Ozempic Supply Issues in Australia: What to Expect in 2025

Australian patients relying on Ozempic (semaglutide) for type 2 diabetes management should prepare for continued supply limitations. Despite the United States Food and Drug Administration (FDA) declaring the Ozempic and Wegovy shortage over, AustraliaS Therapeutic Goods Administration (TGA) anticipates that supply will remain constrained until December 31, 2025. This prolonged shortage stems from “continued,unprecedented demand” both locally and globally,according to a Novo Nordisk spokesperson.

Why the Continued Shortage?

Ozempic, initially introduced in 2017, experienced a surge in demand following a 2021 clinical trial that highlighted its potential for significant weight loss. This led to widespread off-label use, exacerbating supply issues. The injectable glucagon-like peptide-1 receptor agonist (GLP-1 RA) has been listed on the TGA’s medicine shortage database since April 2022.

• Global Demand: The primary driver is the overwhelming global demand for Ozempic.
• Off-Label Use: Significant off-label prescribing for weight loss further strains available supplies.
• Manufacturing Capacity: While Novo Nordisk is investing heavily to expand production,it “takes time to build supply levels to meet global and local demand.” Thay state that “As 2023, Novo Nordisk has committed to investing at least 41 billion AUD to build production capacity.”

TGA Advice for Pharmacists and Patients

The TGA provides clear guidance to pharmacists to manage the ongoing shortage:

• Inform Patients: Pharmacists should “inform patients that supply of Ozempic is expected to be limited in 2025.”
• Discuss Alternatives: When Ozempic is unavailable, pharmacists should “discuss option treatments” with affected patients.
• Adherence to Indications: The TGA emphasizes that “both Ozempic and Wegovy should be prescribed and supplied according to their approved indications; for the management of type 2 diabetes and chronic weight management respectively.”
• Monitor Stock Levels: “Pharmacists should be aware that stock availability can change and sudden spikes in demand due to stockpiling or off-label use may affect continuity of care for patients stabilised on Ozempic,” according to the TGA.

The Wegovy Factor and PBS Subsidies

While ozempic is subsidized under the Pharmaceutical Benefits Scheme (PBS) for type 2 diabetes, Wegovy, another GLP-1 RA, is TGA-approved for chronic weight management but currently not subsidized. This means Australians using Wegovy for weight loss face out-of-pocket expenses of approximately $250–500 each month.

Novo Nordisk plans to resubmit an request to the PBAC for Wegovy in 2025, factoring in its new TGA indication for cardiovascular disease. A spokesperson stated, “Novo Nordisk plans to resubmit Wegovy to the PBAC in 2025,” potentially making it more accessible to a broader range of patients.

US Market Dynamics and Lessons Learned

The FDA’s decision to lift the Ozempic and Wegovy shortage declaration in the United States has faced some controversy. “We are pleased the FDA has declared that supply of the only real, FDA-approved semaglutide medicines is resolved, affirming that Novo Nordisk is meeting or exceeding current and projected nationwide demand,” said Dave Moore, Executive Vice President, US. Operations and Global Business Growth and president of Novo Nordisk Inc.

However, this move has been met with lawsuits from compounding pharmacies, who argue that patients are still struggling to access the medication and that the FDA relied too heavily on manufacturer assurances. This situation underscores the complexities of managing drug shortages and the importance of verifying supply chain stability through multiple sources.

Navigating the Shortage: Practical advice

• Consult Your Doctor: Discuss alternative treatment options for managing your condition if ozempic is unavailable.
• Stay Informed: Keep up-to-date with the latest data from the TGA and your healthcare provider regarding Ozempic supply.
• Avoid Stockpiling: Purchase only the medication you need to ensure fair distribution for all patients.
• Consider Clinical Trials: Explore opportunities to participate in clinical trials for new or alternative treatments.

The Ozempic shortage in Australia presents ongoing challenges for patients and healthcare providers. By staying informed, exploring alternative treatments, and advocating for policy changes, patients can navigate this period effectively. Keep open communication channels with your healthcare team, and follow guidance from the TGA to ensure the best possible management of your condition during this period of limited supply. Understanding that the situation is dynamic and changes constantly may impact your specific needs.

what are the potential long-term health consequences for patients with type 2 diabetes who are unable to access ozempic due to the ongoing shortage?

