Budget Impact of Keytruda for the Treatment of Patients with Recurrent or Metastatic (R/M) and Locally Advanced (LA) Cutaneous Squamous Cell Carcinoma (cSCC) in the United States

Abstract

<h3>Purpose/Objective(s)</h3> cSCC is a type of non-melanoma skin cancer and represents 20% of skin cancer deaths. When not cured by local therapy, cSCC is associated with mortality rates exceeding 70%. KEYTRUDA, an immuno-oncology therapy, was recently approved by the FDA for the treatment of patients with R/M and LA cSCC that is not curable by surgery or radiation. The objective of this study was to estimate the budget impact of adding KEYTRUDA to a US healthcare plan formulary as a therapy in advanced cSCC. <h3>Materials/Methods</h3> A budget impact model (3-year time horizon) was developed to compare the direct costs of treating R/M and LA cSCC patients with and without the introduction of KEYTRUDA. Comparators included commonly used systemic therapies (cemiplimab-rwlc, cetuximab, cisplatin + paclitaxel and cisplatin + 5-fluorouracilMT). Market shares were estimated from market research data for comparators, and assumed for KEYTRUDA as follows: 30%, 36%, 42% in R/M; and 13%, 15%, 18% in LA for years 1-3 respectively. Costs included drug Wholesale Acquisition Cost, administration, monitoring and Grade 3-5 adverse event management costs. A one-way sensitivity analysis and two scenario analyses (including Q6W schedule for KEYTRUDA, and equal KEYTRUDA and cemiplimab-rwlc treatment durations) were conducted. <h3>Results</h3> In a hypothetical 1 million member health plan, the number of R/M and LA cSCC patients were 60/60/61 and 52/52/53, respectively in years 1-3. Of these, 18/22/25 (R/M) and 7/8/9 (LA) patients receive KEYTRUDA in years 1-3. In R/M cSCC, KEYTRUDA was associated with cost savings of $1.967m over 3 years. In LA cSCC, KEYTRUDA resulted in a 3-year budget impact of $0.425m. In total, the adoption of KEYTRUDA in cSCC population was projected to lead to cost savings of $1.541m over 3 years (7% decrease). The cost saving was driven by the shorter treatment duration of KEYTRUDA versus cemiplimab-rwlc resulting in decreased drug acquisition, administration, and monitoring costs, and a less costly safety profile of KEYTRUDA versus chemotherapies. Sensitivity and scenario analyses indicate sensitivity to time on treatment assumptions. <h3>Conclusion</h3> The introduction of KEYTRUDA for R/M and LA cSCC patients in a hypothetical plan of 1 million members is projected to lead to budgetary savings of 7% over three years. Results are most sensitive to assumed time on treatment.