Objectives This study aimed to evaluate the economic impact of new dosing regimen of pembrolizumab (Q6W) for the treatment of advanced or adjuvant melanoma in Italy, considering nurse and physician time, preparation costs and administration time.

Methodology The analysis was developed considering two subsequent methodological steps: unit costs estimation for innovative oncologic drugs administration (nurse time, physician time and preparation costs); the cost of the drug was not considered; time consumption calculation for each administration of pembrolizumab, nivolumab or ipilimumab in Italy. The data were collected through a survey that was sent to ten Italian hospitals treating metastatic or adjuvant melanoma. The source of the dosing regimens were the product SPCs published on the European Medicines Agency website. Finally, the economic impact was estimated considering a standardized 1.000 patients treated with Q6W pembrolizumab vs Q3W pembrolizumab, Q2W nivolumab, Q4W nivolumab and Q3W ipilimumab for a time horizon of 6 weeks. 

Results Three of the 10 hospitals answered to the questionnaire: 1) Istituto Nazionale Tumori IRCCS Fondazione "G. Pascale," Naples, Italy, 2) Istituto Dermopatico dell'Immacolata IDI-IRCCS, Rome, Italy, 3) IRCCS Ospedale Policlinico San Martino, Genoa, Italy. The results demonstrate that every 1.000 patients the Q6W dosing regimen could generate € 36,726, € 48,750, € 30,551 and € 24,375 of savings in a time horizon of 6 weeks if compared with Q3W ipilimumab, Q2W nivolumab, Q4W nivolumab and Q3W pembrolizumab respectively.

Conclusions The Q6W pembrolizumab extended dosing schedule will require fewer visits to infusion centers offering greater convenience and flexibility to hospitals and patients. Our analysis suggests that Q6W pembrolizumab regimen could generate savings vs other dosing regimens, reducing nurse and physician time, preparation costs, administration time and the number of hospital access for melanoma treatment.

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Key words: economic impact, advanced melanoma, adjuvant melanoma, treatment, Q6W regimen, pembrolizumab, Italy, cost saving, optimization, 6 weeks schedule