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Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.
As governments struggle to rein in public spending in the European Union, drug pricing "is becoming increasingly intertwined with the on-going financial crisis". And the consequences are that life is likely to get harder for people designing clinical trials, according to European Healthcare Policy, a new report from the GlobalData business intelligence service.
With "proper pricing for pharmaceuticals" now a major topic of debate in Europe, drugmakers’ profits "are under attack from multiple angles", concludes the report, highlighting recent developments in Germany. GlobalData sees the German determination to make use of reference pricing as threatening a downward spiral in Europe. Because most of Germany’s neighbours have weaker economies, they make "poor benchmarks for price referencing. This could quickly lead to a race-to-the-bottom for drug prices as countries drive the base price lower and lower", says the report. The new German pricing system's heavy reliance on an assessment of relative benefit subjects drug companies to additional uncertainties as they struggle to demonstrate superiority to the authorities in order to obtain adequate pricing.
"One of the critical questions that remain ambiguous is the definition of the comparator", points out GlobalData. "Drug developers will have to determine the identity of the necessary comparator before designing clinical trials to ensure adequate data collection", but "for therapies targeting an indication without approved drugs it is unclear what the comparator will be".
The report identifies the biggest problem facing drug manufacturers as the use of an improper comparator. German regulators now determine the standard of care for each treatment area, so to gain favorable pricing and reimbursement, drug companies must provide data demonstrating the benefits of the new therapy. In order to show that a new drug offering is better than the standard of care, specific comparator trials need to be conducted.
"In the short term, it is likely that many drugs will continue to struggle with the issue of inappropriate comparators", says the GlobalData report, because clinical trials for drugs being approved now were planned years ago, before the new review system was in place. The question looking forward, it predicts, is whether or not clinical trials will be planned to meet these expectations in the future. And that, in turn, will depend on whether countries can agree on the form of the appropriate comparators for each drug. As the report points out, if a drug manufacturer has to run 15 different clinical trial protocols in order to show benefit over the standard of care in each individual country, problems will abound. "If, on the other hand, countries – especially in the EU – can agree on standards for these trials, the process will be much more manageable."
From my discreet vantage point at what some consider to be the centre of countries in the EU, the likely speed of progress towards any such agreement is still achingly slow. The recast of the EU clinical trials rules and the extensive debates over health technology assessment are, indeed, underway. But they are not going to deliver results for a long while yet. The patience of clinical trials designers will be tested as intensively as their products over the coming years as the EU inches towards finding some consensus on standards.