 | Horacio Coutino, multi-asset strategist |
Overview
January, with its promises of a new starts and a clean slate, means that millions of people yet again promise themselves that “this is the year I’ll lose the weight and get in shape.” However, diets can be difficult to follow and time-consuming, while finding time to exercise, when there are so many other things to do, becomes lower on the list of priorities. And it can be hard not to be tempted by the “fat jabs”, the drugs like Ozempic and Wegovy making headlines that appear to promise easy weight loss. Are these a worthwhile investment in your physical health? Studies are still being done to determine just how effective these drugs are, for how long, and what the full impact of any side effects may be. So although we can’t answer the question of should you or shouldn’t you take them for your physical health, we’ll do our very best to explain and assess how these medications are revolutionising the healthcare sector and how they may affect your financial health if you are considering them for your portfolio.
Although estimates of the global addressable market for obesity treatments are substantial, previous therapies have failed to generate the same level of interest from users and investors as Ozempic, Wegovy, and Zepbound. This heightened attention is due to their demonstrated efficacy in weight loss combined with their potential to address serious health conditions beyond obesity.
Within this research, we focus on:
- key features of the GLP-1 landscape
- current barriers to access in the US market (price and coverage)
- supply constraints dynamics
- the potential effect of oral GLP-1 therapies
- the potential spillover effects in consumer preferences on the food and beverages sector based on initial findings.
Despite the current dominance of Novo Nordisk and Eli Lilly in the obesity treatment market, it is crucial to consider the potential disruptive impact of next-generation products. The product cycle of these emerging assets warrants close attention as they may significantly reshape the competitive landscape and have an effect on the share price of companies.
Finally, our analysis incorporates the impact of healthcare policy uncertainty, considering factors such as pending nominations to the Department of Health and Human Services and the FDA Commission, the implementation of the Inflation Reduction Act and the Prescription Drug User Fee Act, and the legal precedent established by Supreme Court overturn of the Chevron doctrine.
Beyond fat: what is the definition of obesity?
Obesity, formally recognised as a complex, chronic, and multifactorial disease by the American Medical Association (AMA) in 2013, presents a significant global health challenge. Affecting over a billion people worldwide, its prevalence in the US reaches 40.3% of adults and 19.3% of children, according to the most recent data from the National Health and Nutrition Examination Survey. Characterised by disordered physiological processes, obesity's regulation is primarily due to the brain’s pathways. The brain communicates with adipose tissue, also known as fat tissue, and the gut to maintain a particular equilibrium weight. This intricate system involves two primary neural pathways: the anorexigenic proopiomelanocortin (POMC) pathway, promoting satiety or “feeling full”, and the orexigenic agouti-related peptide (AgRP) pathway, stimulating appetite. Dysregulation or poor control within these pathways, often influenced by a complex interplay of genetic, developmental, environmental, and behavioural factors, can lead to obesity.
From gut to brain: GLP-1s and the biology of appetite control
Contrary to common misconceptions that attribute obesity solely to poor diet and insufficient exercise, the underlying causes are multifaceted. The advent of glucagon-like peptide-1 (GLP-1) receptor agonists marks a significant inflection point in obesity management. Unlike previous weight-loss medications, GLP-1 drugs directly target the critical brain pathways governing food intake and storage. By stimulating the POMC pathway and inhibiting the AgRP pathway, these medications effectively reduce appetite and promote satiety.
GLP-1 is a naturally occurring hormone released by the gut in response to food intake. While there is no direct measure of individual GLP-1 levels, clinicians can assess its influence by inquiring about patients' frequency of thoughts related to food and hunger. Individuals with higher GLP-1 activity tend to experience fewer food-related thoughts, while those with lower activity may exhibit a greater preoccupation with eating. GLP-1 medications, by mimicking the actions of this hormone, offer a targeted approach to managing appetite and promoting weight loss.
