Applied Clinical Trials
July has seen one very positive development in the faltering attempts by Europe's governments to resolve that challenge of providing patients with innovative medicines without bankrupting health budgets.
July has seen one very positive development in the faltering attempts by Europe's governments to resolve that challenge of providing patients with innovative medicines without bankrupting health budgets. A joint decision on reimbursement was reached by two European countries on an expensive new drug-very much a first for a continent divided by dozens of distinct national pricing authorities. Belgium and the Netherlands reached an agreement with Biogen on the pricing and reimbursement of Spinraza, the company's nusinuren, indicated for 5q spinal muscular atrophy at a list price of close on $1 million per patient. After three years of cooperative efforts aimed at conducting joint negotiations with drug companies, they have at last got a result. Negotiations began in February, and involved a joint health technology assessment as well as three-way talks between Biogen and the Belgian and Dutch health ministries. Spinraza will be reimbursed for specific groups of patients in both countries under similar conditions, and at price that both countries characterized as "acceptable"-although neither revealed just what the agreed price was. Belgian health minister Maggie de Block was quick to hail the achievement as a watershed moment for Europe-"a giant step forward". So too was her Dutch counterpart, Bruno Bruins. He saw the outcome as "a very clear and promising example of the benefits of working together on price negotiations and pharmaceutical policy. " The success is well-timed, because the Belgian-Dutch cooperation has only recently been expanded to five countries (with Ireland joining Luxembourg and Austria only last month), and this makes it look as though the so-called Beneluxa exercise is more than just a talking shop, or a vehicle for smaller countries to vent their resentment at being picked off one by one and victimized by the big battalions of international pharma in pricing talks on innovative medicines. It is also well-timed since something like a tipping point has been reached in the entire discussion of how far European countries can find common ground in their dealings with Big Pharma. One of the other leading attempts to work together-known as the Valletta process-appears to be in serious trouble as it tries to define the next steps towards its avowed goal of achieving "fair" prices for new medicines. Greek Health Minister Andreas Xanthos outlined the challenges as he hosted the latest meeting of the group in Athens in mid-July, and he frankly admitted that despite the readiness of the ten signatory countries from southern and eastern Europe to go beyond exchanging information and expertise, the drug industry is not going to play ball unless there is more clarity about its legal status and its procedures. "We share the political will to work together and we have some strong common views", he said. But, he went on, the diversity of national laws is holding back progress, and "reinforcing the expected reticence of the pharmaceutical industry." "Reticence" among research-based drug firms has been evident, out of apprehension that premature commitment to such embryonic systems could divert previous management resources, increase rather than decrease the tasks involved in pricing negotiations, and even damage their own ability to maintain the revenue cycle that funds their research. Vertex negotiated at length and at a high level with Beneluxa before eventually both sides pulled out of talks because it was impossible to agree a mutually acceptable price. Others have backed off sooner, discouraged by the risk of additional bureaucracy. The disparate membership of the Valletta group, mixing countries of different sizes and wealth, makes engagement even more of a challenge than with the more homogenous (and so far better organized) Beneluxa group. So too does the Valletta approach, spelled out by Xanthos: "The pharmaceutical industry joins forces to exert greater influence on political decisions. It is time for us to do the same thing." Xanthos recommended that the Valletta group should set up a new regulatory framework that could offer drug firms rapid access to a market of its 160 million citizens. He also called for more regular well-prepared technical meetings to move towards an international convention to bind national health systems, patients, and the pharmaceutical industry. An ambitious approach. But first it will be necessary to get the drug industry back to the Valletta negotiating table-and since the last joint discussion between industry and health ministry sherpas broke up in some disarray last March, there has been no further contact, and as summer sets in across Europe, no date on the horizon for a resumption. Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium