Cemiplimab-rwlc (Libtayo), a new PD-1 inhibitor, has transformed the treatment of advanced cutaneous squamous-cell carcinoma (CSCC), significantly extending survival for patients.
According to a new economic analysis presented at the ASCO 2020 virtual annual meeting, this immunotherapy is also cost-effective. Cemiplimab is cost-effective compared with historical standard of care, according to Andreas Kuznik, PhD, Executive Director, Global Health Economics and Outcomes Research, Regeneron Pharmaceuticals.
“Relative to drugs that were previously available to patients, cemiplimab is a real game-changer,” Dr Kuznik said. “The survival curves of cemiplimab and standard-of-care regimens are nowhere close to one another. Cemiplimab provides great value not just to patients, providers, and payers, but to society as well, as these patients continue to live longer, healthier lives.”
Although the majority of patients with CSCC have a good prognosis when treated early, advanced CSCC is associated with poor outcomes.
In September 2018, the FDA approved cemiplimab for the treatment of patients with metastatic or locally advanced CSCC who are not candidates for curative surgery or radiation, based on data from the pivotal phase 2 clinical trial that showed substantial antitumor activity, durable response, and acceptable safety profile.
For this analysis, Dr Kuznik and colleagues used a survival model to evaluate the cost-effectiveness of cemiplimab in patients with advanced CSCC from a US payer perspective. They used data from the pivotal phase 2 clinical trial to determine clinical inputs for cemiplimab, and for comparison with historical standard of care, they performed a systematic literature review and pooled analysis of single-arm clinical trials and retrospective studies evaluating chemotherapy and EGFR inhibitors in the setting of CSCC.
The overall survival (OS) and progression-free survival (PFS) were extrapolated over a lifetime horizon using guidelines from NICE (National Institute for Health and Care Excellence). In addition to the drug acquisition and administration costs, the researchers evaluated costs associated with adverse events, subsequent therapy, disease management, and terminal care.
According to Dr Kuznik, the most important driver of value in oncology is the effect of a drug on long-term survival. If you can demonstrate improved survival, you can show that you are extending life-years gained and quality-adjusted life-years (QALYs) gained.
“At the end of the day, the thing that matters most for cancer drugs is the survival gain, and cemiplimab extends survival by several years,” he said. “This is the biggest gain in survival I’ve seen in my career. It’s not 1 or 2 years—it’s several years.”
The median OS and the median duration of response have not been reached in the pivotal phase 2 study, and the probability of survival at 2 years was approximately 73%. Moreover, median PFS has only been reached in 1 of 3 groups. Although the costs of short-term adverse events for cemiplimab and for the historical standard of care were factored into the analysis, these were not major drivers of value, said Dr Kuznik.
Compared with the standard of care, cemiplimab had an incremental cost-effectiveness ratio of $99,024 per QALY. The accepted value benchmarks in the United States range from $100,000 to $150,000 per QALY. With a willingness-to-pay threshold of $150,000 per QALY, this analysis suggests a 91% probability that cemiplimab is cost-effective compared with the standard of care, Dr Kuznik reported.
“The bottom line is that cemiplimab is a huge step forward for patients,” said Dr Kuznik. “It’s not a cheap medicine, but the price is justified by the survival gain it generates. It’s money well spent, because of the massive impact on long-term survival.”