by Peter O'Donnell
BRUSSELS, July 24 (APM) - The study on payment models for high-cost medicines is proceeding within the EU's advisory machinery, and an opinion is scheduled for release this autumn to feed into the European Commission's policy formation.
The European Commission's expert panel on effective ways of investing in health has just released an update of its work so far in assessing innovative payment models for innovative medicines.
Under the chairmanship of Italian public health academic Walter Ricciardi , a draft text is now nearing completion.
The expert group has now held five meetings since it was set up earlier this year (APMMA 52908).
The latest draft retains some of the framework initially suggested.
It will cover challenges to health systems; challenges to innovative payment models for high-cost innovative medicines; principles to be followed in facing the challenges; what instruments may be useful; and the views of the panel.
Recent changes include beefing up the section explaining the challenges to health systems with additional illustrations and providing more detailed outlines of managed entry agreements alongside other options for payment models for new products.
A policy decision has been made to use the word "innovation" less frequently in the published opinion, and to replace it with "new products".
A section on governance is to be introduced, covering questions such as data and openness, and who is responsible for data collection.
There will also be new information on the prerequisites for innovative payment models to work, including instruments to increase efficiency.
A section dealing with new institutional design contains a recognition that bargaining is a way to set prices. But the accompanying text is currently being slimmed down.
One section will deal with international cooperation and real-world data.
A sub-section on adaptive pathways is being shortened.
The terms of reference require the group to comment on the current role of the national pricing and reimbursement authorities in improving access to innovative medicines.
It has to explore ways of setting prices that improve access, but it also has to balance that with consideration of costs, benefits, budget impact and return on investment.
There is a particular emphasis on transparency in assessing return on investment.
Initially it had planned to complete its work by October, but this has now slipped to November.
To achieve resilience of health systems, said the European Commission as the update was released, it is necessary "to focus on strengthening capacity and [the] evidence base for price setting mechanisms and monitoring of the costs of pharmaceuticals."
It underlined that health outcomes should be reflected in price-setting.
But it is sticking to the minimalist line of no new legislation. "The Commission is committed to use existing tools to create the necessary conditions at EU level," it said.
It said the opinion will merely "clarify methodologies and provide a tool for national competent authorities". Where it identifies gaps in current models, any proposals it makes will be limited to "areas to further develop for those authorities willing to increase their resilience."
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