complicated cases
professionals, and broad access to care. of obesity. Their roles might include coordinating
It is time to move on from the environment of criti- multidisciplinary teams as well as training and con-
cism among patients, physicians, insurance companies, sultation for their primary care colleagues. Patients
food companies, pharmaceutical companies, and fed- should be referred for bariatric surgical procedures when
eral agencies to ensure access to comprehensive care appropriate, and bariatric surgeons should engage in
and the antiobesity medication armamentarium for programs for proper evaluation of patients and have
patients living with obesity.13 All stakeholders need sufficient training and experience to ensure optimal
to share responsibility and engage in concerted action. outcomes and follow-up. Given the current price of
antiobesity medications, bariatric surgery is more cost-
Patients effective.14 All healthcare professionals should advocate
Every patient deserves to be treated with respect for patients and the need for access to the full spectrum
while their disease is appropriately evaluated and the of management options in their healthcare systems, in
full spectrum of therapeutic options is considered. interacting with payers, and in society at large.
Patients should be informed and empowered to par-
ticipate with their healthcare team in the therapeutic Healthcare systems
plan and should be provided the knowledge and tools Healthcare systems and their leaders should provide
they need for long-term success. Given the necessary the infrastructure for coordinated multidisciplinary care
support and information, patients are responsible for programs over the lifetime of patients who live with
lifestyle modifications that improve nutrition, such as obesity, including the full spectrum of evidence-based
reduced consumption of processed food and increased care and treatment options.15 They should ensure that
physical activity. Support should be delivered by an patients have access to affordable care and receive it.
interdisciplinary team that can include physicians and It is their responsibility to maintain adequately trained
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 BURGUERA AND COLLEAGUES

TABLE 1
US list prices (monthly cost) of second-generation antiobesity medications compared
with selected other countries
United United
States Spain Denmark Netherlands Kingdom Japan Canada Dubai
Semaglutide $1,349 $314 $343 $296 $233 $69 $388 $326
2.4 mg
Tirzepatide $1,069 $400 $632 $444 $162 $319 $104 $472
10–15 mg

Information based on web searches, direct pharmacy pricing information, and reference 22.

healthcare professionals and support continuing medical Services (CMS) announced20 that health plans in the
education, informatics, and process improvement based Medicare Part D program will start providing limited
on outcomes, together with community-based preven- antiobesity medication access to patients with obesity
tion efforts. Leadership should advocate for affordable and preexisting cardiovascular disease (the good news),
medication prices with insurance companies, pharmacy but not for obesity per se, which of course is the underly-
benefit managers, regulators, policymakers, and govern- ing problem (the bad news). About 3.6 million Medicare
ment agencies. beneficiaries (7% overall) had established cardiovascular
disease and obesity or overweight in 2020.21
Employers The CMS recently began to implement its first round
A workplace environment that promotes employee of Medicare drug price negotiations under the Inflation
health is essential, particularly for managing obesity as Reduction Act (IRA). The IRA allows for negotia-
a chronic disease. A setting that encourages physical tions between CMS and pharmaceutical companies for
activity, balanced nutrition, and mental wellness can the cost of medications covered by Medicare Part D to
help employees maintain a healthy lifestyle, improve establish the maximum fair price for each drug. It is
productivity, and decrease absenteeism. expected that the IRA will contribute to reduced drug
costs for CMS and other payers. However, the negotia-
Third-party payers
tions do not consider the disproportionate costs paid by
A limited number of insurance companies and self-
the United States compared with other countries (Table
insured employers provide coverage for obesity care
1).22 Further, the first 10 drugs selected for negotiation
or antiobesity medications, particularly second-
do not include any antiobesity medications.23
generation medications like GLP-1 receptor agonists.
Third-party payers need to find ways to include
Pharmacy benefit managers are intermediaries between
coverage for all antiobesity medications on behalf of
pharmaceutical companies and the healthcare ven-
patients. The current system of nontransparent nego-
ues. Negotiations between these 2 parties generally
tiations involving pharmacy benefit managers does not
increase costs without adding value.16 About 50 million
appear to be working for patients living with obesity.
Americans with obesity could be eligible for insurance
coverage for semaglutide,17 and about 67% have cover- Policymakers
age for tirzepatide.18 Many of these are required to have There is a clear need for obesity to be considered as a
diabetes for prescriptions to be covered. Each week, chronic disease and its treatment covered by all insur-
US clinicians write more than 500,000 prescriptions ance companies and governmental programs. Policies
for semaglutide and 300,000 for tirzepatide.18 must ensure access and affordable care for obesity. To
In the United States, Medicare Part D does not tackle drug prices, the government recently announced
cover antiobesity medications by statute, and, despite legislative actions in addition to the IRA to lower pre-
having more flexibility, a minority of state Medicaid scription drug costs. The Treat and Reduce Obesity
programs cover antiobesity drugs, but not second- Act,24 introduced in the US House of Representatives
generation medications.19 A few weeks after publication in 2023, would expand Medicare coverage of inten-
of the results of the SELECT (Semaglutide Effects on sive behavioral therapy for obesity. The bill also would
Cardiovascular Outcomes in People with Overweight allow coverage of drugs used to treat obesity under
or Obesity) trial,8 the Centers for Medicare & Medicaid Medicare’s prescription drug benefit.
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ANTIOBESITY MEDICATION ACCESS

