Obesity is one of the fastest evolving commercial opportunities in the pharmaceutical industry – yet access, pricing, and reimbursement remain major barriers for manufacturers and patients. In this article, Louise Maddison (Senior Consultant – Global Pricing and Market Access, Petauri Evidence) explains how shifting disease recognition, payer expectations, and real-world evidence are reshaping the landscape, and what manufacturers must do to secure sustainable access and long-term value, globally.
Obesity rates have increased dramatically over the last 30 years, with estimates of more than 1 billion people now living with obesity – or 1 in 8 people globally, making it a significant public health threat. From 1990 to 2022, global obesity rates more than quadrupled in children, nearly tripled in men, and more than doubled among women (1).
High prevalence of obesity has a significant impact on healthcare systems, with associated complications driving expenditure in every category of care. It is expected that half of the world’s adult population will be living with a high body mass index (BMI) by 2035 and that the global economic impact will reach US$4.32 trillion annually. This is roughly equivalent to the entire annual Gross Domestic Product (GDP) of Germany (2).
In adults, a BMI ≥30 kg/m2 is defined as clinically obese (3). Obesity is associated with increased risk of various metabolic, cardiovascular, and skeletal comorbidities, as well as cancer and psychosocial health (4,5).
Medical weight management is one treatment option. Recent drug advances have led to modern obesity therapies that are highly effective, revolutionizing treatment alongside lifestyle changes in diet and exercise. These new therapies also offer options for those who are not candidates for bariatric surgery, which remains the ‘gold standard’ for weight loss.
When obesity is recognized as a disease, not only is the social stigma reduced, but healthcare systems can establish frameworks for their activities and pathways for treatment.
Recognition of the disease brings it to the attention of policymakers and the public, and enables education programs for healthcare professionals to receive time and budget. It also facilitates creation of reimbursement and access routes for Pharmaceutical and Medtech interventions.
Several medical and healthcare organizations such as the World Health Organization, American Medical Association, and US Centers for Disease Control and Prevention now consider obesity to be a chronic disease.
In some countries, however, there is debate over its classification. In the UK, obesity is not formally classed as a disease for several reasons including that the evidence base is considered too weak (e.g., no symptoms are unique to obesity), there is a lack of agreed diagnostic criteria, and there are limitations to using BMI as a diagnostic tool (6,7).
Anti-obesity medications (AOMs) are now an acceptable part of the treatment landscape. Prior to these medications being made available, there were very few effective and durable interventions to reduce body weight and target the increased cardiovascular risk of obesity.
Despite the clinical benefits for those with obesity and the broader benefits to the healthcare ecosystem and wider economy, coverage and reimbursement of AOMs have historically been limited and remain challenging. With an ever-growing eligible population for long-term use of these innovative medicines, the potential high costs to payers and healthcare systems are difficult to bear.
Indeed, Bernard Sanders, in his role as the Chair of the US Senate Committee on Health, Education, Labor and Pensions (HELP), released a report that modeled the impact of AOM prescriptions. This model demonstrated that AOM spending could bankrupt the US healthcare system, with estimates of more than US$411 billion per year if uptake was at 50% of adults with obesity (8).
Similarly, Canada’s Drug Agency (CDA-AMC) estimated that, based on public list prices, the budget impact for one AOM in a narrower indication of obesity with pre-existing cardiovascular disease could exceed CA$3.5 billion over 3 years (9).
However, if AOMs are viewed through the wider lens of macroeconomics with benefits to the healthcare system, population health, and economy, there are substantial gains for payers to realize.
Economic modeling undertaken by the Tony Blair Institute in the UK suggests that faster and broader access to AOMs could deliver cost-benefit neutrality by 2035, with net gains in following years, leading to a cumulative saving of £52 billion by 2050 (10).
Despite the evidence base for these therapies, there are a variety of reasons for the lack of reimbursement for AOMs in different markets; however, pressure is mounting on policymakers to expand access.
In Germany, AOMs are excluded from the statutory health insurance system as they are viewed as ‘lifestyle drugs’. Italy and Spain take a similar stance. Paradoxically, these countries do recognize obesity as a medical condition, yet there is little in the way of policy to support treatment of the disease, and payers may eventually shift their thinking towards reimbursement of AOMs (11-13).
In France, the Haute Autorité de Santé (HAS) has issued favorable opinions on the reimbursement of glucagon-like peptide-1s (GLP-1s) in obesity, but under strict criteria:
Since June 2025, however, access to AOMs has broadened. French general practitioners (GPs) are now able to prescribe these medications, rather than just hospital specialists (14).
The Netherlands is taking a cautious, evidence-first approach to access. Zorginstituut Nederland (ZIN) has begun a new assessment of GLP-1s for obesity to determine if they should be included in the basic health insurance package (15). Previously, these drugs were excluded based on lack of long-term data on health benefits. ZIN will focus on two patient populations: those with BMI >30kg/m2 and related health conditions (e.g., heart failure, chronic kidney disease), and those with severe obesity, i.e., BMI >35 kg/m2.