Although GLP-1 drugs have been available for a decade, recent advancements have yielded significant improvements in efficacy. First-generation GLP-1 receptor agonists, those drugs or substances that bind to a receptor inside a cell or on its surface and cause the same action as the substance that normally binds to the receptor, such as liraglutide, achieved an average total body weight loss of approximately 6.5%, compared to nearly 10% with phentermine-topiramate. Phentermine is part of a class of medications called anorectics which work by decreasing appetite. Topiramate is an anticonvulsant which works by decreasing appetite and by causing feelings of fullness to last longer after eating. However, the introduction of second-generation GLP-1s, like semaglutide (Novo Nordisk’s medication marketed as Ozempic for diabetes and Wegovy for obesity), has resulted in a substantial increase in weight loss, averaging around 14.9%. Furthermore, the recent FDA approval of tirzepatide (Eli Lilly's Mounjaro for type 2 diabetes and Zepbound for weight loss), a dual agonist targeting both GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) receptors, has demonstrated even greater efficacy, with an average weight loss of approximately 22.5%. The surpassing of the 10% and 20% weight-loss thresholds by these newer agents has positioned GLP-1 receptor agonists as a groundbreaking advancement in the treatment of obesity.
Are GLP-1s the miracle drug some people dream of?
Although average total body weight loss is substantial for users of GLP-1 drugs, individual responses vary considerably. Studies by Wilding and Jastreboff indicate that approximately 10-15% of patients on GLP-1 receptor agonists experience minimal or no weight loss.
In addition, it seems that GLP-1s are not suitable for all individuals with obesity. Firstly, alternative treatment modalities may be more appropriate for certain patients. Secondly, contra-indications exist, precluding their use in individuals with a history of medullary thyroid cancer, multiple endocrine neoplasia type 2, pancreatitis, or those who are pregnant or breastfeeding, among other conditions. Thirdly, potential side effects, ranging from mild (fatigue, nausea, vomiting) to more serious (gastroparesis, intestinal obstruction, gallbladder disease), may limit tolerability for some patients.
Finally, patient preference plays a significant role. Some individuals, particularly those accustomed to more traditional weight loss approaches, may be hesitant to adopt a weight loss regimen that requires weekly injections. While oral formulations of semaglutide, such as orforglipron, are under development, the need for daily administration may still deter some patients. Additionally, the prospect of having to take the medication for the rest of their lives poses a challenge for many obese people.
Another obstacle, particularly in the US, is Insurance coverage. Currently, US Medicare provides coverage for these drugs and associated dietary counseling for patients with diabetes. The FDA approval in March 2024 of Wegovy for the prevention of heart disease, coupled with subsequent guidance from the Centers for Medicare & Medicaid Services (CMS), has extended coverage to individuals with heart disease. However, despite long-standing FDA approval of GLP-1s for weight loss, decade-long efforts to secure Medicare coverage for obesity through the Treat and Reduce Obesity Act (TROA) have been unsuccessful.
Therefore, while GLP-1 medications offer a promising new avenue for weight loss, they are not a panacea. It is essential to maintain realistic expectations and recognise that GLP-1s, while a valuable tool, are not the definitive solution for the global obesity epidemic.
Barriers to access
Approximately 105 million adults in the US are overweight or obese, based on the World Health Organisation's body mass index (BMI) classifications. Current estimates suggest that only 2 million individuals utilise GLP-1 receptor agonists for weight loss, primarily due to high costs, limited insurance coverage, and supply constraints. However, with expected improvements in supply, increased insurance coverage, and manufacturing expansion, this number is projected to reach 15 million by 2030, representing a 14% penetration rate among US adults with obesity.
While the list price for injectable GLP-1s is expected to rise in the near term due to persistent supply-demand imbalances, the net price for consumers should decrease as insurance coverage expands and competition intensifies. Furthermore, the introduction of oral GLP-1 formulations, which are expected to be priced lower than injectables, could further expand the market.
Recent clinical trials have yielded promising results that suggest an even larger market potential for GLP-1s. Notably, Novo Nordisk's SELECT cardiovascular outcomes study demonstrated a 20% reduction in major adverse cardiovascular events among patients receiving semaglutide (Wegovy). Other studies have shown significant benefits for patients with diabetes and kidney disease, and ongoing research is exploring the potential of GLP-1s, including the FDA’s authorisation of Eli Lilly's Zepbound, for sleep apnea in adults with obesity. While current market size estimates primarily consider weight loss indications, the potential benefits of GLP-1s for other serious health conditions could significantly expand the eligible patient population.
The anticipated widespread availability of oral GLP-1 therapies has the potential to further expand the addressable market projections. Although oral formulations are still undergoing clinical trials, they are positioned to become a significant component of chronic weight management strategies in the coming years. Phase 2 studies have demonstrated promising efficacy and tolerability, and the lower manufacturing costs associated with oral formulations suggest a potential for reduced pricing compared to injectable GLP-1s, thereby increasing patient access.
