Delays in the availability of new therapies and unjustifiable increases in the prices of well-established treatments disadvantage patients. These results were presented at the 2017 European Cancer Congress.1, 2
Patients with cancer are living longer, and often the disease becomes a chronic rather than an acute condition. Both of these issues make access to drugs that extend and improve the quality of life and the availability of fair prices imperative for more people.
The European Commission grants approval decisions for cancer therapies to ensure that assessment of risks and benefits is equally applied across the European Union (EU).
Nonetheless, individual EU member states decide reimbursement and cost, which decides access to new drugs. This causes variability in overall availability and in the amount of time elapsed before patients can access new treatments.
For this study, researchers examined the approval processes of 48 new cancer medications evaluated between 2011 and 2015 by the European Medicines Agency for use in the EU.
Approvals were based on a principal trial using overall survival (n = 17), progression-free survival (n = 19), and overall response rate (n = 12) as primary end points.
“These new drugs all show clinical benefit,” explained one study’s first researcher Markus Hartmann, PhD, principal consultant at European Consulting and Contracting in Oncology, a regulatory affairs consultancy based in Trier, Germany.
“Our data indicate in the overall survival group a median survival gain of 3 months, while in the progression-free survival group the median gain was 3.8 months. However, the trial design, trial end point, and magnitude of effect is evaluated quite differently by the health technology assessment (HTA) authorities in the UK, France, and Germany, even though they reviewed the same, or very similar, clinical data.”
A number of different factors affect differences in national HTA outcomes, and HTAs use different methods in their evaluations. France and England use health economics to determine final reimbursement, while Germany relies solely on an assessment of benefit followed by price negotiation.
In addition, drug prices in England, including generics, have increased sharply.
The researchers were surprised to find several companies were consistently increasing their prices for cancer treatments. In the last 5 years, price increases of more than 100% were seen for 20 treatments. Prices for 2 treatments, busulfan (used to treat leukemia) and tamoxifen (breast cancer), increased by more than 1000%, explained Andrew Hill, MD, senior research fellow in the department of pharmacology and therapeutics, University of Liverpool, England.
“We have found that some companies take over the supply of some generic cancer medicines and then raise the price progressively.”
High prices strain health care systems such that disease progression and survival could be negatively affected.
“We hope that, by explaining what we have found in the UK, other European countries will take note and protect themselves against these kinds of price rises,” concluded Hill.
“At a time when cancer patients are living longer and better lives due to effective treatments, this situation is particularly worrying.”
- Hartmann M, Droeschel D, Vollmer L, De Paz B, Walzer S. Access to innovative cancer drugs: divergent outcomes of HTA bodies’ appraisals in France, Germany and the United Kingdom impact on the availability of new medicines. Paper presented at: the European Cancer Congress 2017; January 27-30, 2017; Amsterdam, Netherlands. Abstract 970.
- Hill A, Barber M. Unexplained rises in UK cancer drug prices between 2011 and 2016. Paper presented at: the European Cancer Congress 2017; January 27-30, 2017; Amsterdam, Netherlands. Abstract 966.