Budget impact (BI) analysis of cemiplimab-rwlc for advanced basal cell carcinoma (BCC) after hedgehog inhibitor (HHI) therapy in the United States.
Authors: Paul Eleanor , Chen Chieh-I , Chowdhury Zahra , Xu Yingxin , Konidaris Gerasimos , LaFontaine Patrick R. , Atsou Kokuvi , Cope Shannon , Philips Zoe , Kuznik Andreas 
Published: June 2021

e18830 Background: A small proportion of patients (pts) with BCC develop advanced disease (locally advanced [la] and metastatic [m] BCC). Until recently, there was no standard treatment regimen for advanced BCC following progression on or intolerance to HHIs. Some pts received systemic therapy (ST), but most received best supportive care (BSC). Cemiplimab-rwlc is the first immunotherapy indicated in the US, fully for pts with laBCC and accelerated for mBCC, post HHIs or for whom HHIs are not appropriate. This study estimated the BI of introducing cemiplimab-rwlc in the US from a healthcare payer’s perspective. Methods: A decision analytic model was developed to estimate the BI of introducing cemiplimab-rwlc to a US healthcare system over 3 years for advanced BCC treatment following HHIs. Published data were used to estimate eligible patient population size. Reference case market shares for platinum chemotherapy (CT; 4%), nivolumab (3%), pembrolizumab (2%), vismodegib (1%), sonidegib (1%), and BSC (89%) were based on market research, as were predicted uptake of cemiplimab-rwlc and changes in market distribution of STs and BSC post-cemiplimab-rwlc launch, with most pts moving from BSC. Treatment costs were sourced from the ProspectoRx drug pricing database. Total costs (2020 US dollars [$]) to the healthcare system included costs related to treatment, disease monitoring, and mitigation of Grade 3–4 adverse events. Results: In a hypothetical US healthcare plan of 1,000,000 members, ̃32 pts per year with advanced BCC would be eligible for cemiplimab-rwlc, resulting in an average additional cost of cemiplimab-rwlc introduction of $0.12 per member per month (PMPM) over 3 years. The proportion of pts receiving ST rather than BSC was estimated to increase from 11% in 2020, prior to cemiplimab-rwlc approval, to 50% in 2023. Cemiplimab-rwlc market share is projected to increase by 41% by year 3 taking shares from BSC (–39%), HHIs (–1%), and CT (–1%). Given the large proportion of pts who currently receive BSC, the availability of cemiplimab-rwlc is expected to increase payers’ 3-year budget from $978,955 to $5,487,507 post-launch. A one-way sensitivity analysis showed that BI estimates were most sensitive to estimation of the size of the eligible population (health plan population [±20%], proportion of pts with advanced BCC [±20%], and those eligible for treatment post-HHI [±19%]), cemiplimab-rwlc treatment duration (±17%), and the cost of cemiplimab-rwlc (±17%). Changes to all other inputs had a < 5% impact. Conclusions: The introduction of cemiplimab-rwlc had a minimal BI on the average PMPM cost. Modest incremental BI is directly attributable to the projected uptake of cemiplimab-rwlc in a market where pts previously received no ST. These analyses provide new insights in the management of advanced BCC noting limited available evidence for post-HHI treatment.