The overall pricing of GLP-1 therapies, across the anticipated range of product profiles, is projected to moderate by 2030. This will be driven by the availability of less expensive oral formulations and increased competition as more companies enter the market. While smaller players may face challenges in capturing significant market share, the substantial market opportunity presents attractive revenue potential, even within niche segments.
However, insurance coverage plays a critical role in patient access to these medications, and private insurance coverage is also falling short. Currently, approximately half of commercially insured individuals have access to GLP-1s through employer-sponsored health plans that opt to reimburse anti-obesity medications. Ongoing research demonstrating the broader healthcare benefits of GLP-1s in managing obesity-related co-morbidities may incentivise greater employer coverage. Expanded indications for prescribing GLP-1s could further strengthen the argument for broader insurance coverage.
Medicare, currently accessed by approximately 66 million people, is currently legally prohibited from covering medications specifically for obesity. Medicaid coverage for GLP-1s varies by state, with only a handful of states opting in. Despite recent promising clinical trial results and increased advocacy for coverage, it remains unlikely that Medicare will cover anti-obesity medications by 2030. This reluctance stems from budgetary concerns, as the Congressional Budget Office stated in October 2024 that, at current prices, the cost of covering anti-obesity medications would exceed the savings from reduced healthcare spending associated with obesity-related complications over a 10-year period. Therefore, insurance coverage, and consequently price, will continue to pose a significant barrier for many individuals seeking access to GLP-1 therapies.
Source: Congressional Budget Office. October 2024, retrieved from cbo.gov on 21st of January, 2025.
Are high GLP-1 prices sustainable?
The potential for drug manufacturers to unilaterally lower prices remains a pertinent question. Currently, there is no indication that companies are considering price reductions. The GLP-1 market is currently a duopoly, with Novo Nordisk and Eli Lilly holding dominant positions. These companies possess significant competitive advantages, including their long-standing leadership in diabetes research and development, which has positioned them at the forefront of GLP-1 innovation. Despite their established positions, both companies continue to invest in research and development, actively pursuing the development of even more effective and tolerable GLP-1 therapies.
For instance, Eli Lilly's orforglipron is considered a benchmark for other oral GLP-1s in development. In this context, there is limited incentive for established players to unilaterally reduce prices. However, this dynamic could shift as the GLP-1 market expands globally. Markets outside the US, particularly those with single-payer healthcare systems, may not be able to sustain current price levels. As supply increases, even leading manufacturers may need to re-evaluate their pricing strategies to ensure accessibility in diverse markets.
Furthermore, insurer restrictions on access due to high costs could also compel manufacturers to consider more flexible pricing models, potentially incorporating lower price points for specific patient segments or geographic regions. Therefore, pricing remains a critical factor to monitor in the evolving GLP-1 landscape.
Source: Congressional Budget Office. October 2024, retrieved from cbo.gov on 21st of January, 2025.
Supply constraints
The initial supply shortages of GLP-1 receptor agonists stemmed from an underestimation of demand by pharmaceutical companies. Following the FDA approval of Wegovy for chronic weight management in June 2021, Novo Nordisk was forced to temporarily halt its US launch due to an inability to meet the surge in demand. This precautionary measure was necessary to prevent patient initiation of a treatment that could become abruptly unavailable, potentially posing significant health risks.
While the synthesis of GLP-1 drugs themselves is relatively straightforward, the manufacturing of autoinjectors, the pen-like devices used for adjustable dosing, presents a significant challenge. These devices are crucial for patient safety, allowing for gradual dose titration to minimise side effects. Establishing a manufacturing facility for these complex devices requires a substantial capital investment and a lead time of 3 - 4 years before operational capacity is reached. Despite pharmaceutical companies investing in the construction of large-scale manufacturing facilities, supply is not expected to match demand until later this decade.
However, the introduction of oral GLP-1 formulations is anticipated to contribute to a more balanced market by 2030. These oral formulations are less complex and capital-intensive to manufacture compared to injectables. With their market entry anticipated in 2027 or 2028, oral GLP-1s are expected to alleviate some of the supply constraints currently hindering broader access to this class of medications.
Unpacking the impact on food choices
The growing popularity of GLP-1 drugs has prompted inquiries into their potential influence on consumer behaviour and the resulting implications for the food and beverage industry. However, a comprehensive assessment of the long-term impact of GLP-1s on consumption habits is premature. While consumer interest in weight management and dietary modifications remains strong, several uncertainties persist regarding the ultimate adoption rates, duration of use, and the enduring nature of any behavioural changes associated with GLP-1s.
