Using a narrative synthesis approach, a recent study performed an assessment of the clinical impact of recently licensed cancer drugs. Of 53 new cancer drugs, 42 were associated with some improvement in the three clinical parameters analyzed: overall survival, quality of life or safety.
Some of the most expensive drugs on the market are those used for cancer treatment, and there is growing concern over the value of patient spending on such high-cost medicines. While some have argued that these prices are justified, it remains unclear because of scarcity of evidence on their clinical impact and risks. This makes it challenging for patients as well as physicians to weigh the expected benefits of treatment with rising drug costs. Since the majority of cancer drugs do not offer lifelong protection, the gold standard for characterizing clinical impact in oncology drug trials is overall survival. Quality of life and safety are also used as measures of therapeutic value by regulators and physicians.
In a new study, Salas-Vega at the London School of Economics and Political Science, in collaboration with Harvard Medical School, sought to evaluate the therapeutic value all new cancer drugs approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) between 2003 and 2013. They reviewed summary publications on these cancer drugs from English, French and Australian health technology assessment agencies. Although 62 drugs were approved between the desired time period, 53 were assessed for overall survival, the primary measure of therapeutic value used in this study, by at least one of the international health technology assessment agencies.
The study, published in JAMA Oncology, found that 69 percent of the drugs evaluated were associated with an improvement in overall survival (OS). Twenty-three increased OS by at least 3 months, six increased OS by less than three months, 8 increased OS by an unknown magnitude and the remaining 16 did not improve OS. The distribution in OS was dependent on the target cancer type. Quality of life was also used to assess therapeutic value, whereby 42 percent of the evaluated drugs improved quality of life. Although a large share (45 percent) reduced patient safety, results indicate that there is evidence of OS, quality of life or safety benefits for 42 of 53 new cancer drugs evaluated. This analysis should be repeated as the bank of available cancer drugs grow.
The assessment of recently licensed cancer drugs suggests that the majority demonstrate some therapeutic value, according to the clinical measures evaluated in this study. However, it also does provide some evidence of a lack of therapeutic value for the others evaluated. This highlights the importance of conducting value assessments on expensive oncology drugs currently on the market.
Written By: Danielle Vitali, BSc