ESMO 2019: Are Novel Anti-cancer Drugs Worth A Higher Price?

European Society for Medical Oncology (ESMO) 2019, held Sep 27, 2019 - Oct 1, 2019 in the Fira Barcelona Gran Via, L'Hospitalet de Llobregat, Spain
European Society for Medical Oncology (ESMO) 2019, held Sep 27, 2019 - Oct 1, 2019 in the Fira Barcelona Gran Via, L'Hospitalet de Llobregat, Spain

The costs of healthcare and novel cancer drugs is often a hotly debated topic.

According the Centers for Medicare and Medicaid Services (CMS), health care costs in the United States, will increase to US $ 5.4 trillion by 2024, making it one of the fastest growing financial segment of the American economy.

The cost of cancer care (which includes the costs of drugs) is the most rapidly increasing component of U.S. health care spending and are expected to increase from U.S. $ 125 billion in 2010 to an estimated U.S. $ 158 billion in 2020, a 27% increase. However, while these numbers seem high, the average cost of cancer drugs are – and have traditionally been – in most cases between 8% and 14% of the total cost of (cancer) treatment, the cost of novel, anti-cancer drugs often seen as excessive.[1]

This is especially the case with the sharp increase in the launch price of new cancer drugs observed since 2009. The average cost of novel cancer drugs launched since that year and 2014 were priced at more than U.S.$ 100,000 per patient for one year of treatment. But with more advanced treatment options, such as (hyper) targeted therapies, which may have fewer adverse effects (AEs) than other types of cancer treatment, some launch prices have exceed more than $ 400,000 for a one year treatment.

But are novel cancer treatments worth these higher costs?

Study results from two studies investigating the link between clinical benefit and costs, presented during the 2019 annual meeting of the European Society of Medical Oncology (ESMO), being held in Barcelona, seems to suggest that many new anti-cancer medicines add little value for patients compared to standard treatment and are rarely worth the extra cost. [2][3]

Marc A. Rodwin, J.D.,Ph.D. Professor, Suffolk University Law School in Boston, USA and co-author of a study of new anti-cancer drugs in France

“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,” noted Marc A. Rodwin, J.D.,Ph.D. Professor, Suffolk University Law School in Boston, USA and co-author of a study of new anti-cancer drugs in France. [2]

The studies looked to see if monthly treatment costs of medicines introduced in the last 10-15 years for solid tumors were associated with clinical benefit scores showing improved outcomes such as survival, quality of life and/or treatment complications versus standard treatment.

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.[2]

New drug costs were, on average, US $ 2,765 (€ 2,525) per month more than comparative drugs used for the treatment of patients with the same type of cancer.

“This was the first study in France to correlate price with well recognized independent scales of added value and it showed that, while there was a link between cost and added value, it was weak,” Rodwin said.

Lower costs in the in Europe
While the costs of novel therapies are generally lower in Europe, compared to the United Stares, an unrelated, second, study of drugs approved for adult solid tumors in four European countries and the United States between 2009-2017, did not show a link between drug cost and clinical benefit measured by ESMO-MCBS and the American Society of Clinical Oncology Value Framework (ASCO-VF).

However, 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 U.S. $ 4,361 (€ 3,985) – 5,273 (€ 4,820) in the European countries compared to U.S. $ 12,436 (€ 11,365) in the USA.

Kerstin Noëlle Vokinger, MD, JD, Ph.D, LL.M, University of Zurich, Switzerland, and affiliated with the Program on Regulation, Therapeutics, and Law (Harvard Medical School, 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,” Vokinger explained.

Barbara Kiesewetter, MD, Ph.D, 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.

Barbara Kiesewetter, MD, Ph.D, Medical University of Vienna, Austria

“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,” Kiesewetter 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 standardized, optimal therapy wherever they live,” she concluded.

References
[1] Dahl BJ. The Cost of Oncology Drugs: A Pharmacy Perspective, Part I. Fed Pract. 2016 Feb;33(Suppl 1):22S-25S.[Pubmed][Article]
[2] Abstract 1629O_PR ‘The price of added value for new anti-cancer drugs in France 2004-17’ will be presented by Patricia Marino during the Proffered paper session on Monday, 30 September 2019, 16:30-18:00 CEST in Salamanca Auditorium (Hall 3). Annals of Oncology, Volume 30, Supplement 5, October 2019
[3] Abstract 1631PD_PR ‘Clinical benefit and prices of cancer drugs in the US and Europe’ will be presented by Kerstin Vokinger during the Poster discussion session on Sunday, 29 September 2019, 10:15-11:45 CEST in Leon Auditorium (Hall 3). Annals of Oncology, Volume 30, Supplement 5, October 2019