Footnote:
Nach Informationen von SSRN wurde die ursprüngliche Fassung des Dokuments April 18, 2023 erstellt
Description:
Background: Rising cancer drug prices pose a challenge for patients and healthcare systems in the US. Whilst prices are routinely assigned to a drug’s original indication receiving US Food and Drug Administration (FDA) approval, the influence of supplemental indication approvals on prices remains uncertain.Objective: To identify and quantify factors associated with cancer drug prices, distinctly analyzing original and supplemental indications.Data and Methods: Clinical trial evidence supporting each indication’s FDA approval was collected from the DrugsFDA database between 2003-2022. Disease incidence and disability-adjusted life years (DALYs) were obtained from the Global Burden of Disease study. Indication-specific monthly treatment costs were calculated for patients covered under Medicare Part B and D. The association between log-prices and collected variables were assessed in univariate regression analyses.Results: We identified 109 drugs approved across 326 cancer indications. Drugs were priced at $22,360 per month on average (median $13,616, IQR 11,226 to 18,294). For original indications, prices did not correlate to improvements in overall survival (β=0.06, 95%CI -0.30 to 0.41, p=0.750) and progression-free survival (β=0.09, 95%CI -0.32 to 0.51, p=0.645). Original indications’ prices were: (1) negatively associated with disease incidence (β=-0.19, 95%CI -0.28 to -0.10, p<0.001) and prevalence; (2) positively correlated for first-in-class drugs (+44.69%, 95%CI 8.08 to 93.72, p=0.014), biologics (+87.71%, 95%CI 38.11 to 155.14, p<0.001), hematologic cancers (+61.35%, 95%CI 22.54 to 112.44, p=0.001), and severe diseases with substantial unmet needs (+4.42% per DALY, 95%CI 1.91 to 6.75, p=0.001); and (3) negatively correlated to indications with randomized controlled phase 3 trials. Prices were only poorly associated with supplemental indications’ efficacy, clinical evidence, and epidemiology.Conclusions: Cancer drug prices are set based on the original indication’s characteristics, thereby omitting the value of supplemental indications. Indication-specific pricing, coverage, and reimbursement policies, considering each indication’s safety, efficacy, innovativeness, and unmet need, are necessary to align a drug’s value and price