Yazılar

NICE to Recommend Eli Lilly’s Obesity Drug Mounjaro for NHS Use

/in /tarafından

The UK’s National Institute for Health and Care Excellence (NICE) announced on Thursday that it plans to recommend Eli Lilly’s obesity drug Mounjaro for use through the National Health Service (NHS), potentially benefiting 220,000 patients over the next three years.

Previously available in the UK only through private, out-of-pocket purchases, Mounjaro, launched in February 2023, will now be prescribed alongside lifestyle changes like diet and exercise. The eligibility criteria include individuals with a body mass index (BMI) over 35 and at least one weight-related condition such as heart disease or type 2 diabetes.

Phased Rollout and Eligibility

Approximately 3.4 million people in England could qualify for the treatment under the stated guidelines. However, during the initial rollout, priority will be given to those with the highest clinical need. The drug will become accessible to NHS patients starting 90 days after NICE’s final guidance is published, scheduled for December 23, unless appeals are lodged. Patients who are part of specialist NHS weight management services will gain earlier access, while others may need to wait up to 180 days.

The phased rollout is essential to ensure that healthcare providers can continue addressing the broader range of patient needs, NICE stated.

Mounjaro’s Potential Impact

Mounjaro, part of the GLP-1 analogue drug class, was initially developed to manage blood sugar levels in type 2 diabetes patients but has shown remarkable efficacy in promoting weight loss. Clinical trials demonstrated an average weight loss of nearly 23%, making it one of the most effective options for obesity management.

This recommendation aligns with earlier guidelines issued by NICE for Novo Nordisk’s Wegovy in March 2023, which targets the same BMI threshold and weight-related conditions.

Addressing Britain’s Obesity Crisis

With nearly one in three adults in Britain classified as obese—the highest rate in Europe according to a 2019 OECD report—Mounjaro offers a new tool to address the nation’s obesity epidemic. The European Union’s obesity average stands at 16.5%, highlighting the urgent need for interventions in the UK.

Eli Lilly has welcomed NICE’s decision and acknowledged the necessity of a phased introduction, ensuring the drug is integrated effectively into the NHS system.

Medicaid Dominates U.S. Coverage for Novo Nordisk and Eli Lilly Weight-Loss Drugs

/in /tarafından

Government Programs Drive Access to GLP-1 Drugs

State Medicaid programs and federal employee health plans are the leading sources of coverage for popular new weight-loss drugs, including Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound. According to data from the AXIACI Obesity Coverage Nexus, government-funded plans provide access to these treatments for over 52 million Americans, significantly outpacing private employer and commercial insurance coverage.

Coverage Breakdown:

  • Medicaid Programs: Cover 31.6 million low-income individuals.
  • Federal Employee Plans: Provide access to 14.6 million federal workers and dependents.
  • State and Local Employee Plans: Cover an additional 6 million individuals.

In contrast, approximately 13.7 million Americans under commercial health plans have coverage for these drugs. An additional estimated 10.7 million privately insured individuals may also have coverage, bringing the total private sector figure to a potential 24.4 million—still less than half of government-backed coverage.

Barriers to Broader Coverage

The discrepancy between public and private plans highlights employer hesitancy to absorb the costs of GLP-1 drugs, which carry list prices exceeding $1,000 per month. Kathy Hempstead of the Robert Wood Johnson Foundation attributes this to rising health insurance premiums, which make funding weight-loss treatments an added challenge for private employers.

Many private insurers impose stringent prerequisites, such as dietary consultations or lifestyle programs, before approving coverage. Additionally, patients often face limited drug availability and may turn to cheaper alternatives from compounding pharmacies.

Impact on Drugmakers and Patients

While Medicaid’s steep drug price discounts may affect Novo Nordisk and Eli Lilly’s profit margins, higher obesity rates among Medicaid recipients present a significant market opportunity. For many patients, insurance coverage is the only feasible way to access these expensive medications, which can be required for long-term use.

Both companies are lobbying for broader insurance coverage, emphasizing the societal cost savings from reducing obesity-related conditions like heart disease and diabetes. Novo estimates that about half of U.S. adults with obesity now have access to weight-loss medications. However, Lilly acknowledges gaps in commercial insurance coverage, citing ongoing stigma and mismanagement of obesity as barriers to treatment.

State-by-State Medicaid Approaches

Currently, 14 state Medicaid programs, including California, Pennsylvania, and North Carolina, offer coverage for GLP-1 drugs to treat obesity. Seventeen states extend coverage to public employees and their dependents, with five—Connecticut, Delaware, Kansas, Massachusetts, and Michigan—offering both.

Medicare, the federal program for individuals 65 and older, does not cover GLP-1 drugs for weight loss, limiting its use to managing type 2 diabetes and cardiovascular disease.

