Increased biosimilar options in oncology and impact on administrative burden caused by drug switches: Implications of step therapy.

18 Background: Within drug classes, some payers require a particular drug to be tried and failed first, before reimbursing other drugs within the same drug . This is called a step-edit. These step edits are mandated despite physician or patient preference. With the increased utilization of biosimilar drugs, the instances of step edits have dramatically increased. With the increase of step edits the administrative burden of inventory management, authorizations, appeals and regimen maintenance has significantly increased. The extent of the increased step therapy requirements and associated costs are unclear. Methods: Drug conversions due to step edit requirements were tracked for twelve months and compared to the same twelve-month period the prior year at Tennessee Oncology, a large community-based practice. Ten drug classes containing biosimilar options were reviewed for ten different payers. The review monitored the addition of biosimilar drug options within the various drug classes and the number of patients that required a switch to an alternate therapy, solely due to payer step edits. A per patient cost was calculated by evaluating the time spent per patient to obtain an authorization, manage inventory, appeal denials and revise regimens. Results: July-Dec 2022, 83 patients required drug conversions due to payer step edits. This included eight payers within the ten drug classes. Each drug class had an average of 3 therapies. July -Dec 2023, over 500 patients were converted due to payer step edits. Each drug class had an average of eight step therapy choices. The cost of conversion, per patient, was an average of $76.00. If extrapolated, $76,000 in 2023 compared to 12,616 in 2022. It was noted that not all required drug switches resulted in the least costly drug being mandated by the payer. There were cases where the practice was required to switch from a less costly drug to a more costly drug due to a payer step edit. Conclusions: There was a six-fold increase in the number of patients requiring a step-edit year over year. This increased the administrative burden of drug management while costing practices over $75 per switch each . Step edit drug classes and drug choices have also grown exponentially highlighting the fact that the step therapy trend continues to grow and become more complex. Physician practices bear the financial burden of the payer UM requirements and patients are placed in the middle. 2022 vs 2023 required drug switches due to step edits. Payer Drug Classes Requiring Step Therapy 2022 Drug Classes Requiring Step Therapy 2023 Total Drug Agents With Step Edits 2022 Total Drug Agents With Step Edits 2023 Payer 1 0 1 0 6 Payer 2 7 9 14 49 Payer 3 0 1 0 6 Payer 4 0 9 0 49 Payer 5 2 9 3 49 Payer 6 2 9 4 49 Payer 7 4 10 12 53 Payer 8 3 10 10 50 Payer 9 7 9 9 49 Payer 10 6 9 18 49 Total 31 76 70 409