Other measures include overriding the patent for the United States are significantly higher compared to
high-priced drugs that have been developed with other high-income countries. The high costs are borne
the help of taxpayer money and letting competitors not only directly by individual patients, but also by the
develop these drugs (known as march-in rights pursu- societies in which those patients live. It is unacceptable
ant to the Bayh-Dole Act). Significantly, no federal that patients in the United States should pay 10 to
agency has exercised its right to march in. This devel- 15 times more than patients in other westernized
opment reflects institutional bias against obesity as a societies.
chronic disease that fundamentally is recognized only Disproportionate costs to societies and regions
in relation to its complications and related diseases. enable drug trafficking. US patients seek antiobesity
medications at lower prices in Canada or Mexico for
Media and health messaging themselves and others. Interestingly, the FDA autho-
Obesity has been a trending topic in social media rized Florida’s drug importation program on January 5,
in recent years, particularly since the launch of the 2024.26 The FDA may authorize proposals from states
more effective second-generation antiobesity medica- or Native American tribes to develop drug importa-
tions. Nearly half of the US adult population wants tion programs under Section 804 of the Federal Food,
to lose weight,25 and there is growing awareness of Drug, and Cosmetic Act (ie, Section 804 Importation
effective recently approved antiobesity medications. Programs) that allow them to import certain drugs
Conventional and corporate mass media now more from Canada as long as doing so will provide savings
than ever should provide solid, scientifically based to American consumers and will not present a risk
information and consult with experts without indus- to public health and safety. This seems to be the first
try bias. Messaging to promote a culture of wellness, step on a path to facilitating importation of certain
disease prevention, and information regarding obesity prescription drugs from Canada.
as a disease is urgently needed. Importantly, messaging
should emphasize the use of antiobesity medications in ■ SUBSTANDARD PRACTICES
combination with lifestyle changes to improve health WITH POTENTIAL HARM
in the context of multidisciplinary medical treatment
programs for obesity as a chronic disease.13 Lack of access to care and the high price of antiobesity
medications have given rise to practices that are not in
Pharmaceutical industry the best interest of patients. Counterfeit or compounded
Pharmaceutical and biotechnology companies should semaglutide or tirzepatide, largely produced by unregu-
be thanked and lauded for developing and earning FDA lated facilities, has been found in up to 16 countries and
approval of antiobesity medications. The industry is has been linked to severe hypoglycemia, seizures, and
also responsible for establishing a price structure that thrombosis.27 Neither the ingredients contained in these
allows these medications to be affordable to patients. A compounded preparations nor the quality or concentra-
fair balance between profits and a pricing scheme that tion of the approved medication being emulated can be
allows patients in need access to antiobesity medica- known for certain. Our patients deserve better.
tions has not been achieved. Given the high costs, the Another substandard practice is the online avail-
people most in need of antiobesity medications are ability of obesity medicine prescriptions without
usually the ones with reduced chances of getting them. adequate assessment of the patient’s health status and
Pharmaceutical companies that produce second- evaluation for the presence and severity of obesity
generation antiobesity medications have developed complications and related diseases.28 At best, prescrip-
digital health initiatives for patients that include lists tions are provided to patients by licensed healthcare
of professionals treating obesity and access to online professionals who never see or examine the patient,
pharmacy services that provide a home-delivery option but rather rely on self-report information collected
for antiobesity medications prescribed by their physi- remotely from the patient. Patients are not evaluated
cians. This measure may reduce some of the burdens regarding the impact of adiposity on health. They are
that patients and healthcare professionals endure to given prescriptions without the physical and historical
gain access to antiobesity medications, but it does not data and standard clinical laboratory results required
solve the cost problem or access for patients without for optimal treatment decisions and long-term follow
coverage or financial means. up—standard recommendations in all evidence-based
Important disparities in the price of antiobesity treatment guidelines produced by professional organiza-
medications occur worldwide (Table 1).22 Prices in tions. This is inconsistent with treatment of obesity as
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 BURGUERA AND COLLEAGUES

