Expanded Indications and Future Outlook for Glp-1 Medications

Expanded Indications and Future Outlook for Glp-1 Medications

GLP-1 medications, originally developed for type 2 diabetes management, are being studied for a variety of potential future uses beyond their current indications. GLP-1, also known as glucagon-like peptide-1 receptor agonists, is a naturally occurring hormone in the body that helps regulate blood sugar levels. It works by:

  • Stimulating insulin release from the pancreas.
  • Slowing gastric emptying, which slows the rate at which food moves from the stomach into the small intestine.
  • Promoting satiety by acting on the brain to increase feelings of fullness and reduce appetite, leading to decreased food intake.

In addition to these well-known mechanisms, other potential benefits are currently being studied.

Cardiovascular Indication

One of the significant advancements is the expanded indication for Wegovy (semaglutide). In March 2024, the FDA approved a new

indication for Wegovy to reduce the risk of major adverse cardiovascular (CV) events, such as heart attack and stroke, in adults with established cardiovascular disease who are either overweight or obese. This approval means that Wegovy, along with a reduced-calorie diet and increased physical activity, can help this specific patient population lower their risk of serious heart problems.

This expanded indication makes sense, as obesity is a risk factor for many complications, including cardiovascular disease. Weight loss, which Wegovy has been proven to promote significantly, is a known factor in reducing cardiovascular risk. Beyond weight loss and glycemic control, GLP-1 medications may reduce CV risk by improving blood pressure and cholesterol levels, reducing inflammation, atherosclerotic plaques and oxidative stress.

Promising Areas of Research

Research into GLP-1 medications has expanded into several promising areas, including:

  1. Non-alcoholic fatty liver disease (NAFLD): Studies have shown that GLP-1 medications can help improve liver function and reduce fat storage in the liver.
  2. Neurodegenerative diseases: There is potential for GLP-1 medications to protect brain cells and improve cognitive function, with neuroprotective effects that may help reduce inflammation and oxidative stress.
  3. Polycystic ovary syndrome (PCOS): GLP-1 medications may help improve insulin sensitivity and regulate ovulation in women with PCOS.
  4. Diabetes prevention: GLP-1 medications are being studied for their potential to prevent the onset of type 2 diabetes in high-risk individuals.
  5. Gastrointestinal disorders: Conditions such as irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD) are being researched for potential treatment with GLP-1 medications.
  6. Psychiatric disorders: Preliminary studies are looking at the impact on mood disorders and cognitive function, given the growing understanding of the gut-brain axis and metabolic influences on mental health.
  7. Chronic kidney disease (CKD): Research is assessing the benefits of GLP-1 medications in slowing the progression of kidney disease and improving renal function in patients with CKD.

Future Coverage Outlook

The future of insurance coverage for GLP-1 medications is uncertain with various challenges ahead.

Arguments in Support of Increased Coverage

There is strong evidence regarding the benefits of GLP-1 medications, as they demonstrate significant advantages beyond diabetes control, including weight loss and potential cardiovascular disease prevention, which could be seen as cost-effective by insurers. Patient advocacy is also gaining momentum, with growing demand for access to these medications, especially for weight management, could push for broader insurance coverage. Additionally, clinical evidence and guidelines play a critical role, as endorsements from major health organizations (e.g., American Diabetes Association, American Heart Association) can drive broader coverage based on clinical efficacy. Lastly, ongoing new research into other potential uses of GLP-1 medications could strengthen the value proposition for insurers.

Challenges Against Increased Coverage

Despite the potential benefits of GLP-1 medications, several challenges may create an obstacle to increased coverage. The current high cost of GLP-1 medications presents a financial burden for insurers. Additionally, an ongoing debate regarding obesity vs. diabetes persists with some insurers potentially hesitating to cover GLP-1 medications solely for weight loss, especially given the current lack of coverage for obesity medications in the ACA Marketplace. Furthermore, there is a need for clearer guidelines from medical organizations on how and when to prescribe GLP-1 medications, as this could help insurers establish consistent coverage policies.

