Anticancer drugs approved by the Food and Drug Administration for gastrointestinal malignancies: Clinical benefit and price considerations
By 2020, the cost of cancer care in the United States is expected to reach $158 billion US dollars.1 Pharmaceutical drugs are the fastest growing aspect of US health care spending, with oncology treatments amounting to nearly $37.8 billion in 2015. Over the past decade, the average monthly price of oncology drugs more than doubled, from $7 103 to $15 535 USD. Concerns arise as the unprecedented increase in price of new anticancer drugs seem disproportionate to the clinical benefit they produce.
To address the growing disconnect between clinical benefit and cost, various frameworks have been developed by organizations including the American Society of Clinical Oncology (ASCO) and the European Society for Medical Oncology (ESMO). The ASCO value framework (VF) was designed to standardize the assessment of value for new anticancer treatment to guide decision-making by physicians and patients. ESMO intends to use the Magnitude of Clinical Benefit Scale (MCBS) to select anti-cancer therapies that offer the greatest benefit, and prioritize their drug funding across the European Union. Notably, more than half of the accelerated US Food and Drug Administration (FDA) approval indications of new anticancer drugs were based on single–arm studies and could not be assessed with the original ESMO MCBS; however these can now be evaluated with ESMO MCBS version 1.1...
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