Economics of alternative dosing strategies for pembrolizumab and nivolumab at a single academic cancer center

Abstract

Background The FDA initially approved pembrolizumab and nivolumab for doses based on patient weight, but subsequently amended approval to fixed doses. We estimated savings from novel dosing strategies based on real‐world patient data from a single cancer center. Methods We analyzed all outpatient doses of pembrolizumab and nivolumab administered at three infusion centers affiliated with our academic hospital between July 1, 2018 and Oct 31, 2018. We estimated savings from several dosing strategies with and without vial sharing between patients. Results A total of 1029 doses of pembrolizumab or nivolumab were administered for multiple cancer types. For 77% of doses, the weight‐based dose was less than the fixed dose. “Dose‐minimization” (DM), defined as the lesser of weight‐based and fixed dose decreased nivolumab spending by 9% without affecting pembrolizumab spending. DM plus vial sharing decreased pembrolizumab spending by 19% without affecting nivolumab. The differences in savings were due to availability of multiple vial sizes for nivolumab but not pembrolizumab. DM plus vial sharing for both drugs would have saved $1.5 million USD over the 4‐month study period. Conclusion New dosing strategies for pembrolizumab and nivolumab can generate large savings without anticipated decrease in efficacy. Barriers include FDA dosing labels, hospital policies against vial sharing, and inaccessibility of smaller vial sizes, which are currently available in other worldwide markets.

Association of extended dosing intervals or delays in pembrolizumab-based regimens with survival outcomes in advanced non-small cell lung cancer

“…Recent pharmacoeconomic analyses comparing alternative dosing strategies of pembrolizumab (including weight-based dosing) to FDA-approved labels have estimated major cost savings for the health system with a personalized approach. 20,21 Randomized non-inferiority clinical trials designed with Bayesian methods would be the gold-standard for evaluating these extended dosing regimens in an effective and cost-efficient manner. 9,[22][23][24] Alternatively, therapeutic drug monitoring for personalized dosing -as commonly used for antibiotics and immunosuppressive agents -to achieve plasma or serum drug concentrations within a known therapeutic range is another potential strategy that can be employed in prospective studies to minimize financial toxicity from drug and pharmacy costs in this growing population.…”

Unraveling the complexity of therapeutic drug monitoring for monoclonal antibody therapies to individualize dose in oncology

“…This is also reflected by the population exposure of fixed doses of pembrolizumab: median exposures relative to mg/kg dosing were –4.6% and +27.1% for 150 and 200 mg fixed dosing, respectively 33 . If a fixed dose of 150 mg pembrolizumab is selected, drug‐related treatment costs are significantly reduced 54,55 …”

Cancer Immunotherapy Dosing: A Pharmacokinetic/Pharmacodynamic Perspective

“…These data suggest that fixed dosing has equivalent efficacy and safety [ 124 ]. But further analysis considering the average weight of cancer patients (75 kg), showed that only 150 mg of pembrolizumab would be actually required [ 125 ]. These FDA PK simulations demonstrated the same exposure between fixed and weight-based dosing, leading to changes in pembrolizumab dosing (200 mg once every three weeks or 400 mg once every six weeks).…”