Possible Future Scenarios

As the landscape of GLP-1 medication coverage evolves, there are several scenarios that insurers may follow. Some insurance companies may implement tiered coverage with higher copays or stricter prior authorization requirements for GLP-1 medications used for weight loss compared to those used for diabetes or cardiovascular disease prevention. Another possible scenario is a focus on evidence-based use, where coverage may become more focused on specific patient populations with strong evidence of the benefits, such as those with both obesity and diabetes. We may also see more negotiations and cost-sharing as increased negotiations between insurers, pharmaceutical companies, and patient groups may make GLP-1 medications more affordable and accessible. More specific scenarios include the following:

  • Current Coverage Rules for Weight Loss: Current coverage rules for weight loss typically require 1) engagement in a trial of behavioral modification and dietary restriction for at least three months, 2) a baseline BMI of >30 or >27 with comorbidities and 3) medication use in conjunction with behavioral modification and a reduced-calorie diet. These requirements aim to ensure that the medication is used as part of a comprehensive weight management approach rather than as a standalone solution.
  • Custom Copay Structure: Some insurers are considering implementing a separate copay structure for specific drugs or classes of While this approach could provide more flexibility in coverage, it could potentially impact manufacturer rebates.
  • Maximum Allowable Benefit: The possible implementation of annual or lifetime benefit caps on weight loss drugs is as also another consideration as a cost-saving However, this approach faces a counterargument as studies show that stopping the medication often results in weight regain. This creates a challenging dilemma for insurers trying to balance cost management with long-term health outcomes.
  • More Stringent Utilization Management: More stringent utilization management approaches are also under This includes developing higher BMI requirements by pharmacy benefit managers (PBMs) and a“risk-managed” approach focusing on high-risk CV comorbidity, BMI >35, prior trials of non-GLP-1 medication for obesity and use as part of a weight loss program.

Ultimately, the actual coverage of GLP-1 medications will depend on ongoing clinical evidence, cost-effectiveness analyses and evolving healthcare policies.

Sources:

Mechanisms of GLP-1. Drucker, D. J. “Mechanisms of Action and Therapeutic Application of Glucagon-like Peptide-1,” Cell Metabolism, 27(4), 740-751, 2018.

Wegovy and Cardiovascular Indications. Press Release. “FDA Approves Wegovy® for Cardiovascular Risk Reduction in Adults with Established Cardiovascular Disease,” Novo Nordisk. (2024).

Further Research:

  • Sharma, D., Verma, S., & Vaidya, S. Therapeutic potential of GLP- 1 Analogs in Non-Alcoholic Fatty liver Disease. Biomedicine & Pharmacotherapy, 123, 109732, 2020.
  • Hölscher, Central effects of GLP-1: New opportunities for treatments of neurodegenerative diseases. Journal of Endocrinology, 246(1), R1- R15, 2020.
  • Løvdal Gulseth, H., & Gjesing, A. P. GLP-1 Analogs in the Treatment of Polycystic Ovary Syndrome: An Overview. Journal of Clinical Endocrinology & Metabolism, 106(5), 1246-1257, 2021.
  • Meier, J. GLP-1 Receptor Agonists for Individualized Treatment of Type 2 Diabetes Mellitus. Nature Reviews Endocrinology, 17(8), 450-466, 2021.
  • Drucker, J. (2016). The Role of Gut Hormones in Metabolic Regulation. Journal of Clinical Investigation, 126(1), 390-398.
  • Bethel, A., et al. Effects of Glucagon-Like Peptide-1 Receptor Agonists on Kidney Outcomes in Type 2 Diabetes: A Meta-Analysis of Randomized Trials. The Lancet Diabetes & Endocrinology, 6(1), 29-39, 2018.

Insurance Coverage and Future Outlook:

  • American Diabetes “Standards of Medical Care in Diabetes—2022. Diabetes Care, 45(Suppl 1), S1-S264,” 2022.
  • American Heart 2023 AHA/ACC Guideline for the Management of Patients with Chronic Stable Angina, 2023.
  • Tran, K., et al.). The economic impact of GLP-1 receptor agonists in the management of type 2 diabetes. Journal of Managed Care & Specialty Pharmacy, 27(10), 1387-1395, 2021.

Change Healthcare Cyberattack Updates

Change Healthcare Cyberattack Updates

Back in February 2024, Change Healthcare, owned by UnitedHealth Group, was hit with a significant ransomware attack. This attack caused widespread disruption across the US healthcare system, affecting critical systems like pharmacy services, payment platforms and medical claims processing. The attackers managed to steal a significant amount of sensitive data, including protected health information (PHI) and personally identifiable information (PII) of many individuals.1

Latest Updates

Just as Change Healthcare was beginning to recover, a second ransomware attack occurred a few weeks later for Change Healthcare, which is still working to restore all its services to full capacity. 1

Despite the second attack, Change Healthcare has made some great progress in restoring its services.

