Analysis determines "value-based" price range for Eli Lilly's experimental lung cancer drug necitumumab

An analysis published Thursday in JAMA Oncology suggests that Eli Lilly's experimental lung cancer drug necitumumab, if approved by the FDA, should be priced between $563 and $1309 per cycle to be a cost-effective option. The work evaluated the range of drug costs for which adding necitumumab to chemotherapy could be considered cost-effective, given in part results from the SQUIRE trial, which demonstrated that Eli Lilly's therapy increased median overall survival by 1.6 months in patients with metastatic squamous cell lung cancer, compared with chemotherapy alone.

Lead author Daniel Goldstein noted that most new cancer drugs cost over $10 000 a month per patient in the US. However, he suggested necitumumab "should have a relatively low price given the low level of efficacy that it's providing," but that more effective therapies should garner higher prices under a "value-based" pricing system.

As part of the analysis, investigators used a mathematical model to compare the costs and patient life expectancies associated with standard chemotherapy, with or without necitumumab, based on data from several sources, including the SQUIRE study. Researchers assessed incremental cost-effectiveness ratios (ICERs) for treatment with necitumumab across a range of values for its cost.

Results demonstrated that adding necitumumab to standard chemotherapy provided an incremental survival benefit of 0.15 life-years and 0.11 quality-adjusted life-years (QALYs). Researchers determined that when the drug was priced below $563 or $1309 per cycle, there was a 90-percent likelihood that the ICER for adding necitumumab would be less than $100 000 per QALY and less than $200 000 per QALY, respectively. Meanwhile, the authors calculated that when the cost of necitumumab exceeded $6628 per cycle, there was a greater than 99-percent chance that the ICER exceeded $500 000 per QALY.

According to Goldstein, a value-based pricing system "would incentivise researchers and industry to develop truly game-changing innovation" and discourage the development of therapies "which add just a few weeks of life for patients." Commenting on the findings, a spokeswoman for Eli Lilly stated that discussions of pricing for necitumumab are premature, as the therapy has yet to receive regulatory approval.

The FDA is expected to make a final decision on whether to approve necitumumab later this year, after an advisory panel said in July that the benefits of the recombinant human IgG1 monoclonal antibody outweigh its risks. In documents released ahead of the panel meeting, FDA staff had cautioned that while the drug prolongs overall survival, it also elevates the risk of potentially fatal thromboembolic events.

Last month, a group of researchers expressed concerns about the growing cost of cancer therapies, which followed similar comments made by Leonard Saltz, chief of gastrointestinal oncology at Memorial Sloan Kettering Cancer Center, who suggested at this year's annual ASCO meeting that prices for new cancer drugs have become "unsustainably high." Meanwhile, ASCO recently proposed a new "conceptual framework" to assist doctors and patients in examining different cancer treatments by considering both their clinical benefits and costs.

For an interview related to the American Society of Clinical Oncology's (ASCO) conceptual framework to assess the value of new cancer treatments, see Spotlight On Interview: Chief medical officer Richard Schilsky discusses ASCO's new cancer drug value framework.

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