The procedure to assess the added value of new medicines needs to move towards a pan-European process, according to Richard Bergstrom, director general of the European Federation of Pharmaceutical Industry Associations (EFPIA).
Bergstrom, who spoke to PMLiVE at the eyeforpharma conference in Barcelona this week, explained that national frameworks for health technology assessment (HTA), such as the UK’s National Institute for Health and Care Excellence (NICE) and Germany’s IQWIG, were not aligned, causing duplication of work and inconsistency in the evaluation of new treatments across the EU.
Typically in the EU, these assessments are done on a national scale once a drug has proved its effectiveness and safety to the European Medicines Agency (EMA).
Once the HTA body recommends a new drug, it can then be used on the national healthcare system at a price agreed between the manufacturer and government, although many companies have criticised negative decisions for denying patients access to innovative medicines.
Any progress towards a more collaborative HTA process in the EU will depend on separating national pricing reimbursement decisions from the scientific assessment of the added value a new treatment offers, said Bergstrom.
“This assessment would take the same data that the EMA has and add more data collected from a real world setting,” said Bergstrom. “And then you can say that a drug is safe and effective, as well as where the efficacy is.
“HTA will be less about comparing products and more about discussing the patients and how do we get to them and monitor them and loop back real outcomes data. The way that’s going to happen is European collaboration.”
Any decision on price will, however, remain a national decision.
Bergstrom compared the need to improve HTA collaboration to the formation of the EMA in 1993, which brought drug regulation in the EU under one body.
“There were people who said it would never work,” he said. “’How can companies agree on the same parameters?’ But look at it now. It’s a beautiful agency.”
A similar process is already underway for HTA, with the creation of the EUnetHTA to link national bodies across the region.
EFPIA already has a working relationships with the body through its pilots on joint working between HTA bodies, while the EU directive on cross border healthcare launched in October last year also helped to progress collaboration efforts.
The EMA will also play a part, said Bergstrom, who said the “real game-changer” will be parallel advice for pharma companies.
This means that when a company with a new medicines goes to the EMA for scientific advice on the clinical trials it needs to prove a drug’s safety and effectiveness, it should also be able to have discussions at the stage on the type of data it needs in order to demonstrate the treatment’s value on an HTA level, including post-approval efficacy studies.
“There is a need for coordination,” said Bergstrom. “So rather than having this discussion with the EMA, then with NICE, then in Germany, the EMA says why don’t we all get around the table.”