Analysis of Launch and Postapproval Cancer Drug Pricing, Clinical Benefit, and Policy Implications in the US and Europe

Abstract

The high cost of cancer medicines is a public health challenge. Policy makers in the US and Europe are debating reforms to drug pricing that would cover both the prices of new medicines when entering the market and price increases after they are launched.OBJECTIVE To assess launch prices, postlaunch price changes, and clinical benefit of cancer drugs in the US compared with 3 European countries (England, Germany, and Switzerland). DESIGN, SETTING, AND PARTICIPANTSThis economic evaluation identified all new drugs that were approved for use in the US, England, Germany, and Switzerland with initial indications for treatment of adult solid tumor and hematologic cancers. Analysis included drugs approved by the US Food and Drug Administration between January 1, 2009, and December 31, 2019, and by the European Medicines Agency and Swissmedic until December 31, 2019. Prices were adjusted for currency and inflation. Clinical benefit of drugs indicated for solid tumors was assessed using the American Society of Clinical Oncology Value Framework and European Society for Medical Oncology Magnitude of Clinical Benefit Scale. Using Spearman rank correlation coefficients, correlations between clinical benefit and launch prices and postlaunch price changes for each country were evaluated.MAIN OUTCOMES AND MEASURES Launch prices, postlaunch price changes, and clinical benefit of cancer drugs. RESULTSThe cohort included 65 drugs: 47 (72%) approved for solid tumors and 18 (28%) for hematologic cancers. In all countries, the lowest median monthly treatment costs at launch

Prices and Clinical Benefit of National Price-Negotiated Anticancer Medicines in China

“…The past decade witnessed great efforts in regulating anticancer medicines pricing by various health systems [ 8 ]. The association between treatment costs and clinical effects, however, varied across countries [ 1 , 18 , 41 ]. To the best of our knowledge, this is the first study investigating the correlation between negotiated price and the clinical benefit of cancer therapies in China.…”

“…High prices and increasing costs of anticancer medicines result in heavy financial burdens for patients and health systems [1][2][3][4][5]. Globally, with the increase of newly diagnosed cancer patients and launch of new therapies, the expenditure on oncologic treatments rose to US$164 billion in 2020 and is estimated to reach up to US$260 billion in 2025, representing a 9-12% growth [6].…”

Clinical Benefit and Expedited Approval of Cancer Drugs in the United States, European Union, Switzerland, Japan, Canada, and Australia

“…For solid tumor drugs, clinical benefit was assessed using the ESMO-MCBS version 1.1 scale 10 and targets for clinically meaningful benefit developed by working groups of ASCO-CRC (limited to randomized controlled trials). 11 Consistent with prior studies 1 , 12 - 16 as well as developers of these frameworks, 17 high clinical benefit was defined as ESMO-MCBS scores of 4-5 (in palliative settings) or A-B (in adjuvant or neoadjuvant therapy settings), and overall survival gains > 2.5 months or progression-free survival gain > 3 months. 11 , 18 …”

Hochpreisigkeit bei Onkologika

“…Für die Berechnung der monatlichen Behandlungskosten wurden die Daten aus Deutschland, der Schweiz, England und den USA herangezogen, wobei die aktuellsten klinischen Studien der Onkologika berücksichtigt wurden. Auch hier zeigte sich, dass es keine Assoziation zwischen klinischem Nutzen und monatlichen Behandlungskosten für Onkologika gibt (Vokinger et al 2021).…”