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In the U.S., the economic burden associated with the latest first-line treatments for locally advanced or metastatic urothelial carcinoma (la/mUC) is significant. Drug acquisition and administration may represent 75% of the direct annual costs to Medicare.

Results from a recent study, in a hypothetical health plan comprised of one million patients, showed that the estimated annual costs associated with first-line treatment for la/mUC totaled $16,673,645 for each Medicare member. This included platinum-based chemotherapy, with and without avelumab first-line maintenance, as well as the use of enfortumab vedotin plus pembrolizumab in cisplatin-ineligible patients.

The estimated monthly cost of first-line treatment was $12,861 per patient with la/mUC, said Chiemeka Ike, MPH, PharmD, MS, of EMD Serono's North America Evidence & Value Development in Rockland, Massachusetts, who reported the results at ASCO's . "Understanding the economic burden associated with la/mUC treatments may facilitate informed decision-making on treatment choice and optimal sequencing."

Ike and colleagues were not available for additional comment; the following highlights are taken from the meeting abstract, edited for length and clarity.

How did you develop your cost model?

We used efficacy and safety data from product prescribing information, epidemiology data from the Surveillance, Epidemiology, and End Results database, and the literature to estimate the number of treated patients per year, treatment duration, progression-free and overall survival, and the incidence of adverse events. We then calculated the costs associated with drug acquisition and administration, disease and adverse event management, and the cost of subsequent therapy. Our market share assumptions were based on market research data.

How many patients with la/mUC were eligible for first-line platinum-based therapy?

We estimated that 108 Medicare members and 22 patients not enrolled in Medicare were eligible in 2023.

Did drug acquisition and administration also represent a significant percentage of the total annual costs associated with first-line treatment in patients not in Medicare?

Yes. From a commercial perspective, we estimated a cost of $4,637,226 per patient annually or $17,852 per patient monthly. Drug acquisition accounted for 64% of the total cost.

How did the annual costs of drug acquisition and administration compare between cisplatin-eligible and cisplatin non-eligible patients?

The annual costs were highest in cisplatin-ineligible patients, whether they were in Medicare or not. The overall cost to Medicare of drug acquisition and administration of enfortumab vedotin plus pembrolizumab totaled $435,945 annually, and $517,844 commercially. By comparison, the cost to Medicare of platinum-based chemotherapy plus first-line avelumab maintenance was $96,402, with costs of $119,766 commercially.

What was the next highest cost associated with first-line treatment of la/mUC?

We found that the management of adverse events represented the second highest estimated annual cost. The cost to Medicare of treating patients with platinum-based chemotherapy plus first-line avelumab maintenance was $11,621. The commercial costs totaled $21,659. Similarly, the care of cisplatin-ineligible patients who experienced adverse events after treatment with enfortumab vedotin plus pembrolizumab cost Medicare $14,292.96 in 2023, while commercial costs totaled $25,662.

What's next?

More real-world studies are needed to assess the impact of these innovative treatments on la/mUC and the costs associated with managing adverse events.

Read the study here.