Christine Ferguson, a healthcare policy expert, noted the fragmented nature of state decisions on coverage, saying, “Everyone is being very cautious here,” with no clear national pattern emerging yet.

Future of GLP-1 Coverage

As the use of GLP-1 receptor agonists continues to reshape obesity treatment in the U.S., the divide between public and private insurance coverage underscores ongoing challenges in integrating weight-loss drugs into broader healthcare frameworks. Drugmakers are likely to intensify advocacy efforts for expanded insurance support, seeking to address both financial and cultural barriers to care.

Zealand Pharma Heralds Obesity Drug Alternative: “Our Crown Jewel” Amid Fierce Competition

/in /tarafından

Zealand Pharma, a Danish biotech company, is aiming to revolutionize the obesity treatment market with what it calls the “next generation” of weight loss drugs. Competing against major players like Novo Nordisk and Eli Lilly, Zealand Pharma’s CEO, Adam Steensberg, expressed optimism about the company’s experimental drugs that could set new standards for weight management, particularly with its amylin analog candidate, Petrelintide. Steensberg referred to Petrelintide as their “crown jewel,” positioning it as an alternative to the increasingly popular GLP-1 treatments, such as Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound.

The Promise of Petrelintide and Dapiglutide

While Zealand Pharma has already reported positive results from early-stage trials of Dapiglutide, a GLP-1/GLP-2 receptor dual agonist, the company’s real focus is on Petrelintide, which offers a novel approach by mimicking the hormone amylin. Amylin, co-secreted with insulin, helps regulate feelings of fullness (satiety), a mechanism different from GLP-1 treatments that suppress appetite by mimicking gut hormones. This differentiation is key, as Petrelintide aims to offer significant weight loss with fewer side effects and reduced muscle loss—common concerns associated with current GLP-1 treatments.

According to Steensberg, the goal is to offer patients a more “pleasant experience” with long-term treatment possibilities. Amylin analogs like Petrelintide are emerging as a new category in obesity treatment, with the potential to become a foundational therapy in the coming years.

Strong Early Results and Growing Competition

In June 2024, Zealand Pharma announced promising results from a phase 1b trial of Petrelintide, which demonstrated an average body weight reduction of up to 8.6% over a 16-week course. The company believes this robust data supports Petrelintide as a viable alternative to GLP-1 treatments, particularly for those who struggle with their side effects.

Novo Nordisk, which currently dominates the obesity market, is also working on its own amylin-based therapy by combining semaglutide (the active ingredient in Wegovy) with amylin analog Cagrilintide in a candidate drug called CagriSema. This further highlights the growing interest in amylin-based therapies within the competitive obesity treatment landscape.

Zealand Pharma’s smaller size presents a challenge in competing with the pharmaceutical giants. Emily Field, head of European pharmaceuticals research at Barclays, noted that while Zealand Pharma’s developments are promising, the company will likely need a larger pharmaceutical partner to scale its operations effectively.

Searching for a Global Pharma Partner

Zealand Pharma, which has seen its share price more than double this year due to excitement around its obesity drugs, is now actively seeking a global pharmaceutical partner to help bring its treatments to market. Steensberg acknowledged that despite the company’s recent $1 billion capital raise, partnership is essential for the next phase of development, particularly as both Petrelintide and Dapiglutide move into phase 2 trials in 2024 and 2025.

With rising competition, including established players like Novo Nordisk and Eli Lilly and an estimated $200 billion market by 2030, partnering with a global firm would provide Zealand Pharma with the resources necessary to scale production and marketing efforts.

Future of Obesity Treatment and Market Fragmentation

The obesity drug market is expected to become increasingly fragmented as different pharmaceutical companies target specific segments and patient needs. Analysts believe that focusing on niche areas, such as treatments that reduce muscle loss, will help smaller companies like Zealand Pharma carve out space alongside the market leaders. As demand for these treatments continues to surge globally, companies are racing to create the next big breakthrough in weight management.

Zealand Pharma’s strategic focus on amylin analogs, coupled with its search for a strong pharmaceutical partner, positions the company to make a significant impact in the coming years. Steensberg remains optimistic, viewing their developments as “an attractive opportunity” for potential partners and asserting that amylin analogs could become a first-line therapy in the near future.

Conclusion

Zealand Pharma’s innovative obesity drug candidates, particularly Petrelintide, hold great promise in reshaping the future of weight management treatments. As the company advances its clinical trials and seeks a global pharmaceutical partner, it faces both opportunities and challenges in an increasingly competitive and lucrative market. With the growing demand for effective and tolerable weight loss solutions, Zealand Pharma’s next-generation treatments may very well play a pivotal role in the future of obesity care.