ICER: Verona's Ohtuvayre COPD treatment cost to limit access

The Institute for Clinical and Economic Review (ICER) has raised concerns regarding the accessibility and affordability of Verona Pharma's recently approved Ohtuvayre (ensifentrine), a groundbreaking medication for chronic obstructive pulmonary disease (COPD). This new treatment, eagerly anticipated by the medical community, received FDA approval three weeks ago.

Post-approval, Verona Pharma disclosed that Ohtuvayre would be priced at $2,950 for a monthly dose. This maintenance treatment, which is administered twice daily through a nebulizer, translates to an annual cost of $35,400. This price is nearly three times higher than the upper limit of ICER’s recommended valuation for the drug.

ICER, a Boston-based non-profit organization that evaluates drug prices based on their health benefits and associated risks, provided a health-benefit price benchmark for Ohtuvayre ranging from $7,500 to $12,700 per year. Their findings are a result of comprehensive analyses, including feedback from patients, clinical experts, and other stakeholders.

ICER acknowledges Ohtuvayre's potential to significantly reduce COPD exacerbations and address an unmet medical need. However, they express concerns about the degree of benefit it adds when used with other inhaled treatments not yet studied. David Rind, M.D., ICER’s chief medical officer, emphasized these uncertainties in a public statement and criticized the pricing strategy adopted by Verona Pharma. According to Rind, the chosen price is significantly higher than the value-based price, which could lead to restrictive measures by payers, ultimately limiting patient and provider access to this promising new therapy.

In response to ICER’s findings, Verona Pharma did not immediately provide any comments. ICER’s alert aims to highlight that the high costs of this new treatment could strain the healthcare system, making it challenging to provide widespread access. ICER urged drug manufacturers to set prices that balance affordability with accessibility, stressing that Verona Pharma missed an opportunity to facilitate broad access and adoption of Ohtuvayre.

This report comes at a pivotal time as the FDA is also evaluating another potential breakthrough treatment for COPD: Dupixent by Sanofi and Regeneron. Recently, the European Union approved Dupixent for use alongside other inhaled treatments and as a standalone therapy. Analysts at Evercore ISI have projected that FDA approval for Dupixent in COPD could increase its annual sales by $3.5 billion. Meanwhile, Global Data estimates that Ohtuvayre's sales will reach $1.05 billion by 2029.

The introduction of these new treatments could benefit a vast number of patients. In the United States alone, 8.6 million individuals receive treatment for chronic COPD symptoms, and worldwide, over 390 million people live with the condition. The development of effective therapies like Ohtuvayre and Dupixent is crucial for improving the quality of life for these patients. However, ensuring these treatments are affordable and accessible remains a significant challenge that the healthcare industry must address.