Launch prices of new cancer drugs are substantially higher in the United States than they are in similar, high-income countries in Europe, including Germany, Switzerland, and England, a new analysis shows.
Moreover, increases in drug prices for the majority of these same drugs were greater than the national inflation rate in the US but not, for the most part, in the comparator countries, the same analysis indicates.
Nor were any of the price increases associated with clinical benefit.
“Not all marketed cancer drugs have a high clinical value and high prices do not automatically mean that the specific drugs have a high clinical value,” lead author Kerstin Vokinger, MD, JD, PhD, University of Zurich, Zurich, Switzerland, said in a statement.
“For both initial costs and post-approval drug prices over time, there is no association between clinical benefit of cancer drugs and their prices and, due to limited resources, it is important to prioritize drugs with high values,” she added.
The study was published online July 1 in JAMA Oncology.
New Cancer Drugs
The analysis included 65 cancer drugs approved for use in the US, Germany, Switzerland, and England for the treatment of adult solid tumors and hematologic malignancies. The drugs were approved in the US between January 2009 and December 2019 and in Europe up until December 31, 2019.
“Prices were adjusted for currency and inflation,” the authors note.
After adjusting for both factors, the median monthly cost at the time the drug was launched was $ 11,755 per patient in the US compared with $ 8305 per patient in Germany, $ 6955 per patient in Switzerland, and $ 7355 per patient in England.
“In all countries, the lowest monthly treatment costs at launch were greater in 2018-2019 vs 2009-2010,” investigators add.
In the US, for example, the lowest monthly treatment cost was $ 14,580 in
2018-2019 compared with $ 5790 in 2009-2010.
This compared with $ 5888 in Germany in 2018-2019 vs $ 4289 in 2009-2010; $ 6593 vs $ 5784 in Switzerland, and $ 6867 vs $ 3939 in England, they add.
The median monthly treatment cost was also 2.5-fold higher in the US than in Germany and over twofold higher in the US than in either Switzerland or England, investigators point out.
Furthermore, the median price increase in almost three quarters (74%) of all new cancer drugs was greater than the national inflation rate in the US, compared with only 2% of drugs in England, no drugs in Germany and 13% of drugs in Switzerland.
Benefit vs Price
When the authors compared price increases of the new cancer drugs vs their clinical benefit, they saw no association between either the launch price or post-launch price changes and clinical benefit in any of the 4 countries analyzed.
Clinical benefit of each of the drugs was assessed using the American Society of Clinical Oncology Value Framework (ASCO-VF) and the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS).
At product launch, the median ASCO-VF score was 46.4 for products used in the treatment of solid tumors whereas the median ESMO-MCBS for the same products was 3.0.
At the end of the study period, the median post-launch ASCO-VF score was 52.8 while the median ESMO-MCBS core was 4.0, investigators note —suggesting that there was no association between either the launch price or the change in post-launch pricing and clinical benefit using either score, they emphasize.
Most of the difference in cancer drug prices was attributable to higher launch prices in the US than launch prices in the other three European countries.
This might be explained by the fact that the US does not have the same mechanism that other countries do to assess the benefit and costs of new drugs and to use that mechanism as a basis upon which to base pricing negotiations.
Conversely, in Europe, “drug pricing is often overseen or directly regulated by the government, and many countries have health technology assessment agencies with wide latitude to review new products and, in some cases, to help negotiate pricing contracts directly with manufacturers,” the authors point out.
“[Thus], the US could learn from the experience of other countries, such as Germany, which has a transparent and evidence-based system for assessing the clinical benefit of new drugs,” they suggest. Recent legislation in the US passed in the House of Representatives and proposed in the Senate include provisions to limit drug price increases to the rate of inflation.
“The Biden administration has echoed the legislative call for a limit on drug price increases and could potentially use existing statutory authority…to implement the limit in the Medicare program,” the authors note.
Policymakers in both the US and in Europe are now debating reforms to drug pricing that would cover both the price of new drugs when entering the market as well as price increases once the products have been launched.
Reforms are surely needed: spending on cancer drugs is projected to grow to $ 100 billion in the US and by $ 50 billion in Europe by 2022.
The study was funded by the Swiss National Science Foundation and the Swiss Cancer Research Foundation. Vokinger has disclosed no relevant financial relationships.
JAMA Oncology. Published online July 1, 2021. Abstract
Author: Pam Harrison
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