New studies question whether novel anti-cancer drugs are worth their extra cost
Many new anti-cancer medicines add little value for patients compared to standard treatment and are rarely worth the extra cost, according to results of two studies investigating links between clinical benefit and pricing in Europe and the USA, reported at the ESMO Congress 2019.
The studies looked to see if monthly treatment costs of medicines introduced in the last 10-15 years for solid tumours were associated with clinical benefit scores showing improved outcomes such as survival, quality of life and/or treatment complications versus standard treatment.
"Most of the new cancer drugs had low added value, so doctors and patients shouldn't assume that just because a drug is new, it's going to be better," said Dr. Marc Rodwin, Law School, Suffolk University, Boston, USA and co-author of a study of new anti-cancer drugs in France.
In this study, almost half of new drugs approved in Europe between 2004 and 2017 for treatment of solid tumours had low added value scores on the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS), and over two thirds had low added value on the Added Therapeutic Benefit Ranking (ASMR) scale used by French drug regulators. On average, new drug costs were EUR2,525 per month more than comparator drugs for the same cancer type.
"This was the first study in France to correlate price with well recognised independent scales of added value and it showed that, while there was a link between cost and added value, it was weak," said Rodwin.
In the second study of drugs approved for adult solid tumours in four European countries and the USA from 2009-2017, there was no link between drug cost and clinical benefit measured by ESMO-MCBS and the American Society of Clinical Oncology Value Framework (ASCO-VF). Overall, median cancer drug prices in Europe were less than half US prices. The median monthly cost for drugs with low benefit scores on ESMO-MCBS ranged from USD4,361-5,273 in the European countries compared to USD12,436 in the USA.
"Drug costs were not associated with clinical benefit score in any of the countries we looked at. For example, some of the more expensive drugs for prostate and lung cancer in Switzerland had lower ESMO-MCBS scores, while cheaper drugs had higher scores," said study co-author, Prof Kerstin Vokinger, University of Zurich, Switzerland, and affiliated with the Program on Regulation, Therapeutics, and Law (Harvard Medical School, USA). "It is important that drug pricing is aligned with clinical value and that our limited resources are spent on innovative medicines that offer improved outcomes."
Dr. Barbara Kiesewetter, Medical University of Vienna, Austria, and a member of the ESMO-MCBS Working Group, pointed out that the new research underlines the growing importance of the ESMO-MCBS in clinical practice in Europe to assist doctors and patients in discussions and decisions on treatment.
"The ESMO-MCBS is very easy to use and anyone can go online to check the scores of cancer drugs, and understand the factors that are used to grade the clinical benefit of medicines. It's very important to have this validated score not only for daily decision making but to influence reimbursement decisions and reduce treatment disparities," she said.
"Cost is one of the main reasons why patients are denied access to the newer anti-cancer drugs, and we can use the ESMO-MCBS to clearly demonstrate which drugs provide greatest benefit for patients. By showing which drugs are most likely to be worth the higher cost, we can hopefully improve access to the drugs with greatest value so that patients receive standardised, optimal therapy wherever they live," Kiesewetter concluded.