Ozempic supply Shortage in Australia: Expert Insights for 2025

The ongoing Ozempic shortage in Australia is causing concern for many patients. Today, we speak with Dr. Eleanor Ainsworth, a leading endocrinologist at the Sydney Diabetes Clinic, to get her expert viewpoint on the situation and what patients can expect in 2025.

Understanding the Ozempic Shortage: An Expert’s View

archyde: Dr.Ainsworth, thank you for joining us. The Therapeutic Goods Administration (TGA) anticipates Ozempic supply constraints will continue until the end of 2025. From your perspective, why is this shortage persisting, even as the FDA has declared the shortage over in the US?

Dr. Ainsworth: It’s a complex issue. while the FDA’s declaration is positive news for the US, Australia faces a unique situation. Global demand for Ozempic remains incredibly high, notably due to its off-label use for weight loss. Novo Nordisk, the manufacturer, is investing heavily to expand production, but scaling up manufacturing lines takes time. This lag, combined with Australia’s smaller market size, contributes to the prolonged shortages here.

Managing Diabetes during the Ozempic Shortage

Archyde: For patients with type 2 diabetes who rely on Ozempic, what choice treatments should they discuss with their doctor?

Dr. Ainsworth: It’s crucial to have that conversation with your healthcare provider. There are several classes of medications that can help manage type 2 diabetes, including other GLP-1 receptor agonists, SGLT2 inhibitors, DPP-4 inhibitors, and traditional options like metformin and sulfonylureas. The best option depends on individual patient factors, such as other health conditions, potential side effects, and cost.

The Wegovy factor: Weight Management Options

Archyde: Wegovy, another GLP-1 RA, is approved for weight loss but not currently subsidized under the pharmaceutical Benefits Scheme (PBS). How does this impact patients struggling with obesity?

Dr. Ainsworth: The lack of PBS subsidy for Wegovy creates a meaningful financial barrier for many patients. While Wegovy can be highly effective for weight management, the out-of-pocket costs, ranging from $250 to $500 per month, can be prohibitive. Novo Nordisk plans to resubmit Wegovy to the PBAC in 2025, which coudl make the medication more accessible if approved.

Lessons from the US Market: A cautionary Tale?

Archyde: The US market is seeing controversies related to compounding pharmacies and perceived imbalances in medication access, despite the declared end of the Ozempic shortage. What lessons can Australia learn from this situation to better manage the ongoing challenges here?

Dr. Ainsworth: The US situation highlights the importance of verifying supply chain stability through multiple sources and maintaining stringent regulations on drug manufacturing. In Australia, we need to focus on ensuring equitable access to approved medications, discouraging off-label prescribing when supply is limited, and transparently communicating updates about the shortage to both healthcare providers and patients. Careful monitoring to prevent stockpiling and ensure patients on Ozempic who need it are prioritized is essential.

Staying Informed and Advocating for Change

Archyde: What’s your most immediate advice for patients and physicians given the current Ozempic shortage situation?

Dr. Ainsworth: For patients, the most vital thing is to stay informed, consult regularly with your doctor about alternative treatments, and avoid stockpiling medication. For physicians, it’s crucial to adhere to TGA guidelines, prioritize prescribing according to approved indications, and educate patients about the importance of responsible medication use. we can also advocate for policy changes that improve access to effective treatments for both diabetes and obesity. Keep in mind that the situation may change rapidly.

Archyde: Dr. Ainsworth, Ozempic and other related drugs have sparked a huge shift in managing conditions like diabetes and obesity, making the supply chain issues a high-profile concern for many Australians. What are your thoughts on patient engagement in advocating for fair access to medications?

Dr. Ainsworth: Informed and empowered patients are crucial. if patients are involved and engaged in advocating for policy changes around medication accessibility,their voices will be heard.Gathering more attention to the supply issues and offering patient perspectives will offer more thorough discussion for potential positive outcomes.

Archyde: One last important question,what’s the biggest challenge facing Australians concerning the Ozempic shortage in 2025,and how should we tackle that challenge? Share your thoughts in the comments below.