—  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 —

BOSTON, March 17, 2022 – The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of trilaciclib (Cosela™, G1 Therapeutics) and plinabulin (BeyondSpring Pharmaceuticals) for the prevention of chemotherapy-induced neutropenia and other myelosuppressive effects.

“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,” said Steven D. Pearson, MD, MSc, ICER’s President.  “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.”

A draft version of this report was previously open for a four-week public comment period. The updated Evidence Report reflect changes made based on comments received from patient groups, clinicians, drug manufacturers, and other stakeholders. Detailed responses to public comments can be found here.

Key Clinical Findings

For patients with extensive-stage small cell lung cancer treated either with the chemotherapeutic agents carboplatin/etoposide or topotecan, ICER has determined that the available evidence provides moderate certainty that trilaciclib is at least comparable to standard care, with the potential of a small net health benefit (C+).

Current evidence on plinabulin suggests that for patients with early-stage breast cancer, the current evidence provides moderate certainty that adding plinabulin to pegfilgrastim is at least comparable to the pegfilgrastim alone, with the possibility of delivering a more substantial net health benefit (C++).

Key Cost-Effectiveness Findings

Trilaciclib was approved by the FDA on February 12, 2021.  Trilaciclib’s current net price is approximately $1,491 per vial.  Based on current evidence, for an individual with an average body surface area, ICER’s health-benefit price benchmark (HBPB) range for trilaciclib is between $430- $670 per vial. 

Plinabulin has not been approved by the FDA, and its manufacturers have not yet announced what the treatment’s US price will be if it is eventually approved.  While further data will be required for plinabulin to receive reconsideration at the FDA, ICER determined that, based on currently available data, plinabulin would meet traditional thresholds of cost-effectiveness between $1,100- $1,600 per dose.

ICER’s HBPB is a price range suggesting the highest US price a manufacturer should charge for a treatment, based on the amount of improvement in overall health patients receive from that treatment, when a higher price would cause disproportionately greater losses in health among other patients in the health system due to rising overall costs of health care and health insurance. In short, it is the top price range at which a health system can reward innovation and better health for patients without doing more harm than good.

Health Improvement Distribution Index (HIDI)

There is no suggestion in the epidemiology of cancer treatment-associated myelosuppressive events that there is a significant difference in prevalence of myelosuppression among key subpopulations.  Therefore, we did not calculate a Health Improvement Distribution Index (HIDI).

About ICER

The Institute for Clinical and Economic Review (ICER) is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER’s reports include evidence-based calculations of prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health care system.