Preliminary data on early adopters of GLP-1 medications reveals a trend towards reduced grocery spending, with an average decline of approximately 6% within six months of adoption. This reduction extends to food-away-from-home expenditures as well, with breakfast and dinner spending decreasing by nearly 4% and 6%, respectively. Furthermore, significant declines in purchases of high-calorie “junk” foods, such as potato chips (crisps), savoury snacks, cookies, sweets (candies), and chocolate, have been observed.
A more granular analysis of grocery categories reveals that the impact of GLP-1 use extends beyond calorie-dense products, with most categories experiencing spending declines. Notably, increased spending is limited to yoghurt and fresh produce, and only among individuals utilising GLP-1s specifically for weight loss.
Looking ahead, it is anticipated that consumers on GLP-1 medications will gravitate towards smaller portions and convenient, nutrient-dense options, such as single-serving or portion-controlled items. However, these trends may evolve as GLP-1 usage expands to a broader demographic. Finally, while a reduction in high-calorie food consumption is evident, the long-term sustainability of these changes remains to be seen. The appetite-suppressing effects of GLP-1 medications may induce temporary shifts in consumption patterns, with some reversion potentially occurring beyond the initial six months.
Stock performance - what’s priced in?
Eli Lilly and Novo Nordisk have demonstrated exceptional performance within the Healthcare sector, largely attributed to their avoidance of the patent cliffs and loss of exclusivity challenges confronting many other pharmaceutical companies. This favourable outlook is largely reflected in their current stock valuations.
Notwithstanding continued growth in demand and utilisation of GLP-1 anti-obesity medications, recent Q3 2024 results from Eli Lilly and Novo Nordisk presented a more nuanced picture. Softer-than-anticipated figures have raised questions about the true level of demand, which was previously assumed to be higher.
On 20th December, Novo Nordisk released data from the Phase 3 REDEFINE 1 clinical trial evaluating CagriSema, a combination of cagrilintide and semaglutide, for the treatment of obesity. The trial demonstrated a 23% weight loss based on the efficacy estimand, falling short of market expectations of 25%.
Despite this slightly lower-than-anticipated efficacy, it is still anticipated that CagriSema will be filed for regulatory approval with the FDA. While the product may not offer clear differentiation compared to Eli Lilly's tirzepatide (Zepbound), it represents a significant advancement for Novo Nordisk, shifting its position from having a clearly inferior product in semaglutide (Wegovy) to one that is on par with tirzepatide in terms of weight loss.
The market reaction to the REDEFINE 1 data was significantly negative, with Novo Nordisk's share price declining by 20% in the days following the release. This suggests that investor expectations for CagriSema were particularly high, and the slight miss on efficacy triggered a reassessment of the product's potential market impact.
What is clear is that several fundamental debates continue to shape the anti-obesity medication landscape. These include the intensity of long-term demand, the progress of manufacturing scale-up for both injectable and oral formulations, the evolving dynamics of the supply chain, and the anticipated data updates from a cascade of mid-to-late stage clinical trials. These trials, expected to begin this year, will unveil the profiles of next-generation agents, including oral small molecule GLP-1 receptor agonists, drugs that are small enough to pass through cell membranes and bind with proteins and enzymes, and other novel combination regimens.
The resolution of these debates will be crucial in determining the future trajectory of the anti-obesity medication market and the ultimate success of these innovative therapies in addressing the global obesity epidemic.
Source: Factset
What’s being cooked up in 2025 and by whom?
Looking ahead, 2025 is poised to be a pivotal year for the development of oral small molecule GLP-1 receptor agonists. These agents possess significant disruptive potential, and upcoming clinical trial data will be instrumental in shaping the ultimate market opportunity. Specifically, Eli Lilly's orforglipron is expected to yield Phase 3 data, providing crucial insights into the efficacy and safety of this class of drugs.
Oral small molecule GLP-1s offer several advantages over peptide-based and injectable formulations, including less complex and more scalable manufacturing processes. This could facilitate a better alignment of supply and demand dynamics, potentially accelerating broader adoption globally and expanding use cases beyond type 2 diabetes and obesity.