The approach by HAS and ZIN demonstrates that health technology assessment (HTA) bodies may consider different target populations (e.g., higher BMI, greater number of comorbidities) than the European Medicines Agency label, targeting patients with the highest unmet need, but further restricting access.
In the US, Medicare was prohibited from offering coverage for AOMs by law due to older AOMs having extremely poor safety profiles. However, from mid-2026, injectable GLP-1s will be covered for non-obesity indications as part of Most-Favored-Nation (MFN) policy (16,17). Additionally, coverage was extended for new oral GLP-1s for obesity, prior to approval by the US Food and Drug Administration (FDA).
Unfortunately for patients, many US health insurers are dropping AOMs from coverage due to cost challenges (18). Recently announced cost-cutting strategies from US insurers have included the requirement to complete a 6-month behavioral modification program before accessing AOMs, and narrowing coverage using a high BMI (>40 kg/m2). As an alternative strategy, some insurers are exploring the use of outcomes-based agreements.
When Canada’s CDA-AMC recently revisited the assessment for an AOM, new clinical information based on a cardiovascular outcomes trial provided enough evidence for them to recommend reimbursement. However, uncertainty remained over long-term patient benefits (9).
Across markets, people with obesity are tired of waiting for AOMs to be reimbursed, and are eager to pay out of pocket (OOP). AOMs are becoming the driving force for changing how treatments are accessed via the emerging frontiers of the private self-pay market and direct-to-patient platforms. The downside is the risk of greater healthcare inequity since, for many people, paying privately for AOMs is not an option.
If payers do cover the use of these drugs, then there are often restrictions to access. These can include:
Further evidence demonstrating long-term effectiveness and safety could be required before greater coverage and reimbursement is allowed; however, innovation needs to be balanced with affordability.
Global shortages of AOMs, seen through 2024 and the start of 2025, have now mostly been resolved as industry has worked to increase their manufacturing capacity to meet the demand.
Despite supply chain gaps being closed, regulators in Europe and the US recently warned against the ‘sharp rise’ in counterfeit versions of branded AOMs. As reported in the British Medical Journal (BMJ), one of the factors driving UK patients to seek medication through the black market is the recent price hikes in the direct-to-consumer market (20). UK private direct-to-consumer prices have risen to close the huge gap in AOM prices, which previously varied by more than tenfold, between the US and Europe (8).
Pricing is likely to remain challenging globally. Whilst some may look to the US administration’s MFN approach to reduce prices, this may not achieve its intended objectives. The Trump administration aim to compel manufacturers to align US prices with those in other markets across a wide range of medications. Instead, we may find ex-US prices for new products converge upward toward the higher US price benchmark.
Therefore, it will be interesting to see if US health insurance plans consider innovative contracting solutions such as outcomes-based agreements to link coverage and reimbursement to real-world evidence. Such agreements are often used in Europe, but high prices coupled with significant demand for AOMs could drive a shift in strategies for access in the US.
As part of the next generation of AOMs, the first oral GLP-1 was launched in January 2026. Over the next few years, a variety of new AOMs will launch featuring different and multiple mechanisms of action (e.g., triple agonist), available as monotherapies and combination therapies, and offering the convenience of oral administration instead of injections (21).
However, within a crowded market, drug efficacy alone will not be enough to convince payers to provide access and reimbursement. Payers will increasingly rely on real-world outcomes to demonstrate value, especially within financially constrained healthcare systems that are facing chronic pharmacotherapy at population scale.
With the potential for patients to choose from a diverse therapeutic landscape, treatment will become more tailored to their needs. Further personalization combined with data-driven approaches may enable manufacturers and healthcare systems to overcome some of the current challenges with AOMs, including variability in responses, side effects, and long-term adherence. Incorporating digital support, data analysis, and behavioral interaction into the patient journey will be critical to generate evidence to demonstrate value to payers beyond efficacy.
Additionally, evidence demonstrates that patients who stop taking AOMs return to their original weight and lose cardiovascular benefits within 2 years (22). Therefore, healthcare systems need to consider the impact of a wave of patients coming off AOMs, and how weight loss and health advantages can be sustained after discontinuation.
AOMs, especially incretin-based therapies, are increasingly being explored for indications beyond type 2 diabetes and weight management, including:
These expanding indications demonstrate the importance of such medications in managing comorbidities and the future positioning of AOMs (23,24).
Access to innovative AOMs will likely remain challenging due to high prices and demand from the eligible patient population. Furthermore, as more AOM treatment options are launched, it is expected that increased competition will reduce prices. As older medicines lose patent protection, further downward pressure could be exerted on prices making these medicines more affordable.
However, payers will continue to manage spending via stringent step edits, narrow indication-based coverage, and value-based contracting. Wider consideration should be given to the valuable positive societal impact of reducing healthcare costs and increasing workforce productivity from obesity and associated comorbidities.
Manufacturers will need to start their launch planning early, shifting their thinking beyond traditional playbooks that consider the drug alone. Integrated care models, data-driven outcomes, and patient-centric journeys will be key to demonstrating and sustaining long-term value.
To explore how to optimize your launch success with our experts, email evidence@petauri.com.
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