Mitsubishi Tanabe models economic impact of IV-to-oral switch

What is the economic impact of introducing an oral version of an intravenous drug? That is the health economics question at the heart of a paper by researchers at RTI Health Solutions and Mitsubishi Tanabe Pharma. The answer? It’s complicated. 

Writing in the journal Dovepress, the researchers describe a review of existing evaluations of the impact of oral formulations and their own model for quantifying the effect of oral edaravone. Mitsubishi Tanabe won FDA approval for the intravenous form of the drug, which is sold as Radicava, in amyotrophic lateral sclerosis in 2017. In May 2022, Mitsubishi Tanabe followed up by winning approval for an oral version of the drug, Radicava ORS.

The literature review identified 14 published evaluations of oral and intravenous formulations from 10 countries across a variety of disease areas. Ten of the studies used cost-effectiveness modeling, with the rest split evenly between cost minimization and cost calculation. The researchers identified limitations of the models.

“We found significant design variations in published models that estimated the impact of an additional formulation option on the treatment costs to payers and the society. Models need to be accompanied with clear descriptions on rationales for their time horizons and assumptions on how different formulations may affect healthcare costs from the selected perspectives,” the researchers wrote.

Only three of the studies estimated indirect costs. In creating their own model, the researchers looked at the effect of oral formulations on factors such as the ability of patients and caregivers to work, leading them to calculate that the 600 hours lost to intravenous administration and maintenance each year is a sizable impact.

The researchers note that such outcomes are typically outside of the scope of the analyses reviewed by third-party payers. However, given the impact on quality of life, they argue that “payers may be interested in reviewing a co-analysis that accounts for these societal outcomes and costs to make coverage decisions based on patient-centered outcomes goals.”