Cancer patients in Europe do not all have access to the latest oncology medicines at the same time, after they have been approved by the European Medicines Agency (EMA). This period can even vary greatly.
This is evident from a study by, among others, the Netherlands Cancer Institute, conducted in six European countries: Hungary, Italy, the Netherlands, Belgium, Switzerland and France, the results of which Julie Vancoppenolle et al. have published in the International Journal of Cancer.
The researchers took six new drugs – olaparib, niraparib, osimertinib,
ipilimumab, nivolumab and ibrutinib – under review for twenty indications, including breast cancer, ovarian cancer, prostate cancer, melanoma, non-small cell lung cancer, renal carcinoma and chronic lymphocytic leukemia. They conducted their research among hospital pharmacists from nineteen hospitals, because anyone who wants to know exactly when the first patients are treated with new medicines must of course obtain their data from hospital databases.
Hungary and Belgium
The time between EMA approval and actual access to the six medicines was on average 2.1 years. With a variation from 1 year before to 7.1 years after drug approval. The average time between EMA approval and treatment was longest in Hungary and Belgium, followed by Switzerland and the Netherlands.
The interval between approval by the national healthcare authorities and the decision to reimburse a new drug through health insurance was also highly variable. On average, it took six months before patients were treated with a new drug, but the variation was also large here: from 6.7 years before to 6.2 years after a reimbursement decision. Research leader Wim van Harten, also chairman of the board of directors of the Rijnstate hospital, calls the differences ‘shocking, especially when you consider that all countries and hospitals basically have the same access to the underlying information. Regardless of the effectiveness of the medicines – which is an issue in itself – some patients get access to them later than others.’
Year of life gained
There are a multitude of causes for the variation found, the researchers said. For example, different countries use different methods to keep their healthcare budget within limits. For example, there is no agreement about what costs are acceptable for one year of life gained. Some hospitals have focused on the treatment of specific tumor types and sometimes their own budgetary considerations are made.
Another important factor is that pharmaceutical companies usually first launch a new medicine in densely populated, rich countries such as Italy, France or the Netherlands, including through so-called early access programs (EAPs). This means delays for patients elsewhere in Europe. In more than half of the cases, the study showed, the first patients gained access to a new drug through such a program. The manufacturer then often pays for the medicine. These EAPs are mainly requested by specialized hospitals, which, for example, have conducted research into such a new drug and already have many contacts with pharmaceutical companies through their clinical studies. Sometimes care is also deliberately concentrated in a number of centers to build up experience with the drug.
Price negotiations
Delays are certainly also caused by lengthy price negotiations between pharmaceutical companies and national healthcare authorities. Although the EU states that it must be clear within 180 days after EMA approval what a medicine will cost and whether it will be reimbursed, but that period is often not met. One of the researchers’ recommendations is to hold pharmaceutical companies to a deadline for launching a medicine in all EU member states and to enforce that 180-day deadline more strongly.
National healthcare authorities should further share information about their price agreements and reimbursement decisions, say Vancoppenolle et al. The problem is that when it comes to price agreements with the pharmaceutical industry, it is often part of the deal that you keep your mouth shut about it. Van Harten knows that, but, he says: ‘It is allowed. Moreover, we know from research that transparency about prices between countries and about the underlying R&D costs actually leads to lower prices in all countries. And that this ultimately does not have to have a negative effect on R&D investments, a counterargument that the industry always struggles with.’
Strict criteria
As far as these early access programs are concerned, Van Harten says, it is important to use them wisely, i.e. for the right medicines and conditions. To this end, the Drug Access Protocol was developed in the Netherlands in 2021, which applies strict criteria, assesses applications and uses the EAPs for real-world research into the effectiveness and safety of a medicine. Van Harten: ‘Real world data collected within those EAPs can help to reduce the gap between EMA approval and actual availability. This is currently done too poorly and there is also no uniformity between countries.’ Furthermore, medical specialists in every country should be able to find in a database in which hospital early access programs are available.
The research shows that such a protocol is not an unnecessary luxury: an evaluation of the approvals of oncology medicines by EMA between 2009 and 2013 showed that 39 out of 68 new medicines (57%) entered the market without evidence of improved overall survival or quality of life. Van Harten: ‘My proposal is: follow an example of how we approach things in the Netherlands and adopt this protocol.’
Deep breath
The study was funded by the European Fair Pricing Network (EFPN), a partnership of cancer funds that aim to promote transparent and fair prices of new cancer drugs and faster access to those drugs. It therefore fits in with the policy of the European Commission, which earlier in 2023 designated rapid and equal access to new, effective and safe medicines as one of the main goals in the revision of EU pharmaceutical legislation. Van Harten: ‘The whole set of changes that are needed will take a long time. But you shouldn’t let that discourage you.’