Eli Lilly's Phase 3 obesity data for orforglipron is anticipated in mid-2025, likely to be announced via a topline press release followed by a presentation at a major medical meeting. These data will serve as a benchmark for the efficacy and safety of oral small molecule GLP-1s, with particular emphasis on tolerability compared to currently approved injectable therapies (Eli Lilly's tirzepatide and Novo Nordisk's semaglutide) and oral semaglutide (Rybelsus).
Eli Lilly has multiple Phase 3 orforglipron trials underway, with readouts expected in mid-2025. These trials encompass patients with type 2 diabetes (primary completion June 2025), obesity or overweight with comorbidities (primary completion July 2025), and obesity or overweight with type 2 diabetes (primary completion August 2025). Based on precedent, it is anticipated that topline results will be announced via press release, with detailed data presented at a subsequent medical conference, potentially the European Association for the Study of Diabetes (EASD) meeting in September 2025.
Tolerability is expected to be a key focus of the upcoming data. Treatment discontinuation rates are considered a critical metric for assessing real-world tolerability by key opinion leaders. Regarding efficacy, Phase 2 data for orforglipron, which showed approximately 15% absolute weight loss at 36 weeks, provides a preliminary benchmark. However, Phase 3 trials, with their longer 72-week timeframe, may demonstrate even greater weight loss, potentially exceeding 20%, thus setting a high standard for competitors.
Pfizer is also actively developing an oral small molecule GLP-1 receptor agonist, danuglipron. Dose optimisation results for this once-daily therapy are expected in Q1 2025. These results will be crucial in guiding Pfizer's obesity program, which has previously demonstrated impressive weight loss (up to 11.7% at 32 weeks in a Phase 2b trial) but also encountered challenges with high discontinuation rates and gastrointestinal intolerance at certain doses.
AstraZeneca's cardiovascular, renal, and metabolic portfolio uniquely positions the company to pursue combination therapies. With a wholly owned SGLT-2 inhibitor and a small molecule PCSK9 inhibitor, AstraZeneca has identified clear potential for patient overlap with its oral GLP-1 asset, AZD5004. Currently in Phase 2 development, an update on this asset is anticipated in 2025.
Roche is also developing an oral small molecule GLP-1, CT996. Following the presentation of detailed data at the EASD meeting, Roche is expected to disclose further Phase 2 data towards the end of 2025.
Structure Therapeutics is advancing its lead oral GLP-1 molecule, GSBR-1290, with a Phase 2b ACCESS trial recently initiated. Phase 2a data, reported in June 2024, showed promising weight loss (6.2% at 12 weeks) and gastrointestinal tolerability comparable to other agents in this class. Notably, discontinuation rates were lower than those observed with Eli Lilly's and Pfizer's candidates. Phase 2b data, expected in 4Q 2025, will be a key readout in the obesity field.
Terns Pharmaceuticals is developing TERN-601, an oral small molecule GLP-1 that has demonstrated impressive weight loss (4.9% over 28 days) with no treatment-related discontinuations to date. Tern Pharmaceuticals plans to initiate a Phase 2 clinical trial for TERN-601 in obesity in early Q2 2025, with initial 12-week data anticipated in H2 2025.
In 2025, Amylin, a hormone that helps regulate blood sugar levels and food intake, is expected to garner increased attention with ongoing research and development efforts by numerous companies highlighting the growing interest in amylin-based therapies as a potential treatment for obesity and related metabolic disorders.
Novo Nordisk is actively developing two promising candidates in this class: amycretin and Amylin 355. Amycretin, a novel drug similar to amylin, is currently in Phase 1 development. Subcutaneous amycretin data (data relating to the fatty tissue layer under the skin where the injections are given) are expected in Q1 2025. It is plausible that Novo Nordisk could opt for an accelerated development strategy, proceeding directly to Phase 3 trials in obesity, contingent upon observing clear dose separation in Phase 1 with respect to efficacy and safety, and obtaining regulatory concurrence from the FDA. Such an approach could potentially expedite the timeline to market launch, enhancing the net present value of this asset. It is noteworthy that the Phase 1 subcutaneous trial was expanded in June 2024 and is now designated as a Phase 1/2 trial.
Amylin 355, another amylin-based therapy, recently entered Phase 1 development. While it has not been confirmed by Novo Nordisk exactly how it works, it is speculated to be a monotherapy amylin agonist, in contrast to cagrilintide, which is a dual amylin calcitonin receptor agonist (DACRA), a class of drugs that activate both the amylin and calcitonin receptors. Based on typical Phase 1 clinical trial timelines, data from this asset could potentially be disclosed in 2025.
