FDA Approves Dupixent: A Breakthrough for Healthcare Executives and Managed Care in COPD

Managed Care Revolution: Dupixent's Approval for COPD

The FDA has recently given its stamp of approval to Dupixent (dupilumab), a significant advancement in managed care for chronic obstructive pulmonary disease (COPD). This biologic therapy, developed by Sanofi and Regeneron Pharmaceuticals, is the first of its kind in the U.S. aimed at helping adults suffering from inadequately controlled COPD.

The Need for Effective Treatments

According to Jean Wright, M.D., CEO of The COPD Foundation, “People living with inadequately controlled COPD have long awaited new medicines to help manage the daily suffering they experience from breathlessness, coughing, wheezing, exhaustion and unpredictable hospitalization.” COPD affects approximately 300,000 people in the U.S., particularly those with type 2 inflammation.

How Dupixent Works

Dupixent is a fully human monoclonal antibody that inhibits critical inflammatory pathways: IL-4 and IL-13. By addressing type 2 inflammation, it mitigates the exacerbations and slow lung function decline typical in uncontrolled COPD patients. It meets a crucial gap in managed care, offering new hope for patients and healthcare systems.

Clinical Trials and Results

The approval arises from two phase 3 trials evaluating its safety and efficacy in COPD patients. Results indicated a 30% reduction in acute exacerbations in one trial and a 34% reduction in the other, proving Dupixent’s effectiveness over placebo. Additionally, lung function showed sustained improvement over 52 weeks.

Cost and Patient Assistance

The list price of Dupixent is $3,803.20 per carton, but Sanofi offers a $0 copay card to commercial patients, capping annual costs at $13,000, alongside patient assistance for those in need.

Conclusion: Moving Forward with Managed Care

This marks a pivotal point for managed care in COPD, with Dupixent expanding treatment horizons. For more information, healthcare executives are encouraged to consult resources on this groundbreaking development.