Pharmaceutical companies are investing heavily in the development of compounds with similar mechanism of action to that of drugs already on the market. New and potentially expensive medications are then approved with minimal if any advantage over existing drugs. We suggest a value-driven model that will tie the economical gains of drug companies with real-world patient outcomes, offering companies a strong incentive to develop novel and superior regimens.
We focused on advanced colorectal cancer that progressed after 1st-line chemotherapy. PFS Kaplan-Meier curves of five common drugs were analyzed (1-5). “Integrated” PFS (iPFS) was defined as the mean of median PFSs of those drugs. For the subset of patients (in those studies) whose disease progressed earlier than a defined iPFS cutoff, the manufacturer were to lose a certain fraction of revenues. For the subset of patients with sustained response longer than a defined iPFS cutoff, the company were to gain extra profits. Total extra revenues and losses for all companies were to equal zero. Drug prices and incidence rates were derived from DrugAbacus and American Cancer Society websites. A mathematical calculation was done to show model feasibility.
iPFS thresholds chosen were 1 and 0.7. For every patient with no progression at 1 iPFS, the company were to gain a randomly-selected value of 30% of launch price. To maintain net zero financial loss/gain for all manufacturers together, it was calculated that companies should lose 41.4% of launch price for every patient who progressed before 0.7 iPFS. With model application, Amgen, Regeneron and Elli Lilli achieved revenues of 105.6% to 109.7% compared with non-model settings. These profits amounted to extra annual gains of approximately 25 million dollars (Amgen) and 53 million dollars (Regeneron). Bristol-Myers and Genentech lost 18.7% and 3.1% of anticipated revenues, respectively. Their absolute annual deductions approximated 8 million dollars (Genentech) and 105 million dollars (Bristol-Myers).
A shared-risk model of cancer drug reimbursement would create a potent incentive for companies to develop medications that significantly improve the overall value of existing compounds.
Clinical trial identification
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All authors have declared no conflicts of interest.