  • Pharmacy services are almost back to normal, with 99% of pre-incident pharmacies able to process claims. (1)
  • Medical claims are flowing at near-normal levels, and the company is working with the few remaining providers who are still experiencing issues (1)
  • Payment processing is at approximately 86% of pre-incident levels and continues to improve.

Change Healthcare is taking extensive measures to support those affected by the breaches. They are offering two years of complimentary credit monitoring and identity theft protection services. They have

also set up a dedicated call center to assist with any concerns and provide necessary information. The detailed review of the stolen data is ongoing, and the company plans to notify all affected individuals once the process is complete. The situation emphasizes the essential need for strong cybersecurity measures in the healthcare sector. Change

Healthcare continues to monitor the situation and work closely with law enforcement to mitigate the impact of these attacks. They are committed to keeping stakeholders informed as they navigate through these challenges.2

Sources:

  1. UHC Press “UnitedHealth Group Updates on Change Healthcare Cyberattack,” UnitedHealth Group, 2024.
  2. Ross “Change Healthcare Shares Details on Medical Data Stolen during Disastrous February Cyber Attack,” IT Pro, 2024.

Biosimilar Outlook

Biosimilar Outlook

Over the past decade, the biosimilar market has undergone a significant transformation, particularly with the recent introduction of biosimilars for the blockbuster drug Humira. This shift has been driven by the urgent need for more affordable medications, potential cost savings associated with biosimilars, the expiration of numerous patents, and increased regulatory support establishing clear approval pathways. Additionally, there is growing acceptance of biosimilars among healthcare providers.

Cost Savings and Market Changes

The entry of multiple Humira biosimilars has led to substantial cost savings for healthcare systems, as these biosimilars are typically priced 15%-30% lower than the original biologic, increasing patient accessibility. Humira’s manufacturer, AbbVie, has seen its market share gradually decline to about 80%, notably after Caremark, one of the big three pharmacy benefit managers (PBMs), excluded Humira from its formulary in April. Despite this, AbbVie has maintained a significant portion of

the market through discounting strategies and by promoting next- generation biologics like Skyrizi and Rinvoq.

Although the biosimilar market is evolving, particularly in the US where the FDA has approved an increasing number of biosimilars, the pace has been slower than initially anticipated. This is due to factors such as prescriber and patient skepticism, the complexity and cost of biosimilar manufacturing, and varied pricing and reimbursement strategies across

different regions. However, the successful approval and launch of Humira biosimilars in major markets like the US have boosted confidence in the biosimilar pathway, encouraging further investment and development.

The global biosimilar market is expected to continue its robust growth, with a projected compound annual growth rate (CAGR) of around 20%-25% over the next few years.

Notably, the introduction of Stelara biosimilars, which have been approved and are awaiting release, is expected to follow a similar pattern of increased access, competition, reduced costs and market share erosion for Janssen Pharmaceuticals. Key factors contributing to this growth include:

  1. Increased Approvals: Ongoing regulatory approvals and the entry of new biosimilar products into the
  2. Regulatory Landscape: The success of Humira biosimilars has set a precedent that could streamline the approval process for other Stelara biosimilars and future Regulatory agencies are now more experienced in evaluating and approving biosimilars, which may expedite market entry.
  3. Expanding Therapeutic Areas: While oncology and autoimmune diseases have been the primary focus, biosimilars for other therapeutic areas such as diabetes, ophthalmology and cardiovascular diseases are
  4. Global Expansion: Expansion into emerging markets with large patient populations and increasing healthcare

Additionally, strategic shifts are occurring in how biosimilars are brought to market. Notable collaborations and partnerships, such as the one between Caremark and Cordavis with Sandoz to commercialize Hyrimoz®, and the relationship between Express Scripts (ESI) and Quallent Pharmaceuticals, are emerging. There are ongoing efforts to educate healthcare professionals and patients about the benefits and safety of biosimilars to enhance adoption rates. Increased competition is also likely to drive down prices, making biosimilars an even more attractive option.

The biosimilar market is poised for significant growth, led by the emergence of Humira biosimilars driven by the need for affordable biologic therapies, regulatory support and increasing acceptance. While challenges remain, strategic collaborations, market education and favorable policies will be key to realizing the full potential of biosimilars in the global healthcare landscape. As the biosimilar market continues to evolve, these trends will likely contribute to more sustainable and accessible healthcare systems worldwide.

Sources: