Interventions of Interest:

  • plinabulin (BeyondSpring Pharmaceuticals)
  • trilaciclib (Cosela™, G1 Therapeutics)

Trilaciclib received FDA approval in 2021 to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage small cell lung cancer. Plinabulin was under development to prevent chemotherapy-induced neutropenia when it received a complete response letter from the FDA in December 2021 requesting a second pivotal trial.

Given current data, trilaciclib would achieve common thresholds for cost effectiveness if priced between $430-670 per vial; plinabulin would achieve common thresholds for cost effectiveness if priced between $1,100 – $1,600 per dose. Due to the FDA action on plinabulin, ICER will not hold a public meeting but has produced as a final document an Evidence Report following consideration of public comment.

Final Documents

Revised Evidence ReportDownload
Draft Evidence ReportDownload
Public Comments on Draft Evidence ReportDownload
Response to Public CommentsDownload

ICER’s President Steven D. Pearson, MD, MSc stated:

“Patients undergoing cytotoxic chemotherapy are at risk of neutropenia and other myelosuppressive side effects that can require dosage adjustments and present a risk for serious infection. ICER had intended to focus this review on an emerging agent, plinabulin, that had promising early data and seemed on track for FDA approval. 

Trilaciclib, an agent approved in 2021 with a similar intended therapeutic goal, was included in the review upon the recommendation of clinical experts.  However, plinabulin received a complete response letter from the FDA in late 2021 that suggested another pivotal trial would be needed to confirm clinical benefit.  Under the circumstances, we have completed a revision to our draft evidence report following consideration of public comment, but we will not proceed to a full public meeting.  A health benefit price benchmark for trilaciclib is provided in the report, and a suggested price range for plinabulin is also provided, based on best currently available data.”

For questions, please contact info@icer.org.

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