Eli Lilly is actively developing eloralintide, an amylin-selective agonist devoid of calcitonin receptor agonism. This compound entered Phase 2 trials in February 2024, with primary completion anticipated in June 2025. Eli Lilly appears to be pursuing a combination strategy with tirzepatide for this asset, as evidenced by ongoing Phase 1 and Phase 2 combination trials with primary completion dates of October 2025 and June 2026, respectively. Although Phase 1 data have not yet been disclosed, Phase 2 data for eloralintide could potentially become available in the coming year. In addition to eloralintide, Eli Lilly is also investigating a DACRA, currently in Phase 1 development, referred to as QW II.
Zealand Pharma's petrelintide represents the most advanced amylin agonist outside of the Novo Nordisk and Eli Lilly pipeline as they have recently dosed the first patient in the Phase 2b ZUPREME trial. The Phase 2 ZUPREME trial is expected to reach completion in 2026. Zealand Pharma is actively seeking a partnership or collaboration agreement with a large pharmaceutical company for the late-stage development and potential commercialisation of petrelintide. Commentary from the company suggests that such an agreement is likely to be announced in 2025.
Gubra is developing GUBamy, an amylin analog currently undergoing Phase 1 evaluation. Following promising single ascending dose (SAD) data, where subjects receive only one dose of the drug, reported in November 2024, completion of dosing in the Phase 1 multiple ascending dose (MAD) trial is anticipated in Q4 2025.
Structure Therapeutics plans to select its first small molecule amylin development candidate in Q4 2024, with clinical development slated to commence in H2 2025.
Viking Therapeutics is also pursuing the development of amylin agonists. Following the presentation of preclinical data at the American Diabetes Association (ADA) meeting in 2024, Viking Therapeutics plans to initiate clinical development in 2025.
AstraZeneca's AZD6234 is currently being evaluated in the Phase 2 APRICUS trial, which is expected to continue throughout 2025, with a primary completion date of January 2026.
US healthcare policy: Making obesity great again?
The re-election of President Trump and subsequent nomination of Robert F. Kennedy, Jr. as Secretary of the Department of Health and Human Services (HHS) has introduced a degree of uncertainty into the Healthcare sector. This uncertainty is compounded by several factors including:
- Potential workforce reductions, driven by the new administration's stated focus on reducing the size of government, could lead to a loss of institutional knowledge and operational delays within HHS and its associated agencies.
- Potential initiatives to modify the Prescription Drug User Fee Act (PDUFA), particularly with regard to industry involvement and financing, could significantly impact the pharmaceutical industry's interactions with the FDA and the drug approval process.
- While the nomination of Dr. Martin Makary as the FDA Commissioner is not expected to cause major disruptions, his appointment could, based on his previously expressed criticisms, lead to a more stringent drug approval process in certain areas, such as orphan drug policy, i.e., the development of drugs to treat rare diseases, and Alzheimer's disease therapies.
- The Supreme Court decision overturning the Chevron doctrine, which allowed Federal agencies to create and implement rules without fear of lengthy legal battles, could diminish agency deference, shifting the responsibility of statutory interpretation to the courts, potentially compelling Congress to adopt more prescriptive legislative language.
- And finally, it is still not clear what will happen in relation to the Inflation Reduction Act (IRA). While a full repeal is considered unlikely due to cost implications, incremental changes to implementation details and the expansion of drugs subject to price negotiation are possible, particularly if the President seeks to intensify efforts to lower drug prices. Pharmaceutical companies have indicated the possibility of raising prices outside the US to offset potential domestic price reductions. Key dates to monitor regarding the IRA include:
- 1st February, 2025: CMS deadline to announce the 15 drugs selected for price negotiation in 2027.
- 1st March, 2025: Public disclosure of the methodology used to determine negotiated prices for the initial 10 drugs.
- 1st June, 2025: Deadline for CMS to submit the initial offer of a maximum fair price.
- 30th November, 2025: Deadline for CMS to publish any negotiated maximum fair prices, with explanations to be published by 1st March, 2026.
These evolving political and regulatory dynamics mean that investors need to pay close attention as they could significantly impact the Healthcare sector, the growth in the availability and use of these anti-obesity drugs, and the pharmaceutical industry in the coming years.
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