a chronic disease. Again, patients deserve better. Both health and quality of life. These antiobesity medica-
the American Association of Clinical Endocrinology29 tions need to be used long term, with very frequent
and the European Association for the Study of Obe- weight regain if discontinued. Yet, many patients
sity30 have endorsed the diagnostic term adiposity-based lack access to these medications and to venues for
chronic disease to formalize a complications-centric comprehensive care. Further, healthcare systems in
approach to care directed at improving the health some countries cannot sustain the high cost of second-
of patients by preventing or treating complications generation antiobesity drugs for patients who need
responsible for morbidity and mortality. them. An informed, concerted effort and assumption
As substantiated in treatment guidelines, obesity of shared responsibilities among all stakeholders are
medications need to be provided by a knowledgeable needed to realize the far-ranging and transformative
interdisciplinary team trained in obesity care. Second- benefits of second-generation obesity medications. ■
generation antiobesity medications are powerful and Acknowledgments: Special thanks to the McWilliams Philanthropic
can lead to excessive weight loss beyond the level Fund, Lennon Philanthropic Fund, Cosgrove Transformation Fund, and
Lozick Philanthropic Fund for their support. The authors acknowledge
that achieves goals for improved health. A significant support of the UAB Diabetes Research Center (P30 DK079626) funded by
percentage of this weight loss is muscle mass. Patients the National Institutes of Health.
need to be actively followed over time by professionals
engaged in continuity of care to optimize outcomes, ■ DISCLOSURES
treat or prevent adverse events, preserve and minimize Dr. Burguera has disclosed serving as an advisor or review panel
loss of muscle and bone mass, and manage nutrition, participant and conducting research as a principal investigator for Novo
Nordisk. Dr. Griebeler has disclosed conducting research as a principal
psychological disorders, and subspecialty referrals. investigator for Boehringer Ingelheim and Novo Nordisk. Dr. Garvey has
disclosed consulting for Boehringer Ingelheim, Carmot/Roche, Eli Lilly,
■ CLOSING THOUGHTS Fractyl Laboratories, Inogen, Lilly, Merck, Novo Nordisk, and Zealand
Pharmaceuticals; ownership interest (stock, stock options in a publicly
owned company) for Bristol-Meyers Squibb, Isis, Lilly, and Novartis; serv-
We have medications of unprecedented efficacy and ing as site principal investigator for Carmot/Roche, Eli Lilly, Epitomee
Medical, Lilly, Neurovalens, Novo Nordisk, and Zealand Pharmaceuticals;
safety for treatment of obesity- and adiposity-based and serving as a data monitoring committee member for Boehringer
chronic disease that can be lifesaving and can improve Ingelheim and Eli Lilly.

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ANTIOBESITY MEDICATION ACCESS

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drugs’ features. April 9, 2024. www.healthaffairs.org/content/ Address: Bartolome Burguera, MD, PhD, Medical Specialty Insti-
forefront/medicare-drug-price-negotiations-policy-implications- tute, F20, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195;
first-10-drugs-features. Accessed October 17, 2024. [email protected]

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