Guest Post: Rapid Effectiveness Assessment Process Could Shape HTA in Eastern Europe

apm, health, hta, assessment, eastern europe, EU, health technology assessment

This article was provided by Richard Staines of APM Health Europe from its coverage of the recent Health Technology Assessment World conference in London.

A rapid European effectiveness assessment process comparing new drugs to standard of care could provide key data for local health technology assessment (HTA) in smaller European countries, experts have been told.

However, Wim Goettsch, project leader at the Netherlands’ CVZ for the EUnetHTA pan-European cost-effectiveness network, said the new rapid effectiveness assessment (REA) would be of less value to those countries with well-developed HTA systems.

They will be even less use to England’s NICE and the Scottish Medicines Consortium, which integrate efficacy and cost effectiveness in their processes, said Goettsch – even though NICE is helping to draw up template forms for the process.
There have already been two pilot projects organised by EUnetHTA that have been completed this year and a third manufacturer has shown an interest in the process, which begins almost immediately after Europe’s CHMP has issued a positive opinion.

It aims to provide an indication of effectiveness compared with existing drugs in time for the European Commission’s decision to grant a marketing authorisation, usually within 90 days of the CHMP’s positive opinion.

Take up focused on Eastern Europe

Goettsch told the Health Technology Assessment World conference in London: “Those countries that don’t have well developed HTA, such as those in eastern Europe, will be happy to use these rapid assessments.
“But I can imagine for larger countries which have well developed HTA systems it is more difficult to use it,” said Goettsch.

“For NICE it is difficult because (efficacy) assessment is incorporated into cost effectiveness calculations, while in other countries cost-effectiveness and effectiveness are clinical effectiveness are separate.”

Goettsch told the conference, organised by Health Network Communications that the pilot schemes involved Sanofi Pasteur MSD’s herpes zoster vaccine Zostavax (varicella-zoster virus) and Janssen’s diabetes drug Invokana (canagliflozin).

He said the model involved an initial assessment by two agencies, followed by a two-tier feedback system from participating member states.

EMA internal discussions

In a panel debate, Spiros Vamvakas, orphan drugs director at the European Medicines Agency, said the organisation was having internal discussions about how it will organise its input into post-authorisation studies.

Vamvakas said the workload for the EMA’s input will likely be shared between existing committees, such as the CHMP and the Pharmacovigilance Risk Assessment Committee.