Regulatory Focus™ > News Articles > EMA, HTA Bodies Pledge Closer Collaboration and Earlier Interactions

EMA, HTA Bodies Pledge Closer Collaboration and Earlier Interactions

Posted 19 November 2013 | By Alexander Gaffney, RAC

EU regulators and health technology assessment (HTA) experts have announced their plans to collaborate more closely over the next three years, saying existing efforts need to be expanded to include earlier interactions and new approaches.

Background

The plan, announced on 19 November 2013, involves the European Medicines Agency (EMA) and EUnetHTA, an EU-wide group of HTA bodies. HTA involves the assessment of medicines for their real-world impact and cost-effectiveness, and is hugely important in countries where public systems ultimately choose whether or not to reimburse for the use of a drug.

The UK's HTA body, the National Institute for Health and Care Excellence (NICE), for example, operates as a de facto second gatekeeper to market access. Even if a drug has obtained EMA's blessing to be marketed across the EU, without HTA bodies having sufficient evidence to show the costs of the treatment are outweighed by its benefits, a drug might not reach many patients.

As a result, in recent years regulators and HTA bodies have been working together to try to harmonize their requirements for evidence in the hopes that evidence used to support regulatory approval might also be used to support approval from HTA bodies as well.

The trend has also coincided with efforts to expand EU-wide HTA capacity. In June 2013, the European Commission implemented a new set of rules to establish an EU HTA network meant to "support and facilitate cooperation and the exchange of information among Member States working within a voluntary network connecting national authorities responsible for HTA."

The network, known as the "HTA Network," is voluntary for Member States to either join or leave, but is intended to avoid the duplication of assessments and the resources it takes to generate them. The assessments themselves are meant to capture the total value of a product within the context of a patient and their place in society, and come up with a reimbursement value that would be reasonable for a government.

New Plans

Since 2010, EMA and EUnetHTA have been collaborating in an attempt to better harmonize regulatory and payor data requirements. According to both, "The project has resulted in a series of improvements to the European public assessment report (EPAR) template," which is used to communicate the benefits and risks of a medicine.

While the outcomes from that initial collaboration are still being analyzed, the groups today said they plan to expand those efforts into four additional areas over the next three years:

  • involving HTA bodies earlier in the regulatory process, such as during solicitations by sponsors for scientific advice
  • involve HTA bodies in the design of clinical trials to generate safety, efficacy and relative effectiveness data
  • develop new standards for collecting postmarketing data to support the needs of regulators and HTA bodies
  • share data to ensure that orphan drug products are available and that payors remain financially stable

The plan will be updated on an annual basis, regulators said.


EMA/EUnetHTA Statement


Tags: EU

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe