EMA Releases Report on Parallel Scientific Advice with HTA Bodies

The European Medicines Agency (EMA) released a report on March 31, 2016 detailing results from the pilot on parallel scientific advice with health-technology assessment (HTA) bodies that began in 2010 and completed at the end of March 2016. According to EMA, the initiative allows developers of new medicines to receive simultaneous feedback on their development plans from both regulators and HTA bodies.

In the report, EMA writes that the initiative has demonstrated positive outcomes and will be continued on an operational basis. EMA says this kind of parallel advice between regulators, HTA bodies, and others offer a key platform to discuss the development of new medicines, and facilitates access to these medications.  

EMA notes parallel scientific advice during a drug’s early development process is “necessary to learn about data requirements at an early stage in the medicine’s development process, and to learn about divergent data requirements between regulators and [Health Technology Assessment Bodies] HTABs, and between participating HTA bodies.” The agency says the focus of the initiative was a project reviewing information on benefits and risks of a medicine how a medicine in the European Public Assessment reports could address the needs of HTABs.

In an analysis of the pilot program, EMA  says that by the end of December 2015, the overall number of completed procedures for all regulatory-HTA scientific advances is 63, an increase since the start of the program in 2010. The agency conduced a comparative analysis of 31 procedures between 2010 and May 2015. According to EMA, this analysis indicates there was a “high level of full or partial alignment between regulators and HTAB across all domains at the culmination of the procedure.” For this reason, the agency says parallel scientific advice with HTA bodies and other relevant stakeholders will now be routinely offered.

Source: EMA